Supplementary Protection Certificates for Medicinal and Plant Protection Products

Introduction

Note: This section relates to Supplementary Protection Certificates for Medicinal and Plant Protection Products and is divided into three parts, with the paragraphs numbered using the prefixes below:

SP	the general introduction below
SPM	a discussion of the details of the Medicinal Regulation by Article, including those aspects common to both the Medicinal and Plant Protection Regulations
SPP	a discussion of the details specific to the Plant Protection Regulation by Article

In the margins:

ArtM	refers to the relevant Article of Regulation (EC) No 469/2009 of the European Parliament and of the Council (for Medicinal Products) (“the Medicinal Regulation” or “the EC Medicinal Regulation”)
ArtP	refers to the relevant Article of Regulation (EC) No 1610/96 of the European Parliament and of the Council (for Plant Protection Products) (“the Plant Protection Regulation” or “the EC Plant Protection Regulation”)
ArtPd	refers to the relevant Article of Regulation (EC) No 1901/2006 of the European Parliament and of the Council (on medicinal products for paediatric use) (“the Paediatric Regulation” or “the EC Paediatric Regulation”)
PA 1977	refers to the Patents Act 1977, “s” refers to the relevant section of the Act, “para” and “sch” refer to the relevant paragraphs of the relevant Schedules to the Act.
reg	refers to the relevant regulation of the Patents (Compulsory Licensing and Supplementary Protection Certificates) Regulations 2007 (SI 2007/3293) (the “2007 Regulations”)
r	refers to the relevant rule of the Patents Rules 2007 (SI 2007/3291) (the “2007 Rules”) and “part” refers to the relevant part of those Rules
Fr	refers to the relevant rule of the Patents (Fees) Rules 2007 (SI 2007/3292)(the “2007 Fees Rules”)
FSch	refers to the relevant Schedule of those Rules

SP 0.01

ArtM 22 is also relevant.

Council Regulation (EEC) No 1768/92 creating a Supplementary Protection Certificate for medicinal products was published in the Official Journal of the European Communities on 2 July 1992, with consequential entry into force on 2 January 1993. This Regulation has subsequently been codified under Regulation (EC) No 469/2009 of the European Parliament and of the Council, which was published in the Official Journal of the European Union L152 on 16 June 2009 and entered into force on 6 July 2009.

Various amendments that had been made to Regulation (EEC) No 1768/92 were consolidated but no substantive changes were made. Regulation (EC) No 469/2009 repealed Regulation (EEC) No 1768/92 and provides for references to it to be construed as references to Regulation (EC) No 469/2009. Regulation (EC) No 1610/96 of the European Parliament and of the Council creating a Supplementary Protection Certificate for plant protection products was published in the Official Journal of the European Communities on 8 August 1996 and entered into force on 8 February 1997.

As set out in the recitals to both Regulations, the certificate is intended to compensate a patentee for the loss of effective protection arising out of the time taken to obtain regulatory approval to place on the market as either a medicinal or plant protection product a product which is protected by a patent (“the basic patent”).

SP 0.02

The basic patent may protect the product as such, a process to obtain the product or an application of the product see SPM1.05.

SP 0.03

A certificate takes effect at the end of the lawful term of the basic patent but does not extend the term of the patent itself. It extends the protection conferred by the patent in respect of the product covered by the authorisation to place the corresponding medicinal or plant protection product on the market, and any use of the product as a medicinal or plant protection product that has been authorized before expiry of the
certificate.

SP 0.04

In the UK, the marketing authorisation for medicinal products takes the form of a Product Licence or Marketing Authorisation granted by the appropriate authority see SPM2.01. Details of granted Licences, including the product, are no longer published in the London, Edinburgh and Belfast Gazettes but are now advertised on the Medicines and Healthcare products Regulatory Agency (MHRA) website see SPM1.02. Marketing authorisation for plant protection products may be an Approval or Authorisation granted by the relevant authority (see SPP2.01) and details are published in the Pesticides Register (monthly).

SP 0.05

reg 1 is also relevant.

A certificate only has effect in the EU State in which it is granted. Certificates granted by the Office have effect in Great Britain and Northern Ireland pursuant to the 2007 Regulations, as well as in the Isle of Man, where the provisions of the 2007 Regulations were given effect by the Patents (Isle of Man) Order 2013 (SI 2013/2602) (the previous application of the 1992 and 1996 Regulations to the territory being revoked by the Isle of Man Patents (Supplementary Protection Certificates) Regulations 2014 (Statutory Document 2014/0091)).. See also paragraph 128B.03.

SP 0.06

reg 2 is also relevant.

The 2007 Regulations amended the Patents Act 1977 to introduce s.128B and Schedule 4A. These make clear how the Act applies in relation to supplementary protection certificates for medicinal products as they relate to certificates and applications for certificates that exist under “the old Regulation” Council Regulation (EEC) No 1768/92; the new Regulation (EC) 469/2009 and to plant protection products as they relate to certificates and applications for certificates that exist under Regulation (EC) No 1610/96. The operation of these provisions is discussed in paragraphs 128B0.1 to 128B.12. The 2007 Rules and 2007 Fees Rules provide specific procedures for certificates and applications for certificates which differ from patents and applications for patents, including the payment and amount of fees.

SP 0.07

ArtM 19 ArtP 18 is also relevant
.
Where neither the Medicinal or Plant Protection Regulations nor the 2007 Rules lays down a special procedure for certificates, the provisions of the Patents Act 1977 and respective Rules apply to certificates and applications for certificates as they do to patents and applications for patents.

SP 0.08

Regulation (EEC) No 1768/92 entered into force with effect from 1 July 1994 in those EFTA States which were at that date party to the European Economic Area Areement (Austria, Finland, Iceland, Norway and Sweden). This necessitated amendment of the Regulation for the purposes of the application of the Regulation to those States, but the amendments do not have retrospective effect on applications for certificates lodged in an existing EU Member State before 1 July 1994. This position was not affected by the accession to the EU of Austria, Finland and Sweden with effect from 1 January 1995. Liechtenstein became a party to the European Economic Area Agreement with effect from 1 May 1995, but did not adopt the Regulation (EEC) No 1768/92 and has not adopted the EC Medicinal Regulation (see SP0.10).

SP 0.08.1

The accession to the EU of the ten States (the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic) on 1 May 2004 also necessitated the amendment of Regulation (EEC) No 1768/92 and the Plant Protection Regulation for the purposes of their application to those States (see SPM13.04.2). The accession of Bulgaria and Romania on 1 January 2007 further amended Regulation (EEC) No 1768/92 and the Plant Protection Regulation for the purposes of applying it to these States. The accession of Croatia on 1 July 2013 has amended Regulation (EC) No 469/2009 for the purpose of applying it to this State.

SP 0.09

Paragraph 8 of Protocol 1 on Horizontal Adaptations to the European Economic Area Agreement reads:

Whenever the acts referred to contain references to the territory of the “Community” or of the “common market” the references shall for the purposes of the Agreement be understood to be references to the territories of the Contracting Parties as defined in Article 126 of the Agreement.

This has the effect that for medicinal product applications lodged under Regulation (EEC) No 1768/92 on or after 1 July 1994, or under the EC Medicinal Regulation, references to the Community in Articles 8(1)(a)(iv), 8(1)(c), 9(2)(e), 11(1)(e) and 13(1) of the Regulation are understood to be references to the Contracting Parties to the Agreement see SP0.08, SPM8.02, SPM9.02, SPM11.01 and SPM13.04. Accordingly, for such applications lodged on or after 1 July 1994 but before 1 May 1995 a first authorisation to place the product on the market in the Community included a first authorisation in Austria, Finland, Iceland, Norway or Sweden. For applications lodged on or after 1 May 1995, it also included a first authorisation in Liechtenstein, even though Liechtenstein has not adopted Regulation (EEC) 1768/92 or the EC Medicinal Regulation. In practice this will be an authorisation in Switzerland, since Swiss authorisations are effective in Liechtenstein and Liechtenstein has not always granted marketing authorisations. However, from 1 June 2005 the bilateral agreement between Switzerland and Liechtenstein was amended so that Liechtenstein now maintains a list of medicinal products whose Swiss authorisations are not automatically recognised. Normally this recognition will be 12 months after the Swiss authorisation.

SP 0.10

Similarly, following Decision No 59/97 of the EEA Joint Committee of 31 July 1997 to adopt the Plant Protection Regulation from 1 August 1997, it entered into force in Liechtenstein on 1 August 1997 and in Iceland and Norway on 2 January 1998, these being the EFTA States which were then party to the European Economic Area Agreement. It follows from paragraph 8 of Protocol 1 on Horizontal Adaptations to the Agreement that, for applications for certificates for plant protection products lodged with the Office under Regulation 1610/96 on or after 1 August 1997, the first authorisation within the territories of the existing EU Member States and Iceland, Norway and Liechtenstein constitutes the first authorisation in the Community for the purposes of Articles 8(1)(a)(iv), 8(1)(c), 9(2)(e), 11(1)(e) and 13(1) of Regulation 1610/96 see SP0.08 and SP0.09. As with the Medicinal Regulation, in practice a first authorisation in Liechtenstein will be a first authorisation in Switzerland see SP0.09.

SP 0.11

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use was published in the Official Journal on 27 December 2006 and entered into force on 26 January 2007. This amended the Regulation (EEC) 1768/92 to provide for a six month extension of a SPC when a requirement was introduced that at the time of marketing authorisation application, data on the use of the medicine in children was included. The amendments relating to medicinal products for paediatric use are incorporated in the EC Medicinal Regulation. Note that Article 7 of Regulation (EC) No 1901/2006 applies from 26 July 2008 and Article 8 applies from 26 January 2009.

SP 0.12

Regulation (EU) 2019/933 of the European Parliament and of the Council of 20th May 2019, amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products, came into force on 1 July 2019. This Regulation amended Regulation (EC) No 469/2009 (in particular amending Articles 1, 5, 11 and 12, and introducing new Article 21a and Annexes -I and -Ia) to create a “manufacturing waiver” for SPCs for medicinal products (see SPM5.05-13).

SP0.13

As with all EU law, Regulation (EC) No 1610/96 and Regulation (EC) No 469/2009 both continue to apply in the UK during the transition period provided by the Agreement on the Withdrawal of the United Kingdom from the European Union. This includes the amendments made by Regulation (EU) 2019/933 (see SP 0.12), and other related provisions, such as the Regulation on paediatric medicines.

SP0.13.1

This means that all references in the Regulations, and therefore this Manual, to “Member States”, the EU and/or the EEA should continue to be interpreted as including the UK during the transition period.

SP0.13.2

Similarly, existing case law of the Court of Justice of the European Union which interprets the Regulations also continues to apply, on the same basis, as will any decisions issued during the period.

Regulation (EC) No 469/2009 of the European Parliament and of the Council (Medicinal Products)

Recital to the Regulation

The European Parliament and the Council of the European Union

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (OJ C 77, 31.3.2009, p 42), Acting in accordance with the procedure laid down in Article 251 of the Treaty (Opinion of the European Parliament of 21 October 2008 (not yet published in the Official Journal) and Council Decision of 6 April 2009), Whereas (1) Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ L 182, 2.7.1992, p. 1) has been substantially amended several times. In the interests of clarity and rationality the said Regulation should be codified. (2) Pharmaceutical research plays a decisive role in the continuing improvement in public health. (3) Medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research. (4) At the moment, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research. (5) This situation leads to a lack of protection which penalizes pharmaceutical research. (6) There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection. (7) A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the establishment and the functioning of the internal market. (8) Therefore, the provision of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary. A Regulation is therefore the most appropriate legal instrument. (9) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of fifteen years of exclusivity from the time the medicinal product in question first obtains authorization to be placed on the market in the Community. (10) All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorization to be placed on the market as a medicinal product. (11) Provision should be made for appropriate limitation of the duration of the certificate in the special case where a patent term has already been extended under a specific national law,

Have adopted this regulation

SPM 0.01

As is stated in Halsbury’s Laws of England (4th Edition, vol 51, pages 346-348), reference may be made to the recitals in the preamble of a measure in order to confirm the interpretations to be given to a provision of EU law. This may be necessary in order to arrive at the clear, as opposed to the literal meaning of a provision: literal analysis of a text is not always appropriate when regard is had to the nature and scheme of a measure, or the circumstances in which a provision was adopted. In Research Corp’s SPC ([1994] RPC 667, the Patents Court, upholding a decision of the hearing officer ([1994] RPC 387), found that Article 5 of the Regulation was clear in the context of Community law as a whole: neither the recitals nor an explanatory memorandum issued by the Commission in 1990 contained anything to suggest that the phrase “same limitations” should exclude endorsement licences of right of a “new existing patent” under the Patents Act 1977. see also SPM5.01. The court found the matter acte claire and declined to refer the construction of Article 5 to the European Court of Justice. Similarly, in Draco AB’s SPC Application [1996] RPC 417 the Patents Court declined to refer the decision of the hearing officer see SPM1.04 to the European Court. However, in Re Yamanouchi Pharmaceuticals Co. Ltd (unreported judgment of 31 October 1994) the Patents Court decided to refer the construction of the transitional provisions of Article 19 of Regulation (EEC) No 1768/92 to the European Court see SPM19.02and Yamanouchi Pharmaceuticals Co. Ltd v Comptroller-General [1997] RPC 844). The Patents Court has also referred Novartis AG and University College London & Novartis AG and Institute of Microbiology and Epidemiology SPC Applications BL O/044/03 and [2005] RPC 33 see SPM8.02 and SPM13.04 and Yissum Research and Development Company of the Hebrew University of Jerusalem BLO/222/04 see SPM1.02, SPM1.04 and, SPM3.05 to the European Court.

SPM 0.02

In Draco AB’s SPC Application the Patents Court, also refusing leave to appeal, held that if the court considered the matter to be acte claire, then leave to appeal to the Court of Appeal should logically be refused. The court also observed obiter that where a point turned on material leading to the enactment of a European
instrument (the travaux preparatoires), it was unlikely to be acte claire.

SPM 0.03

The Patents Court in Draco AB’s SPC Application, considering the recitals to Regulation (EEC) No 1768/92, held that the scheme of the Regulation was not for the general protection of the fruits of research. It was to compensate for lost time in the exploitation of inventions which were patented.

SPM 0.04

Recital 10 of the EC Medicinal Regulation (i.e. “Whereas all the interests at stake…”) is, following the entry into force of the Plant Protection Regulation on 8 February 1997, to be interpreted as directed in recital (17) of the latter regulation which states:

(17) Whereas the detailed rules in recitals 12, 13 and 14 and in Articles 3(2), 4, 8(1)(c) and 17(2) of this Regulation are also valid, mutatis mutandis, for the interpretation in particular of recital 9 and Articles 3, 4, 8(1)(c) and 17 of Council Regulation (EEC) No 1768/92.

In accordance with Article 22 of the EC Medicinal Regulation, reference to recital 9 of Regulation (EEC) No 1768/92 is to be read as reference to recital 10 of the EC Medicinal Regulation. Recitals 12, 13 and 14 of the Plant Protection Regulation are as follows:

(12) Whereas all the interests at stake in a sector as complex and sensitive as plant protection must nevertheless be taken into account; whereas, for this purpose, the certificate cannot be granted for a period exceeding five years; (13) Whereas the certificate confers the same rights as those conferred on the basic patent; whereas, consequently, where the basic patent covers an active substance and its various derivatives (salts and esters), the certificate confers the same protection; (14) Whereas the issue of a certificate for a product consisting of an active substance does not prejudice the issue of other certificates for derivatives (salts and esters) of the substance, provided that the derivatives are the subject of patents specifically covering them;

This amplification of recital 10 is consistent with the approach that had already been adopted by the UK Office with regard to the inclusion of salts and esters in the definition of the product see SPM1.03, SPM2.03, SPM2.04 and SPP1.03-04.

Article 1: Definitions

For the purposes of this Regulation, the following definitions shall apply: (a) ‘medicinal product’ means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medicinal diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals; (b) ‘product’ means the active ingredient or combination of active ingredients of a medicinal product; (c) ‘basic patent’ means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate; (d) ‘certificate’ means the supplementary protection certificate. (e) ‘application for an extension of the duration’ means an application for an extension of the duration of the certificate pursuant to Article 13(3) of this Regulation and of Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use. (f)‘maker’ means the person, established in the Union, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export to third countries or for the purpose of storing, is carried out.

Product and Medicinal Product

SPM 1.01

Article 1 distinguishes between the terms “medicinal product” and “product”. Although the Medicinal Regulation creates a certificate for medicinal products, it is the product – defined by Article 1(b) as the active ingredient or
combination of active ingredients – which is the subject of the certificate pursuant to Article 2.

SPM 1.02

These definitions do not always correspond to the terminology used in UK Product Licences and Marketing Authorisations, or the details published in the official Gazettes see SP0.04. Thus, the product specified in a Product Licence or Marketing Authorisation is generally broadly equivalent to the “medicinal product” as defined by Article 1(a), and the “active constituent(s)” or “active ingredient(s)” are generally broadly equivalent to the “product” as defined by Article 1(b). However, as the hearing officer determined in Yissum Research & Development Company of the Hebrew University of Jerusalem BL O/222/04 such definitions need not restrict the definition of active ingredient in accordance with Article 1(b) see SPM1.04.1

SPM 1.03

In view of the imposition of the terms of recital (14) of the Plant Protection Regulation through recital (17) therein in the interpretation of recital 10 of the EC Medicinal Regulation, the term “active ingredient” in Article 1(b) is generally interpreted as including any closely related derivative, in particular a salt or ester, which has obtained an authorisation to be placed on the market and is protected by the basic patent, unless the derivative in question can be regarded as a new active ingredient. See also SPM0.04 and SPM2.03-04.

