The Russian Supreme Court has upheld the Russian government’s power to issue compulsory licenses for essential medications, including generic versions of Ozempic (active ingredient: semaglutide), according to Forbes.
The Appeals Board of the Supreme Court rejected the complaint filed by Danish Novo Nordisk and upheld the government orders from November and December 2024, which permit OOO PSK Pharma and OOO Promomed Rus to produce medicines containing semaglutide by the end of 2025. The orders were adopted in accordance with Article 1360 of the Civil Code, which allows the government to authorize the use of a patented invention without the patent holder’s consent in cases of “emergency”. The list of patents includes six owned by Novo Nordisk, two of which were involved in court disputes—No. 2421238 and No. 2657573.
The newspaper notes that Patent No. 2421238 was partially canceled even before the signing of the orders, while Patent No. 2657573 pertains to a therapy for obesity, not diabetes. Novo Nordisk argued that there was no emergency situation in the country justifying the compulsory use of these patents. They also stated that they had not been notified of the acts taken nor received any compensation.
The court also determined that the termination of supplies of Novo Nordisk’s original semaglutide drugs, Ozempic and Rybelsus, to Russia starting January 1, 2024, poses a threat to the health of a significant number of patients. Semaglutide is included in the list of vital and essential drugs (VED). Based on this, the Supreme Court acknowledged the existence of a state of extreme necessity and affirmed the legality of applying Article 1360 of the Civil Code of the Russian Federation.
Semaglutide was initially introduced to the Russian market under the Ozempic and Rybelsus brands. After Novo Nordisk halted Ozempic supplies in March 2023, domestic manufacturers introduced analogues: Semavic from Geropharm, Quincenta from Promomed, and Insudive from PSK Pharma. By 2024, Russian pharmaceutical companies had nearly 100% of the domestic semaglutide market, as sales of analogues increased more than threefold compared to the previous year, reaching 8.8 billion rubles. Additionally, government procurement contributed another 1.7 billion rubles to manufacturers’ revenue.
Novo Nordisk A/S and Eli Lilly & Co, the pharmaceutical giants dominating the global obesity and diabetes drug market, now face their first serious rival in China from the Suzhou-based Innovent Biologics, whose weight loss medication Mazdutide has been granted approval from China’s National Medical Products Administration (NMPA).