Mr Justice Arnold recently held that Merck’s SPC for Atripla did not comply with either Article 3(a) or Article 3(c) of the SPC Regulation (Teva & others v Merck Sharp & Dohme [2017] EWHC 539 (Pat)).
Under Article 3(a) Teva argued that the product for which the SPC was granted (“A combination of efavirenz, emtricitabine or a pharmaceutically acceptable salt or ester thereof, and tenofovir or a pharmaceutically acceptable prodrug, salt or ester thereof, particularly tenofovir disoproxil, especially tenofovir disoproxil fumarate”) was not protected by the basic patent. In particular Teva argued that the product was not protected by claim 16 which related to “A combination of the compound of claim 12 [efavirenz] or a pharmaceutically acceptable salt thereof with a nucleoside analog having biological activity against HIV reverse transcriptase”. Arnold J agreed, concluding that that the scope of protection of claim 16 of the patent extended to a combination of efavirenz and tenofovir or to a combination of efavirenz and emtricitabine, but not to a combination of all three agents.
Under Article 3(c) Teva argued that the product had already been the subject of an SPC because Merck had previously obtained an SPC for efavirenz based on the same patent. Taking into account the CJEU case law, in particular Case C-443/12 Actavis v Sanofi and Case C-577/13 Actavis v Boehringer, Arnold J held that Article 3(c) precludes the grant of an SPC for a combination of active ingredients if the patent has already been the basis of an SPC for one of the active ingredients and the combination does not represent a distinct invention over that active ingredient. Arnold J concluded that Merck’s SPC was invalid under Article 3(c) because the combination claimed in claim 16 did not represent a distinct invention over the claims relating to efavirenz alone.