SPM 1.04

In the case of Draco AB’s SPC Application [1996] RPC 417, the applicants applied for a certificate based on a product licence for an unpressurised asthma inhaler containing the corticosteroid budesonide in the form of agglomerated micronised particles. However, two earlier product licences had been granted for inhalers containing budesonide in the form of micronised particles together with a propellant and surfactant as “other constituents”. The hearing officer found that the “product” as defined in Article 1(b) was “budesonide” in the case of all three inhalers and thus rejected the applicant’s submission that it was “additive free budesonide in the form of agglomerated micronised particles” in the case of the later inhaler and a combination of “budesonide, a propellant and a surfactant” in the two earlier inhalers. The applicant’s alternative submission that the agglomerated form of budesonide was a different “product” from the non-agglomerated form used in the earlier inhalers was similarly rejected. The Patents Court upheld the decision, holding that the scope of protection was strictly confined to the active ingredient in view of the definitions in Articles 1(a) and 1(b) See also SPM4.02. The applicants obtained leave to appeal to the Court of Appeal but withdrew their appeal before being heard.

SPM 1.04.1

In Yissum Research & Development Company of the Hebrew University of Jerusalem BL O/222/04 the hearing officer considered that the definition of active ingredients found in a marketing authorisation should not necessarily be used to restrict the definition of product in accordance with Article 1(b). The product “calcitriol” had been the subject of previous marketing authorisations and for the purposes of Article 3(d) it was not possible to distinguish these marketing authorisations on the basis of a different medical application. However, the hearing officer found that the active ingredients which define the product are those protected by the basic patent when strictly confined to the corresponding ingredients of the authorized medicinal product. Thus it was possible for a certificate to be granted for calcitriol in combination with the specific ointment base found in the approved medicinal product. On appeal the Patents Court [2004] EWHC 2880 referred this issue to the European Court of Justice (ECJ case C-202/05) which found that Article 1(b) is interpreted as meaning that where a basic patent protects a second medical use of an active ingredient, that use does not form an integral part of the definition of the product SPM0.01, SPM1.02 and SPM3.05. Questions of a similar nature regarding the interpretation of the term “combination of active ingredients of a medicinal product” were submitted by the German Federal Court to the ECJ in Massachusetts Institute of Technology (ECJ case C-431/04). The Court ruled that the interpretation of Article 1(b) does not include within the concept of this term a combination of two substances wherein only one substance has a therapeutic effect and the other substance enables a pharmaceutical form of the medicinal product which is necessary for the therapeutic efficacy of the first substance. Following Massachusetts Institute of Technology C-431/04 in the decision Abraxis BioScience LLC BL O/410/16 it was concluded that the product “paclitaxel formulated as albumin bound nanoparticles” comprised albumin acting as a carrier and that the product did not qualify as an active ingredient in its own right or as a combination of active ingredients. This view was upheld on appeal in Abraxis Bioscience LLC v Comptroller General of Patents [2017] EWHC 14 (Pat), where Arnold J referred questions to the CJEU (C-443/17) in this regard but nonetheless opined that the ECJ has held that Article 1(b) should be strictly interpreted and that it would be inconsistent with such an interpretation for Article 3(d) to permit SPCs to be obtained for new formulations.

The meaning of the term “product” has also been considered in GlaxoSmithKline Biologicals S.A. BL O/506/12, wherein the Hearing Officer rejected applications comprising an adjuvant. On appeal to the patents court GlaxoSmithKline Biologicals S.A. v Comptroller General of Patents [2013] EWHC 619 Pat questions were referred to the CJEU, at the CJEU in case C-210/13 it was determined that an adjuvant does not fall within the definition of “product”, when considered either alone or in combination with an active ingredient. In Forsgren v Österreichisches Patentamt C-631/13 it was determined that a product, which is identified as a “carrier protein” in a MA, and is covalently bonded to other active ingredients, can itself be the subject of a SPC if it produces a “pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation”.

SPM1.04.2

In order to determine which components of a medicinal product are active ingredients and which are not this Office may refer to the summary of product characteristics and (if available) European public assessment reports as well as other evidence complied by the applicant. This practice was approved of in Abraxis Bioscience LLC v Comptroller General of Patents [2017] EWHC 14 (Pat).

Basic Patent

SPM 1.05

The basic patent may be either a UK patent or a European patent (UK), and may protect the product as such, a process to obtain the product or an application of the product. However, a process for obtaining a known product may not give rise to a new product. The term “basic” does not mean that the patent must be the first patent to protect the product: it is open to a patent holder to designate any patent fulfilling the criteria of Article 1(c) as the basic patent.

Maker

SPM 1.06

Article 1(f) was introduced by Regulation (EU) 2019/933 and defines the “maker” for the purposes of the provisions in Article 5 that relate to the “manufacturing waiver” (see SPM5.05-09). The “maker” is defined in Art. 1(f) as the person, established in the EU, on whose behalf this making takes place; Recital 14 of Regulation (EU) 2019/933 makes it clear it is possible for the maker to directly carry out the making. Article 5 places certain responsibilities on the maker in order for them to take advantage of the waiver as discussed in SPM5.06-12.

Article 2: Scope

Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67) or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1) may, under the terms and conditions provided for in this Regulation, be the subject of a certificate.

SPM 2.01

ArtM 1(b) is also relevant.

A certificate can thus be granted in the UK for a product which has received an authorisation to be placed on the market in the UK in accordance with Directive 2001/83/EC (for pharmaceutical products) or Directive 2001/82/EC (for veterinary products). The authorisation may be granted for the UK only, whereupon it takes the form of a Product Licence issued under the Medicines Acts, or a Marketing Authorisation issued under the Medicines for Human Use (Marketing Authorisation etc) Regulations 1994 (SI 1994/3144) or the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (SI 1994/3142). UK (only) Product Licences and Marketing Authorisations are granted either by the Medicines and Healthcare Products Regulatory Agency of the Department of Health for a pharmaceutical product, or by the Veterinary Medicines Directorate of the Department for Environment, Food and Rural Affairs for a veterinary product. Alternatively there is a centralised system for granting marketing authorisations for medicinal products for human and veterinary use, established under Council Regulation (EEC) No 2309/93, now repealed and replaced with Regulation (EC) No 726/2004, which provides authorisations which are simultaneously granted in all Member States of the European Union. This type of authorisation is granted by a decision of the European Commission following a favorable opinion from the European Medicines Agency (EMA) and is accepted by the Office as equivalent to a national authorisation. In Generics (UK) Ltd v Synaptech Inc (C-427/09) and Synthon BV v Merz Pharma Gmbh & Co KG (C-195/09) the Court of Justice of the European Union held that Article 2 should be interpreted as meaning that a product which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65/EEC (now Directive 2001/83/EC) and, in particular, without undergoing safety and efficacy testing, is not within the scope of the Regulation, and may not be the subject of a supplementary protection certificate. It went on to confirm that any SPC granted for a product which was outside the scope of the Regulation was invalid see also SPM13.04.1 In Leibniz-Institut BL O/328/14 Cerus Corporation BL O/141/14 and Angiotech Pharmaceuticals Inc. And University of British Columbia BL O/466/15 the hearing officer found the application out of scope in that the device was subject of an EC Design Examination Certificate under Directive 93/42/EEC as opposed to Marketing Authorisations under Directive 2001/83/EC. In the judgment 14W (pat) 13/16 considering the latter “Angiotech Pharmaceuticals Inc” application the German Federal Patent Court has referred a question to the CJEU (C-527/17) to determine if an authorization according to 93/42/EEC for a drug-device-combination is equivalent to a marketing authorization according to 2001/83/EEC. In Boston Scientific Ltd v Deutsches Patent-und Markenamt (C-527/17) the Court of Justice of the European Union has confirmed that an authorization procedure under Directive 93/42 for a device incorporating, as an integral part, a substance which if used separately may be considered a medicinal product, cannot be treated as a marketing authorization granted under Directive 2001/83, see also SPM3.03.2.

SPM 2.02

A certificate is granted for a product which constitutes the active ingredient or combination of active ingredients of a medicinal product see SPM1.01.

SPM 2.03

A certificate can only cover a single product, i.e. a single active ingredient or combination of active ingredients. Different products will need to be the subject of different certificates, even if they are protected by the same basic patent. Whether a new certificate is required for a derivative (eg a salt or ester) of a product which has already been granted a certificate depends on whether or not the derivative can be regarded as a new active ingredient see SPM0.04 and SPM1.03. A new certificate may only be granted for a combination of (a) an active ingredient for which a certificate has already been granted with (b) one or more other active ingredients, if the combinations are themselves the subjects of separate patents are specifically identifiable from the patent as viewed by the person skilled in the art at the priority or filing date using the test set out in Teva (C-121/17). A further certificate will not be granted for the same active ingredient notwithstanding any changes to the physical form of that ingredient or to other features of the medicinal product (eg use of a different excipient or different pharmaceutical presentation). See also SPM1.04 and SPM3.02.6.1.

SPM 2.04

ArtM 3(a) and (ArtP 3(1)(a)) are also relevant.

A certificate may be granted for a compound optionally in derivative form to the extent that derivatives are protected by the basic patent see SPM0.04. Examples of wording which have been accepted are:

X optionally in the form of the hydrochloride;

X optionally in the form of a pharmaceutically acceptable salt such as the hydrochloride;

X optionally in the form of a pharmaceutically acceptable salt.

see also SPM3.02 and SPM3.02.1.

Article 3: Conditions for obtaining a certificate

A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application: (a) the product is protected by a basic patent in force; (b) a valid authorization to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate; (c) the product has not already been the subject of a certificate; (d) the authorization referred to in point (b) is the first authorization to place the product on the market as a medicinal product.

SPM 3.01

The conditions of Article 3 must be satisfied at the date of making an application. Thus, at that date: the basic patent protecting the product must be in force in the UK; the product must not previously have been the subject of a certificate in the UK; a valid authorization to place the product on the market in the United Kingdom as a medicinal product must have been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC see SPM2.01; this authorisation must be the first authorisation to place the product on the market as a medicinal product in the United Kingdom (although there may have been an earlier authorisation elsewhere in the EU).

SPM 3.02

The question of whether the product is protected by the basic patent is determined in accordance with the usual canons of construction of patent claims, as was confirmed by the European Court of Justice in Farmitalia Carlo Erba S.r.l.’s SPC Application (2) ([2000] RPC 580 – ECJ Case C-392/97). In Takeda Chemical Industry’s
Application (unreported oral decision on application No SPC/GB93/017), the hearing officer held that a product comprising the acetate salt of a peptide was protected by a basic patent, even though the claims did not on a literal construction include derivatives of the polypeptide, on the grounds that the description made it clear that the polypeptide could be obtained in the form of the acetate. In Centocor Inc’s SPC Application [1996] RPC 118, the hearing officer held that a product consisting of a monoclonal antibody was not protected by claims to a combined preparation of a monoclonal antibody and an anti-microbial agent. In Takeda Chemical Industries Ltd’s Applications [2004] RPC 1 (upheld on appeal to the Patents Court [2004] RPC 3) the hearing officer held that products comprising a combination of ingredients were not protected by patents which related to only one of the ingredients. The basic patents contained no reference to the combinations specified in the SPC applications. The Court of Appeal in Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd [2009] EWCA Civ 646, [2009] RPC 23 upheld the earlier decision of the Patents Court ([2008] EWHC 2413 (Pat), [2009] RPC 4) confirming this interpretation. The Court found the SPC for levofloxacin, the (-) enantiomer of the racemic mixture, ofloxacin, to have been properly granted despite the existence of earlier marketing authorisations to this racemic mixture. In Gilead Sciences, Inc. BL O/006/08 the hearing officer held that a basic patent which protected a specific active compound and which claimed a combination of the active substance optionally in combination with other (unspecified) therapeutic ingredients did not protect the combination of the active compound with another specific active compound which was the subject of the SPC application. The claim and a corresponding reference in the description were the only indication of a combination of active ingredients in the basic patent. On appeal the Patents Court held (in Re Council Regulation (EEC) No 1768/92 [2008] EWHC 1902 (Pat)) that although the specific combination was not disclosed in the specification of the basic patent such a claim did protect the combination within the meaning of Articles 1(c) and 3(a) and therefore that the applicant was entitled to a certificate to the combination of specific active ingredients. In Astellas Pharma Inc. BL O/052/09 the hearing officer similarly found that a patent which disclosed one active ingredient but did not disclose, either specifically or generically, a combination of active ingredients was not a basic patent which protected a combination of active ingredients for the purposes of Article 3(a). On appeal to the Patents Court (Astellas Pharma Inc v Comptroller-General of Patents [2009] EWHC 1916 (Pat)), Arnold J upheld the decision of the hearing officer after applying the test articulated in Gilead. Arnold J distinguished the facts of Astellas from Gilead because, unlike in Gilead, the basic patent did not specifically disclose and claim a combination of active ingredients.

SPM 3.02.1

In Sankyo Company Limited BL O/271/10 the hearing officer similarly rejected an SPC application for a combination of active ingredients on the basis that it did not meet the requirements of Article 3(a) of the Regulation. On appeal to the Patents Court (Daiichi Sankyo Company Limited v Comptroller General of Patents, [2010] EWHC 2897 (Pat)), Floyd J referred questions to the Court of Justice of the European Union (CJEU) for a preliminary ruling concerning the correct test to apply when deciding whether a product is protected by a basic patent under Article 3(a) of the SPC regulation (C-6/11, Daiichi Sankyo Company v Comptroller-General of Patents). The CJEU provided its decision by reasoned order with reference to C-322/10 (Medeva) (see SPM3.02.4 below), confirming that Article 3(a) precludes the grant of an SPC relating to active ingredients which are not identified in the wording of the claims of the basic patent relied upon in the SPC application (also see referrals to the CJEU in Georgetown et al., University of Queensland, CSL Ltd SPM3.02.4, and Yeda Research and Development Company Ltd SPM3.02.2. Following Takeda where a combination is not claim ed but is disclosed in the description, it may be possible to amend the granted patent under s.27 of the Patents Act 1977 to provide the protection required under Article 3(a) questions concerning this practice were referred to the CJEU in Actavis Group and Actavis UK v Boehringer Ingelheim Pharma [2013] EWHC 2927 (Pat) however in C-577/13 Actavis Group PTC EHF, Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG these questions were not answered see also SPM3.02.5, 10.14.1).

SPM 3.02.2

In Imclone Systems Inc. Ltd & Aventis Holdings Inc. BL O/066/10, the hearing officer found that a marketing authorisation for a single active ingredient which additionally specified the clinical use of that active in conjunction with another active ingredient was not, for the purposes of Article 3(b) of the Regulation, a valid authorisation to place a combination product on the market as a medicinal product. The MA referred to how the active ingredient, an antibody known as cetuximab (medicinal product name Erbitux®), which had cytostatic properties, could be used clinically in conjunction with another active ingredient, an anti-cancer drug irinotecan, with cytotoxic properties, to treat certain types of cancer and that the presence of the cetuximab reduced the amount of irinotecan required to achieve a clinical effect. However, the hearing officer found that the MA has to be considered in its entirety and not just in respect of the clinical particulars when deciding what is the authorised medicinal product, and hence what is the product that can be protected by an SPC. Furthermore, in following the approaches taken in Takeda, Gilead, Astellas and Centocor Inc, the hearing officer found that a patent protecting a combination of active ingredients did not protect a single active ingredient for the purposes of Article 3(a). On appeal to the Patents Court (Yeda Research and Development Company Ltd v Comptroller General of Patents [2010] EWHC 1733 (Pat), [2010] RPC 29), Lewison J upheld the decision of the hearing officer to refuse the applications and dismissed the appeal, confirming the approaches taken in previous decisions. On appeal to the Court of Appeal (Yeda Research and Development Company Ltd v Comptroller General of Patents) the Court referred a question for a preliminary ruling to the Court of Justice of the European Union (CJEU) concerning whether or not secondary infringement should be part of any proposed infringement test for determining what is protected by the basic patent under Article 3(a) (C-518/10, Yeda Research and Development Company Ltd, Aventis Holdings Inc v Comptroller-General of Patents). The CJEU provided its decision by reasoned order with reference to C-322/10 Medeva see SPM3.02.4 below, confirming that Article 3(a) precludes the grant of an SPC where the active ingredient specified in the application, even though identified in the wording of the claims of the basic patent as an active ingredient forming part of a combination in conjunction with another active ingredient, is not the subject of any claim relating to that active ingredient alone (see also the referrals to the CJEU in relation to Daiichi Sankyo Company Limited SPM3.02.1, Georgetown et al., and University of Queensland/CSL Ltd SPM3.02.4.

SPM 3.02.3

In Farmitalia Carlo Erba S.r.l’s SPC Application (2) the Court also ruled that where an active ingredient in the form of an individual salt is referred to in the notice of authorisation, under Article 3(b) the certificate is capable of covering the active ingredient both as referred to and in its derived forms such as salts and esters as medicinal products, provided that the derived forms also enjoy the protection of the basic patent.

