Preprint of the WP22 "BRICS Competition Law and Policy Series" dedicated to the discussion of national and global problems of competition development and development of fundamentally new methodological approaches to regulation in the context of large-scale transformation of key markets.
This paper critically reviews the draft proposal that would introduce patent linkage to Russia’s drug approval system. The paper looks at the emergence and spread of patent linkage in the USA and further in several jurisdictions. This research concludes that patent linkage and the interests it protects are far from the goals that the state should set in the post-pandemic period. Even if adopted, the proposed changes will be unable to incorporate the best practices of mitigating the effect of patent linkage on the pharmaceutical market demonstrated by the experience of jurisdictions that employ this mechanism. The new initiative reveals its total incompatibility with the new priorities of public policy in the field of intellectual property and health care that came to light thanks to the COVID-19 pandemic.