AG's Opinion on how a product must be identified by a patent for SPC protection
May 2018
In February the CJEU heard the latest referral from Arnold J relating to SPCs in Teva and others v Gilead, C-121/17. This referral concerns the correct approach to whether a product is ̔protected by a basic patentʼ under Article 3(a) of the SPC Regulation. Specifically, the question in issue was whether or not Truvada (a combination of tenofovir disoproxil and emtricitabine) is protected by a patent claiming tenofovir disoproxil and ̔optionally other therapeutic ingredientsʼ.
In his referral, Arnold J asked the CJEU to rule on the following simple question:
What are the criteria for deciding whether ̔the product is protected by a basic patent in forceʼ in Article 3(a) of the SPC Regulation?
At the same time, the judge suggested that the answer should be to consider whether the product is part of the ̔inventive advanceʼ or technical contribution of the basic patent.
On 25 May 2018, however, Advocate General Wathelet delivered his Opinion on the question, stating as follows:
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. (Bold added)
The use of the wording 'specifically, precisely and individually identifiable' appears intended to advise a much stricter approach by the AG than that suggested by Arnold J. It is also a different test to those previously set by the CJEU. The next step is for the CJEU to rule on the referral. The CJEU may decide not to follow the AG's Opinion. Furthermore, as we discussed in the February edition of Synapse, there are two other references pending before the CJEU on the subject of Article 3(a), concerning functional claims and Markush claims, respectively. As previous rulings have demonstrated, these may set yet further tests. The AG's Opinion in this case will not, therefore, be the last word on the subject.
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Paul England
Paul is a senior associate and professional support lawyer in the patents group based in our London office.
"The use of the wording 'specifically, precisely and individually identifiableʼ appears intended to advise a much stricter approach by the AG than that suggested by Arnold J."