Context: In September 2020, Orexo AB sued Sun Pharmaceutical Industries Ltd. over two patents related to its sublingual tablet Zubsolv (buprenorphine and naloxone), which was approved to treat opioid dependence in 2013, in the United States District Court for the District of New Jersey. Zubsolv is a relatively lucrative drug for Orexo – the company reported it sold 131 million Swedish kroner (US$11 million) worth of Zubsolv in Q3 2024 in the U.S. alone. In June 2023, the United States District Court for the District of New Jersey handed down a bench ruling which found that both of Orexo’s Zubsolv patents were valid and that Sun Pharmaceutical had infringed them. Sun Pharmaceutical appealed against the decision two months later.
What’s new: The companies announced they settled their dispute on Sunday, bringing an abrupt ending to the litigation. An appellate hearing was due to be held in the United States Court of Appeals for the Federal Circuit on January 7, 2025.
Direct impact and wider ramifications: The settlement has already benefited Orexo, which reported a jump in 20.2% of its shares to 20.60 Swedish kronor (US$1.89) today. The agreement also means Sun Pharmaceutical will be allowed to enter the U.S. market with its generic versions of Zubsolv from September 2030.
Here is notice of the settlement to the Federal Circuit:
Orexo is an Uppsala-based speciality pharmaceutical company which was founded in 1994 and develops and commercializes innovative pharmaceuticals and digital therapies that focus on mental health and substance use disorders, including deprexis for the treatment of depression, vorvida for alcohol management, abstral for the treatment of breakthrough pain in cancer patients, and edluar for the treatment of insomnia. Mumbai-based Sun Pharmaceuticals is the world’s fourth-largest generic drugs manufacturer, with the U.S. making up 30% of its global revenue. It develops innovative technology to address the different dosage needs of patients, such as tablets, capsules, injectables, inhalers, ointments, creams and liquids.
In September 2020, Orexo alleged that Sun Pharmaceutical infringed the following patents:
- US Patent No. 9,439,900 (“Abuse-resistant pharmaceutical composition for the treatment of opioid dependence”)
- US Patent No. 11,020,387 (“Abuse-resistant pharmaceutical composition for the treatment of opioid dependence”)
Sun Pharmaceutical had filed an Abbreviated New Drug Application (ANDA), seeking approval to market generic versions of Zubsolv before the expiration of Orexo’s patents, the plaintiff alleged.
From January 30, 2023 to February 3, 2023, the United States District Court for the District of New Jersey held a non-jury bench trial, during which Sun Pharmaceutical filed a counterclaim seeking a declaratory judgment that its ANDA products did not infringe on Orexo’s patents – and those patents were “invalid” and “unenforceable” anyway.
The court then handed down a bench ruling in June 2023, stating that Orexo’s enforced patents were valid and that Sun Pharmaceutical’s ANDA products had infringed them. It noted in its decision that the ANDA products contained the same active ingredients as Zubsolv – buprenorphine and naloxone – as well as similar inactive ingredients, the same five dosage strengths, and in the same dosage form.
Two months later, Sun Pharmaceutical filed an appeal against the decision in the United States Court of Appeals for the Federal Circuit. It filed an opening brief in October 2023, which was followed by Orexo’s response in January 2024 and a second reply brief by Sun Pharmaceutical a month later. A hearing was scheduled to take place on January 7, 2025 – almost a year after the completion of the briefing.
Orexo was represented by Steptoe LLP’s John J. Molenda, Vishal C. Gupta, Jordan P. Markham and Michael I. Green, while Sun Pharmaceutical was represented by Winston & Strawn LLP’s Charles B. Klein, Jovial Wong, Claire Fundakowski, and Eimeric Reig-Plessis.
Sun Pharmaceutical has been the target of many major recent patent infringement disputes, particularly before the District Court of New Jersey, including disputes brought by Astellas Pharma Inc. over patents related to its prostate cancer drug Xtandi in December 2022, which was settled last year. It was also the target of lawsuits brought by Aurina Pharms. Inc., Allergan Pharms. Int’l Ltd., Eisai R&D Management Co. Ltd., Corcept Therapeutics, Inc. and Celgene Corp.
Sun Pharmaceutical has had some success, however, signing a licensing agreement with Italian drugmaker Philogen in May 2023, which allowed its under-development skin cancer drug to reach patients in Europe, Australia and New Zealand.
Some other major settlements include a $2.15 billion agreement with Pfizer in 2013 and a non-exclusive royalty-free licensing agreement for Eli Lilly’s Baricitinib in 2021.