SPM 3.02.4

The requirements of Articles 3(a) and 3(b) of the Regulation have also been considered in a number of cases relating to medicinal products in the vaccine field. In Medeva BV’s SPC Applications BL O/357/09 the hearing officer, in following the Astellas and Gilead decisions, found that a basic patent protecting only two particular active ingredients did not protect, for the purposes of Article 3(a), a product containing these two active ingredients in combination with other active ingredients. He also found that a marketing authorisation for a medicinal product comprising a combination of active ingredients which included, among others, the two active ingredients was not, for the purposes of Article 3(b), a valid authorisation to place a product consisting of these two active ingredients on the market as a medicinal product. On appeal to the Patents Court (Medeva BV v The Comptroller General of Patents, [2010] EWHC 68 (Pat), [2010] RPC 20), Kitchin J upheld the decision of the hearing officer and dismissed the appeal, noting that “…It is plain that “product” must have the same meaning in Article 1(b) and Article 3(a). If the product of Article 1(b) is the whole combination of active ingredients then so it remains for the purposes of Article 3(a)…”. On appeal to the Court of Appeal (Medeva’s SPC Applications, [2010] EWCA Civ 700, [2010] RPC 27), the Court referred questions concerning the interpretation of Articles 3(a) and 3(b) to the Court of Justice of the European Union (CJEU) for a preliminary ruling (C-322/10, Medeva v Comptroller-General of Patents). The CJEU ruled that, for the purposes of Article 3(a), in order to be protected active ingredients needed to be ‘specified’ in the wording of the claims of the basic patent filed in support of the SPC application, thereby rejecting the so-called ‘infringement test’. In relation to Article 3(b), it also ruled that SPCs can be granted for a combination of active ingredients specified in the wording of the claims of the basic patent relied on where the medicinal product of the marketing authorisation submitted in the SPC application also contains other active ingredients in addition to the combination specified in the basic patent. In light of the answers from the CJEU the Court of Appeal confirmed that Medeva’s applications did not meet these requirements and dismissed their appeal (Medeva BV v Comptroller General of Patents [2012] EWCA Civ 523). In Georgetown University, Loyola University of Chicago, and University of Rochester’s SPC applications BL O/401/09 the hearing officer rejected SPC applications for single active ingredients in the vaccine field on the grounds that they did not satisfy the requirements of Article 3(b) of the Regulation as the marketing authorisations provided in support of these applications related to products with multiple active ingredients. On appeal to the Patents Court, Kitchin J referred a question concerning the interpretation of Article 3(b) to the Court of Justice of the European Union (Georgetown University, University of Rochester, Loyola University of Chicago v Comptroller-General of Patents, C-422/10; the question was the same as that referred in Medeva in respect of Article 3(b)). Consistent with the approach taken in C-322/10, the CJEU ruled that SPCs can be granted for an active ingredient specified in the wording of the claims of the basic patent where the marketing authorisation relied upon in the SPC application is for a product that contains other active ingredients in addition to the active ingredient specified in the basic patent. The hearing officer followed similar approaches to those in BL O/357/09 and BL O/401/09 in relation to Articles 3(a) and 3(b) in rejecting multiple SPC applications in the vaccine field for either combinations of active ingredients or single active ingredients in University of Queensland & CSL Limited BL O/335/10. On appeal to the Patents Court, Arnold J referred further questions to the Court of Justice of the European Union concerning the interpretation of Article 3(a) and 3(b) (C-630/10, University of Queensland, CSL Ltd v Comptroller-General of Patents, Designs and Trade Marks). The CJEU provided its decision by reasoned order with reference to C-322/10 (Medeva) and C-422/10 (Georgetown). The CJEU reiterated its answers from its decisions in Medeva and Georgetown, and clarified that if a basic patent relates to a process by which a product is obtained, Article 3(a) only allows an SPC to be granted for a product which is identified in the wording of the claims of the patent as the product deriving from the process in question. The Court also stated that whether it is possible to obtain the product directly as a result of the process is irrelevant in that regard. Applying the CJEU’s decision, the Patents Court determined the compliance or otherwise of the applications before it (University of Queensland and CSL limited v Comptroller General of Patents, [2012] EWHC 223 (Pat)). C-630/10 University of Queensland, CSL Ltd v Comptroller-General of Patents, Designs and Trade Marks was also applied in Icahn School of Medicine at Mount Sinai BL O552/14 which determined that Article 3(a) is complied with if the product identified in the patent claims is the product deriving from the process protected by that patent, but that it is not also necessary to establish that the product is produced by the method of the basic patent.

SPM 3.02.5

The Office will determine that a product is specified/identified in the wording of the claims of the basic patent filed in support of the SPC if having regard to the normal canons of claim interpretation it is: i) indicated in a claim; ii) encompassed by a Markush formula; iii) shown to result from the process protected by the basic patent; or iv) encompassed by a functional definition. In respect of (iii) and (iv) it may be necessary to ask the applicant to provide evidence that this is the case, for example, in the form of a witness statement from a suitable patent addressee. In Sandoz Ltd & Anor v G.D. Searle & Anor [2017] EWHC 987 (Pat), the Patents Court held that Article 3(a) is complied with if the product falls within the scope of a Markush formula; although this interpretation needs to be qualified in light of a later CJEU decision relating to a functionally-defined claim: Royalty Pharma Collection Trust v Deutsches Patent und Markenamt C-650/17. In this latter case the referring court sought clarification from the CJEU whether Article 3(a) is to be interpreted as meaning that a product is protected when it falls within the functional definition of a claim in the basic patent, but is not individualized as an embodiment. The CJEU, applying the test developed in its earlier decision Teva C-121/17 (see SPM 3.02.6.1) for situations where the product is not expressly mentioned in the claims, found that such a product is protected if the skilled person in the art can identify it specifically on the basis of the common general knowledge in the art, and the prior art at the priority date of the basic patent. However, the CJEU held that a product is not protected by a basic patent if the product falls within the scope of the claims but the product was developed after the filing date of the patent, following an independent inventive step. Therefore, in relation to Markush formulae (ii) or functional definition claims (iv), it is necessary to consider whether the product was identifiable at the priority date of the basic patent, using the test set out in Teva (C-121/17) as informed by Royalty Pharma (C-650/17). In order to meet the requirement that the product is “…in the wording of a claim” an applicant may have recourse to section 27 of the Patents Act to amend the basic patent accordingly. Questions concerning the practice of amending a basic patent to render an application compliant with Article 3(a) were referred to the CJEU in Actavis Group and Actavis UK v Boehringer Ingelheim Pharma [2013] EWHC 2927 (Pat) however in C-577/13 Actavis Group PTC EHF, Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG these questions were not answered see also SPM3.02.1, 10.14.1).

SPM 3.02.6

In Novartis Pharmaceuticals UK Limited and Medimmune Limited/Medical Research Council [2012] EWHC 181 (Pat) Arnold J commented at paragraph 53 that “the test laid down by the Court of Justice in Medeva and its progeny is unclear save in its rejection of the infringement test in combination cases. In particular, it is unclear precisely what is meant by “specified (or identified) in the wording of the claims””. However, after interpreting and applying the Medeva C-322/10 decision (along with the decisions C-422/10 Georgetown University and Others, C-630/10 University of Queensland and CSL, C-6/11 Daiichi Sankyo, and C-518/10 Yeda Research and Development) he went on to find that a claim to a general method of producing a molecule with binding specificity for a particular target did not adequately specify or identify the specific antibody ranibizumab for the purposes of Article 3(a). In Actavis Group PTC EHF / Actavis UK Limited and Sanofi and Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 Arnold J reiterated his doubt surrounding what is meant by “specified (or identified) in the wording of the claims” and that the proceeding references do not provide a clear test which can be applied to cases such as the present. Accordingly, he referred a further question on the interpretation of Article 3(a) to the Court of Justice of the European Union for a preliminary ruling (C-443/12). The court established that an SPC is to compensate for delay in marketing “the core inventive advance” of a patent. Further questions were referred to the CJEU for a preliminary ruling (C-493/12) from the Patents Court in Eli Lilly & Company v Human Genome Sciences Inc [2012] EWHC 2290 (Pat), the court determined that a functional definition may suffice for a product to be protected by a basic patent if:

the claims relate, implicitly but necessarily and specifically to the active ingredient in question.

On coming back before the high court the judgment in Eli Lilly & Company v Human Genome Sciences Inc [2014] EWHC 2404 (Pat) confirmed that the question of compliance with Article 3(a) is simply ‘does the product fall within the scope of the claims’, but that in the case of combination products a proviso exists, in that a product is not protected solely by wording such as “comprises” that extends the claim beyond its principle scope.

SPM3.02.6.1

Arnold J in Teva UK & Ors v Gilead [2017] EWHC 13 (Pat) (“Teva I”) reviewed the judgments of the CJEU in respect of how combination products at least may satisfy Article 3(a) and again referred to the CJEU (C-121/17) the question “what are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a)”. The Grand chamber of the CJEU in C-121/17 has ruled that a product is protected by a basic patent if the claims relate necessarily and specifically to that product, and that this is to be judged from the point of view of a person skilled in the art on the basis of the prior art at the priority date of the basic patent. The Court effectively provided a two step test:

i) the product must necessarily, in light of the description and drawings fall under the invention of the basic patent

and

ii) the ingredients must be specifically identifiable in light of all the information disclosed.

In Teva & Ors v Gilead Sciences Inc [2018] EWHC 2416 (Pat) (“Teva II”), Arnold J applied the judgment of the CJEU in C-121/17 as requiring both steps in a two-step test to be satisfied. Firstly, having regard to Eli Lilly C 493/12, that the product “must be one that the skilled person would understand, on the basis of the description and drawings and their common general knowledge, to embody the technical contribution made by the patent”; And in a second step, that “the product must be specifically identifiable by the person skilled in the art in the light of the description and drawings and the prior art, which must mean their common general knowledge, as at the filing date or priority date of the patent, and not merely in the light of information which becomes available later.”. Thus, as Arnold J confirmed in Eli Lilly and Company v Genentech [2019] EWHC 388 (Pat), it is not a question of whether or not the product was or was not created before the priority date of the patent, but whether the skilled person, armed with the common general knowledge available at the priority or filing date, would consider the product specifically identifiable from the patent. However, whereas Arnold J concluded the first step of the test required that the product embodies the technical contribution made by the patent, the Court of Appeal in Teva & Ors v Gilead [2019] EWCA Civ 2272 concluded that the correct interpretation of the first step is merely an elaborate exposition of the “necessarily” part of the test in Eli Lilly C 493/12, so that in a combination product each component must be required by the claim. The Court of Appeal held that the reference in the test to the common general knowledge of the skilled person is the means by which the skilled person decides what the claims relate to, rather than as a means to formulate the technical contribution.

SPM 3.02.7

In Forsgren v Österreichisches Patentamt C-631/13 it was determined that an SPC is precluded for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation.

SPM 3.03

Although Article 3(b) requires a valid authorisation to have been granted, there appears to be no requirement that the authorisation should still be in force at the date of making the application for a certificate (e.g. it may be withdrawn or have lapsed before the date of the application for the certificate).

SPM 3.03.1

In British Technology Group Ltd’s SPC Application [1997] RPC 118 the hearing officer found that a letter from the Medicines Control Agency granting permission for a product to be supplied for a proposed clinical trial was not an acceptable market authorisation in that it was not issued in accordance with Directive 65/65/EEC or Directive 81/851/EEC nor did it provide a summary of product characteristics as required by Article 8(1)(b) see SPM2.01, SPM10.17.1 and SPP3.02). Directives 65/65/EEC and 81/851/EEC were the Directives in accordance with which the authorisation had to have been granted under Article 3(b) of Regulation (EEC) 1768/92. They were repealed and consolidated with Directive 75/319/EEC into 2001/83/EC and 2001/82/EC respectively.In C-567/16 Merck Sharp & Dohme Corporation v Comptroller General of Patents the court confirmed the views expressed
by Arnold J in [2016] EWHC 1896 (Pat) (an appeal from Merck Sharp & Dohme Corporation BL O/117/16) that an end of procedure notice issued by a relevant national competent body for authorising medicines under Article 28(4) of the Medicinal Products Directive is not a valid authorisation for the purposes of Article 3(b).

SPM 3.03.2

In Cerus Corporation BL O/141/14 Leibniz-Institut für Neue Materialien Gemeinnützige GmbH BL O/328/14 and Angiotech Pharmaceuticals Inc. and University of British Columbia BL O/466/15 the hearing officer found that a EC design examination certificate relating to a medical devices did not meet the requirements of Article 3(b). The EC design examination certificates were issued having regard to Article 1(4) of Directive 93/42/EEC because the devices incorporates as an integral part, a substance which, if used separately, may be considered a medicinal product and which acts upon the body with action ancillary to that of the device. Such “class III” devices (as defined in Article 9 and Annex IX of Directive 93/42/EEC) require the safety quality and usefulness of the substance to be assessed, in an analogous way to authorisation under Directive 2001/83/EC. However this assessment process was not found to be the same or equivalent to the process carried out to authorise a medicinal product for human use in accordance with Directive 2001/83/EC. The CJEU in Boston Scientific Ltd v Deutsches patetn-und Markenamt (C-527/17) has confirmed that the authorisation procedure under Directive 93/42 cannot be treated as an authorisation granted under Directive 2001/83/EC, see also SPM 2.01

SPM 3.04

Article 3(c) precludes the grant of a second certificate for a product where the first certificate has been granted before the date of application for the second certificate. However, in Chiron Corporation and Novo Nordisk A/S [2005] RPC 24 the hearing officer concluded that the grant of a supplementary protection certificate for a product to one holder of a basic patent before an application is lodged in relation to the same product by a different holder of a different basic patent on the basis of a common marketing authorisation does not provide a ground for rejecting the later application under Article 3(c) of the Regulation. The European Court of Justice in AHP Manufacturing BV v Bureau voor de Industriële Eigendom [2009] C-482/07 held that Article 3(c) of the Regulation does not prevent the grant of a certificate to the holder of a basic patent for a product if, at the time of the submission of the application for a certificate, one or more SPCs have already been granted to one or more holders of one or more other basic patents. Thus it may be possible in specific circumstances for a further certificate to be granted when a certificate already exists. In Takeda Chemical Industries Ltd’s Applications [2004] RPC 2, the hearing officer held that products comprising a combination of ingredients were not precluded from grant of an SPC because one of the ingredients had already been granted an SPC. However, in light of the comment made in Medeva that “only one certificate may be granted for the basic patent”, Arnold J in Actavis Group PTC EHF / Actavis UK Limited and Sanofi and Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 determined that the correct interpretation of Article 3(c) was not clear and referred the following question to the CJEU for preliminary ruling (C-443/12), “In a situation in which multiple products are protected by a basic patent in force, does the Regulation, and in particular Article 3(c), preclude the proprietor of the patent being issued a certificate for each of the products protected?” A similar question was referred from the district court of The Hague in Georgetown University and Octrooicentrum Nederland C-484/12. In the resulting decisions, the CJEU determined that it is possible, on the basis of a patent which protects several different products, to obtain several SPCs in relation to each of those products provided that each of those products is protected by the basic patent, (C-484/12, paragraph 30), but that Article 3(c) prohibits successive SPCs based on a single patent for the same active in combination with another active not itself protected by the patent (C-443/12, paragraph 30). Commenting on Art 3(c) in C-577/13 Actavis Group PTC EHF, Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG (paragraph 39), the CJEU held that, where an SPC has already been granted relating to an active ingredient which constitutes the sole subject matter of the invention, the patent holder is precluded from obtaining an SPC for a combination product claimed in a subsequent claim of the same patent comprising that active ingredient and another substance not constituting the subject matter of the invention. In reference to this judgment, Arnold J in Teva UK Limited & Ors v Merck Sharp & Dohme Corporation [2017] EWHC 539 (Pat) held that, if the combination represents a distinct invention protected by the patent, it should not matter whether it is protected by the same patent or by a different patent. In other words, it is the active ingredients found to represent the subject matter of the invention that are critical in determining what the product is, and not if aspects of the subject matter of the invention are found in one or more patents.

SPM 3.04.1

Recital (17) of the Plant Protection Regulation (see SPM0.04) must also be considered in respect of Article 3(c) as, from 8 February 1997 when said regulation came into force, Article 3 of the Medicinal Regulation is to be interpreted in accordance with Article 3(2) of the new regulation which states:

Article 3(2) [EC Plant Protection Regulation]

The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders.

SPM 3.04.2

Consequently, the grant of one certificate to each patent holder in respect of the same product on two or more applications each specifying a different basic patent protecting the product is now allowed. The hearing officer in Takeda Chemical Industries Ltd’s Applications [2004] RPC 2 found that only one certificate for a product should be granted to the same applicant, having also considered the European Court of Justice decision in Biogen Inc. v Smithkline Beecham Biologicals SA ([1997] RPC 23 ECJ Case C-181-95).

C-354/19 Novartis AG v Patent-och registreringsverket (PRV) may also bear on how Article 3(2) of the Plant Protection Regulation is applied. See also SPM3.05.2 and SPP3.03](/guidance/manual-of-patent-practice-mopp/regulation-ec-no-1610-96-of-the-european-parliament-and-of-the-council-plant-protection-products/#ref3-03).

