Extended Patent Protection for Pharmaceutical Companies
Prospect of Legal Certainty for all EU Member States
Maiwald obtains a referral to the European Court of Justice.
A decision is expected in 2019.
The Federal Patent Court (BPatG) referred a case regarding a Supplementary Protection Certificate to the European Court of Justice (CJEU) for a preliminary ruling. This referral is based on an appeal filed by Maiwald Patentanwalts GmbH, Munich, in the name of Royalty Pharma, New York. Dirk Bühler, patent attorney and partner at Maiwald in Munich says, “The decision of the European Court of Justice will provide legal certainty for pharmaceutical companies in all EU member states”. He expects a decision in 2019. Dirk Bühler is handling the case together with patent attorney Annelie Wünsche from Maiwald.
Extension of the relevant patent unclear
The underlying patent stems from an invention, which formed the basis for founding the German Company ProBiodrug. At a later point in time, Maiwald’s client, Royalty Pharma, acquired the patent. The patent protects a new therapeutic concept for treating Diabetes mellitus with so-called DPIV-inhibitors, also known as gliptins. In view of the significance of this concept, Merck Sharp&Dohme, Novartis, Boehringer Ingelheim and Takeda in-licensed the patent. These companies sell the active agents sitagliptin, vildagliptin, linagliptin and saxagliptin. In December 2015, Royalty Pharma filed an application for a Supplementary Protection Certificate (SPC) covering sitagliptin, in order to obtain extended patent protection. However, as the active agent was developed after the filing of the patent application, it is not specifically mentioned in the underlying patent, so that it is unclear whether a Supplementary Protection Certificate can be obtained. “In this regard, the jurisprudence in the EU member states varies,” Annelie Wünsche explains.
Legal certainty for pharmaceutical companies in Europe
“For pharmaceutical companies in Europe, there are presently many questions open regarding Supplementary Protection Certificates”, Dirk Bühler comments. He is convinced that that the CJEU decision will provide the long-awaited clarity regarding this matter. “For pharmaceutical companies it would be of great advantage to know whether an active agent must be specifically mentioned in a patent, in order to obtain an SPC,” Dirk Bühler explains. This question is of particular relevance for start-ups. Such start-ups often contribute significantly in the development of new therapeutic concepts. However, they do not have sufficient resources to conduct clinical trials for regulatory approval. “A patentee friendly position in line with the British jurisprudence would be highly important for such start-ups to invest in research,” Annelie Wünsche concludes.
Supplementary Protection Certificates compensate a delay in regulatory approval
With Supplementary Protection Certificates (SPC), pharmaceutical companies can extend patent protection by a maximum of five and a half years. The SPC does not extend the patent per se. Instead, it provides protection for active agents within the scope of the patent, for which the regulatory approval was time-consuming and costly. Based on this concept, the SPC compensates for the time lost between the filing of the patent application and the regulatory approval.