1. Pink Sheet
  2. >>Legal & IP

Sanofi Improperly Listed Lantus Patent In FDA's Orange Book, Appeals Court Finds

 
• By Brenda Sandburg

First Circuit reverses dismissal of direct purchasers' suit alleging improper listing of patent on device drive mechanism delayed competition; district court to decide if this constitutes antitrust violation.

Justice in front of Law
Appeals court revives antitrust claims against Sanofi for improper patent listing in FDA's Orange Book

An appeals court revived an antitrust suit against Sanofi, finding the company erred in improperly listing a patent in the US Food and Drug Administration's Orange Book since the patent did not mention Lantus SoloSTAR (insulin glargine injector pen), the drug for which it submitted a supplemental new drug application.

In a 13 February

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legal & IP

More from Pink Sheet

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
• By Cathy Kelly

President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.