'I'm quite frankly baffled': Teva's $235M overturn in GSK patent case has judge 'bewildered'

Facing claims it induced doctors to prescribe a generic version of GlaxoSmithKline’s Coreg that violated its patents, Teva was hit with a hefty $235 million penalty in 2017. But a federal judge overruled that jury’s verdict last year—and now, one federal appeals judge says she's "baffled" by the decision.

During an appeals hearing Wednesday in GSK’s suit against Teva, a federal judge on the U.S. Federal Circuit Court's panel in Washington, D.C., said she was "bewildered" by U.S. District Judge Leonard P. Stark’s decision to strike the jury's original verdict.

The Circuit Court judge, who was not identified in a recording of the proceedings, said she couldn’t "imagine a stronger case for induced infringement" of a drug’s patent. Press releases Teva issued before and after its generic Coreg approval presented its copycat as an "equivalent" to the branded drug despite GSK's patent protection, she pointed out.

"What was Teva’s intent when it issued those releases?" the judge asked a lawyer representing Teva. "Just goodwill? To let the world know? Or to let doctors know so they could prescribe this drug?"

The lawyer told the judge Teva never attempted to present its generic as exactly the same as Coreg and only issued the press releases to inform physicians that a generic was expected to enter the market. 

A Teva spokesperson declined to comment on the case Thursday.

The harsh words from the three-judge panel adds a new wrinkle to the patent "carve out" suit Teva hoped it was rid of back in March 2018, when Stark ruled in its favor. Teva had cited all three of Coreg's approved indications on its generic's 2011 label, despite the fact that GSK still had patent protection on its heart-failure use.

Stark said a Delaware jury should not have concluded that Teva’s published releases beguiled doctors into infringing GSK's patent, both before the generic's label rewrite—when heart failure wasn't on its indications list—and after. Stark argued that GSK had not presented sufficient evidence to prove that "even at least one" doctor had been induced to prescribe the generic.

GSK’s Coreg, initially approved in 1995, eventually racked up green lights to treat hypertension, left ventricular dysfunction following a heart attack and congestive heart failure. GSK only marketed Coreg for congestive heart failure in the U.S., and Teva's generic wasn't approved to treat congestive heart failure because of remaining patent protections.

GSK's heart failure patents were in force through 2015. But in 2011, the FDA instructed Teva to rework its label, and Teva's revised version included that heart failure use.

GSK sued for infringement during both the "skinny label" and "full label" periods and prevailed in a jury verdict in 2017. On Wednesday, the federal panel of judges appeared split in their deliberations.

The GSK suit is just one of a suite of lawsuits and scandals Teva has faced in recent years—a revolving door of legal troubles that has sent investors scrambling for the exits.

In mid-August, Teva’s share price approached a 20-year low as looming federal opioid lawsuits threaten the drugmaker’s bottom line and Moody’s debt-rating agency lowered its outlook for the company from "stable" to "low."

Moody’s said possible opioid settlements reaching into the billions of dollars could hamper Teva’s ability to pay back its $2 billion in debt that will mature over the next two years. 

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