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UK – Teva UK Limited and others v. Gilead Sciences / SPC

13 Jan 2020

Teva UK Limited and others v Gilead Sciences, Inc. [2019] EWCA Civ 2272

The Court of Appeal has dismissed Gilead Sciences, Inc.’s appeal against a decision by Arnold J (as he then was) that its supplementary protection certificate for a product used in the treatment of HIV was invalid.

The appellant, Gilead Sciences, Inc. (“Gilead”) is the holder of an SPC numbered SPC/GB05/041 (“the SPC”) for a combination product containing tenofovir disoproxil fumarate and emtricitabine. The product is used in the treatment of patients suffering from the effects of HIV and is marketed by Gilead under the trade name Truvada.

First judgment
At the first instance trial, Teva, Accord, Lupin and Mylan challenged the validity of the SPC. The dispute centred on whether Gilead’s product was “protected by a basic patent in force” in accordance with Article 3(a) of the SPC Regulation.

Gilead argued that the product was protected by European Patent (UK) No 0 915 894 (“the patent”), specifically claim 27 of the patent which covers a composition comprising tenofovir disoproxil “and optionally other therapeutic ingredients”. Gilead argued that emtricitabine was an “other therapeutic ingredient”, however the claimants contended that claim 27 did not protect the combination in the manner required by the SPC Regulation.

In his judgment ([2017] EWHC 13 (Pat)), Arnold J (as he then was) concluded that the SPC Regulation remained unclear. He stayed the proceedings and referred the following question to the CJEU for preliminary ruling: “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?”

CJEU judgment
The Grand Chamber of the CJEU handed down its judgment on 25 July 2018 (Case C-121/17). It ruled that:

“Article 3(a) of [the SPC Regulation] must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination.

For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

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

Second judgment
When the case returned to the UK court, Arnold J (as he then was) considered that that neither of the limbs of the CJEU’s test were satisfied. He determined that there is no basis for the skilled person to understand that the combination of tenofovir disoproxil and emtricitabine embodies the technical contribution of the patent.

Furthermore, as emtricitabine is not mentioned in the patent nor is it a member of a specific class of compounds mentioned in the patent, it is not specifically identifiable. He declared the SPC to be invalid.

Gilead appealed the decision. It contended that the test for what is protected by a basic patent for the purposes of Article 3(a) of the SPC Regulation remained an extent of protection test subject only to the CJEU’s two-limbed test. Gilead argued that the judge had gone wrong in failing to find that the two limbs of the CJEU’s test were satisfied in this case. The first limb was satisfied because the claim did refer to “other therapeutic ingredients”. The second limb was also satisfied because emtricitabine was identifiable based on the prior art at the priority date.

Gilead claimed that the judge had erred by applying the “inventive advance” or “technical contribution” test, and had assessed the second limb of the CJEU’s test by reference to CGK, when the court had expressly ruled that all the prior art formed the relevant pool of knowledge.

The Respondents argued that the “technical contribution” test was used in the sense meant by the court – i.e. was the product the actual subject matter of the patent. Limb 1 could not be satisfied when “other therapeutic ingredients” is made optional; limb 2 was not satisfied as the language of claim 27 was too general to make emtricitabine specifically identifiable.

The appeal was dismissed. The Court of Appeal held that:

(1) In applying the first limb of the CJEU’s test, the term “fall under the invention covered by the patent” was not intended by the court to refer to the inventive advance or technical contribution of the patent. In fact, the judgment specifically discusses the Advocate General’s opinion in Sandoz v. Searle (conjoined cases C-650/17 and C-114/18), in which AG Hogan expressed the view that “the ‘core inventive advance’ of the patent does not apply and is of no relevance in the context of Article 3(a).”

(2) The first limb is simply a more elaborate exposition of the “necessarily” part of the test first advanced in Eli Lilly, namely that “the claims relate … necessarily … to the active ingredient in question”. This is not a simple extent of protection test, applying Article 69 and the Protocol. It instead requires examination of whether each component of the combination is required by the claim.

(3) The addition of “other therapeutic ingredients” to tenofovir disoproxil in claim 27 of the patent is expressly made optional. Gilead’s submissions on why the combination of tenofovir disoproxil and other therapeutic ingredients is protected were not accepted. No assistance was provided by the fact that the claims might have been drafted differently, and it was noted by Floyd LJ that claim drafting is of importance in this area (as made clear by Actavis C-577/13). Although the CJEU did not decide that the word “optionally” was fatal to Gilead’s case, it did draw specific attention to the use of the word. However it left it for the national court alone to decide on its meaning.

(4) Focussing on the claims and description of the patent “there is nothing to suggest to the skilled person that claim 27 requires the presence of another ingredient.” The skilled person would not assume that the presence of a known anti-viral agent for the treatment of HIV was required by the claim.

(5) Additionally, the phrase “other therapeutic ingredients” is not limited to anti-viral agents. Hence there is no reason to limit the claim to require a second anti-viral agent known to have potential for HIV treatment. It was held that “there is no basis for the skilled person to conclude that “the product [i.e. TD plus another therapeutic ingredient] is specified as required for the solution of the technical problem disclosed by the patent”.

(6) The above reasons were sufficient to dismiss the appeal and it was not necessary to consider the application of the second limb of the CJEU’s test. The Court of Appeal acknowledged that there were difficult questions to be addressed, namely the type of knowledge that can be relied on in the second limb (prior art or CGK), whether evidence could be brought on the existence of other therapeutic agents, and whether emtricitabine would be excluded from consideration as a “therapeutic ingredient” (it was not known it was effective in humans against HIV and was not approved for human use).

Floyd LJ added that he did not endorse Arnold J’s view 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.” This would impose too high a standard considering none of this was known for tenofovir disoproxil.

The full judgment can be accessed here.

Summary: Imogen Kelso, Marks & Clerk