German patent court publishes reasoning in Gilead SPC dispute

Germany’s Federal Patent Court (Bundespatentgericht, BpatG) has published the reasoning behind its decision to revoke Gilead Sciences’ supplementary protection certificate (SPC) for HIV/AIDS treatment Truvada,

Alexa von Uexküll and Oswin Ridderbusch, both partners at Vossius & Partner’s Munich office, shared the development on the Kluwer Patent Blog yesterday, November 5.

American biotech Gilead owns the rights to Truvada, which contains tenofovir disoproxil and emtricitabine.

In 2011, the BpatG determined that the combination of the ingredients specified by Gilead falls within the scope of protection of the “basic patent” specified in article 3(a) of regulation 469/2009 (the SPC regulation).

As a result, Gilead obtained an SPC in Germany for the product “tenofovir disoproxil and salts, particularly the fumarate salt, hydrates, tautomers and solvates thereof in combination with emtricitabine”.

Gilead proceeded to sue generic manufacturers for infringing this SPC, which the manufacturers then sought to revoke in response.

In August 2017, the Munich District Court rejected Gilead’s claim for injunctive relief, and in May 2018, the BpatG announced that the Truvada SPC would be revoked.

However, before the BpatG could issue its decision in writing, the Court of Justice of the European Union (CJEU) ruled on  Teva v Gilead (C-121/17), a parallel Truvada SPC case stemming from the UK.

In the decision, delivered on July 27, the CJEU clarified when a product is “protected by a basic patent” within the meaning of article 3(a) of the SPC regulation.

According to the CJEU, even when the combination of active ingredients in the product is not expressly mentioned in the claims of the basic patent, the product will be protected by a basic patent if the claims “relate necessarily and specifically to that combination”.

Following the CJEU’s decision, the English High Court ruled that Truvada is not entitled to an SPC.

As noted by the Kluwer Patent Blog, “practitioners have since been waiting in suspense to see how exactly the Federal Patent Court, in knowledge of this later-issued CJEU ruling, would justify the revocation of Gilead’s German Truvada SPC.”

In the newly-published written judgment, the BpatG confirmed that Gilead’s combination of tenofovir disoproxil with emtricitabine is not protected by the basic patent within the meaning of article 3(a).

This is because the active ingredient, emtricitabine, was not sufficiently included as part of the subject matter of the invention claimed in Gilead’s basic patent, the BpatG explained. Gilead’s basic patent referred to “other therapeutic ingredients” rather than specifically disclosing emtricitabine.

The Kluwer Patent Blog said it is “noteworthy” that the BpatG did not find it necessary to assess anything else in the context of article 3(a), such as whether the combination of the ingredients has inventive quality.

Instead, the BpatG held that the SPC regulation does not leave room for assessing the inventive step of the basic patent.

This decision is in line with the CJEU’s findings, the BpatG said.

Gilead may request permission to appeal against the decision, to the Federal Court of Justice (Bundesgerichtshof).

Earlier this year, the Paris Court of First Instance similarly nullified Gilead’s SPC for Truvada after finding that it does not meet the conditions necessary to obtain a certificate under the SPC regulation.

The Danish Maritime and Commercial High Court came to the same conclusion last year, when it invalidated Gilead’s SPC at the request of generics maker Accord.

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