Lidings Intellectual Property team has helped a major Russian manufacturer of pharmaceuticals, Pharmnovations, to achieve the annulment of the marketing authorization for a generic drug of a competitor company.
In September 2022, Pharmnovations sued the Russian Ministry of Health based on the breach of the data exclusivity regime reasoned by the fact that an application for the generic drug’s registration was submitted to the Ministry of Health within the data exclusivity term.
Under the data exclusivity regime (art. 18 (20) of the Federal Law “On the Circulation of Medicines”), the holder of the reference drug shall enjoy a 4-year exclusive period during which generic manufacturers are not entitled to initiate the registration procedure for generic drugs.
Lidings team elaborated a strategy to convince courts that there had been a breach of data exclusivity. As a result of the proceedings, the Court of Appeal ordered the Ministry of Health to terminate the registration of the generic drug and exclude it from the public register of medicines (link to the case). The court separately noted the importance of the institute of data exclusivity in ensuring a balance of interests on the pharmaceutical market.
Lidings Partner and Head of Intellectual Property Boris Malakhov, representing Pharmnovations, comments on the case:
It is the first decision on the data exclusivity dispute since 2016, when the legislator significantly revised the exclusivity regime mechanism. the decision not only sets a precedent in the legal dimension but is also important for the entire industry. the pharmaceutical market received a signal: the exclusivity principle shall be enforceable and protect innovative drugs.The case has been widely publicized in the mass media. For details refer to reports by Pharmvestnik.
***
Lidings has extensive experience in Life Sciences sector providing leading pharmaceutical and healthcare sector companies with comprehensive legal advice and representation in respect of regulatory issues, routine commercial activities, tax and antitrust matters, intellectual property, personal data protection, resolution of disputes and bankruptcy assistance.
The firm is annually recognized for its expert industry knowledge by the leading Russian and international legal directories as Pravo-300, Kommersant, Chambers and Partners, LMG Life Sciences.