http://ipkitten.blogspot.com/2023/12/unambiguous-disclosure-without-patent.html
US patent attorneys wishing to understand certain peculiarities of European patent drafting need look no further than the recent Board of Appeal decision in T 2171/21. This case is a textbook example of the EPO’s strict approach to added matter. The decision highlights the inadequacy of mere lists of various features for satisfying the basis requirements in Europe. The decision may further help elucidate to the confused US attorney why their European colleagues continue to fill patent drafts with so-called US “patent profanities”. Striking the middle ground between satisfying the strict basis requirement in Europe and avoiding patent profanity in the US, renders the decision of when to file a patent application all the more critical.
Legal background: Basis for selections from lists
The EPO has a famously strict bar for basis. Common with other jurisdictions, a European patent application or patent may not be amended to introduce subject-matter that was not disclosed in the application as filed (Article 123(2) EPC). However, the EPO has a particularly narrow definition of what it means for subject matter to have been “disclosed in the application as filed”. The EPO, for example, takes a very strict stance against the “cherry-picking” and combining of features from separate embodiments or lists of features provided in the application as filed. As such, at the EPO, it is not permissible to select and combine features from multiple lists unless the singled-out combination is specifically disclosed or pointed to elsewhere in the specification.
Added matter or economical drafting?
The Novartis patent EP 3111954 in T 2171/21 related to the second medical use of the anti-IL-17 antibody secukinumab. Secukinumab is marketed by Novartis in Europe as Cosentyx for a number of inflammatory diseases, including psoriasis and ankylosing spondylitis (AS). The SPC on the composition of matter case for secukinumab expires in 2030. The patent in T 2171/21 claimed a loading dosage regime of secukinumab in AS, expiring 2031.
| Profanity |
The patent was opposed for added matter. On appeal the Opponent argued that in order to arrive at the subject matter of claim 1, it was necessary to combine multiple selections from embodiments disclosed in the earlier application as filed (of which the patent in question was a divisional). Particularly, it was necessary to 1) select AS from a list of four inflammatory diseases, 2) select the claimed dosage regimen from a list, and 3) select a particular induction dose from a list of two induction dosages. The Opponent argued that there was no pointer to the selected combination in the application as filed and as such the selection lacked basis.
The Patentee argued that an applicant should not be forced to claim or describe as individual embodiments all the possible combinations of, in this case, the dosage regimens and diseases described in the application as filed. In their particular case, the Patentee argued that a summary table provided in the description represented a shorthand for stating all the disclosed combinations individually.
Given the established case, law, it is no surprise that the Board of Appeal was not convinced by the Patentee’s defence. The Board of Appeal noted:
“a difference exists between the conceptual disclosure of a number of possible combinations and the individualised disclosure of specific combinations. While the former might be a more economical way of drafting a patent application, it does not necessarily allow the skilled person to derive each and every individual combination directly and unambiguously”.
The Board of Appeal agreed with the Opponent that, in order to arrive at the claimed subject-matter, the skilled person had to select and combine elements from the three different lists. The Board of Appeal was not convinced that such a selection could be considered equivalent to the gold standard for basis: namely that the subject-matter was disclosed directly and unambiguously in the earlier application as filed (r. 5).
Profane pointers
In Europe, in order to provide basis for certain selections, pointers towards certain embodiments may often be given by using terms such as “preferably” (Case Law of the Board of Appeal, II-E-1.6.2c)). However, in the present case, the Board of Appeal found no pointer in the application as filed towards the selected subject matter. If anything, the application as filed appeared to point towards a different disease (rheumatoid arthritis) and different doses. Whilst AS was mentioned in the examples, this was only in the context of a different dosage regime. The Board of Appeal thus concluded:
“The earlier application as filed therefore does not contain a pointer to the chosen combination of features. The claimed subject-matter thus represents a single individualised combination in the absence of a preference for this combination or, at least, a preference for one of the combined features having been disclosed in the earlier application as filed. The claimed subject-matter thus extends beyond what a skilled person would derive directly and unambiguously, using common general knowledge, and seen objectively and relative to the date of filing, from the whole of the earlier application as filed.“
Final thoughts
In the present case, the Board of Appeal noted the absence of any “preference or pointer” towards the claimed subject matter. The selected subject matter could not therefore be said to have basis in the application as filed. The case law relating to pointers and selection inventions is well established CLBA, II-E-1.6.2c)). In T 68/99, for example the fact that certain features were disclosed as preferred in the application as filed acted as a pointer for a selected combination of features.
In the US, however, including terms such as “preferably” in the specification may unduly limit claim scope during litigation (see e.g. 212 F.3d 1241 (Fed. Cir. 2000)). “Preferably” and related terms are therefore considered US patent profanities that should be strictly avoided when drafting. However, as the EPO case law demonstrates, many US “patent profanities” are the exact same phrases which might help a selected combination of features satisfy the strict basis requirements in Europe.
How then should patent be drafted? In order to avoid both US patent profanity and ensure adequate basis, careful decisions need to be made with regards to the timing of filing and what to include in the patent application. The applicant in the present case, for example, may have had better success by a) avoiding any mention of doses that were not exemplified, and b) avoiding any mention of AS in an application primarily directed to rheumatoid arthritis. A later application to the selected disease and doses may then have been pursued after it became clear that this subject matter was commercially relevant. The danger of this approach, however, is that the novel subject matter of the selected disease and dose would also have to be demonstrably non-obvious in view of the prior art, e.g. by possessing an unexpected technical effect. Regardless, the lesson for US practitioners from T 2171/21 is that lists of features will not provide basis for a combination of features in the absence of a specific embodiment of the combination or patent profanities directing the skilled person towards the combination.
Further reading
- Does the requirement for a “technical contribution” in a novel selection survive? (if selecting from convergent lists) (T 1621/16) (March 2020)
- Adding matter by cherry-picking from separate embodiments: Philip Morris v BAT ([2023] EWHC 2616 (Pat)) (Oct 2023)
- Defining what the invention is not can be as important as defining what the invention is (T 0273/22, Chimeric antibodies/REGENERON) (Nov 2023)
- The criteria for the novelty and inventive step of pharmaceutical selection inventions (T 1356/21) (Dec 2023)
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