Teva, Accord, Lupin, Generics (UK) t/a Mylan v Gilead [2017] EWHC 13 (Pat)

13 January 2017

Daniel Alexander QC and Lindsay Lane appeared for one claimant (Teva), Daniel Alexander QC and Jaani Riordan appeared for another claimant (Lupin), and James Whyte appeared for the defendant (Gilead), in these actions concerning Gilead’s Supplementary Protection Certificate (SPC) for an anti-retroviral drug combining tenofovir disoproxil and emtricibatine (marketed by Gilead as ‘Truvada’).

The claimants contended that the product the subject of the SPC was not protected by Gilead’s patent in accordance with article 3(a) of Regulation 469/2009/EC (the “SPC Regulation”). The question of compliance with article 3(a) turned on whether claim language referring to tenofovir disoproxil and “optionally other therapeutic ingredients” was enough to protect the combination .

After a review of the CJEU case law, Arnold J concluded that it was not clear whether it was sufficient for the grant of an SPC in regard to such a product that it fell within the scope of the claims of a basic patent in force, or whether something more was required. He therefore referred to the CJEU the question:

“What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in article 3(a) of the SPC Regulation?”

View judgment