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Is the fog finally clearing? Truvada SPC invalidation confirmed by Court of Appeal

The UK Court of Appeal recently dismissed Gilead Sciences’ appeal of the Patents Court’s decision to invalidate the SPC for Gilead’s HIV combination drug Truvada®. After years of uncertainty on eligibility of basic patents for SPC protection in the EU, the Court of Appeal’s decision may finally begin to provide some clarity on this vital issue for the pharmaceutical industry.

Background – what is meant by “protected” by a basic patent?

Article 3(a) of the EU medicines SPC Regulation (469/2009) requires the approved medicinal product to be “protected” by a basic patent in force in order for it to be eligible for SPC protection. However, ever since the CJEU decision in Medeva (C-322/10) almost a decade ago, what is meant by “protected” has been unclear. The only matter on which there is consensus is that the CJEU has rejected a simple infringement test. It is not therefore sufficient for the product to simply fall within the claims of the basic patent.

Teva v Gilead - the facts of the case

The dispute between Gilead Sciences and a number of generic pharmaceutical companies relates to the combination drug Truvada® which is approved in the EU for treating HIV. The two active ingredients of the combination are tenofovir disoproxil (“TD”) and emtricitabine.

The parties are agreed that the basic patent describes and claims TD specifically, but combinations only generally. The sole claim relating to combinations reads as follows: “A pharmaceutical composition comprising a compound of claims …and optionally other therapeutic ingredients.”

However, the patent does not include any specific examples of combination products, and does not disclose emtricitabine anywhere.

The first instance and CJEU decisions

The SPC was granted by the UKIPO in 2008. However, in view of Medeva and the subsequent line of case law which rejected the “infringement test”, a number of generics companies sought revocation of the SPC before the Patents Court of England and Wales in 2016.

The Patents Court was unsure on whether Article 3(a) was complied with. The judge (Mr Justice Arnold) stated “more is required, but it is not clear what more is required”, over and above the product simply falling within the claims of the basic patent. In view of this uncertainty, he referred the matter to the CJEU.

The CJEU issued its decision (case C-121/17) in summer 2018, formulating a two-part test to decide if Article 3(a) was complied with:

  1. Test 1: the combination of 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. Test 2: each of those actives must be specifically identifiable, in the light of all the information disclosed by that patent.

The case then returned to the Patents Court to apply the CJEU decision. The court interpreted test 1 to mean that the product must “embody the technical contribution made by the patent” in other words, at the filing date, had the patentee actually invented the product? The court was less certain on how test 2 was to be interpreted, but noted that emtricitabine was not specifically identified anywhere in the patent. On these grounds, the court ruled that the SPC was invalid.

The Advocate General intervenes …

Before Gilead’s appeal could be heard before the Court of Appeal, the Advocate General had issued his legal opinion on the related cases C-650/17 and C-114/18. The Advocate General opined that the tests of C-121/17 should apply both to combination medicinal products and those consisting of a single active.

The Advocate General considered that test 1 was not met by a product if, at the filing date of the basic patent, the claims in a patent in relation to that product “are not required” for the solution of the technical problem disclosed by the patent. On test 2, the Advocate General’s view is this was not met if, in the light of all the information contained in a patent, a product or constituent element of the product “remains unknown” to a person skilled in the art on the basis of the prior art at the filing date of the patent.

Although the Advocate General did not elaborate on what was meant by the claims being “not required”, for the purposes of test 1, the Advocate General seemingly distinguished this from the “core inventive advance” test adopted by previous CJEU case law. The Advocate General opined this test was “of no relevance” in assessing whether Article 3(a) is met. The Advocate General’s opinion was seemingly taken into account by the Court of Appeal, which ruled that the “inventive advance” test must now be regarded as wrong, and that express mention of the active ingredient(s) in the claim is enough.

… and the Court of Appeal listens

In the light of the Advocate General’s opinion, the Court of Appeal interpreted test 1 such that each component of a combination product must be required by the claim. They considered this to be a reformulation of the test in Eli Lilly v HGS (C-493/12), which required that “the claims relate … necessarily … to the active ingredient in question”.

Based on this, the court considered test 1 meant that, for a combination drug A+B to be “protected” by a basic patent, the claim must “require” both compounds (A and B) to be present. The court clearly distinguished this test from normal “extent of protection” claim interpretation rules, under which a claim to “a formulation comprising compound A” also covers the combination A+B.

The Court of Appeal ruled that this was not met by the claim wording “… and optionally other therapeutic ingredients”. The Court of Appeal considered that the express indication that the second ingredient was optional meant there was nothing to suggest to the skilled person that the claim “required” the presence of another active ingredient. Therefore, the Court of Appeal considered there was no basis for the skilled person to conclude that a combination product was specified as required for the solution of the technical problem disclosed by the patent. On these grounds, the Court of Appeal ruled that test 1 above was failed and the appeal dismissed.

In view of its decision on test 1, the Court of Appeal did not reach a view on whether test 2 was met. In obiter comments, the court raised the question of whether the breadth of the term “other therapeutic ingredients” meant that the “specifically identifiable” arm of the test was not met, and also took note of the fact that, at the priority date, it was not yet known that emtricitabine was effective in humans against HIV. However, the court decided to leave those issues to a case in which their resolution affected the result.

What does “required” require?

In many ways, the Court of Appeal’s decision in this case merely confirms previous UK case law on SPCs. Even before the CJEU’s Medeva decision, it has been UK law since Takeda (2004) that a claim which recites only a mono-product A and does not recite any combinations with other active ingredients does not “protect” a combination product for the purpose of SPC eligibility under Article 3(a). A claim which recites an “other active ingredient” but expressly states it is only optional is arguably no different from this in scope, so the decision in this respect is not surprising.

Of greater interest is how the courts will interpret the ruling of “required for the solution of the technical problem”. Will this assessment be purely based on whether both active ingredients are mandatory requirements (as opposed to optional) in the claim, or will further analysis and data be required to show that the combination solves a technical problem? The Advocate General’s and the Court of Appeal’s rejection of the previous “inventive advance” test would appear to indicate they favour the former.

Brexit and SPCs – the same, but different?

The UK left the EU on 31 January 2020. The transition period, under which all existing EU legislation will remain in force and CJEU decisions will continue to apply to the UK, will end on 31 December 2020.

After the end of the transition period, UK legislation on SPCs will largely mirror the existing EU Regulations (see our “IP After Brexit” guide). However, CJEU decisions will no longer be binding on UK courts. Given the difficulties the CJEU has encountered with formulating clear judgments on SPCs, and in particular on compliance with Article 3(a), it will be interesting to see whether the UK patents courts continue to follow the CJEU line of case law or choose to follow a different path.

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