"MIC" is again trying to cancel the patent for Trikafta in Russia

The IPSC obliged Rospatent to review the objection filed by MIK with the regulator back in February 2023. It contained a demand to terminate the validity of Eurasian patent No. 39280 on the group of inventions "Modulator of the transmembrane conductance regulator in cystic fibrosis, pharmaceutical companies, methods of treatment and a method for producing the said modulator" in Russia. The document is valid in the Russian Federation until 2038. MIK insisted that the first of the three compounds covered by the patent does not meet two of the three patentability requirements - novelty and inventive step. Rospatent was unable to confirm these statements during the consideration of the application, and therefore refused to satisfy MIK's demands.

Then, in February 2024, MIC applied to the IPPC - the company wanted to oblige Rospatent to reconsider its conclusion. The court involved Vertex, the Eurasian Patent Organization and Irvin LLC as third parties. The IPPC came to the conclusion that the conclusion on the novelty of the first compound was "premature". Rospatent saw such a sign in the hepatocyte clearance indicators demonstrated by the substance. The court also indicated that the regulator, when studying the patentability condition on the inventive step, "avoided an objective and comprehensive" assessment of the arguments presented by MIC.

In September 2023, MIK was able to obtain a compulsory license for inventions under ten patents through the court. Two more patents for elexacaftor, including the now disputed patent No. 39280, could not be included in the license agreement, since the four-year period from the date of their issue had not expired at that time. The plaintiff then stated that Trikafta was underrepresented on the Russian market and did not meet patient demand. The company planned to start importing a generic of the original drug under the TN Trilexa from Tuteur into the country.

The bioanalogue entered the domestic market in the fall of 2024, but in contracts for the supply of the drug through the Federal Center for Planning and Organization of Drug Provision for Citizens (FCDPiLO) of the Russian Ministry of Health for the needs of the wards of the "Circle of Good", the pharmaceutical distributor "Irvin" was listed as the executor of the purchase. The French Sanofi, the official distributor of the original Trikafta in Russia, tried to recognize its actions as illegal through the FAS, the Arbitration Court of Moscow and the Ninth Arbitration Court of Appeal. Sanofi indicated that Trilexa violates the current patents of Vertex, a compulsory license for some of which was received by "MIC". Meanwhile, Tuteur holds the registration certificate for the analogue. The MIK license, as Sanofi emphasized, is non-exclusive, “which means that it is impossible for MIK LLC to “sublicense” the rights under the compulsory license, that is, to grant any other persons the rights to the patents specified in the court decision.”

At the moment, it has not been possible to interrupt the procurement process with Sanofi, but the dispute is currently being considered in the cassation instance – the Moscow District Arbitration Court.