In brief, Merck Sharp & Dohme (MSD) was granted an SPC for a combination product of efavirenz, emtricitabine and tenofovir disoproxil fumarate based on EP (UK) 0 582 455 (the product is marketed as Atripla by Bristol-Myers Squibb Co. and Gilead Sciences Inc). At trial, MSD relied on claim 16 as protecting the product. Claim 16 reads:
“A combination of the compound of claim 12 or a pharmaceutically acceptable salt thereof with a nucleoside analog having biological activity against HIV reverse transcriptase.”MSD also previously obtained an SPC for efavirenz based on the same patent. Teva, Accord and Mylan challenged the validity of the SPC.
Mr Justice Arnold found that the SPC was invalid because it did not comply with either Article 3(a) or Article 3(c) of the SPC Regulation. More specifically, he found that the scope of protection of claim 16 extended to a combination of efavirenz and tenofovir or a combination of efavirenz and emtricitabine, but not to a combination of all three actives. He also found that the SPC does not comply with Article 3(c) because claim 16 does not represent a distinct invention from the invention protected by the claims for efavirenz.