Challenging Patent Term Extensions

A patent term extension is a lawful tool for extending the monopolistic position of a right holder; however, if statutory requirements are violated, it may be challenged and invalidated as creating unjustified restrictions on competition.

Legal Basis for Extensions in Russia and the EAEU

In Russia, the duration of exclusive rights is set out in Article 1363 of the Civil Code: 20 years for inventions, 10 years for utility models (non-extendable), and up to 25 years for industrial designs, subject to extension.

Extensions primarily apply to inventions related to pharmaceuticals, pesticides, and agrochemicals and may not exceed five years. They compensate for lengthy administrative procedures, such as regulatory testing and marketing authorisations. As a result, a supplementary patent is issued confirming the extension, and the total term of protection may reach up to 25 years from the filing date.

The legal basis for extending Eurasian patents is established under Rule 16(5) of the Eurasian Patent Convention (EAPC Implementing Regulations). Such extensions are effective only in those contracting states whose national legislation allows them and are carried out in accordance with that legislation.

They are available only for subject matter recognised under national law (for example, pharmaceuticals in Russia), must not exceed the statutory limits, and are processed through the Eurasian Patent Office (EAPO) in accordance with applicable national filing deadlines.

Why Patent Term Extensions Are Challenged

Challenging a patent term extension is not merely a legal procedure but an important business tool.

Key objectives include eliminating unjustified monopolies (for example, enabling generic market entry after the basic patent term expires), reducing licensing fees, weakening competitors’ positions in the pharmaceutical and agrochemical sectors, and lowering investment risks in patent portfolio assessments during M&A transactions.

Features of Challenging Extensions before Rospatent and the EAPO

Since 2022, a patent term extension may be declared invalid if the requirements of Article 1363(2) of the Civil Code are not met (Federal Law No. 386-FZ). In Russia, challenges are filed as an opposition with Rospatent under Article 1398(2) of the Civil Code, and its decisions may be appealed to the Intellectual Property Rights Court.

For Eurasian patents, the procedure is more complex: an opposition may be filed with the EAPO under the EAPC Implementing Regulations; however, the extension may also be challenged in national courts of the contracting states (Article 13 EAPC). As noted by the Presidium of the Intellectual Property Rights Court, the Implementing Regulations are an act of an intergovernmental organisation rather than an international treaty and therefore cannot exclude judicial review of the validity of a Eurasian patent term extension in Russian courts. This creates a two-tier system of protection – administrative review (EAPO) and judicial review (national courts).

Services by Zuykov and partners

Challenging patent term extensions is an effective market protection tool, particularly in the pharmaceutical and agrochemical sectors, where extensions may delay generic entry.

Eurasian patents offer additional opportunities for challenges but require consideration of both EAPC rules and national legislation, which increases procedural complexity.

Professional legal support at all stages – from assessing grounds for challenge to representing clients before Rospatent, the EAPO, or the Intellectual Property Rights Court – significantly improves the chances of success.

We assist clients throughout the entire process and develop optimal strategies to protect their interests in cases of unjustified patent term extensions.