• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Appeal board to review Sanofi’s Lantus insulin injection patents

December 14, 2017 By Sarah Faulkner

SanofiThe 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.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Diabetes, Drug-Device Combinations, Featured, Legal News, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Merck, Mylan, Sanofi-Aventis

IN CASE YOU MISSED IT

  • Insulet hires new chief HR officer from J&J
  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes
  • Medtronic Diabetes names CFO with consumer experience ahead of separation
  • Diabeloop launches insulin delivery algorithm in Germany
  • GlucoModicum has positive data for needle-free CGM

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS