Teva UK Ltd & Ors v Gilead Sciences Inc

For a combination product to be protected by a basic patent under Article 3(a) of the SPC Regulation, the combination must be expressly mentioned in the claims or relate to them necessarily and specifically.

Where it is not expressly mentioned, the skilled person must understand from the patent, its description and drawings, and common general knowledge at the filing or priority date that the product embodies the patent’s technical contribution. Each active ingredient must also be specifically identifiable at that date. A mere possibility that the product falls within the patent’s scope is insufficient.

The claimants challenged the validity of Gilead’s supplementary protection certificate for the combination of tenofovir disoproxil and emtricitabine marketed as Truvada. The dispute concerned whether the combination was protected by European Patent No 0 915 894 within Article 3(a) of the SPC Regulation.

Following an earlier judgment and a reference to the CJEU, the Grand Chamber gave its ruling in Case C-121/17. The claimants sought final judgment. Gilead sought permission to adduce further expert evidence and to have a second trial. The central issues were whether the CJEU’s two-stage test was satisfied and whether further evidence should be admitted.

1. Further evidence. The court accepted that it retained jurisdiction to admit further evidence before a final order, applying Re L (Children) [2013] UKSC 8. However, Gilead’s application would require a second trial after the parties had already presented their cases. It was therefore an abuse of process, analogous to post-trial attempts to amend patent claims, and in any event was inconsistent with the overriding objective. The CJEU ruling elaborated the existing approach derived from Eli Lilly and Company v Human Genome Sciences Inc EU:C:2013:835; it did not justify reopening the factual case.
2. Article 3(a). The first requirement was not a simple extent-of-protection inquiry. The skilled person had to understand from the patent, its description and drawings, and common general knowledge at the priority date that the combination embodied the patent’s technical contribution. The second requirement was that each active ingredient had to be specifically identifiable from the patent in the light of the prior art at the filing or priority date. Later research could not be used.
3. Application. The patent said nothing about combining tenofovir disoproxil with emtricitabine for HIV treatment and did not even mention emtricitabine. The skilled person could not therefore understand that the combination embodied the patent’s technical contribution. Although tenofovir disoproxil was specifically identifiable, emtricitabine was not. It was neither mentioned nor identified as part of a relevant class, and there was no evidence that its effectiveness against HIV in humans was common general knowledge at the priority date.
4. The SPC consequently failed to comply with Article 3(a) of the SPC Regulation and was to be revoked. Gilead’s application was refused.

The judgment itself describes an earlier first-instance judgment and a reference to the CJEU, but this was a resumed first-instance determination rather than an appeal.