The German Federal Supreme Court revokes a supplementary protection certificate of the US pharmaceutical company Gilead for the HIV drug Truvada®
The generic product of Maiwald client Generics UK was and is legally on the market.
Munich, September 30, 2020: Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH in Munich has won an important victory for its client Generics UK Ltd. before the German Federal Supreme Court (Bundesgerichthof – BGH). On September 22nd, the BGH definitively declared the supplementary protection certificate DE 12 2005 000 041.8 for the active ingredient combination of Tenofovir Disoproxil and Emtricitabine null and void and dismissed the appeal of the US pharmaceutical group Gilead Sciences Inc.
HIV drugs with this combination of active ingredients are in high demand
The active ingredient combination is contained in Gilead’s HIV drug Truvada®, among others, and is a central component in HIV treatment. The decision of the BGH brings the German proceedings to an end. Only recently, the parallel proceedings in the United Kingdom concerning this combination of active ingredients were concluded. With its latest decision, the BGH endorsed the views of the British courts and numerous other European courts.
No basis for supplementary protection certificate
The BGH confirmed that there is no basis for the protection of tenofovir disoproxil and emtricitabine via a supplementary protection certificate. The reason: In the opinion of the Supreme Court of the Federal Republic of Germany, the protection certificate does not meet the criteria established by the European Court of Justice (ECJ) in its decision “Teva” (C-121/17) on July 25, 2018, namely criteria that are necessary to protect a product of the supplementary protection certificate on the basis of a basic patent. The ECJ had dealt with the parallel case from the United Kingdom following a request for a preliminary ruling from the UK court.
Market entry of generic products could not be prevented
Even before this ECJ decision, the Federal Patent Court had, in May 2018, in the first instance proceedings (4 Ni 12/17), upheld the suit of four generics companies, including Generics UK Ltd. Previously, Gilead had unsuccessfully tried to prevent the market entry of all generic products: the applications for interim injunctions based on the supplementary protection certificate failed.
Representation by Maiwald attorneys Dr. Derk Vos (patent attorney) and Heike Röder-Hitschke (attorney at law)
Patent attorney Dr. Derk Vos and attorney at law Heike Röder-Hitschke represented the pharmaceutical company Generics UK Ltd before the Federal Supreme Court. “With these nullity proceedings, the Federal Supreme Court had the opportunity, after some time and under a new chairmanship, to comment on a procedure that was much discussed in Europe. We are very pleased with this positive decision for our client,” says patent attorney Vos. Although the grounds are not yet available, it is to be expected, says Vos, that the Federal Court of Justice will consistently implement the criteria established by the ECJ in its recent case law and will also provide clear guidance for future cases.
Protection certificates compensate for waiting periods until market authorisation
By means of Supplementary Protection Certificates (SPCs), pharmaceutical manufacturers can extend the initial patent-protected protection of an authorised medicine by up to five years. The certificate does not extend the patent itself. Within the scope of protection of the basic patent, it protects already authorised drugs, the development and research of which is usually very complex and cost-intensive. Thus, with the supplementary protection certificates, the legislator is seeking to compensate patent holders for the “lost” time between the patent application and the market authorisation for a medicinal product required for commercial use by means of a corresponding extension.