Following his decision to refer questions to the Court of Justice of the European Union relating to the SPC for Gilead's Truvada product, Arnold J has decided, in the light of the relevant claim in the basic Patent, that the SPC for the triple combination product Atripla (marketed by Gilead and Bristol-Myers Squibb) is invalid. Atripla is an anti-viral medication used in the treatment of HIV, consisting of three active ingredients: (1) efavirenz, (2) tenofovir in the form of the disoproxil fumarate and (3) emtricitabine.
The SPC (in the name of Merck Sharp and Dohme) was invalid for the following reasons:
- It did not comply with Article 3(a) of the SPC Regulation which requires that the product be protected by a basic patent in force. Arnold J assessed the scope of protection of the relevant claim, claim 16, as extending to a combination of efavirenz and tenofovir or to a combination of efavirenz and emtricitabine, but not to a combination of all three.
- Even if the Patent did cover the product, the SPC did not comply with Article 3(c) of the SPC Regulation, which requires that the product has not already been the subject of a certificate. MSD had previously obtained an SPC for efavirenz based on the Patent, which had expired.
- Arnold J confirmed that an SPC cannot be granted for a combination of active ingredients where one of those ingredients embodies the 'core inventive advance' or 'sole subject-matter of the invention' of the basic patent and has already been the subject of an SPC based on that patent, even if the patent contains one or more claims which protect the combination. However, it would be possible to obtain an SPC for a combination, even if one of those active ingredients is protected by the basic patent and has already been the subject of an SPC, if the combination represents a distinct invention protected by the patent (in which case, it should not matter whether it is protected by the same or a different patent).
- In this case, Claim 16 was not independently valid over the claims which protected efavirenz and did not represent a distinct invention. As Arnold J put it, the question was not the conventional one of whether a claim is invalid over a particular item of prior art but whether, given the invention of efavirenz, claim 16 represented a distinct invention which meant that it could in principle form the subject matter of a separate patent.