AstraZeneca challenged the patent for the Russian analogue of its cancer drug

AstraZeneca has challenged the patent for an analogue of its cancer drug Tagrisso, registered by its Russian competitor Axelpharm (the drug Osimertinib). The objection was received back in September 2023.

Tagrisso is used in the treatment of lung cancer. AstraZeneca registered this drug in Russia in 2017. The medicine, which is protected by a patent until 2032, is manufactured at the plant of AstraZeneca in the Kaluga region. AstraZeneca emphasizes that the drug is produced in volumes that "fully meet the needs of Russian patients." The drug is in demand on the market. According to the DSM Group, in 2023, the drug was purchased for 6.1 billion rubles.

In May 2023, Axelpharm registered its counterpart. AstraZeneca unsuccessfully tried to challenge the registration of this generic in court. In July 2024, AstraZeneca complained about Axelpharm because of the Tagrisso analogue to the Prosecutor General's Office in connection with the conclusion of state contracts for the supply of Osimertinib. Now this complaint is still under consideration.

Despite the dispute over the drug, the Tagrisso analogue has already entered circulation and is actively supplied in public procurement. According to Roszdravnadzor, the first batch of the Akselfarm analog went into circulation on July 4 this year, and regional government customers have already signed 43 contracts with distributors supplying Osimertinib.

Ten purchases are currently being contested, AstraZeneca told RBC. "The legislation on public procurement limits the list of persons who can challenge the results of tenders, therefore, in terms of appeal, much depends on the participants, that is, distributors," the company explained. They believe that the state agencies — the Federal Antimonopoly Service and regional customers - should play a "key role" in the current situation.

The results of the tender have already been challenged by one of AstraZeneca's partners, the distributor Farmriva. But Sergey Shulyak, CEO of DSM Group, doubts that all the tenders concluded under Osimertinib can really be challenged. "This threatens to collapse with the supply of drugs, which the Ministry of Health would definitely not want," the expert explains. The state customer is not obliged to monitor whether someone's patent rights are violated in the framework of purchases, his task is to give preference to Russian drugs, as well as to purchase what is cheaper, recalls Shulyak.

Sergey Zuykov, patent attorney and Managing Partner of Zuykov and partners, does not exclude that Axelpharm will try to challenge the cancellation of the patent in the Intellectual Property Rights Court. In practice, the IP Court cancels quite a lot of decisions on patents, since Rospatent's positions are not always well motivated, Zuykov notes. The lawyer recalls that Axelpharm tried to obtain from AstraZeneca through the court a compulsory license to produce an analog of Osimertinib. Now, judging by the information in the file of arbitration cases, the proceedings in this case have been suspended. However, this does not automatically mean that Axelpharm will be banned from producing and selling the controversial drug, Zuykov notes. There are other mechanisms for using the patent, for example, with the permission of the government, he recalls.

Source: RBC