Intellectual Property in Pharmaceutics. Balance Between Private and Public Interests

The IX St. Petersburg Legal Forum held the discussion on disputes related to violations of rights and the issues of compulsory licensing in pharmaceutics.

The discussion was moderated by Vitaliy Kastalsky, Managing Partner, Kastalskiy and Partners. The session was joined by Anna Guseva, Partner, Ernst and Young, Anna Kostyra, Managing Partner, Deloitte, Nikolay Lyskov, Head of the Department of Chemistry, Biotechnology and Medicine, Federal Institute of Industrial Property, Vironika Pilyugina, Counsel, Hogan Lovells CIS, Pavel Sadovsky, Counsel, Egorov Puginsky Afanasiev and Partners, Dmitriy Zaytsev, Deputy Director General of Intellectual Property, JSC Pharmstandard, Kseniya Nasonova, Head Patent Expert, GEROPHARM, Polina Presnyakova, Legal Affairs Director and Compliance Officer, EAEU, JSC Servier, Irina Chernenko, Legal Affairs Director, Johnson & Johnson LLC.

Vitaliy Kastalsky opened the discussion by inviting the participants to discuss disputes on exclusivity violations in pharmaceutics, compulsory licensing, inventions quality assessment, and patents invalidations procedures.

Vironika Pilyugina regretted that litigation practice in exclusivity violations had not been crystallized. “Volumes of cases are pending court rulings, and new claims are filed”, she noted. Pavel Sadovsky, Counsel, agreed with his colleague. “It seems fair to say that the litigation practice exists in a sense that courts rely on expert studies, all the cases are decided after court-ordered expert reviews and the judgements rely upon them, the outcome is predetermined by an expert opinion”, he said. The expert noted that, however, there are plenty of issues related to the court-appointed expert studies.

Anna Kostyra, Managing Partner, Deloitte, pointed out that a legal proceeding is not the only remedy in exclusivity violation cases. “Exclusive right is actually your privilege. I always tell my clients that in terms of existing remedies legal proceeding is not the only option. Remedies include full enjoyment of your rights, e.g. injunctions, permissions, licensing, alienation”, explained Anna Kostyra.

Anna Guseva, Partner, Ernst and Young, following in the same lines of exclusive rights, supported the initiative of a unified patent register that was proposed during the session on state policy on intellectual property in pharmaceutics. “We should prevent price fixing if a brand-name drug patent has not yet expired. Such cases could be settled within the framework of legal proceedings. However, after a certain period of time it turns out that a company has registered a generic drug, has fixed the price, bids for government tenders, sells its drug while the brand-name drug producer incurs losses over the same period of time”, she noted.

Nikolay Lyskov, Head of the Department of Chemistry, Biotechnology and Medicine, Federal Institute of Industrial Property, said that the Russian Federal Agency for Intellectual Property, Patents and Trademarks is aware of challenges in the industry and is committed to resolve the issues faced by the pharmaceutics community. “The renewal strategy, which has been repeatedly mentioned today and which is also known as ‘an evergreen patent’, will include a set of measures to ensure a balance of interests”, he added.

St. Petersburg Legal Forum takes place 14 to 18 May, 2019 in the Eastern wing of the General Staff Building, State Hermitage. SPBILF is supported by the Russian Federation President and organized by the Ministry of Justice of Russian Federation.