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SCOTUS Rejects Sanofi Appeal To Revive EpiPen Suit Against Viatris

 |  April 17, 2023

The US Supreme Court declined to consider Sanofi SA’s antitrust lawsuit against Viatris Inc, alleging that the latter had illegally monopolized the market with its EpiPen auto-injector, a device used to treat severe allergic reactions, reported Reuters. 

The Supreme Court declined to hear Sanofi’s appeal regarding their accusation that Viatris had monopolized the market by making exclusive deals with prescription drug intermediaries, as ruled by a lower court.

In 2009, Sanofi obtained the rights to Auvi-Q, an epinephrine auto-injector. The device was created to compete with EpiPen. From 2013 to 2015, the company sold the device until it was recalled for failing to deliver the proper dose of epinephrine. Sanofi terminated its rights to Auvi-Q in the following year. Epinephrine injection is used to treat severe and potentially life-threatening allergic reactions caused by foods, medications, bee stings, and other factors.

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The formation of Viatris occurred in 2020 as a result of the merger between Mylan N.V. and Pfizer Inc’s Upjohn business. In 2017, Sanofi filed a lawsuit against Mylan, claiming antitrust violations due to the provision of rebates to pharmacy benefit managers in exchange for exclusivity, which they use to maintain formularies for health plans.

Sanofi has filed a lawsuit stating that they suffered significant losses in sales in the U.S. epinephrine auto-injector market, amounting to hundreds of millions of dollars, due to the actions of Mylan. They are seeking monetary compensation for these damages.

In 2020, a federal judge in Kansas City ruled in favor of Mylan after Sanofi was unable to prove that Mylan’s negotiation methods were illegal or had negative effects on consumers. The 10th U.S. Circuit Court of Appeals in Denver also supported this decision in July, stating that exclusive contracts are a common competitive strategy in the epinephrine auto-injector industry.

The 10th Circuit stated that Sanofi had the option to compete on equal terms, but opted to market Auvi-Q as a higher-priced product. In 2014, Sanofi changed its approach and CVS Caremark was the only pharmacy benefit manager to switch to Auvi-Q on some formularies.

The EpiPen has undergone price increases over the years, with the cost of two devices rising from $100 in 2008 to $600 in 2016. Currently, the price is close to $700.