SPM 3.05

In Yissum Research & Development Company of the Hebrew University of Jerusalem BL O/222/04 the hearing officer found that the condition specified in Article 3(d) will not be met if an authorisation to place the product on the market is not the first for the product, regardless of whether the earlier authorisation was for a different medical condition. The product “calcitriol” had been the subject of previous marketing authorisations and for the purpose of Article 3(d) these earlier authorisations could not be distinguished on the basis of their different therapeutic applications. This decision was appealed to the Patents Court [2004] EWHC 2880 which referred the matter to the European Court of Justice for a preliminary ruling (case C-202/05) see SPM0.01, SPM1.02, SPM1.04.1. The ECJ found that when a basic patent protects a second medical use of an active ingredient, that use does not form an integral part of the definition of the product. Questions of a similar nature regarding the interpretation of the term “combination of active ingredients of a medicinal product” were answered by the ECJ in Massachusetts Institute of Technology (case C-431/04) see SPM1.04.1.

SPM 3.05.1

[Deleted]

SPM 3.06

It is considered that a process for obtaining a known product already covered by a certificate may not give rise to a new certificate see SPM1.05.

Article 4: subject-matter of protection

Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorization to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorized before the expiry of the certificate.

SPM 4.01

A certificate extends the protection conferred by the basic patent beyond the term of that patent but only in respect of the product covered by the authorisation to place the corresponding medicinal product on the market and any use of the product as a medicinal product that has been authorised before expiry of the certificate. It does not, however, extend the term of the patent itself.

SPM 4.01.1

Article 4 of the Medicinal Regulation is to be interpreted in the same way as Article 4 of the Plant Protection Regulation in view of recital (17) of the latter which states:

Article 4 [EC Plant Protection Regulation]

Subject-matter of protection

Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorizations to place the corresponding plant protection product on the market and for any use of the product as a plant protection product that has been authorized before expiry of the certificate.

SPM 4.01.2

The plural “authorizations” makes clear that one certificate will suffice for the first and subsequent authorizations.

SPM 4.02

In Draco AB’s SPC Application [1996] RPC 417 the Patents Court held that Article 4 was the operative Article to confer protection on the product, which was the active ingredient as defined in Article 1(b).

SPM 4.03

In Novartis AG v Actavis UK Limited, questions concerning the interpretation of Article 4 (and Article 5) of the Regulation were referred to the Court of Justice of the European Union (C-442/11). The Court of Justice provided its decision by reasoned order with reference to its decisions in C-322/10 Medeva, C-422/10 Georgetown University and Others, C-630/10 University of Queensland and CSL, and C-6/11 Daiichi Sankyo (see above), confirming that SPCs provide patent-like infringement protection for the duration of the SPC also see SPM5.03.

Article 5: Effects of the certificate

1. Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations. 2. By way of derogation from paragraph 1, the certificate referred to in paragraph 1 shall not confer protection against certain acts which would otherwise require the consent of the holder of the certificate (“the certificate holder”), if the following conditions are met: (a) the acts comprise: (i) the making of a product, or a medicinal product containing that product, for the purpose of export to third countries; or (ii) any related act that is strictly necessary for the making, in the Union, referred to in point (i), or for the actual export; or (iii) the making, no earlier than six months before the expiry of the certificate, of a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making, in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate; or (iv) any related act that is strictly necessary for the making, in the Union, referred to in point (iii), or for the actual storing, provided that such related act is carried out no earlier than six months before the expiry of the certificate. (b) the maker, through appropriate and documented means, notifies the authority referred to in Article 9(1) in the Member State in which that making is to take place, and informs the certificate holder, of the information listed in paragraph 5 of this Article no later than three months before the start date of the making in that Member State, or no later than three months before the first related act, prior to that making, that would otherwise be prohibited by the protection conferred by a certificate, whichever is the earlier; (c) if the information listed in paragraph 5 of this Article changes, the maker notifies the authority referred to in Article 9(1) and informs the certificate holder, before those changes take effect; (d) in the case of products, or medicinal products containing those products, made for the purpose of export to third countries, the maker ensures that a logo, in the form set out in Annex -I, is affixed to the outer packaging of the product, or the medicinal product containing that product, referred to in point (a)(i) of this paragraph, and, where feasible, to its immediate packaging; (e) the maker complies with paragraph 9 of this Article and, if applicable, with Article 12(2). 3. The exception referred to in paragraph 2 shall not apply to any act or activity carried out for the import of products, or medicinal products containing those products, into the Union merely for the purpose of repackaging, re-exporting or storing. 4. The information provided to the certificate holder for the purposes of points (b) and (c) of paragraph 2 shall be used exclusively for the purposes of verifying whether the requirements of this Regulation have been met and, where applicable, initiating legal proceedings for non-compliance. 5. The information to be provided by the maker for the purposes of point (b) of paragraph 2 shall be as follows: (a) the name and address of the maker; (b) an indication of whether the making is for the purpose of export, for the purpose of storing, or for the purpose of both export and storing; (c) the Member State in which the making and, if applicable, also the storing is to take place, and the Member State in which the first related act, if any, prior to that making is to take place; (d) the number of the certificate granted in the Member State of making, and the number of the certificate granted in the Member State of the first related act, if any, prior to that making; and (e) for medicinal products to be exported to third countries, the reference number of the marketing authorisation, or the equivalent of such authorisation, in each third country of export, as soon as it is publicly available. 6. For the purposes of notification to the authority under points (b) and (c) of paragraph 2, the maker shall use the standard form for notification contained in Annex -Ia. 7. Failure to comply with the requirements of point (e) of paragraph 5 with regard to a third country shall only affect exports to that country, and those exports shall, therefore, not benefit from the exception. 8. The maker shall ensure that medicinal products made pursuant to point (a)(i) of paragraph 2 do not bear an active unique identifier within the meaning of Commission Delegated Regulation (EU) 2016/161 (*). 9. The maker shall ensure, through appropriate and documented means, that any person in a contractual relationship with the maker who performs acts falling under point (a) of paragraph 2 is fully informed and aware of the following: (a) that those acts are subject to paragraph 2; (b) that the placing on the market, import or re-import of the product, or the medicinal product containing that product, referred to in point (a)(i) of paragraph 2 or the placing on the market of the product, or the medicinal product containing that product, referred to in point (a)(iii) of paragraph 2 could infringe the certificate referred to in paragraph 2 where, and for as long as, that certificate applies. 10. Paragraph 2 shall apply to certificates that are applied for on or after 1 July 2019. Paragraph 2 shall also apply to certificates that have been applied for before 1 July 2019 and that take effect on or after that date. Paragraph 2 shall only apply to such certificates from 2 July 2022. Paragraph 2 shall not apply to certificates that take effect before 1 July 2019.

(*1) Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).

SPM 5.01

Article 5(1) states that subject to Article 4, a certificate confers the same rights as the basic patent and is subject to the same limitations and obligations. Provisions under national law relating to such matters as infringement therefore apply equally to a certificate. In certain circumstances the Office will provide a non-binding opinion as to whether or not an SPC is infringed, see Section 74A.

SPM 5.02

In Research Corp’s SPC ([1994] RPC 667), see also SPM0.01, the Patents Court, upholding a decision of the hearing officer reported at [1994] RPC 387, held that the endorsement of the basic patent licences of right under the provisions of paragraph 4 of Schedule 1 of the 1977 Act was a limitation within the meaning of Article 5. The comptroller therefore had jurisdiction to entertain an application to settle the terms of licence of right under a certificate, pursuant to s.46(3) of the Patents Act 1977 and reg 5 of the Patents (Supplementary Protection Certificate for Medicinal Products) Regulations 1992.

SPM 5.03

In Novartis AG and Actavis UK Limited, questions concerning the interpretation of Article 5 (and Article 4) of the Regulation were referred to the Court of Justice of the European Union (C-442/11). The Court of Justice provided its decision by reasoned order with reference to its decisions in C-322/10 Medeva, C-422/10 Georgetown University and Others, C-630/10 University of Queensland and CSL, and C-6/11 Daiichi Sankyo (see above), confirming that SPCs provide patent-like infringement protection for the duration of the SPC also see SPM4.03.

SPM5.04

To assist in determining if particular compositions or acts infringe an SPC it is possible to request this Office gives a non-binding opinion on infringement, See Section 74A or Opinions: resolving patent disputes.

SPM 5.05

Articles 5(2)-(10) were introduced by Regulation (EU) 2019/933 and establish a “manufacturing waiver” for SPCs for medicinal products; the Recitals of Regulation (EU) 2019/933 provide context for the interpretation of these provisions. The waiver confers an exception to the rights provided under Art. 5(1) and allows manufacturers of generic or biosimilar versions of SPC-protected medicines to carry out specified acts that would otherwise require the permission of the SPC holder.

SPM 5.06

Firstly. as set out in Art. 5(2)(a)(i), the waiver permits the making of SPC-protected medicines for export to third countries outside the EU. The Recitals of Regulation (EU) 2019/933 make it clear that this is intended to allow manufacturing for export to countries outside the EU where protection does not exist or has expired, and Recital 18 states that it is the responsibility of the maker to verify that protection does not exist or has expired in a country of export.

SPM 5.07

Second, as set out in Art. 5(2)(a)(iii), the waiver permits the making of SPC-protected medicines, in the last six months of the SPC term, for storing in the member state in which they are manufactured, ready for sale in the EU when SPC protection expires (sometimes referred to as “stockpiling”).

SPM 5.08

In addition, the waiver permits any “related act” that is strictly necessary for the making, export or storing of the medicine under Art. 5(2)(a)(i) or (iii), and that would otherwise require the permission of the SPC holder. These related acts may take place in the same or a different member state to that in which the making takes place. Any related acts strictly necessary for making for the purpose of stockpiling, or for the actual stockpiling, can only take place in the final six months of the SPC term. Recital 9 provides examples of “related acts”; including possessing, offering to supply, supplying, importing, using or synthesising an active ingredient for the purpose of making a medicinal product, or the temporary storage or advertising for the exclusive purpose of export to third-countries.

SPM 5.09

As set out in Art. 5(3), the acts permitted by the waiver do not include the importation of active ingredients or medicinal products merely for the purpose of repackaging, re-exporting or storing. Recital 11 of Regulation (EU) 2019/933 also makes it clear that the waiver does not permit sale of medicines made under these provisions in EU member states where an SPC is in force, and nor does it allow re-importation of medicines made for export into EU member states where an SPC is in force. The waiver does not permit storage of active ingredients or medicinal products for any reasons other than those set out in Art. 5(2)(a). The maker is obliged to ensure, through appropriate and documented means, that anyone performing any of the permitted acts under the waiver under a contractual relationship with the maker is aware of that these acts are subject to the provisions of Art. 5(2) and that sale, import or re-import of products or medicinal products in EU member states could infringe the relevant SPC for as long as it is in effect (Art. 5(9)).

SPM 5.10

Articles 5(2)(b) and (c), and Articles 5(4) to 5(7), concern the notification requirements that the maker must comply with to make use of the waiver. At least three months before any making or related acts, the maker must provide certain information to both the SPC holder and the relevant authority – in the UK, the Intellectual Property Office. As set out in Art. 5(5), this information is the name and address of the maker; an indication of whether the manufacture is for export, stockpiling or both; the EU member state in which the making, and if applicable, also the storing, is to take place and the relevant SPC number for that state, and – if any related acts are to take place before the making – the member state (and the associated SPC number) where the first of these acts is to take place. Finally, for medicinal products produced for export, the maker must provide the reference number of the marketing authorisation, or its equivalent, in each third country of export, as soon as it is publicly available. Failure to provide this last item in respect of any country of export will only invalidate the waiver in respect of exports to that country (Art. 5(7)). The maker must inform both the Office and the SPC holder of any changes to this information (Art. 5(2)(c)), and the SPC holder must only use this information for the purposes of verifying whether the requirements of the waiver have been met and, where applicable, initiating legal proceedings for non-compliance (Art. 5(4)). Recital 15 of Regulation (EU) 2019/933 states that the information should not include confidential or commercially sensitive information, and indeed as discussed in SPM11.04 the Office will publish the information as soon as possible after receiving it.

SPM 5.11

The maker must notify the Office of this information using the standard form provided at Annex -Ia of the Medicinal Product Regulation as required by Art. 5(6); this standard form is to be used for both the initial notification and for notifying any changes to the information. The maker must use a paper version of the standard form when notifying the Office. The same form may be used for notifying the SPC holder but this is not compulsory.

SPM 5.12

Products and medicinal products made for the purpose of export under the waiver must carry a logo bearing the words “EU export” as provided in Annex -I of the Medicinal Product Regulation as required by Art. 5(2)(d). The logo must be black, of sufficient size to be visible and must be affixed to the outer packaging and, where feasible, the immediate packaging of the medicine. Article 5(8) requires that medicinal products produced for export must not carry an active unique identifier (as required under the EU system for ensuring security of pharmaceuticals under the Falsified Medicines Directive); this does not apply to medicines produced for stockpiling.

SPM 5.13

The manufacturing waiver initially applies only to SPCs applied for on or after 1 July 2019; the date on which Regulation (EU) 2019/933 came into force. From 2 July 2022, the waiver also applies to SPCs applied for before 1 July 2019, but only if the basic patent had not expired before that date and so the SPC had not come into effect. The waiver does not apply to SPCs that were already in effect before 1 July 2019. These transitional provisions are set out in Art. 5(10).

Article 6: Effects of the certificate

The certificate shall be granted to the holder of the basic patent or his successor in title.

SPM 6.01

Article 6 does not prevent an application from being lodged by a person other than the proprietor of the basic patent. However, irrespective of who lodged the application, the certificate can be granted only to the person registered at the time of grant as the proprietor of the basic patent.

SPM 6.02

The question of whether, having regard to the wording of Article 6, the holder of a marketing authorisation may refuse to give a copy to the holder of the basic patent or his successor in title where it is required by Article 8(1)(b) in order to complete the application was referred to the European Court of Justice by the Tribunal de
Commerce, Nivelles, Belgium in Biogen Inc v SmithKline Beecham Biologicals SA [1997] RPC 833. The Court ruled that the Regulation does not require the holder of the marketing authorisation to provide a copy to the patent holder. Such an obligation may, however, be deemed to be inherent in the contractual relationship between the parties. (See also SPM8.04.1.)

SPM 6.03

In Eli Lilly & Company v Human Genome Sciences Inc [2012] EWHC 2290 (Pat) Warren J held

that the holder of a basic patent can make an application for an SPC in reliance on an MA granted to a third party having no connection of any sort with that holder.

However, in Eli Lilly and Company v Genentech Inc [2019] EWHC 388 (Pat), Arnold J concluded that this issue is not acte clair and referred a question to the ECJ to determine if the Regulation precludes the grant of an SPC to the proprietor of a basic patent in respect of a product which is the subject of a marketing authorisation held by a third party without that party’s consent.

Article 7: Application for a certificate or an extension of a Certificate

1. The application for a certificate shall be lodged within six months of the date on which the authorization referred to in Article 3(b) to place the product on the market as a medicinal product was granted. 2. Notwithstanding paragraph 1, where the authorization to place the product on the market is granted before the basic patent is granted, the application for a certificate shall be lodged within six months of the date on which the patent is granted. 3. The application for an extension of the duration may be made when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Article 8(1)(d) or Article 8(2), respectively, are fulfilled. 4. The application for an extension of the duration of a certificate already granted shall be lodged not later than two years before the expiry of the certificate. 5. Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No 1901/2006, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate.

SPM 7.01

Except where the transitional provisions of Article 19 of Regulation (EEC) No 1768/92 applied, the application must be lodged within six months of the date of grant of either the first UK authorisation or the basic patent, whichever is later. In Abbott Laboratories’ SPC Application [2004] RPC 20 the Hearing Officer held that the
relevant date in Article 7(1) is the actual date of grant of the authorisation and not the date of publication of grant in the relevant Official Gazette. It was also held that the six month deadline set out in Article 7 is extendable under r.110(1) of the Patents Rules 1995 (now rule 108(1) of the 2007 Rules), in accordance with the provisions of Article 18 of Regulation (EEC) No 1768/92 (now Art 19 of the EC Medicinal Regulation) see
SPM19.11. In respect of Article 7(2); in accordance with Article 97(4) of the European Patent Convention, the date of grant of a European Patent is the date the European Patent Bulletin mentions grant. For a UK patent, the relevant date of grant is taken to be the date of publication of the notice of grant in the Patents Journal under Section 24(1) of the Patents Act 1977 (rather than the date of grant under Section 18(4)).

SPM 7.02

An application for an extension can be lodged when an application for a certificate is filed or whilst the application for a certificate is pending or it may be filed after a certificate has been granted. When a certificate is already granted the application shall be lodged not later than two years before the expiry of the certificate.
However, for five years from the entry into force of Regulation 1901/2006 an application for an extension must be lodged not later than six months before the expiry of the certificate.

SPM 7.03

The time periods expressed in Article 7 are to be determined in accordance with Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time limits.

