Teva delayed generic EpiPen, Nuvigil in illegal scheme, new suit says

EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016. REUTERS/Jim Bourg/File Photo
  • Plaintiffs say Teva, Viatris, Pfizer entered into quid-pro-quo involving two drugs
  • Viatris and Pfizer previously settled related allegations for combined $609 million

(Reuters) - Teva Pharmaceutical Industries Ltd has been accused in a new class action lawsuit of delaying its launch of a generic version of Viatris Inc's EpiPen allergy treatment injector in exchange for Viatris' promise not to compete with Teva's narcolepsy drug Nuvigil.

The lawsuit, filed Friday in Kansas City, Kansas, federal court by two individuals and a health insurer, comes less than a year after Viatris, agreed to pay $264 million to settle related litigation. Pfizer, which manufactured the EpiPen for Viatris and owns patents on it, last year agreed to pay $345 million to settle the claims against it.

The earlier litigation did not name Teva as a defendant, or include the allegations about Nuvigil.

"These claims challenge settlements from more than 10 years ago and we believe they are clearly time-barred and without merit," said Kelley Dougherty, a spokesperson for Teva.

Lawyers for the plaintiffs did not immediately respond to requests for comment.

The EpiPen is a pen-like device that allows its user to easily self-administer an injection of the drug epinephrine to treat potentially life-threatening severe allergic reactions. In 2009, Teva revealed plans to make a generic version of the device, and Pfizer and Viatris — then called Mylan NV — sued for patent infringement.

Also in 2009, Cephalon Inc, which made Nuvigil, sued Mylan over its plan to make a generic version of that drug. Teva took over that litigation after buying Cephalon in 2011.

Both lawsuits settled in 2012. Mylan agreed in April of that year not to sell generic Nuvigil until 2016, and Teva agreed in July not to sell a generic EpiPen until 2015.

The plaintiffs in Friday's lawsuit — an EpiPen purchaser, a Nuvigil purchaser and Hawaii-based UHA Health Insurance — said the two settlements were in fact a quid pro quo to avoid competition, which violated federal and state antitrust laws. They cited internal communications discussing negotiations of the two deals together.

Through the deals, the companies "ensured there would be no generic competition for years — meaning that they would each make far more on their respective monopoly drug than they ever would from bringing a generic competitor into the others' markets," the plaintiffs said. Consumers paid hundreds of millions of dollars more than they would have without the agreements, they alleged.

The case is Edgar v. Teva Pharmaceuticals Industries Ltd, U.S. District Court, District of Kansas, No. 2:22-cv-02501.

For plaintiffs: Lynn Sarko of Keller Rohrback; and Rex Sharp of Sharp Law

For Teva: Not available

Read more:

EpiPen antitrust litigation settled; Viatris to pay $264 million

Pfizer agrees to pay $345 mln to resolve EpiPen pricing lawsuit

Our Standards: The Thomson Reuters Trust Principles.

Thomson Reuters

Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at brendan.pierson@thomsonreuters.com.