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10 August 2021AmericasRory O'Neill

Fed Circuit split over $235m skinny label verdict

The US Court of Appeals for the Federal Circuit has reinstated a $235 million verdict against Teva in a split decision which could have major implications for skinny label generics.

In a precedential opinion, a 2-1 majority found that Teva induced infringement of GlaxoSmithKline’s Coreg (carvedilol) by failing to carve-out a patent-protected use of the drug on its generic label.

The majority moved to assuage fears that the ruling could impact other generic makers who sell skinny label drugs, remarking that their “narrow, case-specific review of substantial evidence does not upset the careful balance struck by the Hatch-Waxman act regarding carve-outs”.

But in a dissenting opinion, Circuit Judge Sharon Prost warned that her colleagues’ “missteps throw a wrench into Congress’s design for enabling quick public access to generic versions of unpatented drugs with unpatented uses”.

The US Food and Drug Administration (FDA) has approved the use of Coreg for treating hypertension, congestive heart failure (CHF), and left ventricular dysfunction (LVD).

Teva launched its generic version of Coreg in 2007 by which time GSK’s patents on the use of Coreg for two of those indications had expired. But its patent on Coreg for the treatment of CHF remained valid. This required Teva to issue a so-called skinny label, and carve out the use of its generic product for that purpose.

Teva initially sold its generic with a label including only the LVD indication and hypertension indications. In 2011, the FDA instructed Teva to submit a new label “identical in content to the approved [GSK Coreg] labeling,” after GSK patents covering other uses of Coreg were delisted from the Orange Book.

Chief Judge Kimberly Moore and Circuit Judge Pauline Newman both held that “substantial evidence supports a jury finding that the patented use was on the generic label at all relevant times and that, therefore, Teva failed to carve out all patented indications”.

The “substantial evidence” relied on by GSK includes both Teva’s skinny label, and press releases advertising its product as the generic version of Coreg. While Teva stated it had carved out the patented CHF indication when it first launched its product, the majority held that the label had still induced doctors to infringe by prescribing the product for the infringing use.

One doctor, testifying for GSK, told the court that LVD was “intertwined with heart failure”, and that the prescription of generic Coreg for the treatment of LVD would, in many cases, have been an infringing use. GSK and the majority also cited Teva press materials advertising its product as the therapeutic equivalent of Coreg, which was still partially under patent.

In a sharply worded dissent, Prost disagreed with her colleagues’ interpretation of the facts, observing: “GSK’s sworn FDA filings identified just one use as patented. So Teva carved out that use and came to market with its ‘skinny’ label. It played by the rules, exactly as Congress intended.”

“The evidence of inducement—that Teva had culpable intent to encourage infringement and that its skinny label or press releases caused doctors’ prescribing practices—was thin to nonexistent,” Prost added.

Despite the majority’s words to the contrary, Prost said she feared the decision would create confusion among generics manufacturers, “leaving them in the dark about what might expose them to liability”.

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Americas
14 July 2022   Generics giant’s petition cites the cost of medicine and first-principles of innovation.

More on this story

Big Pharma
10 February 2021   The US Court of Appeals for the Federal Circuit has agreed to reconsider its precedential ruling against Teva Pharmaceuticals for producing a generic hypertension and heart failure treatment, according to a Bloomberg Law report.
Americas
14 February 2022   A split US Court of Appeals for the Federal Circuit has declined to rehear a generic drug labelling dispute between Teva and GlaxoSmithKline.
Americas
14 July 2022   Generics giant’s petition cites the cost of medicine and first-principles of innovation.