Article 8: Content of the application for a certificate

1. The application for a certificate shall contain: (a) a request for the grant of a certificate, stating in particular: (i) the name and address of the applicant; (ii) if he has appointed a representative, the name and address of the representative; (iii) the number of the basic patent and the title of the invention; (iv) the number and date of the first authorization to place the product on the market, as referred to in Article 3(b) and, if this authorization is not the first authorization for placing the product on the market in the Community, the number and date of that authorization; (b) a copy of the authorization to place the product on the market, as referred to in Article 3(b), in which the product is identified, containing in particular the number and date of the authorization and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC or Article 14 of Directive 2001/82/EC; (c) if the authorization referred to in (b) is not the first authorization for placing the product on the market as a medicinal product in the Community, information regarding the identity of the product thus authorised and the legal provision under which the authorization procedure took place, together with a copy of the notice publishing the authorization in the appropriate official publication. (d) where the application for a certificate includes a request for an extension of the duration (i) a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of Regulation (EC) No 1901/2006; (ii) where necessary, in addition to the copy of the authorisations to place the product on the market as referred to in point (b), proof of possession of authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No 1901/2006. 2. Where an application for a certificate is pending, an application for an extended duration in accordance with Article 7(3) shall include the particulars referred to in paragraph 1(d) of this Article and a reference to the application for a certificate already filed. 3. The application for an extension of the duration of a certificate already granted shall contain the particulars referred to in paragraph 1(d) and a copy of the certificate already granted. 4. Member States may provide that a fee is to be payable upon application for a certificate and upon application for the extension of the duration of a certificate.

For a certificate

SPM 8.01

ArtM.8, ArtP.8, r.116(1) FSch 1 is also relevant

An application for a certificate must contain a request for the grant of a certificate on Form SP1 but see also SPM19.04 accompanied by the prescribed application fee (currently £250).

SPM 8.02

This request should specify:

the name and address of the applicant (Section 3 of Form SP1);

the name of the applicant’s agent (if any) and the address for service in the European Economic Area or Channel Islands (Section 4);

the EC Regulation (469/2009 or 1610/96) under which the application is made
(Section 5);

the product in respect of which the certificate is sought (ie the active ingredient or combination of active ingredients of the medicinal product) (Section 6);

the number, title, expiry date and (if later than the first UK authorisation) the date of grant of the basic patent (Section 7);

the number and date of the first UK authorisation (Section 8);

(where different from the first UK authorisation) the State, number and date of the first authorisation in the EU, plus the identity of the authorised product and the legal provision under which the authorisation took place (Section 9). Although the wording of Articles 8(1)(a)(iv) and 8(1)(c) does not appear to require such a first authorisation to have been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, in Synthon BV v Merz Pharma Gmbh & Co KG (C-195/09) and Generics (UK) Ltd v Synaptech Inc (C-427/09) the Court of Justice of the European Union ruled in relation to Article 2 that a product which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65/EEC (now Directive 2001/83/EC) and, in particular, without undergoing safety and efficacy testing, is not within the scope of the Regulation, and may not be the subject of a supplementary protection certificate also see SPM2.01, SPM13.04.1 and Novartis AG and University College London & Novartis AG and Institute of Microbiology and Epidemiology SPC Applications BL O/044/03. For applications lodged on or after 1 July 1994, the relevant authorisation for the purposes of Articles 8(1)(a)(iv) and 8(1)(c) includes the first authorisation in a State which is a Contracting Party to the European Economic Area Agreement. In AstraZeneca AB C-617/12 the CJEU confirmed by reasoned order referring to Novartis and others C-207/03 and C-252/03 that a Swiss authorisation automatically recognized in Liechtenstein was the first in the EEA and therefore constituted the first authorisation in the Community even if that authorisation was suspended at a later date see also BL O/146/12 and SP0.08-09, SPM9.02, SPM11.01 and SPM13.04.

SPM 8.03

Where more than one authorisation for the product was granted on the date of the first UK or EU authorisation, details of all of the relevant authorisations should be given at Sections 8 and 9 of Form SP1.

SPM 8.03.1

The relevant date having regard to Article 8(1)(a)(iv) or 8(1)(b) will be the date of grant of the authorisation unless evidence is provided which shows a different date of legal effect, see also SPM13.05.1. Following decision BL O/418/13 (Genzyme Corporation) where the earliest authorisation is one granted by a decision of the European Commission following a favourable opinion from the EMA under Regulation (EC) 726/2004 the date of the authorisation will be taken to be the date of notification, this date may be evidenced such as by providing a suitable excerpt from the OJEU, see SPM13-05-1, 10.15). The relevance of the “date of notification” in these circumstances has been confirmed by the CJEU in Seattle Genetics Inc. v Österreichisches Patentamt C-471/14.

SPM 8.04

The request should be accompanied by a copy of the first or each UK authorisation. This authorisation should identify the product and contain the number and date of the authorization and a summary of the product characteristics listed in Directive 2001/83/EC (for pharmaceutical products), Directive 2001/82/EC (for veterinary products) (see SPM2.01). Thus, in the case of a pharmaceutical product, it is necessary to file a copy of the Product Licence or Marketing Authorisation granted by the Medicines and Healthcare Products Regulatory Agency, the Veterinary Medicines Directorate or the European Commission following a favourable opinion from the EMA (see SPM2.01). The copy should include any enclosure or Schedule referred to in the document of grant, such as an attached authenticated copy of the licence application setting out the particulars of the product.

SPM 8.04.1

The question of the applicant’s obligation to provide a copy of the authorisation in the Member State was referred to the European Court of Justice by the Tribunal de Commerce, Nivelles, Belgium in Biogen Inc v SmithKline Beecham Biologicals SA [1997] RPC 833. The Court ruled that, where the owner of the basic
patent and the holder of the marketing authorisation were different persons and the patent owner was unable to provide a copy of the authorisation in accordance with Article 8(1)(b) of the Regulation, the application for the Supplementary Protection Certificate could not be refused on that ground alone. It was open to the national
authority granting the certificate to obtain a copy of the marketing authorisation from the national authority which issued it. In the light of the Biogen ruling, the Office will proceed on the basis that, whilst it cannot reject the application merely because the copy of the authorisation is provided by someone other than the applicant, equally it cannot waive at least the minimum requirements of Art 8(1)(b). Thus it is not sufficient for the applicant merely to ask the Office to obtain a copy of the authorisation without first having established his own inability to do so. Also, the Office will not make good the lack of a copy by referring to or copying authorisation documents held on other files, such as an SPC application filed by another patent holder. Accordingly, where an applicant is unable to obtain a copy of the authorisation from the person holding it, the Office will first require the applicant to provide evidence of this and also to provide such information as is available from the authority issuing the authorisation such information (eg a gazette notice, a letter or a database printout) as will enable the Office to verify the identity of the product and the date of the authorisation stated on Form SP1. The Office will then ask the issuing authority to supply a copy of the relevant (usually confidential) summary of product characteristics listed in Directive 2001/83/EC or Directive 2001/82/EC (see SPM2.01). It is important to note that this latter document may be covered by a request for confidentiality under Rule 53(1) of the Patents Rules 2007 from the authorisation authority and is then solely for Office use and under no circumstances will be made available to the applicant or the public. (See also SPM 6.02).

[ Copies of confidential authorisations obtained from the authorisation authorities invoking the Biogen ruling are filed in a separate envelope marked “Not open to the Applicant or the Public” ]

SPM 8.05

r.113 is also relevant

In addition, in order to meet the requirements of Article 8(1)(c), where the UK authorisation above is not the first authorisation to place the product on the market in the EU (or, where appropriate, in a State which is a Contracting Party to the European Economic Area Agreement – (see SPM 8.02), the application should be accompanied by a copy of the notice publishing the (or each) such first authorisation in the appropriate official gazette. However, Article 8(1)(c) of the Medicinal Regulation is to be interpreted in the same manner as Article 8(1)(c) of the Plant Protection Regulation (as from 8 February 1997 when the latter regulation came into force) which reads:

Article 8 [EC Plant Protection Regulation]

Content of the application for a certificate

1. (c) if the authorization referred to in (b) is not the first authorization to place the product on the market as a plant protection product in the Community, information regarding the identity of the product thus authorized and the legal provision under which the authorization procedure took place, together with a copy of the notice publishing the authorization in the appropriate official publication or, failing such a notice, any other document proving that the authorization has been issued, the date on which it was issued and the identity of the product authorized.

SPM 8.05.1

If no such publication in a gazette has therefore been made, the copy of the authorisation itself or any other document proving that the authorisation has been issued, such as a confirmatory letter from the authorisation authority, should be furnished in lieu. Any document not in the English language should be accompanied by
a translation which need only be verified if there is reason to doubt the accuracy of the translation.

SPM 8.06

Except where it is immediately apparent that the product in question is protected by the basic patent, the applicant should also provide whatever information is necessary to enable the Comptroller to confirm that this is so, eg by specifying a claim of the basic patent which refers to the product or indicating how the product is derived from a general formula in a claim. For an extension of a certificate

SPM 8.07

The application for an extension must be made on Form SP4 and accompanied by the prescribed application fee (currently £200).

SPM 8.08

This request should specify:

a granted certificate number or certificate application number if these exist
(Section 2 of Form SP4);

the name and address of the applicant (Section 3 of Form SP4);

the name of the applicant applicant’s agent (if any) and the address for service in the EEA or Channel Islands (Section 4);

the product in respect of which the certificate is sought (i.e. the active ingredient or active substance, or combination thereof, of the medicinal product) (Section 5);

the number, title and expiry date of the basic patent (Section 6);

the number and date of the authorisation containing the statement of compliance with an agreed paediatric investigation plan, including the state if necessary (Section 7);

whether the product has been authorised in all Member States by an authorisation issued by the EMA or by national authorisations granted by each Member state (Section 8).

SPM 8.09

ArtsPd 36(1),(2), ArtPd 28(3) is also relevant

The request should be accompanied by a copy of the statement indicating compliance with an agreed paediatric investigation plan as referred to in Art 36(1) of Regulation (EC) No 1901/2006. In Merck & Co., Inc. (BL O/035/09) the hearing officer considered whether an opinion of the Paediatric Committee of the EMEA indicating compliance with a PIP was sufficient to meet this requirement. He found that it was not and that the statement of compliance included in the marketing authorisation of the medicinal product was the necessary copy of this statement. The hearing officer considered that the applicant could rectify this deficiency by filing this document (see SPM19.11). In his decision concerning E I Du Pont de Nemours & Co.’s SPC Application (BL O/096/09), [2010] RPC 4) the hearing officer similarly found that an application which did not contain a copy of the statement of compliance did not meet the requirements of Article 8(1)(d)(i). This decision was appealed to the Patents Court in E I Du Pont Nemours & Co.’s SPC Application [2009] EWHC 1112 (Ch), [2010] RPC 5 and the appeal on these grounds was dismissed. The Court found that while the requirement for the statement to be in the marketing authorisation is merely informative, the only substitute for it would be equivalent information on compliance from a properly reliable source. However, the Court of Appeal has since reversed the earlier decisions of the Patents Court and the Office (E I Du Pont Nemours & Co. v UK Intellectual Property Office [2009] EWCA Civ 966, [2010] RPC 6). Jacob LJ directed that failure to comply with the provisions of Article 8(d) at the time of submitting an application for an extension of the duration of an SPC is an irregularity which may be cured after the date of application under Article 10(3). Having regard to Dr Reddy’s Laboratories (UK) Ltd and Dr Reddy’s Laboratories Ltd v Warner-Lambert Company LLC [2012] EWHC 3715 (Pat) it was determined that studies outside the strict power of the PDCO to demand but
nonetheless included in the PIP do not render the PIP unlawful or invalid, and that the requirement for studies to be “significant” in Article 45(3) of Regulation (EC) No 1901/2006 is not of general application but only refers to studies completed before entry into force of Regulation (EC) No 1901/2006.

SPM 8.10

ArtPd 36(3) is also relevant

The request should also be accompanied by proof that it has authorisations to place the product on the market in all other Member States as referred to in Art 36(3) of Regulation (EC) No 1901/2006. The hearing officer in EI Du Pont de Nemours & Co.’s SPC Application (BL O/096/09) found that the application did not fulfil the conditions of Article 8(1)(d)(ii) as the documents supplied did not prove that the product was approved for use in all member states and so satisfy all the requirements of Art 36 of Regulation (EC) No. 1901/2006. The appeal to the Patents Court in E I Du Pont Nemours & Co.’s SPC Application [2009] EWHC 1112 (Ch) on this matter was dismissed, the Court finding that an application for an extension that does not meet all the requirements of Art 36 is defective. The Court held that Art 36 must be considered as a whole and that the marketing authorisation application must be completed before the reward of an extension is available. However, the Court did find that there may be circumstances where if the medicinal product is being approved through the mutual recognition procedure and the reference member state has granted the authorisation then the extension could be granted lawfully, if the only issue outstanding was the administrative completion of the authorisation procedure in every member state. The Court held that the deficiencies in the application in this respect were not ones which could be described as irregularities that could be rectified under Art 10(3). However, as noted above, the Court of Appeal has since reversed the earlier decisions of the Patents Court and the Intellectual Property Office on this point (E I Du Pont Nemours & Co. [2009] EWCA Civ 966, [2010] RPC 6) and directed that such deficiencies can be rectified by the applicant under Article 10(3) after the date of application for the extension. In Otsuka Pharmaceuticals Company Limited. (BL O/98/15) the hearing officer found the application did not comply with article 8(1)(d) as it lacked a compliance statement resulting from the incomplete agreed PIP. In reference to obiter dicta in E I Du Pont Nemours & Co. [2009] EWCA Civ 966, [2010] RPC 6 the hearing officer determined this was an irregularity that could only be corrected before expiry of the
SPC.

SPM 8.11

When the certificate has been granted the request should not only should state its number on Form SP4 but must be accompanied by a copy of the granted certificate.

SPM 8.12

Except where it is immediately apparent, the applicant should also provide whatever information is necessary to enable the Comptroller to confirm that the product in question satisfactorily completed the agreed paediatric investigation plan and was consequently authorized in all Member States, e.g. where the medicinal product
has not been authorized through the centralised EMEA mechanism by providing a list of relevant national market authorisations for the medicinal product in all Member States that can be confirmed.

Article 9: Lodging of an application for a certificate

1. The application for a certificate shall be lodged with the competent industrial property office of the Member State which granted the basic patent or on whose behalf it was granted and in which the authorization referred to in Article 3(b) to place the product on the market was obtained, unless the Member State designates another authority for the purpose. The application for an extension of the duration of a certificate shall be lodged with the competent authority of the Member State concerned. 2. Notification of the application for a certificate shall be published by the authority referred to in paragraph 1. The notification shall contain at least the following information: (a) the name and address of the applicant; (b) the number of the basic patent (c) the title of the invention; (d) the number and date of the authorization to place the product on the market, referred to in Article 3(b), and the product identified in that authorization; (e) where relevant, the number and date of the first authorization to place the product on the market in the Community. (f) where applicable, an indication that the application includes an application for an extension of the duration. 3. Paragraph 2 shall apply to the notification of the application for an extension of the duration of a certificate already granted or where an application for a certificate is pending. The notification shall additionally contain an indication of the application for an extended duration of the certificate.

SPM 9.01

The competent industrial property office for the purposes of lodging an application for a certificate or an extension of a certificate in the UK is the Intellectual Property Office, irrespective of whether the basic patent is a UK patent or a European Patent (UK).

[ All new applications for certificates are referred to an examiner. Upon receipt of an application a filing receipt is issued. ]

SPM 9.02

r.44(7) is also relevant

The information prescribed by Article 9(2) concerning an application for a certificate is taken from Form SP1, together with the generic name of the product when this appears in the market authorisation document but not on Form SP1, and is published in the Patents Journal, together with the date of lodging the application. For
applications lodged on or after 1 July 1994, the first authorisation for the purposes of Article 9(2)(e) is the first authorisation in a State which is a Contracting Party to the European Economic Area Agreement (see SP0.08-09 and also SPM8.02, SPM11.01 and SPM13.04. The application number (see SPM9.03), product in respect of which protection is sought (from Form SP1) and date of lodging the application are also entered in the register under the entry for the basic patent. However, no separate publication of the application corresponding to the ‘A’ publication of a patent application under the Patents Act 1977 is made.

SPM 9.02.1

Article 9(3) requires that the information prescribed by Article 9(2) is also published in the Patents Journal for an application for an extension. Any additional ArtsM 8, 10(3) (ArtsP8, 10(3)) information necessary will be taken from Form SP4.

[An examiner arranges the publication in the Journal and the entry in the register. ]

SPM9.03

Applications are numbered in a yearly sequence, eg SPC/GB93/001.

The granted certificate retains this number, (see SPM10.19).

SPM 9.03.1

Applications for extensions will also be given the number of the application for a certificate or the granted certificate it will extend as appropriate (see SPM10.19.1).

Article 10: Grant article of the certificate or rejection of the application for a certificate

1. Where the application for a certificate and the product to which it relates meet the conditions laid down in this Regulation, the authority referred to in Article 9(1) shall grant the certificate. 2. The authority referred to in Article 9(1) shall, subject to paragraph 3, reject the application for a certificate if the application or the product to which it relates does not meet the conditions laid down in this Regulation. 3. Where the application for a certificate does not meet the conditions laid down in Article 8, the authority referred to in Article 9(1) shall ask the applicant to rectify the irregularity, or to settle the fee, within a stated time. 4. If the irregularity is not rectified or the fee is not settled under paragraph 3 within the stated time, the authority shall reject the application. 5. Member States may provide that the authority referred to in Article 9(1) is to grant certificates without verifying that the conditions laid down in Article 3(c) and (d) are met. 6. Paragraphs 1 to 4 shall apply mutatis mutandis to the application for anextension of the duration.

