Source: https://hsfnotes.com/ip/2018/07/25/1060/
Timestamp: 2019-04-24 01:05:32+00:00

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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.
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 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).

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