Article 3 of the Supplementary Protection Certificate – SPC Regulation – (469/2009/EC) sets out the conditions required to obtain an SPC, with Article 3(a) of the Regulation specifying that a certificate shall be granted provided that the product is “protected by a basic patent in force”.
In recent years the Court of Justice of the European Union (CJEU) has repeatedly attempted to clarify the meaning of Article 3(a) of the SPC Regulation. However, three requests for preliminary rulings concerning the interpretation of Article 3(a) of the SPC Regulation are currently pending before the CJEU, suggesting that this issue is still a legal grey area. In an attempt to further clarify the interpretation of Article 3(a), the UK High Court referred the following question to the CJEU:
“What are the criteria for deciding whether “the product is protected by a basic patent in force”?
Advocate General Wathelet delivered his advisory opinion on 25 April 2018 in response to this fundamental question.
Facts of the main proceedings
The request by the UK High Court was made during proceedings between Teva, Accord, Lupin, and Mylan (the Applicants) and Gilead (the Defendant) regarding the Applicants’ attempt to invalidate Gilead’s SPC (SPC/GB05/041) on the grounds that the SPC does not satisfy Article 3(a) of the SPC Regulation.
Gilead’s product, marketed under the name TRUVADA®, is an anti-retroviral used in treating HIV, and comprises tenofivir disoproxil (TD) and emtricitabine. The combination product was granted marketing authorisation in February 2005. Gilead relied upon this first marketing authorisation and upon claim 27 of European patent EP(UK)0915894 as basis for the combination SPC.
Claim 27 of the basic patent recites: “A pharmaceutical composition comprising a compound according to any one of claims 1-25 [claim 25 discloses TD] together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients”.
Importantly, emtricitabine is not mentioned anywhere in the patent.
A variety of approaches
Gilead argued that the only criteria that needs to be satisfied is whether the product in question, TRUVADA®, falls within the scope of protection of at least one claim, i.e. claim 27. However, in previous decisions (Medeva C-322/10 EU; Daiichi Sankyo C-6/11 EU), the CJEU has held that an SPC can be granted only when the active ingredients are “specified in the wording of the claims”. The Applicants therefore argued that the broad term “other therapeutic ingredients” does not identify emtricitabine specifically; not least because emtricitabine was not approved for clinical use until seven years later, and so was not known to be efficacious for the treatment of HIV at the priority date of the patent.
A number of European Governments submitted written observations to the CJEU suggesting that, in addition to the above approach, it should also be determined whether the combination of active ingredients embodies the core inventive advance of the basic patent.
Advocate General Wathelet’s Opinion
In his recent opinion, AG Wathelet disregarded the core inventive advance test on the basis that this test relates to Article 3(c) of the SPC Regulation and therefore is irrelevant for interpreting Article 3(a). Furthermore, AG Wathelet considered that the scope of protection test, while necessary, is not sufficient on its own to conclude that the product is “protected by the basic patent” as required by Article 3(a) of the SPC Regulation. Instead, referring to Eli Lilly and Company (C-493/12 EU), AG Wathelet emphasised the importance of the wording, or the interpretation of the wording, of the claims of the basic patent stating that: “A product is protected by a patent within the meaning of Article 3(a) of that regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically, precisely and individually identifiable in the wording of the claims of the basic patent.”
Whilst the Advocate General’s opinion appears to provide further guidance on the interpretation of Article 3(a) of the SPC Regulation it is, of course, not binding. We will therefore have to wait to see whether the CJEU adopts the opinion of the Advocate General, or provides an alternative test altogether.