SPM 10.01

SPM 10.01

ArtsM 8, 10(3), ArtsP8, 10(3) is also relevant

An initial examination for formal matters is carried out to determine whether the application is in the required form, (including the requirements of rule 14 of and Schedule 2 to the Patents Rules 2007 as to size and presentation of documents), and accompanied by the prescribed fee (see SPM8.01); was lodged within the period prescribed by Article 7 (see SPM7.01); contains the information prescribed by Article 8(1)(a) (see SPM8.02-03); is accompanied by a copy of the (or each) first UK product licence (see SPM8.04-04.1;contains, where appropriate, information regarding the first authorisation in the Community and a copy of the relevant notice (see SPM8.05); and whether the basic patent was in force and a marketing authorisation was granted by the date that the SPC application was lodged, it being confirmed by the CJEU in C-567/16 that the latter requirement is not “an irregularity” that can be cured having regard to Article 10(3).

[ A formalities examiner in PD carries out the examination. ]

SPM 10.02-03

[Deleted]

Substantive examination of an application for a certificate

SPM 10.04

ArtM 3(a), (ArtP3(1)(a)), ArtM 3(b) (ArtP3(1)(b)), ArtM 3(c), (ArtP3(1)(c))is also relevant

A substantive examination is also carried out to determine whether the following conditions of Article 3 were complied with at the date of the application: the product is protected by the basic patent;

a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC (see SPM2.01);

the product has not already been the subject of a certificate. (The examiner carries out a search of certificates granted in the UK in order to establish this.) Generally, the substantive examination is carried out at the same time as the formalities examination, and all objections arising are reported to the applicant in a single letter
(see SPM10.12). If the basic patent has already expired or is about to expire, substantive examination should be carried out as a matter of urgency, in order to avoid delay in the entry into force of the certificate. Substantive examination may however be deferred in cases where the examiner considers it likely that the application may not be able to meet a formal objection.

[ A substantive examiner carries out the examination. ]

SPM 10.04.1

PA 1977, s.21 is also relevant

The applicant may request accelerated examination giving a reasoned statement for the request. If allowed, the applicant is warned that, even when the application is found to be in order for grant at an earlier date, grant will not occur until a period of at least three months has elapsed from the date of publication of the notice of
filing of the application in the Patents Journal to allow for third-party observations.

SPM 10.05

ArtsM 3(d),10(5), (ArtsP3(1)(d), 10(5)) is also relevant

Although no search is at present carried out to establish whether the authorisation specified was the first authorisation to place the product on the market in the UK as a medicinal product, the examiner should also consider whether this requirement is met where there is reason to do so (eg on the basis of information
supplied by the applicant, observations by a third party (see SPM10.06) or information in another application for the same product). See also Draco AB’s SPC Application [1996] RPC 417.

SPM 10.06

PA 1977, s.21, sch 4A, para 4 is also relevant

Any observations by a third party, on the question whether the application meets the conditions of the Regulation should be considered by the examiner as in the case of an application for a patent. However, as in the case of a patent application such observations must be in writing and must be made before a
certificate is granted.

SPM 10.07

r.82(1)(a) is also relevant

Where the examiner requires further information in order to make any determination, the applicant should be required to furnish this within a prescribed period.

Formalities examination of an application for an extension

SPM 10.08

ArtsM 8, 10(6) is also relevant

An initial examination for formal matters is carried out to determine whether the application:

is in the required form, (including the requirements of rule 14 of and Schedule 2 to the Patents Rules 2007 as to size and presentation of documents), and accompanied by the prescribed fee (see SPM8.07);

was lodged within the period prescribed by Article 7 (see SPM7.02);

contains the information prescribed by Article 8 (see SPM8.08);

is accompanied by a copy of the statement indicating compliance with an agreed paediatric investigation plan as referred to in Art 36(1) of Regulation (EC) No 1901/2006 as prescribed by Article(1)(d)(i) (see SPM8.09);

contains proof that the product has been authorized in all Member States by an authorisation issued by the EMA or by national authorisations granted by each Member state as prescribed by Article(1)(d)(ii) (see SPM8.10);

where an application for a certificate is pending a reference to the certificate already filed as prescribed by Article 8(2) (see SPM8.08);

where a certificate is granted a copy of the certificate already granted as prescribed by Article 8(3) (see SPM8.11);

[ A formalities examiner in PD carries out the examination. ]

Substantive examination of an application for an extension

SPM 10.09

ArtsPd 36(1), (2)ArtPd 36(3)ArtPd (5) is also relevant

A substantive examination is also carried out to determine whether, at the date of the application, it entitles the holder of the patent or certificate to the reward set out in Art 36(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council. The examiner may seek to establish that:

the marketing authorisation identified includes the required statement indicating the compliance with an agreed paediatric investigation plan;

the product is authorized in all Member States;

the product has not already been the subject of one of the alternative rewards set out in Regulation (EC) No 1901/2006 of the European Parliament (see SPM 8.13).

Generally, the substantive examination is carried out at the same time as the formalities examination and at the same time as the pending application for a certificate, if appropriate, and all objections arising are reported to the applicant in a single letter (see SPM10.12).

[ A substantive examiner carries out the examination. ]

SPM 10.10

PA 1977, s.21, sch 4A, para 4 is also relevant

Any observations by a third party, on the question whether the application meets the conditions of the Regulation should be considered by the examiner as in the case of an application for a patent. However, as in the case of a patent application such observations must be in writing and must be made before an extension is granted.

SPM 10.11

r.82(1)(a) is also relevant

Where the examiner requires further information in order to make any determination, the applicant should be required to furnish this within a prescribed period.

Examination report

SPM 10.12

ArtsM10(2), 10(3), 10(4), (ArtsP 10(2), 10(3), 10(4)), r.108is also relevant.

Where it appears to the examiner that formal objections arise, and/or that any of the conditions of Article 3 is not met or that the holder of the patent or certificate is not entitled to the reward set out in Art 36(1) of Regulation (EC) No 1901/2006, the applicant should be informed accordingly and allowed a specified period
(generally four months for the first report, two months for the second and two months for the third) for reply. As in the case of formal or substantive examination of an application for a patent, this period may be extended at the request of the applicant. In Medeva BV v The Comptroller General of Patents [2010] EWHC 68 (Pat), [2010] RPC 20, Kitchin J (at paragraph 42 of his decision) confirmed that an examination report in respect of an SPC application is not a decision against which an appeal can properly be filed under s.97 of the Patents Act 1977.

SPM 10.12.1

Where an application is not in the required form, does not contain all of the required particulars and documents and/or is not accompanied by the prescribed fee, the filing date will not be lost if the applicant rectifies the irregularity or settles the fee within the specified period. If the applicant wishes to extend this period, he should
request this in writing before the period expires otherwise the application may be rejected under Article 10(4). For an application for an extension of the duration of a certificate, Jacob LJ directed in E I Du Pont Nemours & Co. [2009] EWCA Civ 966, [2010] RPC 6 that failure to comply with the provisions of Article 8(d) at the time of
submitting the application for an extension is an irregularity which may be cured after the date of application under Article 10(3).

Amendment and correction

SPM 10.13

The details on Form SP1 or SP4 may be amended or corrected in response to the examination report.

SPM 10.14

r.105 is also relevant

Where a proposed correction affects the details of application or grant which have already been published (see SPM9.02, SPM11.01), the details of the correction will also need to be published. In such cases a request to correct should be made in writing identifying the proposed correction. If the Office considers that the correction is allowable, details will be advertised in the Patents Journal.

SPM 10.14.1

Post-grant amendment of an SPC grant certificate may be permitted under Section 27 of the Patents Act 1977 (which applies by virtue of Schedule 4A to the Patents Act 1977). Questions concerning this practice were referred to the CJEU in Actavis Group and Actavis UK v Boehringer Ingelheim Pharma [2013] EWHC 2927
(Pat) however in C-577/13 Actavis Group PTC EHF, Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG these questions were not answered (see also SPM3.02.1, SPM3.02.5).

SPM 10.15

r.31 is also relevant

Where, before a certificate or extension has been granted, an applicant desires to amend Form SP1 or SP4 other than in response to an official objection (eg to add details of further relevant authorisations of which he has become aware) the amendment should be formally requested in writing. For rectification of the duration of
an SPC following decision BLO/418/13 (see SPM 8.03.1, SPM 13.05.1.

Re-examination

SPM 10.16

Where the applicant has amended or corrected the application, and/or made submissions in response to any objection to formal or substantive matters raised by the examiner, the application should be re-examined as soon as possible. If formal objections have been met, any deferred substantive examination should now be carried out. Where the examiner is still not satisfied that the conditions of the Regulation are met, either the outstanding objection(s) should be pursued in further correspondence, by telephone or at an interview, or the rejection procedure (see SPM10.17) should be initiated. Unlike the case of patent applications, there is no overall period within which an application for a certificate or certificate must be in order for grant. However, where the basic patent has already expired or is about to expire, re-examination should be carried out as a matter of urgency see SPM10.04).

Rejection of application

SPM 10.17

ArtM 18, (ArtP 17) is also relevant

Where the applicant has not replied to objections raised by the examiner in respect of formal or substantive matters, or the examiner having considered any amendments, corrections and/or submissions made by the applicant in response is still not satisfied that the applicant fully meets the conditions of the Regulation, the
applicant should be informed in an official letter of the examiner’s opinion and the reasons therefor, and that accordingly, unless the applicant requests to be heard in the matter, the Comptroller proposes to reject the application under Article 10.2 and/or 10.4 as appropriate. As in the case of an application for a patent, any hearing will be taken by a senior officer of the Office acting for the Comptroller and any adverse decision will
be subject to appeal to the Patents Court.

SPM 10.17.1

In British Technology Group Ltd’s SPC Application [1997] RPC 118, where it had been found that a valid product licence had not been granted, the Hearing Officer went on to refuse permission to keep the application open until the time that the applicants provided a valid authorisation in accordance with Article 3(b). To do
otherwise would put third parties at a considerable disadvantage. The correct procedure was to file a fresh application when all the requirements of the Regulation could be met, particularly the provision of a valid market authorisation. Article 3(c) is then not contravened because the first filed application has not been granted (see SPM3.03.1).

Withdrawal of application

SPM 10.18

PA 1977, s.14(9) is also relevant

An applicant may request in writing that his application is to be withdrawn at any time before a certificate or an extension is granted (see 14.199-208). Any such withdrawal may not be revoked. Whilst there appears to be no bar on an application being withdrawn before grant and subsequently being refiled at a later date, grant of such an application would depend upon the time limits of Article 7 being met.

Grant of certificate

SPM 10.19

When all requirements are met, a certificate is granted. In Merck and Co., Inc. (BL O/108/08) the hearing officer found that where an application met the requirements of Article 10 an SPC could be granted even if by applying the calculation of Article 13(1) it would never take effect at the end of the lawful term of the basic patent. The certificate retains the application number (see SPM9.03). It states the date of expiry of the maximum possible period of its duration and indicates that entry into force is dependent upon the payment of fees.

SPM 10.19.1

When an extension is granted on an application for a certificate or pending application then the certificate granted will indicate that the extension has been included in the maximum possible period of its duration. However, if the extension is granted for an existing certificate then an amended certificate stating the extended
maximum possible period of duration will be granted.

SPM 10.19.2

ArtM 3(a) is also relevant

The Medicinal Regulation does not require that grant of the certificate must occur before the basic patent expires, merely that the latter is in force on the date of filing. Consequently, grant is retrospective to the day after the basic patent expired (see SPM13.01. Therefore, when details of filing of an application are published in the Patents Journal, the public is put on notice that grant of the certificate may occur at any time subsequently.

[An examiner issues the certificate]

SPM 10.20

ArtM 19(2), (ArtP 18(2)) is also relevant

Opposition to the grant of a certificate or an extension is not allowed (see SPM19.06; see also SPM10.06, SPM10.10 for procedure where a third party makes observations in writing).

SPM 10.21

The Medicinal Regulation does not appear to invest the competent industrial property office of the Member State with the power to refuse to grant a certificate on the grounds that the marketing authorisation has lapsed or been withdrawn, provided that the requirement of Article 3(b) has been met. Action may, however, be considered after grant for declaration of lapse under Article 14(d) when the certificate has come into force see SPM14.02 to 14.05.

Article 11: Publication

1. Notification of the fact that a certificate has been granted shall be published by the authority referred to in Article 9(1). The notification shall contain at least the following information: (a) the name and address of the holder of the certificate; (b) the number of the basic patent; (c) the title of the invention; (d) the number and date of the authorization to place the product on the market referred to in Article 3(b) and the product identified in that authorization; (e) where relevant, the number and date of the first authorization to placethe product on the market in the Community; (f) the duration of the certificate. 2. Notification of the fact that the application for a certificate has been rejected shall be published by the authority referred to in Article 9(1). The notification shall contain at least the information listed in Article 9(2). 3. Paragraphs 1 and 2 shall apply to the notification of the fact that an extension of the duration of a certificate has been granted or of the fact that the application for an extension has been rejected. The authority referred to in Article 9(1) shall publish, as soon as possible, the information listed in Article 5(5), together with the date of notification of that information. It shall also publish, as soon as possible, any changes to the information notified in accordance with point (c) of Article 5(2).

SPM 11.01

r. 44(7) is also relevant

The information prescribed by Article 11, including the generic name of the product when this appears in the market authorisation but not on original Form SP1 or Form SP4, is published in the Patents Journal, together with the date of grant or rejection. For applications lodged on or after 1 July 1994, the first authorisation for the
purposes of Article 11(1)(e) is the first authorisation in a State which is a Contracting Party to the European Economic Area Agreement see SP0.08-09 and also SPM8.02, SPM9-02 and SPM13.04. The certificate number see SPM9.03, product, date of grant or rejection and duration of a granted certificate and extension are also entered in the register under the entry for the basic patent.

[An examiner arranges the publication in the Journal and the entry in the register. ]

SPM 11.02

In both the Journal and the register:

the product is identified as that for which the certificate has been granted, and may differ from that published upon application see SPM9.02;

the duration of a granted certificate is identified by the date of expiry of the maximum period of duration as determined by Article 13 and if an extension has been granted.

SPM 11.03

A copy of the certificate of grant is retained on the file of the application which is open to public inspection. However, no separate publication of the certificate or an extension of a certificate corresponding to the ‘B’ publication of a patent under the Patents Act 1977 is made.

SPM11.04

Article 11(4) was introduced by Regulation (EU) 2019/933 and requires the Office to publish, as soon as possible, the information provided by manufacturers intending to make generic or biosimilar versions of SPC-protected medicines under the manufacturing waiver; the information to be provided and the form in which it is provided is discussed at SPM5.10-11. The Office will publish such information in the electronic Patents Journal under the entry for the basic patent. In addition, this information will also be published under the entry for the basic patent on Ipsum.

[An examiner arranges the publication in the Journal and on Ipsum. ]

Article 12: Annual fees

1. Member States may require that the certificate be subject to the payment of annual fees. 2. Member States may require that the notifications referred to in points (b) and (c) of Article 5(2) be subject to the payment of a fee.

Annual fees

SPM 12.01

Entry into effect of the certificate is subject to the payment of annual fees in accordance with paragraph 5 of Schedule 4A to the Patents Act 1977 and rule 6 of the 2007 Fees Rules. (See paragraph 128B.10)

SPM 12.01.1

The Regulation does not appear to invest the competent industrial property office of the Member State with the power to refuse to allow a certificate to come into force on the grounds that the marketing authorisation has lapsed or been withdrawn, provided that the requirement of Article 3(b) had been met. Action may,
however, be considered later for declaration of lapse under Article 14(d), after the certificate has come into force see SPM14.02 to 14.05.

[An examiner deals with all matters relating to the payment of annual fees. ]

Effective period of the certificate

SPM 12.02

r.116(5) is also relevant

The certificate holder is required to pay annual fees for the effective period of the certificate. This is the maximum period of duration of the certificate, as defined by Article 13, less any period for which the certificate holder does not desire it to have effect.

SPM 12.03

ArtM 13(1), 13(3), (ArtP13(1)), r.116(5) is also relevant

The effective period must consist of a single period starting the day after the expiry of the basic patent. Where the certificate holder opts for an effective period less than the maximum period of the certificate, this period cannot subsequently be extended. This follows from rule 116(5), which states that “once the certificate has taken effect no further fee may be paid to extend the term of the certificate unless an application for [a paediatric extension] is made…”. In Genentech Inc v The Comptroller General of Patents [2020] EWCA Civ 475, it was argued that this rule allows an applicant who has paid a for period and less than the maximum duration to pay additional annual fees if they file an application for a paediatric extension. The Court rejected this argument and held that the correct interpretation of r.116(5) is that, once the SPC has taken effect, no further fee may be paid to extend the certificate except (if necessary) the application fee for a paediatric extension.

Date for payment

SPM 12.04

r.116(2)(a) is also relevant

The date by which the annual fees are payable is normally the date on which the certificate is due to take effect at the end of the lawful term of the basic patent. The annual fees may not be paid earlier than three months before that date.

SPM 12.05

r.116(2)(b) is also relevant

However, where the certificate is granted later than three months before the expiry of the basic patent, the date for the payment of annual fees is three months after the grant date of the certificate.

Calculation of annual fees

SPM 12.06

Fr.6(2)is also relevant

An annual fee is payable for each year of the effective period of the certificate. Any final period of less than 12 months is treated as a whole year, eg an effective period of 3 years 6 months will therefore require the payment of 4 years’ annual fees.

