Mylan Defeats EpiPen Antitrust Lawsuit Brought by Rival Sanofi

Mylan Inc. has dodged claims that it unlawfully shielded its EpiPen from competition by driving Sanofi’s epinephrine auto-injector from the market through exclusive agreements with insurers and pharmacy benefit managers, according to a ruling unsealed in a Kansas federal court.

Judge Daniel D. Crabtree granted summary judgment for Mylan, finding that it didn’t violate antitrust laws by offering rebates to insurers and PBMs that excluded Sanofi’s Auvi-Q from their drug formularies. Exclusive distribution deals are legal as long as they don’t involve threats or coercion, he said.

“In some instances, Mylan offered payors greater rebates if they agreed to exclusivity,” but “Mylan also offered smaller rebates for payors who chose to cover other EAI devices” and “imposed no penalties or supply shortages against” them, Crabtree wrote. “Simply offering price discounts is not coercion.”

The judge also threw out Mylan’s counterclaim accusing Sanofi of wrongly disparaging the EpiPen by promoting the Auvi-Q as preferred by patients and emphasizing its retractable needle, a safety feature not available on the EpiPen.

Sanofi has asked the U.S. Court of Appeals for the Tenth Circuit to overturn the ruling, which effectively ended its antitrust case in the U.S. District Court for the District of Kansas, where it’s consolidated with a consumer lawsuit accusing Mylan of using kickbacks to gouge EpiPen buyers.

The consumer case is one of two class actions targeting Mylan and the country’s top PBMs following an uproar in 2016 over revelations of a sixfold increase in the U.S. price of EpiPen, which can reverse potentially fatal allergic reactions.

The drugmaker also faces a parallel wholesaler suit in the U.S. District Court for the District of Minnesota, where a judge last month let antitrust and racketeering claims move forward.

In his unsealed ruling, Crabtree rejected claims that Mylan’s agreements with insurers and PBMs rose to the level of per se antitrust violations. Instead, the 157-page opinion evaluated the deals in detail to determine whether they were anti-competitive overall.

The agreements were short in duration, easily terminated or renegotiated, and appeared to leave about 80% of the market open to the Auvi-Q, the judge found. Sanofi also sought to reach similar exclusive deals, and in some instances it succeeded, he noted.

The ruling was made public Jan. 29 after being filed under seal Dec. 17.

Mylan is represented by Robbins, Russell, Englert, Orseck, Untereiner & Sauber LLP. Sanofi is represented by Weil, Gotshal & Manges LLP.

The case is In re EpiPen (Epinephrine Injection, USP) Mktg., Sales Practices & Antitrust Litig., D. Kan., No. 17-md-2785, 1/29/21.