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25 April 2018Big Pharma

AG opines on ‘thorny issue’ in Truvada SPC clash

Advocate General Melchior Wathelet has advised the Court of Justice of the European Union (CJEU) on a case involving a supplementary protection certificate (SPC).

Today, April 25, Wathelet said that the request for a preliminary ruling affords the court a “further opportunity to rule on the thorny issue” of the criteria for determining whether a product is ‘protected by a basic patent in force’ within the meaning of article 3(a) of regulation No 469/2009 (SPC regulation).

The clash involves an SPC for Truvada (emtricitabine/tenofovir), an anti-retroviral medication used in the treatment of HIV. Truvada is marketed by Gilead Sciences.

Teva, Accord Healthcare, Lupin and Mylan challenged the SPC’s validity, disputing that the SPC is protected by European patent (UK) number 0 915 894.

According to the plaintiffs, for article 3(a) to be satisfied, the product must be “specified in the wording of the claims” and, where the claim contains a functional definition, it must “relate, implicitly but necessarily and specifically”, to that product.

Gilead claimed that for article 3(a) to be satisfied, it is sufficient that the product falls within the scope of protection of at least one claim of the basic patent.

In January last year, Mr Justice Arnold of the English High Court referred the dispute to the CJEU and asked: “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?”

At the time, Arnold presented his suggested answer to the case, stating that it is not sufficient that the product falls within at least one claim of the basic patent, and that “more is required”.

Wathelet advised the CJEU to find that article 3(a) precludes the grant of an SPC relating to active ingredients which aren’t specified in the wording of the claims of the basic patent.

“The fact that a substance or combination of substances falls within the scope of protection of the basic patent is a necessary, but not sufficient, requirement for it to constitute a product protected by a patent within the meaning of article 3(a),” he said.

Wathelet went on to say that a product is protected 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”.

Where there’s a combination of active ingredients (such as in this case), each active ingredient must be “specifically, precisely and individually identifiable” in the wording of the claims.

Looking at the facts of the case before him, Wathelet noted that (subject to verification by the English court), on the priority date of the patent, it wouldn’t have been obvious to a person skilled in the art that emtricitabine was “specifically and precisely identifiable”.

It was common ground that the active ingredient emtricitabine was not expressly named in the claims of the basic patent, said Wathelet.

He concluded that emtricitabine is “claimed solely through the use of completely indeterminate expressions such as ‘comprising’ and ‘optionally other therapeutic ingredients’” and because of this, Truvada is not protected by the basic patent within the meaning of article 3(a), even though that combination may fall within the protection of claim 27 of the patent.

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More on this story

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4 June 2018   The Paris Court of First Instance has nullified a supplementary protection certificate covering Gilead’s HIV/AIDS treatment Truvada.
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28 June 2018   Switzerland’s highest court held that new supplementary protection certificates for combination products should be governed by the relevant EU law, in a dispute over a Swiss SPC owned by Gilead Sciences.
Big Pharma
25 July 2018   Earlier today, the Court of Justice of the European Union clarified when a product is ‘protected by a basic patent’ within the meaning of article 3(a) of the SPC regulation.

More on this story

Big Pharma
4 June 2018   The Paris Court of First Instance has nullified a supplementary protection certificate covering Gilead’s HIV/AIDS treatment Truvada.
Big Pharma
28 June 2018   Switzerland’s highest court held that new supplementary protection certificates for combination products should be governed by the relevant EU law, in a dispute over a Swiss SPC owned by Gilead Sciences.
Big Pharma
25 July 2018   Earlier today, the Court of Justice of the European Union clarified when a product is ‘protected by a basic patent’ within the meaning of article 3(a) of the SPC regulation.