From 4-8 October 2024, Novo Nordisk and each of Mylan Pharmaceuticals (a subsidiary of Viatris), Dr Reddy’s, Apotex and Sun Pharma filed joint motions notifying the US Patent Trial and Appeal Board (PTAB) that they had settled their dispute regarding the validity of Novo Nordisk’s US patent no. 10,335,462. The patent covers specific dosages of semaglutide used to treat type 2 diabetes.
Mylan had filed a petition for inter partes review (IPR) challenging the validity of the ‘462 patent on 16 March 2023 and the IPR proceeding was instituted on 4 October 2023 (IPR2023-00724). IPRs instituted based on petitions filed by Dr Reddy’s, Apotex and Sun Pharma in relation to the ‘462 patent were subsequently joined to the Mylan IPR proceeding. The joint motions recently filed by the parties now request termination of the IPR proceedings.
On 7 October 2024, Natco Pharma, Mylan’s partner in relation to the development of generic Ozempic® products, announced in a regulatory update that Mylan and Novo Nordisk “have reached a settlement of the U.S. patent litigation related to generic Ozempic® (Semaglutide)” and confirmed that the terms of that settlement are confidential.
We have previously reported on Novo Nordisk’s litigation against Sun Pharma and Mylan for US patent infringement, as well as legal action taken to prevent sale of counterfeit versions of Ozempic®. Novo Nordisk’s annual report for 2023 notes that Ozempic® generated US$14 billion in sales, with sales projected to reach about US$18 billing in 2024, whereas Wegovy® sales are about a third of that achieved by Ozempic®.
Notably, on 8 October 2024, scientists from Novo Nordisk published a peer-reviewed study that highlighted significant differences between its branded products and various copied versions. The Danish pharmaceutical company tested 16 injectable formulations of semaglutide, the active ingredient in its Ozempic® and Wegovy®. These included copy products obtained from a range of sources, such as compounding pharmacies, telehealth providers, and medical spas. The article concludes that copied products are inferior, and may give rise to safety concerns, hence the need for regulatory intervention.