On January 12, 2018, the Russian Federation published an ambitious Roadmap For Development of Competition in Healthcare, including the latest shot across the bow of innovative drug developers, who are bracing for the possible loss of antitrust immunity, the establishment of procedures for compulsory licensing of pharmaceutical patents, the loss of exclusivity to data in applications for registration of pharmaceuticals, and other measures.
Legislative initiatives to limit the scope of patent protection for pharmaceutical products are driven by the Federal Antimonopoly Service (FAS) but opposed by the Ministry of Health and the Russian patent and trademark office (“Rospatent”). At least one of the FAS proposals, seeking an Amendment to Article 1360 of the Russian Civil Code, is incorporated in the Roadmap, which calls for –
- clarification of conditions for patentability of inventions in connection with the patenting of any new property or new application of a known existing substance of a drug
- establishment of periods for examination of disputes involving intellectual property protection; and
- development of procedures for compulsory licensing
For further information about these developments, contact Bruce A. McDonald in the firm’s Intellectual Property Group.