Pharmaceutics 2022: outcome of the Pravo.ru conference
On April 12, the Pravo.ru conference Pharmaceutics - 2022: Legal Issues took place. The leading lawyers discussed price regulation and the availability of medicines, patent litigation, tax issues, risk sharing, electronic prescriptions, and patient support programs.
First of all, the speakers turned to topical legal issues in the pharmaceutical industry. Sergey Zuykov, a managing partner of Zuykov and partners, spoke at the session about innovations in the legislative regulation of the pharmaceutical industry. In view of recent events, the issue of compulsory licensing has gained new relevance. Thus, on October 18, 2021, the Government adopted Decree No. 1767. The procedure implies a special exclusive goal which means the interests of the security and defense of the state. According to Sergey Zuykov, "the judicial procedure is complicated, non-working, there are no such cases." Therefore, the lawyer stands for the administrative procedure with non-use and campaigns to support it in order to simplify the work of business.
Ksenia Yakunina, a senior lawyer at Zuykov and partners, spoke at the session on the problematic aspects of intellectual property protection in the pharmaceutical market. Ksenia Yakunina presented an analysis of judicial practice on the topic of legal regulation of generics.
In her report, Ksenia noted that “if the active substance is protected by a patent, then the sale of a generic drug will violate the patent. This seems to be understandable, but the court cases are still ongoing.” According to statistics, from 2013-to 2020, the courts considered 40 relevant claims of patent owners, and the peak was 2018 (16 cases). Ksenia Yakunina also spoke about the tactics of not only originator companies but also generic drug manufacturers. The latter have developed a standard set of actions, including challenging the grant of a patent for an invention that may be infringed (non-compliance with the conditions of patentability), and the requirement of a compulsory license.