27 July 2018 - Authored by:Steven Baldwin
Those looking for clearer guidance on the practical application of Art 3(a) are likely to be left disappointed by this week’s CJEU judgment in the Teva v Gilead SPC litigation. In summary, the Court (who heard this case in a Grand Chamber of 13 judges) has adopted a Lilly v HGS-based approach to Art 3(a) for combination products but in doing so has formulated an additional two-stage test to be applied when determining whether the claims of the basic patent “relate necessarily and specifically to that combination”. The judgment provides little guidance as to how this new two-stage test is to be applied in practice and raises as many questions as it does answers. These questions are discussed in the more detailed analysis below. As with previous cases, the CJEU’s position is that the application of the tests set out in the judgment is a matter for national patent law. That said, the Court did suggest that Gilead’s SPC does not satisfy the new test for Art 3(a) (see ).
The two-stage test requires that “from the point of view of the skilled person and on the basis of the prior art at the filing date or priority date of the basic patent: (i) the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent; and (ii) each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.” In adopting this test, the Court declined to adopt the “individually disclosed” requirement for each active ingredient proposed by AG Wathelet.
We have previously set-out a re-cap of the facts and the AG’s Opinion here. By way of reminder, the question referred to the CJEU from the English High Court was:
“What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?”
(See here for the referring court’s decision).
Analysis of the decision
This judgment raises a number of key questions:
- What level of specificity is required for an active ingredient to be “specifically identifiable” in light of the information disclosed by the patent?
The level of specificity required repeatedly rears its head in Art 3(a) cases. Those hoping for further clarity on this question will be disappointed, as no guidance is offered by the CJEU. We will have to wait for the pending references in Sandoz v Searle (summarised here) and Royalty Pharma (sitagliptin) for this issue to (hopefully) be resolved. However, if the CJEU adopts the same approach in those cases as it did yesterday it will remain unclear whether a compound, which was not known at the priority date but could be reached by the skilled person making appropriate selections under a Markush claim, would be “specifically identifiable” for Art 3(a) purposes. Similarly, would a post-priority antibody falling within a functionally-defined claim be specifically identifiable if it wasn’t known at the priority date but clearly falls within the functionally-defined class.
- What does it mean for the combination to “fall under the invention”? Is it that the combination must fall within the extent of protection of the claims pursuant to Art 69 EPC and its Protocol, or that the combination must embody the core inventive advance or subject matter of the patent?
The CJEU expressly emphasises the “key role played by the claims” and the fact that “the extent of protection conferred by…a patent is determined by the claims”, as read in light of the description and drawings of the patent in accordance with Art 69 EPC. Indeed at  the Court suggests that it is Art 69 that determines whether the product “falls under the invention”. However, this statement is then confused by the Court’s suggestion at - that the Art 69 approach is consistent with the earlier CJEU cases of Actavis v Sanofi C‑443/12 and Actavis v Boehringer C-577/13 in which the Court appeared to adopt a core inventive advance approach, rather than focusing on the wording of the claims, read in the light of the description and drawings, under Art 69 EPC.
Indeed, taking a step back and looking at the two-stage test in the round, it seems most likely that “fall under the invention” means that the active ingredient must fall within the extent of protection of the claims as interpreted in accordance with Art 69. Otherwise, the second limb of the test would arguably be redundant since if an active ingredient is determined to embody the core inventive advance of the Patent, then surely said active must also be “specifically identifiable in light of all the information in the patent”.
- What impact will the patent law requirement to conduct the Art 3(a) analysis at the priority date and on the basis of the prior art, without having the marketed compound in the mind of the skilled person, have on the type of evidence required in SPC law cases?
The inclusion of the priority date/prior art requirement appears to be directed primarily at limiting the availability of third party SPCs (see, e.g.,  and ). The approach of the English Courts to date, including the Court of Appeal in Sandoz v Searle, has been that the Art 3(a) analysis should be conducted with knowledge of the marketed product in mind. Removing that requirement and asking whether “without any doubt” (see ) the skilled person would understand that an active ingredient is specifically identifiable in light of the information disclosed in the patent may certainly create additional requirements for expert evidence on both sides. In this case it was agreed, for example, that emtricitabine was not known at the priority date. In many other cases, similar arguments will not be so clear cut. All patent litigators know that what was, or was not, within the common general knowledge of the skilled person at the priority date is often a ground of significant debate between experts and, in the UK, cross-examination. Further, the new test appears to provide additional scope for parties to argue, in particular through expert evidence, that an active ingredient is specifically identifiable based on a disclosure in the description/drawings (i.e. based on “information disclosed by that patent”), rather than the wording of the claims.
- Does the priority date-based approach actually disadvantage rights holders who have invested significant R&D in products covered by a basic patent but developed only after the priority date?
The requirement to conduct the Art 3(a) examination at the priority date without knowledge of the marketed product may disadvantage innovative companies who own the basic patent and have put significant post-priority R&D efforts into products which would, with the marketed product in mind, “immediately be recognised” (see Floyd LJ in Sandoz v Searle) by the skilled person as falling within a claimed class of compounds. This is particularly so given that, in many cases, a compound of interest is not isolated until many years after the priority date of a patent. The question to be asked is therefore whether the desire to limit third party SPCs should take precedence over compensating patentee companies for their significant R&D efforts, which is precisely the purpose of the SPC Regulation.