Legal Aspects of Compulsory Licensing in the Pharmaceutical Sector in Russia by Evgeny Alexandrov

Legal Aspects of Compulsory Licensing in the Pharmaceutical Sector in Russia by Evgeny Alexandrov. In The Global IP Matrix Magazine Issue 23, Evgeny Alexandrov, Senior Partner at Gorodissky & Partners, explores Russia’s evolving approach to compulsory licensing (CL) in the pharmaceutical industry. Against a backdrop of public health emergencies, market disruptions, and judicial ambiguity, this article unpacks the complexities of Russia’s legal framework and the tension between patent exclusivity and the public’s right to essential medicines.

Understanding the Legal Landscape

Compulsory licensing allows third parties to produce patented drugs without the consent of the patent holder. Russian law recognises two forms of CL government-granted in emergencies, and court-ordered when a patent is underused or dependent on another. Since COVID-19, Russia has cautiously embraced CL to address medicine shortages, highlighting a global trend toward greater intervention during crises.

Insufficient Use and Patent Dependency

One of the most controversial grounds for seeking a compulsory license in Russia is "insufficient use." Courts often struggle to define what qualifies as “sufficient,” leading to inconsistent rulings. Alexandrov illustrates how overly simplistic court interpretations, such as linking drug demand solely to patient statistics, fail to reflect the real-world nuances of pharmaceutical use. Judicial Gaps and Global Context

The article discusses landmark Russian court cases involving patent dependency, noting the lack of unified criteria for granting CLs. Alexandrov also places Russia’s framework in a global context, comparing it to TRIPS, the Paris Convention, and the EU’s new unified mechanism for emergency CLs. AIPPI survey data underscores the global push for harmonisation.

Trade Secrets, Voluntary Licensing, and Sustainable Alternatives

Alexandrov warns that even if a patent is licensed compulsorily, manufacturers often lack access to crucial trade secrets, impacting drug quality and safety. Instead, he advocates for voluntary licensing agreements and localisation of pharmaceutical production as more practical and sustainable solutions to meet public health needs.

Conclusion

As Alexandrov explains, compulsory licensing is no longer a theoretical fallback; it’s a real-world legal instrument with serious implications for public health and innovation. A nuanced, transparent approach is essential to balance patent protection with equitable access in times of crisis.

Read the full article in The Global IP Matrix Issue 23, for an expert legal analysis of Russia’s approach to compulsory licensing, and how it fits into the global framework of access to medicines, patent rights, and public welfare.

READ THE FULL ARTICLE NOW!