The U.S. Patent and Trademark Appeal Board has instituted inter partes review on all claims against two patents owned by Sanofi (NYSE:SNY) for the company’s Lantus insulin glargine injection.
Sanofi filed a patent infringement suit against Mylan (NSDQ:MYL) in October after the EpiPen-maker submitted an NDA for a pre-filled insulin glargine pen, challenging the patents listed for Sanofi’s Lantus products.
“The PTAB’s decision to institute IPR proceedings against the two Orange Book-listed patents for Lantus is another step forward in our ongoing efforts to bring an interchangeable insulin glargine to diabetes patients as soon as possible,” CEO Heather Bresch said in prepared remarks.
“There are more than 29 million people in the U.S. living with diabetes who deserve access to more affordable treatment options. As a leading producer of oral diabetes medicines, we are deeply committed to this patient community and believe bringing lower-cost alternatives to Lantus and Lantus SoloStar will fulfill a critical medical need.”
It’s not just Mylan and Sanofi fighting over the Lantus patents in court. In August, Sanofi filed a patent lawsuit against Merck Sharp & Dohme Corp. (NYSE:MRK), alleging that Merck’s product infringes upon two patents covering Lantus.
Merck won tentative approval for its follow-on biologic version of Sanofi’s Lantus in July. The agency’s final regulatory nod is contingent upon the resolution of these patent infringement suits, according to Reuters.
Sanofi said its suit was triggered by a notification received by Merck in June. Merck reportedly told the company that its the application for regulatory approval included a section challenging all of the Sanofi patents listed for its Lantus and Lantus SoloStar products.
Late last year, Sanofi brought a lawsuit against Merck, alleging infringement of 10 patents covering its Lantus products, in the U.S. District Court of Delaware.
