MIC succeeded in extending the compulsory licensing agreement for Trikafta through the courts.

According to the case materials, the plaintiff initially demanded that the Moscow Arbitration Court oblige Vertex to enter into a licensing agreement with MIK and grant the company a simple (non-exclusive) license to use inventions protected by 12 patents in the Russian Federation back in 2022. Most of the patents were obtained by the originator between 2005 and 2011, and three more between 2015 and 2021. Under the terms of the agreement, MIK was to be granted the rights to import, store, and sell goods containing the results of intellectual activity for two years (with the possibility of extension). The agreement also provided for remuneration for the patent holder—3% of the total value of all goods protected by the defendant's intellectual property and sold by the distributor. In May 2023, the court denied MIK's claims, but in September of that year, the applicant succeeded in appealing the decision to the Ninth Arbitration Court of Moscow and obtaining a compulsory license for 10 patents registered before 2016.

In April 2025, MIK again filed a complaint with the Moscow Arbitration Court seeking to amend the terms of the agreement regarding its term and to compel Rospatent to register these amendments. The licensee requested an extension of the agreement "for the duration of the exclusive rights to the inventions under the patents." In justifying this request, MIK cited the impossibility of exercising its right under the compulsory license from June 2023 to November 2024, as the drug the distributor planned to import was in the registration process. The drug in question is a generic version of the original Trikafta from the Argentinian company Tuteur, under the trade name Trilexa.

Furthermore, the plaintiff stated that, at the time of his initial appeal to the court, he assumed that the generic would only be in demand for patients over 18, while younger cystic fibrosis patients, as MIC had hoped, would be provided with the original Trikafta. It later emerged that the state foundation "Circle of Good" was also interested in purchasing Trileksa. The Moscow Arbitration Court's decision also stated that "the plaintiff presented evidence confirming that the need for the relevant medications increased after the entry into force" of the 2023 appellate court decision. Specifically, the letter from Circle of Good, presented by MIC at the court hearing, stated that the total number of patients for whom the foundation's expert council approved the provision of the drug containing ivacaftor, tezacaftor, elexacaftor, and ivacaftor in 2025 was 1,558 children, and the total need for the drug during this period would exceed 20,000 packages. MIK also cited an excerpt from a letter from Vertex to Trikafta's official distributor in Russia, the French company Sanofi. In it, the American manufacturer states that it can produce the product in Russian packaging at a rate of 800 packs per month, or 9,600 per year. Therefore, according to the plaintiff, the originator is unable to meet the growing national demand for the product.

The Moscow Arbitration Court found the applicant's arguments valid and extended the license agreement "for the duration of the exclusive rights to the inventions under the patents." The court's decision did not specify a specific year, but Vertex's patents for the active ingredients of Trikafta are valid in Russia until 2038. The court rejected MIK's claims against Rospatent.

Trilexa, which MIC planned to supply, was registered in the Russian Federation in November 2024. Prior to this, in the summer of 2024, the Federal Antimonopoly Service (FAS) refused to approve three contracts between the Federal Center for Planning and Organization of Medication Provision to Citizens and the sole procurement participant, Sanofi, with a total starting price of 8.14 billion rubles. In response to Vademecum's inquiry, the FAS explained that the suspension of the contracts was due to the federal center's "unjustified increase" in the volume of goods purchased. The antimonopoly service cited the need to await the registration of a new generic version of Trilexa from the Argentine company Tuteur.

The Federal Antimonopoly Service filed three lawsuits with the Moscow Arbitration Court, demanding that the FAS's decisions be declared unlawful. In two cases, the Moscow Arbitration Court rejected the claims, and higher courts upheld its position. These cases are currently being heard in the Supreme Court. In the third case, the arbitration court ruled the federal agency's position unlawful, but this decision has been appealed.

In September 2025, the Moscow Arbitration Court also rejected Sanofi's challenge of the FAS's March 2025 decision, when the regulator found the company's complaint against the results of an auction held by the N.A. Semashko Republican Clinical Hospital (Buryatia) unfounded. The institution was purchasing a drug for cystic fibrosis, and Medembaikal, the company that offered to supply Trilexa, was chosen as the contractor.

Sanofi's position in the thematic disputes is that MIK's license is non-exclusive and does not allow for the transfer of rights to third parties, while various entities are involved in the procurement. Trikafta's official distributor also points out that MIK holds a compulsory license for an incomplete set of patents protecting the original drug.