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The English High Court has referred a supplementary protection certificate (SPC) dispute over Truvada (emtricitabine/tenofovir) to Europe’s highest court, the Court of Justice of the European Union (CJEU).
Truvada is an anti-retroviral medication used in the treatment of HIV, marketed by Gilead Sciences.
The case was brought against Gilead, the owner of the SPC, by Teva, Accord Healthcare, Lupin and Mylan.
The SPC’s validity was challenged by the companies, which disputed that the SPC is protected by European patent (UK) number 0 915 894.
Gilead’s application had originally been rejected by the comptroller-general of patents, but Gilead appealed and was granted the SPC in July 2008,
According to the ruling, Mr Justice Arnold said that since Gilead was awarded the SPC, “there have been a number of judgments of the CJEU which are relevant to the issue raised by the claimants.”
Arnold ruled that the test to be applied in order to determine whether a product is protected by a basic patent within the meaning of article 3(a) of Regulation 469/2009/EC (SPC regulation) remains unclear, so he referred the case to the CJEU.
One of the concerns raised in the judgment is that there have been divergent decisions reached across Europe with regard to the interpretation of article 3(a).
In order to clarify the case, Arnold asked a question with reference to Actavis v Sanofi: “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?”
Arnold presented his suggested answer to the case, stating that “it is not sufficient that dealings in the product would infringe a claim applying the infringing act rules. It is also clear that it is necessary that the product falls within at least one claim of the basic patent applying the extent of protection rules.”
He added: “It is not sufficient that the product falls within at least one claim of the basic patent applying the extent of protection rules. As explained … and as the facts of the present case illustrate, the scope of protection test proves too much in this context. Accordingly, more is required.”
English High Court, CJEU, SPC, Truvada, Teva, Accord Healthcare, Lupin, Mylan, Gilead, patent