The US Patent and Trademark Office’s Patent Trial and Appeal Board has declined to review two patent challenges around Novo Nordisk’s semaglutide brought by generics maker Mylan Pharmaceuticals.
Mylan, now part of Viatris, petitioned the PTO to review key patents protecting semaglutide, the active ingredient in Novo Nordisk’s GLP-1 type 2 diabetes blockbuster Ozempic and weight loss drug Wegovy. Viatris reported in its recent second quarter earnings presentation that its generic versions for both Ozempic and Wegovy were under regulatory review.
A PTO appeal board soured those plans on Monday when it declined Mylan’s request for review of two patents dubbed ‘343 and ‘122, which expire in 2031 and 2026, respectively. The board ruled that Mylan “has not demonstrated a reasonable likelihood” that any of the claims are unpatentable. It has yet to decide on a third challenge to patent ‘462, expiring in 2033, according to the FDA’s Orange Book.
“We are pleased with the ruling of the USPTO from yesterday, which denied institution on all challenges against Novo Nordisk’s US Patent Nos. 8,129,343, and 8,536,122,” a Novo spokesperson said via email on Tuesday.
Novo brought Viatris to Delaware federal court in January in an attempt to stop the company from bringing a Wegovy generic to market. The company argued that Viatris’ submission of an abbreviated new drug application for its Wegovy generic prior to the drug’s patent cliff would cause Novo “foreseeable harm and injury.”
Novo’s obesity and diabetes care sales surged in recent months, up 39% in Q2 2023 compared to Q2 2022, according to the company’s latest earnings report. Analysts predict Ozempic sales will continue to climb in 2024, potentially pulling in more than $15 billion in worldwide sales, according to Evaluate’s latest report. Wegovy and Ozempic contain the same active ingredient, semaglutide, but Wegovy contains a higher dose and is specifically approved for obesity. Ozempic is only approved to treat diabetes, though off-label use is fueling concerns about supply.
Viatris did not respond to a request for comment as of press time.