[Guest Post] CJEU weighs in on supplementary protection certificates in Merck v Teva/Clonmel decision

The CJEU also considered the “Teva test,” which was developed in its previous ruling in Teva v Gilead (Case C-121/17) regarding the specific interpretation of Article 3(a) of the SPC Regulation.

The two referrals

The first referral (C-119/22) came from the Finnish Market Court (markkinaoikeus). It concerned Merck’s Janumet® drug for the treatment of diabetes, which combines sitagliptin and metformin. Merck obtained the SPC based on patent EP 1412357 (EP ‘357). This patent claimed protection for sitagliptin alone (a new and inventive active ingredient) as well as sitagliptin combined with metformin, an active ingredient that was already known and had been used for decades by the time EP ‘357 was filed.

Merck had previously obtained an SPC for a drug called Januvia® with sitagliptin as its sole active ingredient. Teva challenged the validity of the Janumet® SPC, arguing that it violated Article 3(c) of the SPC Regulation, which prohibits granting an SPC for a product that is already subject to an existing SPC. Teva contended that since sitagliptin was already protected by an SPC, the Janumet® SPC constituted an inadmissible second SPC. Furthermore, Teva argued that the SPC failed to meet the requirements of Article 3(a) of the SPC Regulation, asserting that EP ‘357 could not be considered a basic patent for the sitagliptin-metformin combination. Merck countered that the SPC was valid because Article 3(c) does not prevent protecting an active ingredient with multiple SPCs, provided the second product (Janumet®) differs from the first (Januvia®).

The SPC Regulation defines a ‘product’ in Article 1(b) as “the active ingredient or combination of active ingredients of a medicinal product.” Article 3 sets four cumulative conditions for granting an SPC to be met at the date of the application for an SPC and in the State in which the application is filed:

(a) the product is protected by a basic patent in force;

(b) a valid authorization to place the product on the market has been granted;

(c) the product has not already been subject to an SPC;

(d) the market authorization in (b) is the first market authorization.

A valid SPC extends protection for the product after the basic patent expires, with a duration no longer than 5 years and equal to the period between the basic patent application filing date and the first market authorisation date in the European Community, minus 5 years.

In addition to the SPC Regulation, the CJEU briefly mentioned Article 69 EPC, referring to some earlier CJEU decisions, including Actavis v Sanofi (C-443/12) and Actavis v Boehringer (C-577/13), which introduced the concept of the “core inventive advance”. However, the relevance of this concept was disregarded in the more recent CJEU decision of Royalty Pharma (C-650/17). 

The Decision

The key issues submitted to the Court can be summarised in two main questions.

Could a combination of active ingredients be considered a new product under Article 3(c)?

The CJEU’s answer was positive. In its analysis, the Court emphasised that the term “product” must be interpreted consistently across all requirements in Article 3 of the SPC Regulation. Specifically, ‘product’ must be understood according to its definition in Article 1(b) of the SPC Regulation, which defines products as the active ingredients or combinations of active ingredients.

Therefore, if a first product (such as in Januvia®) has already been put on the market with a marketing authorisation as a monotherapy product, a second product consisting of the combination of the monotherapy product with another active ingredient (such as in Janumet®) cannot be considered the same product as the monotherapy, as it has a different composition.

Beyond the consistency of the interpretation of “product” within the context of Article 3(a) and 3(c), the Court explicitly stated that considerations applying when assessing the requirement under Article 3(a) – such as whether or not one of the active ingredients is protected as such by the basic patent – are totally irrelevant when assessing the requirement under Article 3(c), as these are completely different and separate evaluations.

Could a combination satisfy the requirements under Article 3(a)?

The Court’s answer is positive, provided that the combination for which another SPC is sought falls under the “invention” covered by the basic patent. The Court based its analysis on the “Teva test” (C-121/17), which holds that even if a product consisting of a combination of active ingredients is not expressly mentioned in the claims of the basic patent, those claims must relate necessarily and specifically to that combination.

This assessment requires a two-step test from the perspective of a person skilled in the art:

1. the combination must, in light of the description and drawings of the basic patent, necessarily fall under the invention covered by the basic patent; and,
2. the person skilled in the art must be able to specifically identify the product based on all information disclosed by the patent, considering the prior art at the filing date or priority date.

While the decision does not provide comprehensive guidelines for assessing whether the composition falls under the invention covered by the basic patent, paragraph 70 tries to offer some guidance: 

“if the basic patent discloses that the combination of the two active ingredients has a combined effect going beyond the mere addition of the effects of those two active ingredients and which contributes to the solution of the technical problem, it may be concluded that the combination of those two active ingredients necessarily falls under the invention covered by that patent.” 

Conclusion

Although the decision aimed to provide clarity in the existing case law, it introduces some additional uncertainties. While the CJEU’s clarification of the meaning of “product” within the context of Article 3(c) is surely welcome, the condition that the cumulative effect of the active ingredients of a combination should not be “merely additive” to satisfy the requirement under Article 3(a) may not be easily met and its evaluation may prove very complicated for the authority asked to assess the validity of the SPC.

The CJEU has also clarified an important procedural point: the assessment for granting an SPC covering a combination product should rely solely on the specific provisions of the SPC Regulation (Article 1(b) and Article 3(c)), without reference to the examination of the basic patent.”