SPM 12.07

Fr.6(2), Fr. 6(3) is also relevant

The annual fees are payable as a single cumulative amount as a condition of the certificate taking effect. The level of the fees is that applying on the date the certificate is due to take effect or, paid if earlier, the actual date of payment. Currently the fees for the five successive years are £600, £700, £800, £900 and £1,000. No additional fees are payable for an extension to a certificate to take effect.

Notification that payment is due

SPM 12.08

r.116(3) is also relevant

The certificate holder is notified not later than two months beforehand of the date on which the fees are payable and of the level of the fee payable in respect of each year. Where the certificate is granted later than three months before the expiry of the basic patent, this notification is sent with the granted certificate.

SPM 12.09

r.116(8) is also relevant

The notification is sent to the address for service provided on Form SP1, or any address replacing it. It is also sent to the following address, where different:

(i) the United Kingdom address specified for the sending of renewal reminders on payment of the last renewal fee relating to the basic patent, or any address replacing it; or

(ii) where there is no address under (i), any address for service entered in the register in respect of the basic patent.

Procedure for payment of fees

SPM 12.10

r.116(5) is also relevant

The payment of the total sum of the annual fees for the whole effective period should be accompanied by Form SP2 (but see SP18.04). There is no electronic payment system for the payment of fees for SPCs BL O/252/11, Tulane Education Fund v Comptroller General of Patents [2012] EWHC 932 (Pat)); see also SPM12.14.1 and SPM14.01.1. The Court of Appeal rejected the appeal that this regime is ultra vires, see Tulane Education Fund v Comptroller General Of Patents [2013] EWCA Civ 890 [2014] R.P.C. 10. The holder of the certificate should state on this Form the date on which fees are payable (the “due date”), the desired effective period of the certificate, and the amount of fees paid in consequence. In Genentech Inc v The Comptroller General of Patents [2020] EWCA Civ 475 the Court of Appeal rejected the argument that the applicant should not be able to choose and pay fees for a shorter period of protection than the maximum duration provided by Article 13. Instead, the Court held that the applicant may elect to take the certificate for a shorter period by paying annual fees for less than the full term if they wished, but if they did this they would not be able to subsequently top up these fees to extend the effective period.

SPM 12.11

The Office confirms the payment of fees and the date of the expiry of the effective period by sending a certificate of payment to the address given in Section 6 of Form SP2. If the holder wishes this certificate to be sent to a different address, he should indicate this at Section 7 of Form SP2 and give the address on a separate sheet.

Late payment of fees

SPM 12.12

r.116(6) is also relevant

Where the annual fees are outstanding, the holder of the certificate is notified within 6 weeks of the due date.

SPM 12.13

Fr.6(4) is also relevant

Annual fees may be paid up to six months after the due date, subject to a late payment fee of one-half of the amount of the unpaid fees. If paying between 30 July 2020 and 31 March 2021, no late payment fee is required. The six-month period for payment cannot be extended. Once paid, the annual fees are treated as having been filed on the due date.

Non payment of fees

SPM 12.14

ArtM 14(c), (ArtP 14(c)) is also relevant

If the fees are not paid by the due date or in accordance with SPM12.13, the certificate is treated as having lapsed on the date of expiry of the basic patent and so does not take effect. The holder is notified accordingly.

SPM 12.14.1

In BL O/252/11 (The Administrators of the Tulane Education Fund) the hearing officer confirmed that an SPC could not be brought into effect where the applicant had failed to pay the prescribed fee within the prescribed time period or within the six months following the end of the prescribed period. In dismissing the applicant’s
appeal at the Patents Court, Roger Wyland QC clarified that neither Rule 107(3) of the Patents Rules 2007 or Section 28 of the Patents Act 1977 could be used to bring the SPC into effect (Tulane Education Fund v Comptroller General of Patents [2012] EWHC 932 (Pat)) see also SPM12.10 and SPM14.01.1.

Fees for manufacturing waiver notifications

SPM 12.15

Article 12(2) was introduced by Regulation (EU) 2019/933 and allows the Office to charge a fee for notifications under Art. 5(2)(b) and (c); as discussed in SPM5.10-11 these notifications are provided by manufacturers intending to make generic or biosimilar versions of SPC-protected medicines under the manufacturing waiver. The Office does not charge a fee for such notifications at present.

Article 13: Duration of the certificate

1. The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorization to place the product on the market in the Community, reduced by a period of five years. 2. Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect. 3. The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case where Article 36 of Regulation (EC) No 1901/2006 applies. In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once. 4. Where a certificate is granted for a product protected by a patent which, before 2 January 1993, had its term extended or for which such extension was applied for, under national law, the term of protection afforded under this certificate shall be reduced by the number of years by which the term of the patent exceeds 20 years.

SPM 13.01

ArtM 12, (ArtP12), PA 1977, Sch4A, para 5 is also relevant

A certificate takes effect at the end of the lawful term of the basic patent, provided that:

the basic patent has not previously lapsed or been revoked;

the annual fees are paid in time see 12.04-05.

SPM 13.02

Article 13 defines the maximum period of duration of the certificate. As confirmed by the Court of Appeal in Genentech Inc v The Comptroller General of Patents [2020] EWCA Civ 475, the effective period may however be less than this maximum period if the certificate holder opts to pay fees for a lesser period, the effective period may however be less than this maximum period if the certificate holder opts to pay fees for a lesser period see SPM12.02-03 and SPM12.10(#refSPM12-10).

SPM 13.03

r.44(7) is also relevant

The date of entry into force of the certificate and the date of expiry of the effective period see SPM12.02 are published in the Patents Journal and entered in the register under the entry for the basic patent.

[An examiner arranges the publication in the Journal and the entry in the register. ]

Calculation of the duration of the certificate

SPM 13.04

Since the term of the basic patent is 20 years, the maximum period defined by Article 13 is either:

a period of 15 years from the date of the first authorisation to place the product on the market in the Community; or

a period of 5 years from the date on which it takes effect,

whichever is the lesser see SPM18.02 for appeal where duration is incorrectly calculated.) For applications lodged on or after 1 July 1994, the period of 15 years runs from the date of the first authorisation to place the product on the market in a State which is a Contracting Party to the European Economic Area Agreement. The European Court of Justice in Novartis AG & University College London & Novartis AG and Institute of Microbiology v Comptroller General of Patents, Designs and Trade Marks for the UK and Ministre de l’Économie v Millennium Pharmaceuticals Inc. (ECJ Joined Cases C-207/03 and C-252/03) [2005] RPC 33 held that when a Swiss authorisation automatically recognized in Liechtenstein was the first in the EEA it constituted the first authorisation in the Community for the purposes of Article 13 see also SP0.08-09, SPM8.02, SPM9.02 and SPM11.01. In AstraZeneca AB BL O/146/12, the hearing officer found that when a Swiss authorisation automatically recognized in Liechtenstein was the first in the EEA it constituted the first authorisation in the Community for the purposes of Article 13 even if that authorisation was suspended at a later date. This decision has been appealed and questions referred to the CJEU for a preliminary ruling in C-617/12. The court determined the questions by reasoned order referring to Novartis and others C-207/03 and C-252/03 see also SPM 8.02. The period of 15 years also runs from the first pharmaceutical or veterinary authorisation for such a State irrespective of whether the first authorisation under Article 3(b) to place the product on the market in the UK is pharmaceutical or veterinary. Thus, in Farmitalia Carlo Erba S.r.l’s SPC Application (1) [1996] RPC 111 the hearing officer held that on the plain meaning of Article 13(1), an Italian veterinary authorisation of 1987 and not a Netherlands pharmaceutical authorisation of 1992 constituted the first authorisation in the Community, in a case where the Article 3(b) authorisation was pharmaceutical. Similarly, in Pharmacia Italia SpA v Deutsches Patentamt [2005] RPC 27 (ECJ Case C-31/03), the authorisation as a veterinary product was held by the ECJ to be the first market authorisation in the Community for an SPC application made on the basis of a medicinal product for human use. The ECJ therefore ruled that the grant of the certificate was precluded by the veterinary authorisation as this took place before the date specified under Article 19(1) of Regulation (EEC) No 1768/92. In Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents [2011] EWCA Civ 228, [2011] RPC 19, the Court of Appeal referred questions to the Court of Justice of the European Union (C-130/11, Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents) concerning the interpretation of the phrase “the first authorisation to place the product on the market in the Community” in Article 13 (along with questions relating to Article 3(d)). In answering the referred questions, the CJEU stated that Article 13(1) must be interpreted as referring to a:

marketing authorisation of a product which comes within the limits of protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate

SPM 13.04.1

The question of whether the marketing authorisation which must be identified under Article 13(1) must be compliant with Council Directive 65/65/EEC or whether any marketing authorisation that enables the product to be placed on the market in the Community or EEA should count for the calculation of the duration of the
SPC has been considered by the Court of Justice of the European Union in two separate cases (Generics (UK) Ltd v Synaptech Inc [2009] EWHC 659 (Ch), referred to the CJEU in Generics (UK) Ltd v Synaptech Inc, C-427/09; and Synthon v Merz Pharma [2009] EWHC 656 (Pat), referred to the CJEU in Synthon BV v Merz Pharma Gmbh & Co KG, C-195/09). In both cases the court held that a product which was placed on the
market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65/EEC and, in particular, without undergoing safety and efficacy testing, is not within the scope of the Regulation, and may not be the subject of a supplementary protection certificate. It went on to confirm that any SPC granted for a product which was outside the scope of
the Regulation was invalid see also SPM2.01.

SPM 13.04.2

Following the accession of the ten new member states to the Community on 1 May 2004, and subsequent enlargements on 1 January 2007 and 1 July 2013, a national authorisation granted in one of these states from the accession date is considered to be valid in the Community. However, such authorisations would
be used to determine the length of a certificate only if no other marketing authorisation had already been granted in the European Economic Area (see SP0.08.1).

SPM 13.05

It follows from Article 13 that a certificate would have no effective duration in the case in which the date of the first authorisation to place the product on the market is not more than five years from the filing date of the basic patent. Previously, no certificate has been granted in such cases. Instead the applicant has been informed that, subject to any comments which he wishes to make, the Office proposes to treat the application as withdrawn. However, the hearing officer found in Merck and Co., Inc. BL O/108/08 that where an application did meet the requirements of Article 10 an SPC can be granted even if it would never take effect and its term could not extend beyond the end of the lawful term of the basic patent unless it was extended under Article 13(3). An equivalent case arising from the German Patent and Trade Mark Office was referred to the CJEU (C-125/10 – Merck & Co Inc v Deutsche Patent- und Markenamt) where it was found that an SPC should be granted where it would have no positive term unless extended under Article 13(3) and that the duration of such an extension should start “from the date determined by deducting from the patent expiry date the difference between five years and the duration of the period which elapsed between the lodging of the patent application and the grant of the first marketing authorisation”.

SPM 13.05.1

The duration of an SPC will be calculated having regard to the date of grant of the first authorisation unless evidence is provided to substantiate a different date of legal effect, see also SPM8.03.1. Following decision BLO/418/13 (Genzyme Corporation) in the situation where the earliest authorisation is one granted by a decision of the European Commission following a favourable opinion from the EMA the office will calculate the duration of the SPC according to Article 13(1) from the date of notification. A suitable excerpt from the OJEU may be provided as evidence of the notification date. see SPM 8.03.1 and 10.15. the relevance of the “date of notification” in these circumstances has been confirmed by the CJEU in Seattle Genetics Inc. v Österreichisches Patentamt C-471/14. Applicants may apply to rectify the duration of an SPC, in this regard, until the certificate (or extensions thereto) expires, in accordance with the practice notice published on 20 November 2013. This practice has been confirmed by judgment of the court in Incyte Corporation v Szellemi Tulajdon Nemzeti Hivatala C 492/16.

Calculation of maximum duration period

SPM 13.06

The Office will generally invite the applicant to confirm agreement with the maximum expiry date calculated by the Examiner on the basis of the facts presented on Form SP1 (see SPP17.01).

Duration of an extension

SPM 13.07

An extension of a certificate increases the period of duration of the certificate by six months. However, as held by the Court of Appeal in Genentech Inc v The Comptroller General of Patents [2020] EWCA Civ 475, this extension applies to the duration of the SPC as laid down in paragraphs (1) and (2) of Article 13. If the applicant has chosen a shorter effective period by paying fees for only part of the maximum duration, this shorter period cannot be extended.

Article 14: Expiry of the certificate

The certificate shall lapse: (a) at the end of the period provided for in Article 13; (b) if the certificate holder surrenders it; (c) if the annual fee laid down in accordance with Article 12 is not paid in time; (d) if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of the appropriate authorization or authorizations to place on the market in accordance with Directive 2001/83/EC or Directive 2001/82/EC. The authority referred to in Article 9(1) may decide on the lapse of the certificate either of its own motion or at the request of a third party.

SPM 14.01

ArtM 17, (ArtP 16) r.44(7) is also relevant

Notification of lapse is published in the Patents Journal, and is also entered in the register under the entry for the basic patent. See also SPM17.01

[An examiner arranges the publication in the Journal and the entry in the register]

SPM 14.01.1

In BL O/252/11 (The Administrators of the Tulane Education Fund) the hearing officer held that an SPC could not be brought into effect where the applicant had failed to pay the prescribed fee within the prescribed time period or within the six months following the end of the prescribed period. In dismissing the applicant’s appeal
at the Patents Court, Roger Wyland QC clarified that neither Rule 107(3) of the Patents Rules 2007 or Section 28 of the Patents Act 1977 could be used to bring the SPC into effect (Tulane Education Fund v Comptroller General of Patents [2012] EWHC 932 (Pat); see also SPM12.10 and SPM12-14-1.

SPM 14.01.2

If the applicant has chosen to pay annual fees for only part of the maximum duration and has thereby selected a shorter effective period (see SPM12.02-03 and SPM12.10), then the SPC will lapse under Art.14(c) at the end of this period (Genentech Inc v The Comptroller General of Patents [2020] EWCA Civ 475).

Declaration of lapse under Article 14(d)

SPM 14.02

PR part 7 is also relevant

The Comptroller may declare that a certificate has lapsed under Article 14(d), either on the application of any person, or on his own initiative.

SPM 14.03

PR part 7 is also relevant

An application by a third party to the Comptroller for a declaration of lapse under Article 14(d) should be made on Form SP3 in duplicate (but see SPM19.04) with duplicate statement of grounds, this action carries a fee of £50. This starts proceedings before the comptroller to determine the matter, the procedure for which is discussed at paragraphs 123.05 – 123.05.13.

[ Applications on Form SP3 for declaration of lapse are referred to Tribunal Section. ]

SPM 14.04

PR part 7 is also relevant

Where the Office becomes aware, other than by an application on Form SP3, of the withdrawal of the appropriate authorisation(s) to place on the market a product covered by a certificate, the certificate holder is informed of the withdrawal in an official letter and that, subject to any observations which the holder may make within a specified period (generally two months), the Comptroller proposes to declare that the certificate has lapsed.

SPM14.05

ArtM18 (ArtP 17) is also relevant

Any decision by the Comptroller, whether on the application of a third party or on his own initiative, is subject to appeal to the Patents Court.

Restoration of certificate after lapse under Article 14(d)

SPM 14.06

Where a new authorisation to place the product on the market is granted, a certificate which has lapsed under Article 14(d) automatically takes effect again from the date of the new authorisation (unless the certificate has also been declared invalid or lapsed on any other ground, eg surrender).

SPM 14.07

r.44(7) is also relevant

The certificate-holder should advise the Office of the grant of the new authorisation. Notice of the termination of lapse under Article 14(d) is then inserted in the Patents Journal see SPM17.01.

SPM 14.08

PR part 7 is also relevant

Any person may apply to the Comptroller for a declaration that the ground for lapse under Article 14(d) no longer exists. This starts proceedings before the comptroller to determine the matter, the procedure for which is discussed at paragraphs 123.05 – 123.05.13.

Surrender of certificate

SPM 14.09

r. 42 is also relevant

Any offer by the holder to surrender a certificate should be made in writing. No fee is at present required. The offer is examined in accordance mutatis mutandis with the procedure under s.29 of the Patents Act 1977 for the surrender of patents (see 29.02-07).

[ Offers on Patents Form 2 to surrender a certificate are referred to Tribunal Section. ]

SPM 14.10

r.106(5)(6)(8) is also relevant

If a certificate is surrendered, a remission of annual fees is made for any complete effective year(s) subsequent to the date of surrender. Thus, if a certificate having a term of 4 years 3 months (for which five years’ fees would have been paid) is surrendered after 3 years 9 months, the fifth year’s fee is remitted.

SPM 14.11

No remission is made if a certificate lapses under Article 14(d) unless the holder first surrenders the certificate. This is because lapse under Article 14(d) may not be permanent whereas once surrendered a certificate cannot be re-instated.

SPM 14.12

The district court of The Hague referred questions concerning whether surrender of a certificate has retrospective effect in Georgetown University and Octrooicentrum Nederland (Dutch Patent Office) C-484/12, but given the responses to other questions referred the questions on surrender did not need to be answered.

Article 15: Invalidity of the certificate

1. The certificate shall be invalid if: (a) it was granted contrary to the provisions of Article 3; (b) the basic patent has lapsed before its lawful term expires; (c) the basic patent is revoked or limited to the extent that the product for which the certificate was granted would no longer be protected by the claims of the basic patent or, after the basic patent has expired, grounds for revocation exist which would have justified such revocation or limitation. 2. Any person may submit an application or bring an action for a declaration of invalidity of the certificate before the body responsible under national law for the revocation of the corresponding basic patent.

