Tenofovir disoproxil & Emtricitabine - UK

On Dec 19, 2019, Court of Appeal dismissed Gilead's appeal & found SPC protecting combination HIV anti-retroviral drugs, Truvada®, invalid.

Gilead’s SPC (SPC/GB05/041) describes a product containing two ingredients, tenofovir disoproxil fumarate and emtricitabine which covers product marketed by Gilead under the trade name, Truvada. In lower court, Justice Arnold handed down decision on 18 September 2018, & held that the SPC was invalid, in the light of the ruling of the Grand Chamber of the CJEU.

Gilead appealed & issue upon appeal is related to criteria for deciding whether the 'product is protected by a basic patent in force' in Article 3(a) of the SPC Regulation. Gilead contends that the product described in the SPC is protected by European Patent (UK) No 0 915 894, because it has a claim (claim 27) to TD "and optionally other therapeutic ingredients". Emtricitabine, says Gilead, is another therapeutic ingredient. The claimants contend that claim 27 does not protect the combination in the manner required by the SPC Regulation.

Court of Appeal said that the question is whether the combination of the active ingredients TD and emtricitabine must ‘necessarily’, in the light of the description and drawings of that patent, fall under the invention covered by the patent. Court further said that the addition of "other therapeutic ingredients" to TD in claim 27 is expressly made optional. That is no different in principle to a claim which "comprises" TD, which we know is not good enough to protect a combination. As to the wording of the claim, it is not possible to understand claim 27 as requiring the presence of another therapeutic ingredient when it expressly states that it is optional. It is clear that claim drafting is of importance in this area, as cases such as C-577/13 Actavis (cited above) make clear. Finally, it is by a focus on the claims and the description that the skilled person (albeit with the benefit of his common general knowledge) decides what the claims necessarily relate to. Although the patent contains lengthy, standard form, material as to how the compounds of the invention can be formulated, there is nothing to suggest to the skilled person that claim 27 requires the presence of another ingredient. Everything points the other way. The skilled person might well know from the common general knowledge that other anti-viral agents would be useful in practice in the treatment of HIV, but he would not therefore assume that the presence of emtricitabine was required by the claim.

Thus, court dismissed the appeal.