EpiPen litigation comes back to haunt Teva a decade after initial settlements

Between opioid litigation, price fixing claims, generic carve-out feuds—and, now, a class-action lawsuit alleging copycat launch shenanigans—Teva Pharmaceutical has certainly kept the courts busy in recent years.

In the latest legal entanglement, Teva is accused of stalling the rollout of its generic EpiPen in a quid pro quo with the epinephrine injector’s owner, Viatris. In return for the epinephrine launch delay, Viatris promised not to undercut Teva’s branded narcolepsy med Nuvigil with its own generic, according to court documents filed earlier this month.

Viatris—which formed from the union of Mylan and Pfizer’s Upjohn established medicines unit in 2020—settled for $264 million in a related lawsuit in February. Big Pharma Pfizer has also been involved in the EpiPen imbroglio, settling alongside two of its subsidiaries for $345 million last July. Previously, Mylan sold the allergic reaction injectable, while Pfizer’s subsidiaries chipped in on production.

The EpiPen legal saga dates back to 2008, when Teva sought out FDA approval for its epinephrine copycat, prompting patent-holder Pfizer to sue. A few months later in 2009, Mylan filed an application for generic Nuvigil, which Teva acquired through its buyout of Cephalon in 2011.

Both the EpiPen and Nuvigil lawsuits were resolved in 2012, with Mylan pledging that April to hold back on Nuvigil sales until 2016. A few months later, Teva agreed not to sell its generic EpiPen until 2015.

The new lawsuit contends the three companies—Teva, Mylan and Pfizer—opted not to “fully litigate the two separate cases,” which would have posed the risk of certain patents falling through in court. Instead, the trio “secretly agreed to a quid pro quo in which each side agreed to allow the other to maintain its respective brand-drug monopoly much longer than either could reasonably expect were they to actually litigate,” according to the lawsuit, which was filed Friday in a Kansas City federal court.

To support their case, the plaintiffs in the suit—a purchaser of EpiPen, a buyer of Nuvigil and Hawaii-based UHA Health Insurance—cited an email between Pfizer and Teva used to arrange a phone call to discuss the ongoing EpiPen patent litigation.

Teva, for its part, sees things differently.

"We are proud to have brought the first generic version of EpiPen to patients in 2018," a Teva spokesperson said over email. "These claims challenge settlements from more than ten years ago and we believe they are clearly time-barred and without merit," she added.

The EpiPen update comes as Teva has largely pacified its long-running opioid and price fixing litigation.

Back in January, the Israeli-American generics giant ponied up $420 million to quiet a case charging Teva with conspiring with other companies to hike drug prices. In hiding the scheme, Teva artificially inflated its share price, investors had claimed.

Then in July, Teva said in its second-quarter earnings release that it would float $4.25 billion as part of a nationwide settlement to end litigation over its alleged role in the U.S. opioid crisis. For the settlement to go through, Teva needed to resolve beef with AbbVie’s Allergan unit over opioid liability. Last month, the companies sorted out that debate, and Allergan advanced its own $2.37 billion agreement.

But Teva’s not in the clear yet. Overseas, the European Commission has been hammering the company over its marketing practices for multiple sclerosis med Copaxone. In October, the commission informed Teva of the preliminary view from its investigation that the company had breached European antitrust rules by angling to delay Copaxone competition. Teva has promised to “defend itself vigorously” in that case, with a spokesperson telling Fierce Pharma earlier this year it believes the commission's “preliminary view is incorrect.”

Editor's note: This story has been updated with comments from Teva.