Amarin Corp Plc (AMRN)

[funnygi2]

Assuming that's the opinion North referred to, it's not the GSK-Teva case we're all interested in. Meanwhile...at your service:

Law360 (December 7, 2021, 7:17 PM EST) -- Teva's warning that a second split panel decision reviving GlaxoSmithKline's $235 million jury win over its heart failure drug Coreg will have a "seismic" impact on the drug industry is overblown, GSK has told the full Federal Circuit.

In a brief filed Monday, GSK urged the full court to deny Teva Pharmaceuticals' October petition for en banc review of the panel's August rehearing decision. GSK said Teva's argument that the revised panel decision still dooms the so-called skinny label regime, which allows generic manufacturers to get regulatory approval for unpatented uses of branded drugs, is itself doomed because the panel properly applied the law to the specific facts of this case. 

There is no need for the full court to revisit the jury's verdict a third time, GSK said, since the panel properly found that substantial evidence supports its finding that Teva induced doctors to infringe a patent on Coreg. 

"Teva's refrain that the panel's rehearing decision is the Armageddon for skinny label generics is belied by the dearth of cases mirroring this one that have been filed in its wake. History shows that generic manufacturers by-and-large know how to execute proper skinny labels. That Teva is on the wrong side of history is no reason to rewrite it now," GSK said.

GSK said the panel majority relied on ample evidence — including Teva's promotional materials, press releases, product catalogs, U.S. Food and Drug Administration labels, and testimony from witnesses on both sides — in finding support for the jury verdict.

The dispute dates back to 2014, when GSK sued Teva, alleging that it changed its label in 2011 to include the treatment of congestive heart failure and induced infringement by encouraging doctors to prescribe the generic tablets for that use.

In 2017, a Delaware federal jury agreed to the tune of $235 million, but that verdict was later overturned by U.S. District Judge Leonard P. Stark, President Joe Biden's pick to fill a soon-to-be-vacant Federal Circuit seat.

During oral arguments in September 2019 in the initial appeal, U.S. Chief Circuit Judge Kimberly A. Moore said she was "bewildered" that Teva had gotten Judge Stark to overturn the jury verdict. She cited press releases Teva circulated before and after the FDA approved its generic, saying those were enough by themselves to show that Teva had encouraged doctors to use the generic as a Coreg substitute. 

Judge Moore's comments during the 2019 hearing proved predictive. A split panel issued its original decision in October 2020 reviving the jury verdict. That decision sparked swift and significant concern from the generics industry, which argued that Teva had perfectly followed the law on how to create a skinny label under the Hatch-Waxman Act, but was still punished. 

Following the uproar, the panel vacated its opinion, held another round of oral arguments in February, and issued its revised opinion in August that still favored GSK, but was more case-specific, according to the panel majority. The rehearing decision pointed to significant evidence proving Teva was actively marketing its drug for a patent-protected purpose, but said the ruling shouldn't have a broader impact on generic drugs with skinny labels. 

Teva, however, asked the full federal circuit to weigh in, saying in its petition for en banc review that the rehearing decision "contradicts settled precedent, eviscerates the carve-out statute, and throws inducement doctrine into disarray."

But GSK said that "doomsday scenario" can't come to pass because the jury specifically found that Teva's label wasn't truly a skinny label since it didn't carve out using carvedilol to treat congestive heart failure, as claimed by GSK's patent. Therefore, GSK said generics can continue to pursue skinny labeling without fear as long as they actually omit patented uses from their labels.

"In reversing, the majority made no legal pronouncements that will bind any panel of this court from concluding, in a different case, on different facts, that a properly executed skinny label strategy and marketing campaign does not create inducement liability. There are thus no exceptional circumstances or contrary precedents warranting en banc review," GSK said.

Counsel for Teva declined to comment, while attorneys for GSK did not immediately return a request for comment Tuesday.

The patent-in-suit is U.S. Patent No. RE40,000.


Read more at: https://www.law360.com/articles/1446435/full-fed-circ-told-teva-overreacting-in-skinny-label-ip-case?copied=1