SPM 15.01

ArtM 17, (ArtP16) r.44(7) is also relevant

Notification of invalidity of a certificate is published in the Patents Journal and is also entered in the register under the entry for the basic patent (see SPM17.01).

[An examiner arranges the publication in the Journal and the entry in the register.]

SPM 15.02

PR part 7 is also relevant

An application for a declaration of invalidity of a certificate may be made to the Comptroller or the Court as in the case of an application for revocation of a patent.

SPM 15.03

In Hässle AB v Ratiopharm (ECJ Case C-127/00)[2003] ECR I-14781 the European Court found that where a certificate had been granted contrary to the requirements of Article 19 of Regulation (EEC) No 1768/92 the certificate was invalid under Article 15. The Court held that this was the case even if it was not possible to
infer that the list of grounds of invalidity of a certificate found in Article 15(1) was not exhaustive also see SPM20.02.

SPM 15.04

In Generics (UK) Limited (trading as Mylan) and Novartis AG, [2011] EWHC 2403 (Pat) Floyd J found the claims of the basic patent filed in support of an SPC to be obvious and invalid, and consequently also found the associated SPC be invalid.

Application to the Comptroller

SPM 15.05

An application to the Comptroller for a declaration of invalidity of a certificate should be made on Form SP3 but see SPM19.04. The procedure is the same as in the case of an application for a declaration of lapse (see SPM14.03. As occurs from time to time judgments of the Courts or CJEU will result in some granted SPCs being invalid. The office will not however re-examine granted SPCs in the period between their dates of grant and coming into force. An interested party may however seek a declaration of invalidity. Alternatively a non-binding opinion may be sought in this regard see Section 74A.

[Applications on Form SP3 for declaration of invalidity are referred to Tribunal Section.]

Article 16: Revocation of an extension of the duration

1. The extension of the duration may be revoked if it was granted contrary to the provisions of Article 36 of Regulation (EC) No 1901/2006. 2. Any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent.

Article 17: Notification of lapse or invalidity

1. If the certificate lapses in accordance with point (b), (c) or (d) of Article 14, or is invalid in accordance with Article 15, notification thereof shall be published by the authority referred to in Article 9(1). 2. If the extension of the duration is revoked in accordance with Article 16, notification thereof shall be published by the authority referred to in Article 9(1).

SPM 17.01

r.44(7), ArtM 14(a), ArtP 14(a) is also relevant

The notifications required by Article 17, and also notification of termination of lapse under Article 14(d) see SPM14.07 and notification of lapse at the end of the effective period of the certificate see SPM14.01, are published in the Patents Journal. These events are also entered in the register under the entry for the basic patent.

[An examiner arranges the publication in the Journal and the entry in the register.]

Article 18: Appeals

The decisions of the authority referred to in Article 9(1) or of the bodies referred to in Articles 15(2) and 16(2) taken under this Regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents.

SPM 18.01

PA 1977, s.97 ArtM 13(1) (ArtP 13(1)) is also relevant

Decisions taken by the Comptroller under the Regulation are open to appeal to the Patents Court in the same manner as decisions taken in respect of patents. In Medeva BV v The Comptroller General of Patents [2010] EWHC 68 (Pat), [2010] RPC 20, Kitchin J confirmed the procedural details for filing an appeal against an SPC rejection by the Intellectual Property Office also see SPM10.12.

[ Matters within the Office relating to appeals from decisions taken under the Regulation are dealt with by Tribunal Section.]

SPM 18.02

ArtsM 13(1),8.1(a)(iv)

Recital (17) of the Plant Protection Regulation see SPM0.04 has the effect that, from 8 February 1997 when said regulation came into force, Article 17 of Regulation (EEC) No 1768/92 (now Article 18 of the EC Medicinal Regulation) is additionally to be interpreted in accordance with Article 17(2) of the Plant Protection Regulation which states:

Article 17(2) [EC Plant Protection Regulation]

Appeals

The decision to grant the certificate shall be open to an appeal aimed at rectifying the duration of the certificate where the date of the first authorization to place the product on the market in the Community, contained in the application for a certificate as provided for in Article 8, is incorrect.

SPM 18.03

(ArtsP 13(1),8(1)(a)(iv))

Such an appeal may be lodged by the applicant or a third party. If the appeal results in a corrected maximum expiry date for the granted certificate the details will be notified to the public in the Patents Journal.

Article 19: Procedure

1. In the absence of procedural provisions in this Regulation, the procedural provisions applicable under national law to the corresponding basic patent shall apply to the certificate, unless that law lays down special procedural provisions for certificates. 2. Notwithstanding paragraph 1, the procedure for opposition to the granting of a certificate shall be excluded.

SPM 19.01

Procedural provisions applicable under national law to the corresponding basic patent apply to the certificate, unless: there are procedural provisions in the Regulation; or national law lays down special procedural provisions for certificates.

SPM 19.02

r.116, FSch 1, Fr.6(2), r.106(5),(6),(8), part 7, r.4, r.44(7) is also relevant.

In the UK such special procedural provisions are laid down in the 2007 Rules and the 2007 Fees Rules and govern:

the application and fee in respect of the application (Articles 8 and 9);

the certificate of grant (Article 10);

annual fees (Article 12);

declaration of lapse or invalidity of the certificate (Articles 14(d) and 15.1(a) and (c));

forms for use in connection with certificates and applications for certificates (Article 19.1); and

publication of certain details (Articles 9.2, 11.1, 11.2 and 17).

SPM 19.03

r.116, Fsch.1, Fr.6(2) is also relevant

In particular the Rules provide for four special Forms:

SP1 (Request for grant) see SPM8.01;

SP2 (Payment of annual fees) see SPM12.10;

SP3 (Application for decision of lapse or declaration of invalidity) see SPM14.03, SPM15.04 and SPM16.01;

SP4 (Application for an extension to the duration of a certificate) (see SP0.11);

and prescribe the fees payable thereon.

SPM 19.04

r.4(2) is also relevant

The requirement to use any of these Forms is satisfied by the use of a form which is acceptable to the Comptroller and contains the required information (such as a replica or photocopy of an official Form).

SPM19.05

r.4 is also relevant

For actions other than those covered by Form SP1, SP2, SP3 and SP4 the relevant Patent Forms should be used and the same fee (if any) paid.

SPM 19.06

It follows from Article 19.2 that opposition to the grant of a certificate is not allowed see SPM10.20.

Requests for information (caveats)

SPM 19.07

r.54 is also relevant

Insofar as rule 54 of the Patents Rules 2007 is applicable, information relating to certificates, applications for certificates, extensions of a certificate and applications extensions of a certificate is available upon request as in the case of patents and applications for patents. Paragraphs 5(a), 5(b), 6(a) and 6(d) of rule 54 appear to have no relevance to certificates and applications for certificates. Paragraph 6(c) appears applicable mutatis mutandis to the provision of information concerning the payment of annual fees see SPM12.10-12.13.

Documents open to public inspection

SPM 19.08

r.51(2)(b) is also relevant

Documents are normally made open to public inspection immediately after they are filed at (or sent to) the Office.

SPM 19.09

r.53 is also relevant

The person filing or sending a document (other than a Form SP1, SP2, SP3 or SP4), or any other person, may request within 14 days that the document be kept confidential (giving reasons). The comptroller may then direct that the document in question, or part thereof, should be treated as confidential. The document is not open to public inspection while the matter is being determined. Where a request is made to keep a document confidential but no reasons are given the person filing the document is requested to provide suitable reasons within a period of 14 days.

SPM 19.10

r.46, 48 is also relevant

Copies of any documents which are not treated as confidential are available upon request as in the case of documents relating to patents.

Extensions of time

SPM 19.11

r.108 is also relevant

In Abbott Laboratories’ SPC Application [2004] RPC 20 it was held that the six month time limit set out in Article 7 is extendable under r.110(1) of the Patents Rules 1995 (which is equivalent to r.108(1) of the Patents Rules 2007). There are no provisions in the Regulation relating to extension of the Article 7 time limit, and there are
no special provisions for such extensions laid down by national law. Hence the applicable provision governing any such extension of time is the appropriate procedural provision under national law corresponding to the basic patent. In Merck & Co., Inc. (BL O/035/09 the hearing officer found that the time limit set by the examiner for rectifying an irregularity in filing the required documents was extendable under r.108 (see SPM8.09). The Court of Appeal in E I Du Pont Nemours & Co. [2009] EWCA Civ 966, [2010] RPC 6 directed that the time periods for curing irregularities under Article 10(3) in an application for an extension of the duration of a certificate can be extended (see SPM8.09).

Article 20: Additional provisions relating to the enlargement of the community

Without prejudice to the other provisions of this Regulation, the following provisions shall apply: (a) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Bulgaria, provided that the application for a certificate was lodged within six months from 1 January 2007; (b) any medicinal product protected by a valid basic patent in the Czech Republic and for which the first authorisation to place it on the market as a medicinal product was obtained: (i) in the Czech Republic after 10 November 1999 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained, (ii) in the Community not earlier than six months prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained; (c) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Estonia prior to1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or, in the case of those patents granted prior to 1 January 2000, within the six months provided for in the Patents Act of October 1999; (d) a medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Cyprus prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained; notwithstanding the above, where the market authorisation was obtained before the grant of the basic patent, the application for a certificate must be lodged within six months of the date on which the patent was granted; (e) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Latvia prior to 1 May 2004 may be granted a certificate. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 May 2004; (f) any medicinal product protected by a valid basic patent applied for after 1 February 1994 and for which the first authorisation to place it on the market as a medicinal product was obtained in Lithuania prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months from 1 May 2004; (g) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Hungary, provided that the application for a certificate was lodged within six months from 1 May 2004; (h) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Malta prior to 1 May 2004 may be granted a certificate. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 May 2004; (i) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Poland, provided that the application for a certificate was lodged within six months starting no later than 1 May 2004; (j) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Romania. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 January 2007; (k) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Slovenia prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months from 1 May 2004, including in cases where the period provided for in Article 7(1) has expired; (l) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Slovakia after 1 January 2000 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or within six months of 1 July 2002 if the market authorisation was obtained before that date. (m) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2003 may be granted a certificate in Croatia, provided that the application for a certificate is lodged within six months from the date of accession.

SPM20.01

In the case of a product which was already authorised before entry into force of Regulation (EEC) No 1768/92 the transitional provisions of Article 19 of that regulation allowed for an application to be filed in the UK within six months of the date on which the Regulation entered into force, (ie filed on or before 2 July 1993) provided
that:

on that date the product was protected by a valid basic patent; and the first authorisation to place it on the market in the Community was obtained after 1 January 1985.

However the application must still have been filed before the basic patent expired. Such transitional provisions no longer exist in the EC Medicinal Regulation.

SPM20.02

ArtM 3(a), (ArtP 3(1)(a)) is also relevant

In Yamanouchi Pharmaceuticals Co. Ltd v Comptroller-General [1997] RPC 844 an application under Regulation (EEC) No 1768/92 had received its first authorisation to be placed on the market in the EC after 1 January 1985, but had not yet received an authorisation to be placed on the market in the UK. The Hearing Officer had declined to accept that the transitional provisions of Article 19 of Regulation (EEC) No 1768/92 obviated the need to comply with the requirements of Articles 3(b), 8(1)(a)(iv) and 8(1)(b) and accordingly refused the application for non-compliance with these Articles. On appeal the Patents Court (unreported judgment of 31 October 1994) decided to refer the matter to the European Court of Justice. Upholding the Hearing Officer’s decision, the European Court ruled that the regulation was intended to prevent the grant of SPCs whose duration varied from one Member State to another. In those circumstances, Article 19(1) of Regulation (EEC) No 1768/92 could not be construed as meaning that the existence of an authorisation in the Member State in which the SPC was sought was of no relevance. Under Articles 3(b) and 4 of the regulation, entitlement to an SPC was strictly linked to the existence of a marketing authorisation granted in the Member State in which the application was submitted and to the date of that application.
Accordingly, the grant of an SPC pursuant to Article 19 of Regulation (EEC) No 1768/92 was conditional on a valid authorisation to place the product on the market as a medicinal product having been granted in the Member State in which the application was submitted and at the date of the application. In Hässle AB v Ratiopharm (ECJ Case C-127/00) [2003] ECR I-14781 the European Court found that the first
authorisation referred to in Article 19(1) of Regulation (EEC) No 1768/92 meant the first authorisation required under the provisions on medicinal products within the meaning of Council Directive 65/65 (now Directive 2001/83/EC, see SPM3.03.1) and not to authorisations required for legislation on the pricing or reimbursement for medicinal products in a member state (also see SPM15.03).

Article 21: Transitional provisions

1. This Regulation shall not apply to certificates granted in accordance with the national legislation of a Member State before 2 January 1993 or to applications for a certificate filed in accordance with that legislation before 2 July 1992. With regard to Austria, Finland, and Sweden, this Regulation shall not apply to certificates granted in accordance with their national legislation before 1 January 1995. 2. This Regulation shall apply to supplementary protection certificates granted in accordance with the national legislation of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Malta, Poland, Slovenia and Slovakia prior to 1 May 2004 and the national legislation of Romania prior to 1 January 2007.

Article 21a: Evaluation

No later than five years after the date referred to in Article 5(10), and every five years thereafter, the Commission shall carry out an evaluation of Article 5(2) to (9) and Article 11 in order to assess whether the objectives of those provisions have been achieved, and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee. In addition to evaluating the impact of the exception of making for the purpose of export, special account shall be taken of the effects of making for the purpose of storing in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate on access to medicines and on public health expenditure, and of whether the waiver and in particular the period provided for in point (a)(iii) of Article 5(2) is sufficient to achieve the objectives referred to in Article 5, including public health.

SPM21A.01

Article 21a was introduced by Regulation (EU) 2019/933 and requires the European Commission to evaluate the provisions relating to the manufacturing waiver introduced by that Regulation (see SPM5.05-5.12 and SPM11.04) within five years of 1 July 2019 and every five years thereafter.

Article 22: Repeal

Regulation (EEC) No 1768/92, as amended by the acts listed in Annex I, is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II.

Article 23: Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States.

SPM23.01

The EC Medicinal Regulation was published in the Official Journal of the European Union on 16 June 2009. It therefore entered into force on 6 July 2009.

Annex 1: Repealed regulation with list of its successive amendments (referred to in Article 22)

Council Regulation (EEC) No 1768/92 (OJ L 182 2.7.1992, p. 1) Annex I, point XI.F.I. of the 1994 Act of Accession (OJ C 241 29.8.1994, p. 233) Annex II, point 4.C.II, of the 2003 Act of Accession (OJ L 236 23.9.2003, p. 342) Annex III, point 1.II, of the 2005 Act of Accession (OJ L 157, 21.6.2005, p. 56) Regulation (EC) No 1901/2006 of the European Parliament and of the Council, Only Article 52 (OJ L 378, 27.12.2006, p. 1)

Annex II: Correlation table
Regulation (EEC) No 1768/92	This Regulation
–	Recital 1
Recital 1	Recital 2
Recital 2	Recital 3
Recital 3	Recital 4
Recital 4	Recital 5
Recital 5	Recital 6
Recital 6	Recital 7
Recital 7	Recital 8
Recital 8	Recital 9
Recital 9	Recital 10
Recital 10	–
Recital 11	–
Recital 12	–
Recital 13	Recital 11
Article 1	Article 1
Article 2	Article 2
Article 3, introductory wording	Article 3, introductory wording
Article 3, point (a)	Article 3, point (a)
Article 3, point (b), first sentence	Article 3, point (b)
Article 3, point (b), second sentence	–
Article 3, points (c) and (d)	Article 3, points (c) and (d)
Article 4 to 7	Article 4 to 7
Article 8(1)	Article 8(1)
Article 8(1a)	Article 8(2)
Article 8(1b)	Article 8(3)
Article 8(2)	Article 8(4)
Article 9 to 12	Article 9 to 12
Article 13(1), (2) and (3)	Article 13(1), (2) and (3)
Article 14 and 15	Article 14 and 15
Article 15a	Article 16
Article 16, 17 and 18	Article 17, 18 and 19
Article 19	–
Article 19a, introductory wording	Article 20, introductory wording
Article 19a, point (a) points (i) and (ii)	Article 20, point (b) introductory wording, points (i) and (ii)
Article 19a, point (b)	Article 20, point (c)
Article 19a, point (c)	Article 20, point (d)
Article 19a, point (d)	Article 20, point (e)
Article 19a, point (e)	Article 20, point (f)
Article 19a, point (f)	Article 20, point (g)
Article 19a, point (g)	Article 20, point (h)
Article 19a, point (h)	Article 20, point (i)
Article 19a, point (i)	Article 20, point (k)
Article 19a, point (j)	Article 20, point (l)
Article 19a, point (k)	Article 20, point (a)
Article 19a, point (l)	Article 20, point (j)
Article 20	Article 21
Article 21	–
Article 22	Article 13(4)
–	Article 22
Article 23	Article 23
–	Annex I
–	Annex II

https://www.gov.uk/guidance/manual-of-patent-practice-mopp/supplementary-protection-certificates-for-medicinal-and-plant-protection-products
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