Mr Justice Arnold gave his ruling earlier this week in Teva UK Limited & Ors v Merck Sharp & Dohme Corporation  EWHC 539 (Pat).
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. 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.
This decision provides guidance on the issues of whether a combination product is protected by a patent for the purposes of the SPC Regulation and whether the product can be considered as a separate invention, and thus can for the basis of a separate SPC.