Client: AstraZeneca AB
Defendants:
- Macleods Pharmaceuticals Limited
- Ministry of Health of Ukraine
Case Overview
AstraZeneca AB, the owner of Ukrainian Patent No. 77306 for the invention “C-aryl glucoside SGLT2 inhibitors and their method of use”, filed a lawsuit against Macleods Pharmaceuticals Limited and the Ministry of Health of Ukraine. The case arose due to the successful registration and potential market entry of the drug “Dapaglin”, which contains dapagliflozin, an active substance identical to the one protected by the patent. AstraZeneca claimed that this violated its exclusive intellectual property rights.
The Ministry of Health issued Order No. 498 on March 16, 2023, approving the registration of “Dapaglin”. AstraZeneca initiated the protection of its intellectual property rights, requesting:
- To prohibit Macleods Pharmaceuticals Limited from using the patented invention in the drug “Dapaglin”.
- To declare the Ministry of Health’s order on the registration of the drug “Dapaglin” invalid.
Client’s Objectives
- To stop the infringement of its intellectual property rights by prohibiting the use of the patented invention in the drug “Dapaglin”.
- To annul the Ministry of Health’s order on the registration of the drug “Dapaglin” and revoke its authorization for sale in Ukraine.
Case Complexity
- Scientific and legal complexity: The case required thorough scientific analysis and the preparation of multiple expert opinions to confirm the patent violation.
- Procedural delays: The proceedings were delayed due to the absence of representatives of the defendants at court hearings and the complexity of evidence collection.
- Regulatory aspects: Resolving the dispute required simultaneous engagement with judicial authorities and regulatory structures.
Polikarpov Law Firm Strategy
- Patent analysis: Conducted a detailed review of Ukrainian Patent No. 77306 and its legal protection to establish the fact of infringement.
- Expert opinions: Engaged certified forensic experts to conduct research that confirmed the active substance of the drug “Dapaglin” violated the patent.
- Litigation: Presented a substantiated position in court to protect the client’s intellectual property rights.
Lawyers
- Anton Polikarpov – Managing Partner, attorney, responsible for strategy development and courtroom representation.
- Vladyslav Zhuravlov – Associate, responsible for preparing procedural documents.
Outcome
On July 11, 2024, the Kyiv Commercial Court ruled in favor of AstraZeneca AB:
- Macleods Pharmaceuticals Limited was prohibited from using the patented invention in the drug “Dapaglin”.
- The Ministry of Health of Ukraine’s order on the registration of the drug “Dapaglin” was declared invalid, and the registration certificate was annulled.
- The court confirmed that the active substance of “Dapaglin” violated the client’s intellectual property rights.
This decision safeguarded AstraZeneca’s rights in Ukraine and prevented further use of its invention without permission.
