UK Patents Court allows Supplementary Protection Certificate for combination product: Gilead Sciences, Inc’s Application

16 October 2008

Gerry Kamstra

Gilead has succeeded in its appeal to the Patents Court (Mr Justice Kitchin) from the UK Intellectual Property Office, which refused the grant of an SPC in respect of a combination product comprising tenofovir and another antiretroviral, emtricitabine.

Claim 1 of Gilead’s patent (EP(UK) 0,915,894) covers a class of antiretrovirals useful in the treatment of HIV and other diseases including tenofovir - Claim 25 covers tenofovir specifically. Importantly, Claim 27 covers “a pharmaceutical composition comprising a compound according to any one of Claims 1-15 with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients”.

On 21 February 2005 Gilead obtained a marketing authorisation for a medicinal product comprising tenofovir and another antiretroviral, emtricitabine. On 1 August 2005 Gilead applied for an SPC with the following product description: “Composition containing both Tenofovir disoproxil optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate thereof, together with Emtricitabine”. The examiner rejected the application, as did the UKIPO Hearing Officer, on the grounds that the product was not protected by the basic patent as required by Article 3(a) of SPC Regulation 1768/92. In doing so the UKIPO relied heavily on the judgment of Mr Justice Jacob (as he then was) in Takeda Chemical Industries Ltd’s Applications (No 3) [2004] RPC 1, in which he rejected an application for an SPC covering a combination of the proton pump inhibitor lansoprazole in combination with two of three antibiotics (for the treatment of H pylori infection) when an SPC had already been granted for lansoprazole and when the “basic patent” (within the meaning of the Regulation) only covered lansoprazole. The UKIPO Hearing Officer in the Gilead case relied upon Takeda as authority for the proposition that not every product that infringes the basic patent can be said to be protected by the basic patent as required by Article 3(a) of the Regulation.

The judge identified the correct test to be applied in cases such as this as to identify the active ingredients of the product which are relevant to a consideration of whether the product falls within the scope of a claim of the basic patent – its is those ingredients, and only those ingredients, which can be said to be protected within the meaning of the Regulation. Applying this test to the Gilead facts provided the judge with a ready answer, namely that the product did not pass the Takeda test if only claims 1 and 25 were considered; but because claim 27 covered the combination product in question it was covered by the basic patent as required by Article 3(a) of the Regulation and therefore an SPC should be allowed.