Compulsory licensing (CL) is on the rise in the Eurasian Economic Union (EAEU). Governmental compulsory licenses were first granted during the COVID-19 public health emergency, and later granted for a limited term to launch products that are not otherwise available in the market. They remain an exception; however, court CL claims might be a game changer.

Historically, CL requests have been mostly dependent patent based, but evolving geopolitical and economic factors are encouraging market players to pursue patent non-use based CL. CL proceedings are becoming a part of generic drug producers’ (“Gx”) strategy, as the number of CLs granted slowly increases. Apart from purely commercial interest to launch, Gx often use this tool to delay pending patent enforcement proceedings, or to stimulate innovators to negotiate outside of the courtroom.

The ambiguity of regulations, broad interpretation of “insufficient” patent use by the courts, and unrestricted scope of CLs granted already attracted attention of higher courts. The Constitutional Court of Russia shall produce in Q1 2026 a ruling on whether the patent non-use based CL regulations are constitutional; it is anticipated that the court will comment on burden of proof in such cases, and on the permitted use of the invention if the innovator’s drug is present on the market. This ruling will likely affect innovators' strategies in the broader EAEU, including for future interactions with Gx’s, and decisions on market access.

The current enforcement practice in the region demonstrates that ignorance of CL requests triggers grant of CL, which at the end can affect territories outside of the EAEU (e.g., when Gx decides to export its product outside of the EAEU).

It comes with no surprise that diligence in collection of evidence of use (e.g., copies of contracts, customs declaration, uninterrupted supplies at the state procurement, donations, market analytics) is a key for arguing against grant of CL. In combination with the challenge of commercial terms of proposed CL - with or without experts involved - this can substantially limit the Gx demands. Where a patentee prefers to avoid a court case, the strategy can vary from settlement negotiations until withdrawal of the patent.

Proactive vigilance in monitoring CL requests in the EAEU continues to serve as the first essential building block in establishing a strong CL prevention program in the region.