The decision to go to court was made “after identifying the risk of a possible violation of the company’s rights,” said Irina Panarina, CEO of AstraZeneca in Russia and Eurasia. However, the company is not aware of the presence of a patent for the generic of this particular drug from LLC “Axelpharm”.
The Axelpharm company, according to the State Register of Medicines, has registered two cancer drugs: Ibrutinib-nativ (ibrutinib) and Sunitinib. In 2020, the oncohematological drug Ibrutinib-nativ was the subject of litigation by the AbbVie subsidiary, one of the developers of the original drug (the second drug developer is Johnson & Johnson).
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The plaintiff demanded to cancel the state registration of the drug Ibrutinib-nativ, which is subject to Eurasian patent No. 018573 until January 2030. As a result, the parties entered into an amicable agreement, according to which Axelpharm and Nativa, the direct manufacturer of the drug, cannot enter civil circulation in the territory of Russia the drug “Ibrutinib-nativ” or any other drug that includes ibrutinib.
Axelpharm is owned by five individuals: Kirill Golovanov, Natalya Treushnikova, Nikolai Uvarov (25% each), Rostislav and Anastasia Mikhailov (12.5% each). Psychiatrist Natalya Treushnikova is the head of the Mental Health Union. Revenue of Axelpharm LLC according to RAS in 2020 amounted to 8.7 million rubles, net loss – 37.9 million rubles.
The likelihood of satisfying AstraZeneca’s claim is extremely high, and if a generic manufacturer starts producing an analogue of Tagrisso without waiting for the patent to expire, the court will prohibit the defendant from using the drug in court, says Sergei Zuikov, a patent attorney, managing partner of Zuikov and Partners.
RBC turned to the Ministry of Health for a comment. It was not possible to contact Axelpharm LLC.