Russian Supreme Court Upholds Compulsory Licensing for Ozempic Generics as Domestic Manufacturers Capture Semaglutide Market
核心洞察
The Russian Supreme Court upheld government orders allowing domestic manufacturers to produce semaglutide generics without Novo Nordisk's consent, citing emergency provisions under Article 1360 of the Civil Code.
Russian pharmaceutical companies achieved nearly 100% market share of the domestic semaglutide market by 2024, with sales reaching 8.8 billion rubles following Novo Nordisk's supply halt in March 2023.
Three Russian manufacturers—Geropharm (搜索), Promomed (搜索), and PSK Pharma (搜索)—successfully launched Ozempic analogues, fully supplying the domestic market for diabetes and obesity treatment.
The Russian Supreme Court has upheld the government's authority to issue compulsory licenses for essential medications, specifically allowing domestic production of semaglutide generics without consent from Danish pharmaceutical company Novo Nordisk. The ruling addresses a critical supply gap created when Novo Nordisk halted Ozempic deliveries to Russia in March 2023.
Court Ruling Validates Emergency Licensing
The Appeals Board of the Supreme Court rejected Novo Nordisk's complaint and upheld government orders from November and December 2024, which permit OOO PSK Pharma (搜索) and OOO Promomed (搜索) Rus to produce medicines containing semaglutide through the end of 2025. The orders were issued under Article 1360 of the Civil Code, which allows the government to authorize patented invention use without patent holder consent in "emergency" situations.
The court's decision involved six Novo Nordisk patents, with two specifically contested in court disputes—Patent No. 2421238 and Patent No. 2657573. Patent No. 2421238 was partially canceled before the government orders were signed, while Patent No. 2657573 relates to obesity therapy rather than diabetes treatment.
Domestic Market Transformation
Russian manufacturers have successfully filled the supply void left by Novo Nordisk's departure. "When the supplier of the drug for the treatment of type 2 diabetes and obesity, the well-known Ozempic, discontinued its supply, several Russian manufacturers began producing analogues. Today, the domestic market is already fully supplied with Russian-made diabetes and weight loss drugs," stated Alla Samoilova, head of Roszdravnadzor, during a meeting with Prime Minister Mikhail Mishustin.
Three domestic companies launched semaglutide analogues: Geropharm (搜索)'s Semavic (搜索), Promomed (搜索)'s Quincenta (搜索), and PSK Pharma (搜索)'s Insudive (搜索). By 2024, Russian pharmaceutical companies captured nearly 100% of the domestic semaglutide market, with analogue sales increasing more than threefold compared to the previous year, reaching 8.8 billion rubles. Government procurement contributed an additional 1.7 billion rubles to manufacturers' revenue.
Regulatory Oversight and Quality Control
Samoilova emphasized that medicines remain subject to mandatory rigorous control, with 13 laboratories established across all federal districts to ensure quality standards. The regulatory framework maintains oversight despite the shift to domestic production.
Legal Justification for Emergency Measures
The Supreme Court determined that the termination of Novo Nordisk's original semaglutide drugs—Ozempic and Rybelsus—starting January 1, 2024, poses a threat to the health of a significant number of patients. Semaglutide's inclusion in the list of vital and essential drugs (VED) supported the court's decision.
Novo Nordisk had argued that no emergency situation existed in the country to justify compulsory patent use and stated they had not been notified of the government actions nor received compensation. However, the Supreme Court acknowledged the existence of extreme necessity and affirmed the legality of applying Article 1360 of the Civil Code.
The August 2025 Supreme Court decision formally allowed production of Ozempic versions without patent owner consent, cementing the legal framework for continued domestic production of this essential diabetes and obesity medication.