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SPCs and Combination Products

The UK Court of Appeal applies the CJEU decision to Gilead’s Truvada Supplementary Protection Certificate.

The UK Court of Appeal has interpreted the Court of Justice of the European Union (CJEU) decision relating to the definition of a “product protected by a basic patent” according to Article 3(a) of the supplementary protection certificate (SPC) regulations.

Background

The case before the Court of Appeal ([2019] EWCA Civ 2272) concerned the validity of the SPC covering Gilead’s product marketed as Truvada. Truvada is used in the treatment and prophylaxis of HIV.

Truvada comprises two active ingredients, tenofovir disoproxil and emtricitabine, in a single, fixed dose tablet. 

Gilead appealed against the High Court’s ([2018] EWHC 2416 (Pat)) finding that the SPC was invalid because the claim relied upon in the underlying European patent does not specifically relate to the combination of active ingredients in Truvada.

Gilead asserted that Truvada was protected by Claim 27 of European Patent No 0 915 894.  Teva (and other generic companies) argued that the Patent did not protect this combination product under Article 3(a) of the SPC Regulation.  Article 3(a) requires that an SPC can only be granted if the product subjectto the SPC is “protected by a basic patent in force”.  

The claim in question read:

“A pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.”

SPCs serve to extend a patent for a maximum of five years for products granted a relevant marketing authorisation (MA). For an SPC to be granted, a medicinal product must be protected by a basic patent in force, and a marketing authorisation must have been issued to place that product on the market as a medicinal product. The MA must be the “first” MA relating to the product and the product should not be the subject of another SPC. 

The CJEU decision 

In 2018 the CJEU was asked to clarify what criteria need to be satisfied for an SPC to cover a product that is “protected by a basic patent”. 

In the subsequent ruling (C‑121/17), the CJEU said that the combination of active ingredients does not need to be expressly mentioned in the claims of the basic patent if those claims relate necessarily and specifically to that combination. The CJEU then set out a two limb test.

The CJEU said that: from the point of view of the person skilled in the art and on the basis of the prior art at the filing date of the basic patent:

1) the combination of the active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent; and  

2) that each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

The Court of Appeal Decision

The Court of Appeal has upheld the High Court’s decision and interpreted the recent CJEU decision regarding whether or not a combination of active ingredients is covered by an SPC.

Gilead’s appeal concerned the way in which the High Court had interpreted the CJEU’s ruling when applying it to its case. The Court of Appeal decision focused on the first limb of the CJEU’s test – that the combination of the active ingredients falls under the invention covered by the basic patent for the purposes of SPC protection.

The Court of Appeal rejected the “inventive advance” test, proposed earlier by Justice Arnold, and said that the relevant test is simply an extension of the earlier legal test i.e., that the claims should relate “necessarily and specifically” to the active ingredient in question.

Extending that test to cases where there is more than one active ingredient, the Court of Appeal said that “to protect a combination product, a claim must require the presence of two compounds, not just one”.

The Court of Appeal said Gilead had not satisfied this requirement in this case because the second ingredient in its combination is expressly stated in the patent claim to be optional. It held that while the word ‘optionally’ was not “fatal to the case” it is no different to the word “comprising”. The exact meaning of the word “optionally” is a matter for national courts to decide.

The breadth of the claim was also considered an issue. The claim is not limited to a pharmaceutical composition containing tenofovir disoproxil for the treatment of HIV, nor is the phrase “other therapeutic ingredients” limited to anti-viral agents.  Claim breadth was considered another reason for not reading a requirement for the presence of a second anti-viral agent into Claim 27. 

Having decided Gilead’s SPC did not satisfy the first limb, the court did not go on to consider the second limb.

Floyd LJ explained that he “would prefer to leave those issues to a case in which their resolution affected the result“.  However, importantly, he said that:

 “I would only add that I would not wish to endorse the view, implicit in the judge’s paragraph [39], that if emtricitabine was otherwise sufficiently identified, it would be necessary to show that it was known at the priority date to be an effective agent for the treatment of HIV in humans, or approved for such use, or that these facts were by then, common general knowledge. Given that none of this was known for [tenofovir disoproxil] at the priority date, it may be that this is to impose too high a standard.”

The second part of the test requires an analysis of what the skilled person knew and when. Gilead had argued that the High Court had erred by applying the “inventive advance” test and by assessing with reference to the common general knowledge when the CJEU had ruled that knowledge was based on all available prior art. Gilead also argued that the second part of the test was meant to “stop the clock” at the priority date to establish the knowledge the skilled person could use to determine whether the ingredient was identifiable. 

Comment

The decisions of the CJEU and the Court of Appeal highlight that the presence and definition of another pharmaceutical ingredient is irrelevant to whether a product falls within the scope of protection of the patent claim but it is relevant to whether the product is protected by an SPC. A patent may protect A+B when B is not specified in the claims; but if the claims do not “relate necessarily and specifically” to A+B, or B is not “required” by the claims, then the SPC cannot protect A+B. Thus, the SPC is not conferring the same rights as the patent.

The decision from the Court of Appeal provides guidance as to how the UK courts will apply the CJEU decision to combination products.

In practice, in view of the Court of Appeal decision, if likely combinations of agents are known, basis for claims to these specific combinations should be provided. When drafting your application ensure that the second agent is sufficiently identified and enabled. Be wary of simply providing long lists of agents as this could provoke added matter objections from the EPO, based on selections from two or more lists. If a large number of agents and combinations are possible, consider filing further applications relating to specific combinations of agents of commercial importance and lead agents in research and development, ideally within the priority year. During prosecution, ensure that any key combinations of agents are included in the claims. 

This is unlikely to be the end of discussion on this matter, as we are awaiting further CJEU decisions relating to the interpretation of Article 3(a) following referrals C-650/17 (Royalty Pharma Collection Trust) and C-114/18 (Sandoz and Hexal). We’ll keep you posted!

Comments provided herein should be considered general guidance on this matter. For specific advice on cases relating to pharmaceutical products, especially combination products, please contact your usual GB attorney or anyone in our Pharma team.