The UK Court of Appeal in Teva & ors v Gilead has held that the UK Patents Court was correct in finding that the SPC for Truvada - a drug combining two antiretroviral medications used to treat and prevent HIV infection - is invalid. The judgment follows an earlier reference from the UK Patents Court to the CJEU as to the criteria for deciding whether a product is "protected by a basic patent in force" under Article 3(a) of the SPC Regulation. The outcome in the Court of Appeal, together with the CJEU's judgment, confirms a clear approach for determining whether a product is "protected by a basic patent in force" under Article 3(a).
Gilead's SPC for Truvada is due to expire in August 2020. Truvada is one of the primary pre-exposure prophylaxis drugs (PrEP) used to prevent the transmission of, and is a treatment for, HIV. It is comprised of two antiretrovirals, Tenofovir disoproxil (TD) and emtricitabine. Emtricitabine is not mentioned or referred to in Gilead's patent upon which the SPC is based. The relevant claim, claim 27, provides for:
"[TD] together with a pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and potentially other therapeutic ingredients".
A number of generic pharmaceutical companies challenged the SPC on the basis that the "basic patent" did not protect the combination of TD and emtricitabine, and the SPC was therefore invalid under Article 3(a) of the SPC Regulation. Gilead maintained that the combination of TD and emtricitabine fell within the scope of claim 27 of the basic patent when construed in accordance with Article 69 of the European Patent Convention.
Mr Justice Arnold (as he was then), concluded at first instance that the test to determine whether a product is protected by a "basic patent" was unclear, and that a reference to the CJEU was necessary. He therefore referred the following questions to the CJEU:
"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?"
The Grand Chamber of the CJEU gave its decision in July 2018. It held that a combination product will be protected by a basic patent within the terms of the SPC Regulation where, even though the combination of active ingredients is not expressly mentioned in the claims of the patent, those claims "relate necessarily and specifically to that combination". This requires an assessment of whether from the point of view of a person skilled in the art and on the basis of the prior art at the filing/priority date of the patent:
- The combination of those active ingredients necessarily, in the light of the description and drawings of the patent, falls under the invention covered by the patent. This requires more than that the product falls within the scope of the claim, the skilled person must understand, on the basis of the description, the drawings and the common general knowledge, that the combination product to which the claims of the patent relate embodies the technical contribution made by the patent.
- Each of those active ingredients is specifically identifiable, in the light of all the information disclosed in the patent.
On 12 September 2018, Mr Justice Arnold applied the CJEU's test and held that, in light of its guidance, the SPC failed both limbs of the above test because the patent said "nothing about the possibility that TD and emtricitabine may be combined to treat HIV" and emtricitabine was not specifically identifiable from the patent.
Over the last year, a number of national courts of EU Member States have also applied the CJEU's test and likewise found Gilead's SPCs in those countries to be invalid, including Ireland, Finland, Italy, The Netherlands and Portugal.
Court of Appeal
Before the Court of Appeal, Gilead argued that the SPC satisfied both limbs of the CJEU's test. It characterised the first limb as intended to exclude products where the claim contained no reference to the other ingredients. That was not the case here, it said, as the claim referred to "other therapeutic ingredients". As for the second limb, Gilead argued that it was intended to "stop the clock" on the relevant knowledge of the skilled person for determining whether the additional ingredient was identifiable. It argued, since emtricitabine was identifiable in the prior art, it also satisfied that limb of the test. The generics argued that Mr Justice Arnold's reasoning was correct - there was simply nothing in the patent which would leave the skilled reader to conclude that claim 27 could "necessarily and specifically" relate to the combination of TD and emtricitabine.
The Court of Appeal handed down its decision on 19 December 2019, agreeing that Gilead's SPC was invalid. The Court made its decision based on the first limb of the CJEU test alone holding that a skilled person would not consider that the combination necessarily and specifically fell within claim 27. In particular, there was nothing to suggest that the claim required the presence of another ingredient since it used the word "optionally". The phrase "other therapeutic ingredients" was not limited to anti-viral agents, and the claim was not limited to a product containing TD for the treatment of HIV.
However, the Court of Appeal did expressly reject any role for the 'inventive advance or technical contribution' of the patent as proxy for assessing whether the product of the SPC fell within claim 27 (an approach which found favour with Mr Justice Arnold at the original trial of the action). Lord Justice Floyd – giving the judgment on behalf of the Court – held that the CJEU had "definitely set its face against the introduction of such a test".
As a result of this decision, generic firms in the UK can continue to market generic combinations of TD and emtricitabine free from the risk of any claim for damages by Gilead.
Aside from the commercial significance of the ruling, the Court of Appeal's decision assists in the interpretation of an area of law that has been heavily criticised for being unclear. In particular the ruling gives a clear pointer to patent attorneys that generic references to optional ingredients in patent applications may no longer provide the requisite support for an SPC application for a combination products.
Mishcon de Reya acted for Lupin Ltd and Lupin (Europe) Ltd, two of the claimants in this action.