Generic manufacturer sues for license with originator of trikafta drug for cystic fibrosis

A medical research company (MIC) is seeking a compulsory license through the courts to use the patents that protect the expensive cystic fibrosis drug trikafta from American Vertex Pharmaceuticals. MIC, which imports the Argentine analogue into Russia, motivates its demand by the fact that the original drug is not available to many patients. However, the patent holder continues to conclude state contracts for the supply of drugs to the Russian Federation, which, according to experts, reduces the applicant’s chances of achieving his goal.

MIK, having lost the case in the Arbitration Court of Moscow, is now asking in the appellate instance to oblige Vertex Pharmaceuticals to conclude a license agreement with it and to provide a compulsory license for the use of patents protecting trikafta for at least two years. MIC is ready to pay the right holder 3% of the total cost of medicines imported into the Russian Federation. The meeting on this case is scheduled for September 4, Kommersant found in the filing cabinet of arbitration cases.

The basis for the lawsuit was the unavailability of the original trikafta for many patients in dire need, Kommersant was told at the MIK. Trikafta, imported into Russia by the French Sanofi, is a targeted drug for cystic fibrosis and can be prescribed for up to 80% of patients older than six years. Adults can receive the drug by decision of the medical commission; for children under 19 years of age, it is purchased by the Circle of Kindness Foundation.

Sanofi does not comment on the lawsuit, but points out the importance of protecting intellectual property rights to spur the development of innovative therapies for cystic fibrosis.

Trikafta was registered in the Russian Federation only in June 2023, and before that it was imported as an unregistered drug. In January-July, according to the Headway Company, the regions purchased it for 1.34 billion rubles. Another 79.1 million rubles. government customers purchased an unregistered Trilexa drug from the Argentinean Tuteur. It is supplied to the Russian Federation by MIK. Trilexa is planned to be registered in Russia, the company says. According to the Headway Company, the average cost of packing trikafta at government auctions in 2023 amounted to 1.8 million rubles, Trilexa – a third cheaper.

The MIC, demanding the issuance of a compulsory license, appeals to Art. 1362 of the Civil Code of the Russian Federation, which allows the applicant to claim the use of patents if the owner does not use them enough within four years from the date of issue. In the first instance, the company failed to prove this. The court considered that Vertex never announced the termination of the supply of trikafta and government contracts for its purchase continue to be concluded. In addition, two out of 12 disputed patents cannot be subject to a compulsory license, since the four-year period fixed in the law has not expired since the moment of their issuance.

According to Roman Sklyar, Managing Partner of Intellectual Capital law firm, the fact of registering the trikafta strengthens the position of Vertex, as it proves that the company is taking the necessary steps to fully use patents. MIC also has not yet confirmed the legitimate interest or ability to use the disputed patents, points out Yulia Yarnykh, a partner at Semenov & Pevzner.

Registration of trikafta in the Russian Federation significantly narrows the possibility of purchasing an unregistered Argentinean analogue. If trikafta is included in the list of essential medicines, the drug will be purchased under the international non-proprietary name (INN), so even the presence of a compulsory license will not make it possible to supply unregistered Trilexa, Konstantin Sharlovsky, head of the Pharmaceuticals and Healthcare practice at Pepeliaev Group, believes. And an application for registration of an analogue, he points out, cannot be submitted earlier than four years after the registration of the original drug. But doctors are unlikely to prescribe the drug if there is a registered original, the expert adds.

In turn, Vertex filed a patent protection lawsuit against other Trilexa suppliers, Atonfarm and Pharmstore, in March. The company will have to prove that the Argentine counterpart repeats the Vertex invention.

Polina Gritsenko