Axelpharm is suing Wyeth Holdings over a compulsory license for an anticancer drug

The Russian Axelpharm is demanding a compulsory license from the American Pfizer, probably for an antitumor drug based on bosutinib, purchased at state auction in 2023 for 681 million rubles. Judicial practice on such claims has not yet been formed, experts point out, so they do not undertake to assess the applicant’s chances.

On January 11, the Moscow Arbitration Court accepted the claim of Axelpharma against Wyeth Holdings (part of the American Pfizer since 2009) and Rospatent for the granting of a compulsory license, and found “Kommersant” in the file of cases. The court materials do not indicate the drug in question. Among the registered generics, Axelpharma has one drug developed by Wyeth Holdings – the antitumor bosutinib, used for chronic myeloid leukemia. Axelpharm, Pfizer, and Rospatent did not respond to Kommersant’s request.

Wyeth Holdings supplies the original drug based on bosutinib, Bozulif, to Russia, according to data from Roszdravnadzor. According to Headway Company, government customers purchased this medicine for 681 million rubles in 2023, which is 19.7% more year-on-year. The patent blocking the release of generic bosutinib in the Russian Federation and Belarus is valid until September 2024, says Mikhail Pasynok, head of the Chemistry and Pharmaceuticals department at Online Patent.

This is Axelpharma’s second lawsuit demanding the issuance of a compulsory license. In November 2023, the company made a similar demand to the British-Swedish AstraZeneca (see “Kommersant” dated November 30, 2023). The lawsuit concerns the antitumor osimertinib, used for lung cancer and protected by a patent in the Russian Federation until 2032. Over the three quarters of 2023, RUB 4.76 billion of this medicine was purchased through state tenders.

At the same time, in January, the Federal Antimonopoly Service agreed on a maximum price for the generic osimertinib, which turned out to be 40% lower than the cost of the original drug. Then the department explained this with a desire to increase the availability of the drug for citizens. AstraZeneca, in turn, warned that putting the analogue into circulation violates Russian legislation, and the company is ready to defend the rights to the drug, including in the courts.

Osimertinib is not the only drug under patent protection for which Axelpharm managed to register a maximum price. For example, the cost of the bosutinib analogue was 32% lower, and that of axitinib by 33–38%. Although axitinib is also protected by a patent until 2025, the generic Axelpharma, according to Roszdravnadzor, was put into circulation in December 2023. As Farmvestnik reported, this analogue has already begun to be sold at government auctions. This is what Pfizer is trying to block. Since December 2023, the company’s structure has filed, according to the arbitration court file, 12 lawsuits against executors and customers of state tenders demanding suspension of execution of the state contract and a ban on selling generic axitinib. No decisions have been made on them yet.

Axelpharm may be associated with Nativa (renamed Spectr), which since 2017 has filed a number of lawsuits against the originators demanding a compulsory license for expensive oncology drugs. Twice the company managed to get it temporarily. From the beginning of 2023, the company began a bankruptcy process, and the rights to the drugs were transferred, among others, to Pharmaceutical Group, 75% of which belongs to the co-owner of Axelpharma Natalya Treushnikova (she has 25%). Another 12.5% ​​each in Axelpharm, presumably, belongs to the children of ex-co-owner of Nativa Oleg Mikhailov.

Axelpharm can use both the scenario of obtaining a compulsory license, previously tested by Nativa, and the recently “shot” scheme from the MIC, when the applicant was based on insufficient use of the medicine, believes Alexey Mikhailov, head of the patent practice of the Patentus bureau. In September 2023, the MIC managed, on this basis, in court to oblige the American Vertex to allow it to use ten patents protecting the expensive anti-cystic fibrosis drug Trikafta (see Kommersant, September 27, 2023). But two remaining patents still prevent the release of a generic product. Nativa based its claims on the company’s dependent patents on various forms of the active ingredient of the original product. It’s difficult to assess Axelpharma’s chances in court, says Alexey Mikhailov, “each compulsory license is a piece goods.”

Polina Gritsenko