US Supreme Court spurns Sanofi appeal to revive EpiPen suit against Viatris

By John Kruzel

WASHINGTON (Reuters) -The U.S. Supreme Court on Monday declined to hear a bid by Sanofi SA to revive its antitrust lawsuit accusing rival pharmaceutical company Viatris Inc of illegally monopolizing the market with its EpiPen auto-injector, a device used to treat severe allergic reactions.

The justices turned away Sanofi’s appeal of a lower court’s ruling rejecting the French company’s claim that Canonsburg, Pennsylvania-based Viatris had effectively cornered the market through exclusive deals with prescription drug intermediaries.

Sanofi in 2009 acquired the rights to Auvi-Q, an epinephrine auto-injector intended to compete with EpiPen. The company sold the device from 2013 to 2015, when it was recalled over concerns that it failed to deliver its dose of epinephrine. Sanofi terminated its rights to Auvi-Q the next year. Injection of epinephrine is used to treat serious and sometimes life-threatening allergic reactions to foods, medications, bee stings and other causes.

Viatris was formed in 2020 through the merger of Mylan N.V. and Pfizer Inc’s Upjohn business. Sanofi sued Mylan in 2017, alleging that it violated antitrust law by giving rebates to pharmacy benefit managers – intermediary companies that maintain the formularies, or lists of covered drugs, used by health plans – in exchange for exclusivity.

Sanofi said in the lawsuit that it lost hundreds of millions of dollars in sales in the $1 billion-plus U.S. epinephrine auto-injector market due to Mylan’s conduct and is seeking monetary damages.

A federal judge in Kansas City, Kansas ruled in 2020 in favor of Mylan, finding that Sanofi failed to show how Mylan’s negotiating tactics were illegal or harmed consumers. The Denver-based 10th U.S. Circuit Court of Appeals last July agreed, noting that the exclusive contracts in question were “a normal competitive tool within the epinephrine auto-injector industry.”

The 10th Circuit added that Sanofi could have competed on those terms, but instead chose initially to market Auvi-Q as a more expensive, premium product. When Sanofi changed course in 2014, one pharmacy benefit manager, CVS Caremark, did switch to Auvi-Q as its only auto-injector on some of its formularies, the panel noted.

The EpiPen has attracted scrutiny for a series of steep price hikes, with the cost of a pair of the devices increasing from $100 in 2008 to $600 in 2016. The price is now nearly $700.

Viatris in February 2022 agreed to pay $264 million to settle a class action lawsuit brought on behalf of consumers and third-party payers like insurers accusing the company of keeping generic competition off the market through an illegal patent settlement.

(Reporting by John Kruzel; Editing by Will Dunham)