AstraZeneca sent a request to the Prosecutor General's Office regarding the purchase of an analogue to Tagrisso

The Russian division of AstraZeneca has complained to the Prosecutor General's Office about the purchase of a generic version of its cancer drug Tagrisso, which has the international nonproprietary name Osimertinib. The complaint states that at the end of June, the Ministry of Health of the Sverdlovsk region, the government agency of the Novosibirsk region, and the Ministry of Health of Ryazan region all signed contracts with the Russian company Axelfarm for the supply of Osimertinib drug for a total amount of 42 million rubles each. The deadline for delivery of all three drugs is until the end of 2024, but in Russia, AstraZeneca has a patent on the active ingredient osimertinib until 2032, and a foreign company has been selling Tagrisso in Russia since 2017 to serve state and municipal needs without permission or a license for using AstraZeneca's patent.

Osimertinib is a medication used in the treatment of lung cancer. In 2017, AstraZeneca registered the drug under the trade name Tagrisso, which is manufactured at its plant in the Kaluga region. In May 2023, Axelpharm also registered a similar drug. AstraZeneca has filed a lawsuit demanding that the registration of the latter be declared illegal. However, the court has refused to satisfy this claim, and the appeal has confirmed this decision. Now, the foreign manufacturer is seeking to challenge this decision in the cassation instance.

In its complaint, AstraZeneca draws attention to the fact that Osimertinib is not currently approved for use in the country. According to the company, both government customers and suppliers who won contracts were "knowingly aware" of this. AstraZeneca is asking the Prosecutor General's Office to investigate possible violations of the law, including the circulation of counterfeit or substandard medicines and violations of procurement regulations, in the actions of those involved in the procurement of Osimertinib.

This is not the first time that AstraZeneca has contacted law enforcement agencies regarding the sale of analogues of their drugs. In April of this year, for example, the company filed a complaint with the Investigative Committee regarding the actions of the Russian company Akrikhin, which had put into circulation a Forsiga – an analogue of AstraZeneca's diabetes medication. The patent for this medication is valid until 2028 and protects the rights of AstraZeneca.

The Prosecutor General's Office may open a criminal case for patent infringement of an invention, which could lead to the seizure of certain actions, such as the procurement of a controversial drug. This explains AstraZeneca's possible appeal to law enforcement agencies, according to Sergey Zuykov, Managing Partner of Zuykov and Partners. He notes that it is "naive" to think that law enforcement agencies would bring domestic companies to criminal responsibility when the Russian market needs medicine. The Prosecutor's Office can conduct a lengthy pre-investigation check, but Zuykov believes that this is unlikely in such circumstances.

Commenting on the news about the absence of the drug Osimertinib from the Russian Axelpharm, for which contracts had been signed, Sergey Shulyak, CEO of DSM Group, explained that in order to sign a contract, a supplier is not required to have stock of drugs. Otherwise, if a tender is lost, there will simply be no place to store these medicines, he explained. He drew attention to the fact that according to the terms of the contracts, the supplier must deliver the medicine by the end of 2024, so there is nothing preventing him from releasing it promptly in the amount specified in the contract. At the same time, the state customer is not obligated to check whether the drug is available from the supplier or whether the purchase infringes anyone's patent rights. His task is to buy what is cheapest, concluded Shulyak.

Source: RBC