The CJEU’s judgment on Gilead’s SPC for Truvada® is out now

Case No. C-121/17 (CJEU) | Decision of 25 July 2018

Note that Hepp Wenger Ryffel has been involved in parallel proceedings in Switzerland on behalf of Teva.

It’s showtime again for the SPC community — but don’t expect big surprises:

The CJEU handed down its judgment in the matter Teva et al. ./. Gilead (C-121/17) earlier today, concerning an SPC for the combination of tenofovir disoproxil (TD) and emtricitabine, i.e. Gilead’s Truvada®.

For ease of reference, the opinion of the Advocate General and Judge Arnold’s referral are also included hereinbelow.

Be remembered that Arnold J had referred the same question from the Actavis ./. Sanofi (C-443/12) case again, i.e.:

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?

Now, in case of a combination product, the CJEU’s answer is as follows (emphasis added):

Article 3(a) of Regulation No 469/2009 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.

It will now be on the referring court to decide how this will play out in the matter at hand. However, there is a quite clear message from the CJEU in ¶56:

Consequently, it does not seem possible that a person skilled in the art, on the basis of the prior art at the filing date or priority date of that patent, would be able to understand how emtricitabine, in combination with TD, necessarily falls under the invention covered by that patent.

Reported by Martin WILMING

DECISION C-121/17

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ADVOCATE GENERAL’S OPINION

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REFERRAL

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