CJEU SETS OUT TEST ON THE INTERPRETATION OF ARTICLE 3(a) SPC REGULATION
The Court of Justice of the European Union (‘CJEU’) has today delivered its decision on the interpretation of Article 3(a) SPC Regulation in Case C-121/17 Teva v Gilead.
The CJEU has said that in the case of an SPC for a combination product, Article 3(a) will be satisfied if, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
- the combination of active ingredients necessarily, in the light of the description and drawings of that patent, falls under the invention covered by that patent, and
- each of those active ingredients is specifically identifiable, in the light of all the information disclosed by that patent.
The CJEU has made it clear that these are matters for national courts to decide.
This is a very important decision for all stakeholders in the pharmaceutical industry. It relates to the ability of patentees to obtain SPCs, a sui generis right, which effectively extends the duration of patent protection for products (i.e. active ingredients or combinations of active ingredients) of medicinal products covered by marketing authorisations (MAs).
It is the first time that the Grand Chamber of the CJEU (sitting as 15 judges) has provided guidance for national courts to interpret Article 3(a) of the SPC Regulation, although other Chambers of the CJEU have also tackled this issue in the past.
Gilead’s UK SPC covers pharmaceutical compositions comprising the combination of tenofovir disoproxil and emtricitabine, a preferred “backbone” of active ingredients for the treatment of HIV. Such products include Gilead’s blockbuster anti-HIV treatments TRUVADA® and ATRIPLA®.
In 2016, Teva, Generics UK (t/a Mylan), Accord and Lupin commenced proceedings against Gilead in the High Court of England and Wales to revoke the SPC, on the basis that the product the subject of the SPC is not protected by the basic patent within the meaning of Article 3(a) of the SPC Regulation.
Mr Justice Arnold delivered his judgment in January 2017, and referred a single question to the CJEU: “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?”
In April, AG Wathelet provided his opinion (reported here) that a product is protected by a patent in accordance with Article 3(a) of the SPC 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.
The CJEU handed down its decision on 25 July 2018, ruling that:
Article 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, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date 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.
The CJEU has not simply adopted the test proposed by AG Wathelet in his Opinion on the case from April this year, but instead has formulated its own test for Article 3(a).
In providing its guidance on Article 3(a), the CJEU referred to its own settled case law that the extent of protection conferred by a basic patent can be determined only in the light of the non-European Union rules governing patents.
The CJEU confirmed that for the purpose of applying Article 3(a) recourse may not be had to the rules governing infringement proceedings, but stated that the relevant rules are those relating to the extent of the invention covered by a patent in Article 69 EPC and the Protocol on its interpretation.
The CJEU also reiterated the key role played by the claims for the purpose of determining whether a product is protected by a basic patent within the meaning of Article 3(a).