Mylan N.V has announced that the US Patent and Trademark Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against two Orange Book-listed patents, US Patent Nos. 7,476,652 and 7,713,930, owned by Sanofi for Lantus (insulin glargine injection) 100 Units/mL.
Mylan's 505(b)(2) New Drug Application (NDA) for insulin glargine in vial and pen dosage forms is under active review with the US Food and Drug Administration. Lantus and Lantus Solostar are prescription medicines indicated for improving glycemic control in adult patients with diabetes mellitus.
Mylan chief executive officer Heather Bresch commented, "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. There are more than 29 million people in the US 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."
In October, Sanofi initiated patent infringement litigation against Mylan's NDA in the United States District Court for the District of New Jersey that includes these two Lantus patents.