AstraZeneca Challenges Osimertinib Registration in Russian Court

At the beginning of September, a major British-Swedish pharmaceutical group, AstraZeneca, made headlines by taking legal action in the Moscow Arbitration Court. They aim to dispute the Russian Ministry of Health’s decision regarding the approval of the oncology drug, Osimertinib, as submitted by Russian pharmaceutical firm Axelfarm.

Osimertinib is a substance invented by AstraZeneca and protected in Russia and Eurasian region by an Eurasian patent valid until 2032.

AstraZeneca considers the drug Osimertinib to be a reproduced pharmaceutical product (generic), meaning a drug with the same qualitative and quantitative composition of active ingredients as its pharmaceutical product Tagrisso, which is supplied to Russia.

The drug is indicated as a therapy for non-small cell lung cancer with EGFR gene mutations. According to data from the phase III ADAURA clinical trial, Osimertinib reduces the risk of recurrence or death by 80% when used as adjuvant therapy for the early stages of this type of cancer.

Axelfarm first submitted documents for the registration of Osimertinib in December 2020. In 2021, AstraZeneca claimed a violation of patent rights for Tagrisso. However, the company’s lawsuit remained unresolved. According to the court’s decision, the intention to register a generic cannot be considered a threat of patent rights infringement.

The preliminary hearing for this new case is scheduled for October 30th.

There were other legal precedents concerning Osimertinib, for example, in the USA AstraZeneca achieved favorable resolutions in its patent infringement litigations with Zydus Pharmaceuticals, Cadila Healthcare, MSN Laboratories, and MSN Pharmaceuticals in 2021 and with Alembic Pharmaceuticals in 2022.

In the meantime, AstraZeneca itself faced a different challenge concerning Tagrisso patents. This is because Puma Biotechnology and Pfizer’s Wyeth initiated their own lawsuit against AstraZeneca in 2022 for infringement of two US patents, the results of which are yet to be seen.