Posted: November 13th, 2019
Gilead vs. Dutch Patent Office (tenofovir / emtricitabine), District Court of The Hague 30 October 2019
The plaintiff in this matter, Gilead Sciences Inc. (“Gilead”), markets a medicinal product under the name Truvada. As many European patent practitioners will know, this product consists of a combination of the active ingredients tenofovir dispoproxil and emtricitabine. According to its SmPC, Truvada is used in combination with other antiretroviral drugs for the treatment of HIV. Gilead was the patentee of the – meanwhile expired – patent EP 0 915 894 B1 titled ‘Nucleotide Analogs’ (“EP 894”).
The compound mentioned in claim 25 of this patent concerns tenofovir disoproxil. Gilead has applied for a supplementary protection certificate (“SPC”) for this medicinal product on the basis of the SPC Regulation with the Dutch Patent Office. Gilead based its SPC application on the basic patent EP 894.
Dutch Patent Office decision
The Dutch Patent Office, however, rejected the application because of non-compliance with Article 3(a) of the SPC Regulation. The condition laid down in this article requires that the product must be protected by the basic patent in force.
The Dutch Patent Office hereby explicitly refers to the interpretation given by the Court of Justice of the European Union (“CJEU”) to Article 3 (a) of the SPC Regulation in previous cases (C-322/10 Medeva, C-631/10 Queensland and C-493/12 Lilly). It follows from these judgments that a product can only be considered to be protected by a basic patent within the meaning of Article 3(a) of the SPC Regulation if it is either expressly mentioned in the claims of that patent or if these claims necessarily and specifically relate to that product. Following on the appeal by Gilead, the District Court of The Hague has asked to consider the validity of the Dutch Patent Office’s rejection.
District Court decision
The District Court reminded the parties that on 25 July 2018, the CJEU issued a judgment (C-121/17) on the interpretation of Art. 3(a) of the SPC Regulation in the parallel the Gilead case (which decision was rendered in the context of the corresponding proceedings in the UK).
According to the District Court, Art. 3(a) of the SPC Regulation must be interpreted as meaning that a product composed of several active ingredients with a combined effect is “protected by a basic patent in force” within the meaning of that provision where the claims of the basic patent necessarily and specifically relate to the combination of the active ingredients of which the product consists, even if that combination is not expressly mentioned in those claims.
This requires, from the point of view of the person skilled in the art and on the basis of the state of the art on the date of filing or priority date of the basic patent:
– the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
– each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.
With regard to the second requirement, the District Court considered that this requirement has not been met. The substance emtricitabine is not mentioned in any way in the basic patent. Nor does the basic patent give the person skilled in the art any indication of a specific category of antiviral agents, let alone of a specific substance. The Court held that the patent simply does not teach anything about this.
Gilead’s argument that the person skilled in the art would consider an NRTI as the first option for another therapeutic ingredient because NRTI combination treatment on the priority date was the “gold standard” does not alter this.
According to the District Court, this still does not imply that the patent also specifically relates to the combination with emtricitabine. Moreover, it does not follow from the documents submitted by Gilead that the therapeutic efficacy of emtricitabine against HIV in humans was a given on the priority date. The Court therefore concludes that the contested decision should be upheld.
A copy of the judgment (in Dutch) can be read here.
Headnote: Jeroen Boelens, NautaDutilh