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28 June 2018Big Pharma

Swiss Federal Supreme Court to adopt EU SPC case law

Switzerland’s highest court held that new supplementary protection certificates (SPCs) for combination products should be governed by the relevant EU law, in a dispute over a Swiss SPC owned by Gilead Sciences.

The Swiss Federal Supreme Court delivered its landmark decision on June 11, when it also upheld the validity of Gilead’s SPC.

At the centre of the clash was the validity of Gilead’s SPC C00915894/01, granted in 2008, for HIV/AIDS drug Truvada (a combination of tenofovir disoproxil fumarate, and emtricitabine).

In January 2017, the Swiss subsidiary of Teva, Mepha Pharma, filed an application to revoke Gilead’s Swiss SPC for Truvada.

Mepha argued that Switzerland’s infringement test should no longer be used to assess SPCs in Switzerland, and EU case law on SPCs should instead be applied.

Switzerland’s infringement test stems from Swiss case law from 1998 ( BGE 124 III 375). It asks whether the product covered by the SPC falls within the scope of one of the patent’s claims and the product doesn’t need to be specified for the corresponding SPC to be valid.

In the EU, article 3(a) of regulation 469/2009 governs SPCs. Case law from the Court of Justice of the European Union (CJEU) requires, following Medeva v Comptroller General of Patents, Designs and Trade Marks in 2011, that the active ingredient of a product covered by the SPC is specified in the wording of the patent’s claims.

Under the application of EU case law, Gilead’s SPC would be invalid on the grounds that the two active ingredients in Truvada were not specified in the claims of the basic patent, Mepha argued.

However, Switzerland is not part of the EU, and the country is therefore not governed by its harmonised SPC rules.

Before the Supreme Court, Gilead argued that Switzerland should stick to its infringement test. It claimed that, even if Switzerland were to diverge from this test, the new standard would apply only to SPC applications which were filed after the change of practice.

The Swiss Federal Patent Court Court last year ruled that it would not depart from its infringement test. It said that the case law put forward by the CJEU is unclear, and Switzerland’s test remains valid, while upholding Gilead’s SPC as valid.

Mepha appealed against the decision but, earlier this month, the Supreme Court dismissed Mepha’s appeal.

Switzerland’s highest court noted that the country’s SPC legislation was intended to be materially similar to that of the EU and therefore, going forward, new SPCs for combination products will be considered in the context of the Medeva ruling rather than the infringement test.

However, the infringement test still applies to existing SPCs, such as Gilead’s SPC for Truvada.

Under the Swiss Patent Act, whether the conditions for granting the SPC are met should be determined by the time of filing, the court said. Gilead’s SPC was valid in light of the infringement test, which was the relevant test at the time that Gilead submitted the application.

The court ordered Mepha to pay Gilead’s costs of CHF17,000 ($17,112), as well as court costs of CHF15,000 ($15,099).

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8 November 2018   The Swiss Federal Institute of Intellectual Property has issued a notice covering a change in the practice for granting supplementary protection certificates (SPCs), following a landmark decision by Switzerland’s highest court.
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