French court knocks out Gilead Truvada SPC
The Paris Court of First Instance has nullified a supplementary protection certificate (SPC) covering Gilead’s HIV/AIDS treatment Truvada.
Gilead’s SPC, number FR05C0032, is directed to the combination of tenofovir disoproxil and emitricitabine.
In the decision, which was reported by The SPC Blog on May 29, the court granted a cancellation request filed last year by French pharmaceutical company Biogaran.
Biogaran had said the SPC does not meet the conditions for obtaining a certificate under the EU’s SPC regulation (No. 469/2009).
The blog was written by Gérard Dossmann and Marianne Gabriel, who acted for Biogaran, and the decision (in French), dated May 25, is available here.
Gilead’s SPC covered “tenofovir disoproxil and its salts, hydrates, tautomers and solvates in combination with other therapeutic compounds such as emtricitabine”.
European patent number 0 915 894, on which the SPC was based, expired in 2017.
Claims 1 to 25 of the patent covered tenofovir disoproxil, the active ingredient for treating infections including HIV, with the compounds being used alone or with other therapeutic ingredients as provided in claim 27.
Dossmann and Gabriel said claim 27 cites a pharmaceutical composition comprising a compound according to any of claims 1 to 25, “together with a pharmaceutically acceptable carrier, and optionally, other therapeutic ingredients”.
According to Dossmann and Gabriel, the court nullified the SPC because the ‘894 patent does not mention emtricitabine, the active ingredient to which the SPC relates in combination with tenofovir disoproxil, in the wording of its claims, nor does the patent make emtricitabine necessarily and specifically identifiable.
The patent also does not mention a “functional formula implicitly but necessarily and specifically aiming at emtricitabine”, meaning that the product is not protected by the basic patent in view of article 3(a) of the SPC regulation.
Article 3(a) requires the product to be protected by a basic patent in force in order for the SPC to be granted.
In the judgment, which is not yet final, the court ordered Gilead to pay Biogaran €160,000 ($187,000).
The ruling comes after an advocate general (AG) at the Court of Justice of the European Union (CJEU) opined on a case involving the SPC for Truvada and the criteria for determining whether an SPC is protected by a basic patent under article 3(a) of the regulation.
In April, AG Melchior Wathelet gave his view on the case, which was referred by the English High Court, advising the CJEU to find that article 3(a) precludes the grant of an SPC relating to active ingredients which aren’t specified in the wording of the claims of the basic patent.
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