Adventures of Extension by Vladimir Biriulin and Elena Nazina
- Hetanshi Gohil
- May 5
- 2 min read
Patent term extensions (PTEs) are often essential for pharmaceutical innovators to recoup R&D investments, particularly in drug development where clinical trials and regulatory approvals consume years. In The Global IP Matrix Issue 21, Vladimir Biriulin and Elena Nazina, Partners at Gorodissky & Partners, examine a pivotal court case that challenged the extended validity of a pharmaceutical patent in Russia, raising fundamental questions about patent law interpretation and the protection of active ingredients.
The Legal Challenge to a Patent Extension
The case centred on Russian patent No. 2245335, granted to Eisai R&D Management Co., covering the anti-cancer drug Halaven (Eribulin). A local pharmaceutical company contested the patent’s term extension, arguing that the extension improperly applied to compounds not related to the drug registered in Russia.
Key objections included:
The patent allegedly covered multiple compounds, not just Eribulin.
Eribulin Mesylate, the actual compound in Halaven, was not explicitly disclosed.
The therapeutic indications in the patent did not match those in Halaven’s registered use.
Court Proceedings and Rospatent’s Role
The Russian IP Court, with Rospatent as a third party, dismissed these claims. They confirmed that:
Independent claim 1 and multiple dependent claims did cover Eribulin.
The general structure and anticancer activity disclosed in the patent were sufficient to justify the extension.
The mesylate salt form did not need to be separately disclosed to validate the extension.
Notably, the Court highlighted that the extension request was filed before January 1, 2015—a critical detail. Under the laws effective at that time, a supplementary patent with narrowed claims was not required, allowing the original broad patent to be extended in its entirety
Impact and Precedent for Patent Holders
The decision affirms that older PTEs remain valid under historical regulations, offering legal certainty for pharmaceutical patent owners. The plaintiff's failure to recognise the importance of the pre-2015 filing date was a decisive factor, reinforcing the need for strategic foresight in challenging or defending patent rights.
Conclusion
This case serves as a landmark precedent in Russian IP law, particularly for pharmaceutical patent extensions. It underscores the evolving legal landscape surrounding supplementary protection certificates and active ingredient disclosures—and reinforces the importance of historical filing timelines in judicial interpretations.
To explore the full article by Vladimir Biriulin and Elena Nazina, read it in the latest issue of The Global IP Matrix.
This crackdown should serve as a wake-up call to the IP community—reminding all stakeholders that transparency, diligence, and ethics are non-negotiable pillars of a fair and functioning IP system.
For more insights from Vladimir Biriulin and Elena Nazina , read the full article in the latest issue of The Global IP Matrix.
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