Mylan said on Friday that the U.S. Patent and Trademark Appeal Board (PTAB) has ruled in favor of Mylan in inter partes review (IPR) proceedings finding all challenged claims of Sanofi’s Lantus® SoloSTAR® device patents, U.S. Patent Nos. 8,603,044, 8,992,486, and 9,526,844 unpatentable.
The PTAB found three claims of the 9,604,008 patent unpatentable, and two claims to be patentable. However, Mylan said it has previously obtained a covenant not to sue from Sanofi on the ‘008 patent and therefore this ruling does not impact Mylan’s ability to launch upon final approval from the U.S. Food and Drug Administration. The PTAB also found Sanofi’s proposed amended claims for the ‘486 and ‘844 patents unpatentable, Mylan noted.
Mylan CEO Heather Bresch said that the decision by the U.S. Patent and Trademark Appeal Board invalidating Sanofi’s Lantus device patents is another significant milestone clearing the pathway for our insulin glargine product Semglee to come to market for the millions of Americans living with diabetes. “We’re pleased with the PTAB’s decision, which will help bring competition to the marketplace and should reduce the cost of this critical medication. Today’s decision is likely the final defeat of Sanofi’s attempts to prevent generic competition. With this final victory in hand, we now look forward to working with FDA to complete the regulatory review process and introduce Semglee in the U.S. as soon as possible.”
Mylan President Rajiv Malik said that Mylan has always maintained that the science behind this product, and Mylan’s overall capabilities in bringing complex, higher value chain products to the market, is a cornerstone of the strength and foundation of the future growth of the company. “While we remain on track to launch Semglee following FDA approval, we will continue to explore all pathways of interchangeability for both dosage forms to achieve the broadest level of access possible for patients in the U.S. and around the world,” Malik said in the press release.
Mylan said that, last month, the PTAB invalidated the sole challenged claim of another Lantus SoloSTAR device patent, U.S. Patent No. 8,679,069, and, in March, Mylan announced that the U.S. District Court of New Jersey found the asserted claims of the ‘844 patent not infringed by Mylan’s insulin glargine product and invalid for lack of written description. Sanofi’s formulation patents (U.S. Patent Nos. 7,476,652 and 7,713,930) were previously affirmed to be invalid by the Federal Circuit. Mylan said that the ‘844 and ‘652 patents are the only remaining patents asserted by Sanofi against its insulin glargine products.
Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes for the control of high blood sugar. Mylan’s 505(b)(2) New Drug Application (NDA) is under active review by the U.S. Food and Drug Administration, Mylan noted.
Sanofi sells the product in vials (Lantus) and as a disposable injection pen (Lantus SoloSTAR®).
Sanofi’s total IQVIA sales for the 12 months ending March 31, 2020, were approximately $1.71 billion for Lantus 100 Units/mL and about $4.32 billion for Lantus SoloSTAR, Mylan noted.