The arbitration court dismissed Sanofi's dispute with the Federal Antimonopoly Service (FAS) over the purchase of Trilexa.

The tender was announced on January 24, 2025, with a starting price of 77.8 million rubles. Medembaikal emerged victorious, offering to supply Trilexa, a generic version from the Argentine company Tuteur, registered in Russia in November 2024, for 67.3 million rubles. Sanofi, the official distributor of the original Trikafta from Vertex Pharmaceuticals, claimed that the generic version infringed patents and should not have been allowed to participate.

The Federal Antimonopoly Service (FAS) rejected the arguments, citing the fact that the generic is registered in the State Register of Medicines (the registration certificate is valid until November 2029) and its circulation in Russia is permitted. Furthermore, the right to supply is confirmed by court decisions granting the pharmaceutical distributor MIK a compulsory license to use several Vertex patents. In 2023, this company secured the right to import and sell ivacaftor, tezacaftor, and elexacaftor-based drugs in Russia, effectively paving the way for Tuteur's generic.

However, Sanofi continues to challenge the legitimacy of this scheme. The company points out that the MIK license is non-exclusive and does not allow for the transfer of rights to third parties, while various entities are involved in the procurement. Sanofi believes this calls into question the legality of Trilexa's participation in the bidding.

The court upheld the antimonopoly service's position, stating that the client had justifiably allowed Medembaikal's application, and that Sanofi had failed to provide evidence of the FAS's actions being unlawful. The arbitration court also rejected the company's motion to suspend the case pending the outcome of another lawsuit involving Vertex.

This is not the only legal dispute surrounding the procurement of drugs containing the combination of ivacaftor, tezacaftor, and elexacaftor. The Federal Center for Planning and Organization of Drug Provision for Citizens (FCPiLO) of the Russian Ministry of Health and Sanofi previously attempted to appeal two of the three FAS refusals to approve contracts for the supply of Trikafta for the needs of the state foundation "Circle of Good" in cassation courts, but were unsuccessful.

The Federal Antimonopoly Service (FAS) explained at the time that the refusal to approve contracts with Sanofi was due to an "unjustified increase" in Trikafta procurement volumes announced by the Federal Center for the Prevention and Control of Legislation (FCPL) for the summer of 2024. The regulator also insisted on the need to wait for the registration of Tuteur's Trilex.