AstraZeneca has challenged the Eurasian patent for an analogue of its cancer drug Tagrisso in Russia

On August 8, 2024, the Patent Disputes Chamber of Rospatent upheld AstraZeneca’s objection to the validity of the Eurasian Patent No. 40996 for the medication Osimertinib by “AxelPharm” in the Russian Federation. The Chamber’s decision was announced in the Rospatent database of decisions on August 15, 2024.

In the objection, “AstraZeneca” presented arguments supporting the fact that the δ-form of osimertinib mesylate specified in Eurasian Patent No. 40996 does not exhibit any unexpected advantages over known forms of osimertinib mesylate and does not comply with the inventive step criterion of patentability.

Moreover, “AstraZeneca” is contesting 10 tenders for the supply of osimertinib.

Several contracts were signed with various government clients for the supply of the medication «Osimertinib» in June 2024. However, in August 2024, the Federal Antimonopoly Service (FAS) deemed the outcome of the regional auction for the purchase of osimertinib, where the application for the supply of «Osimertinib» was declared as the winner, unlawful.

Osimertinib is utilized in the production of the drug «Tagrisso», which is utilized in the treatment of lung cancer and is manufactured by “AstraZeneca” at its own facility in the Kaluga Region (Russia) in quantities that adequately meet the demands of the Russian market. The medication has been provided to government clients under the contract system for the acquisition of goods to fulfill state and municipal needs from 2017 to the present time. “AstraZeneca” asserts that there has been, and continues to be, no scarcity of this medication.

“AstraZeneca” has stressed that patent disputes frequently occur because the responsibility for adhering to the requirements for safeguarding exclusive rights when introducing pharmaceuticals into circulation lies solely with the applicant, with regulators having no duty to verify the existence of a patent and the trustworthiness of any guarantees provided, if any.

“AstraZeneca” highlights potential measures to enhance the situation, including: firstly, compulsory oversight by regulators over the adherence to exclusive rights when registering a medication, and when determining the maximum retail price for a medication — imposing a postponed effective date until the expiration of patent protection. Secondly, it is crucial to establish an approach for the widest possible utilization of interim measures when addressing disputes related to the infringement of patent rights for medications, while establishing minimal deadlines for their enforcement by regulatory bodies.

According to “AstraZeneca”, these measures will help prevent the breach of intellectual property rights and swiftly halt any infringement that may occur. Bolstering patent protection is crucial not only for the advancement of the Russian pharmaceutical industry, but most importantly for patients, who must have confidence in the quality of the medications supplied and the consistency of their availability.