An English Court has determined that the contested supplementary protection certificate (SPC) on Truvada® held by Gilead is invalid by applying the criteria laid down by a recent referral to the Court of Justice of the EU (CJEU). Mr Justice Arnold held that Gilead’s SPC failed the CJEU’s test as Gilead’s basic patent on which the SPC was based did not describe the combination of tenofovir and emtricitabine and did not specifically identify emtricitabine.

 

This judgment applying the CJEU decision should now assist in the resolution of a number of parallel cases in national courts across Europe.

 

Of course, this ruling will have a very meaningful impact on the HIV patient community and those at risk of contracting HIV, who could not afford the monthly 355GBP treatment cost of Truvada®. This ruling is a major first step in ensuring timely and appropriate generic competition that ultimately will increase patient access to this vital medicine, bring society a huge leap forward in combatting HIV, and contribute to healthcare system sustainability.

 

“This decision is a step forward in ensuring certainty and quality of the patent and SPC systems, and sets the stage for rapid court decisions to invalidate this SPC across Europe to enable greater access to this important HIV therapy” said Adrian van den Hoven, Director General at Medicines for Europe.

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