Axelpharm demands a license for anti-cancer drug from AstraZeneca

The Russian pharmaceutical distributor Axelpharm, having a patent for the crystalline form of osimertinib used in the treatment of lung cancer, is trying to obtain a compulsory license for it through the court. The original medicine Tagrisso is produced by the British-Swedish company AstraZeneca under a special investment contract in Russia. This is one of the most expensive oncology drugs, the volume of government procurement for which in the nine months of 2023 reached almost 5 billion rubles. Before its bankruptcy, another Russian pharmaceutical company, Nativa, operated under a similar mechanism, trying to bring its generics of popular drugs to the market. It is possible that this company may be associated with Axelpharm.

On November 13, Axelpharm filed a lawsuit against AstraZeneca and Rospatent in the Moscow Arbitration Court, and found “Kommersant” in the file of cases. The essence of the requirements is not given. AstraZeneca explained to Kommersant that Axelpharm is demanding through the court to issue a compulsory license to use the patent for osimertinib, used in lung cancer: the British-Swedish company produces it under the Tagrisso brand. Axelpharm did not respond to Kommersant’s request. Rospatent declined to comment.

Osimertinib is one of the most expensive cancer treatments: its maximum cost, registered by the Ministry of Health, is 251 thousand rubles. per package excluding VAT. According to Headway Company, in the three quarters of 2023, the volume of government purchases of the drug increased by 31% year-on-year, to RUB 4.76 billion.

In May 2023, Axelpharm registered its generic drug, Tagrisso, despite the fact that AstraZeneca’s osimertinib patent in the EAEU is valid until 2032. AstraZeneca is trying through the court to cancel Axelpharm’s registration of the analogue, and is demanding that the Ministry of Health declare the decision to register it illegal, but so far has been unsuccessful (see Kommersant on September 7). The Russian company has an EAEU patent for the crystalline form of osimertinib. Using this mechanism, Axelpharm has registered methods and forms of 11 drugs for various diseases at the EAEU level since April 2022. Most of these drugs are under patent protection, but this did not stop the company from registering six drugs, although it has not yet put them into circulation.

Axelpharm is following the path of Nativa (rebranded as Spectrum), which received patents for modifying a number of well-known anticancer drugs. This allowed the company to obtain a compulsory license through the courts, for example, for sunitinib from Pfizer. The proceedings between the parties lasted for several years, which did not prevent Nativa from selling its generic product at state auctions in 2019–2022. From the beginning of 2023, the company began the bankruptcy process.

It is possible that Axelpharm has connections with Nativa. According to Kartoteka.ru, 12.5% ​​of Axelpharma each belong to Rostislav and Anastasia Mikhailov, who, as Farmvestnik previously wrote, may be the children of the ex-co-owner of Nativa, Oleg Mikhailov. Another 25% of the company belongs to Nikolai Uvarov, Natalya Treushnikova, and Kirill Golovanov. Mr. Uvarov previously headed F-Sintez, which at one time transferred part of its drugs to Nativa. In turn, Nativa transferred some of its funds to Farmmental Group in 2021, where 75% belongs to Ms. Treushnikova.

The head of the Vegas Lex directorate, Kirill Nikitin, assesses the prospect of satisfying Axelpharma’s claim against AstraZeneca as “above average” due to the presence of a dependent patent. At the same time, the expert points out, an obstacle may be the fact that, by law, the Russian company must prove that the copyright holder has not used its patent for the last three years.

At the same time, according to Mr. Nikitin, in the current situation, the courts will evaluate the behavior of the copyright holder in the Russian market. AstraZeneca says that it is producing the drug under a special investment contract in the Kaluga region “in volumes that fully satisfy the needs of the Russian market.”

The market should not expect a serious wave of effective attempts to challenge the patent protection of original drugs, says Nikolay Bespalov, development director at RNC Pharma. According to him, Nativa’s past experience “in this field for the most part cannot be considered successful,” while the general position of regulators in relation to Western companies holding patents has not changed much.

Polina Gritsenko