Split Fed Circuit refuses Teva 'skinny label' ruling review

A split US Court of Appeals for the Federal Circuit has declined to rehear a generic drug labelling dispute between Teva and GlaxoSmithKline.

On Friday, February 11, six Federal Circuit judges held that they would not review a panel’s finding that Teva’s generic drug labelling had infringed GSK’s patented Coreg heart drug (Carvedilol), with three judges dissenting.

Coreg has been approved for treating hypertension, congestive heart failure (CHF), and left ventricular dysfunction (LVD).

In 2007, when GSK’s patents on the use of Coreg for treating hypertension and LVC had expired, Teva launched its generic version. GSK’s patent on Coreg for the treatment of CHF remained valid, requiring Teva to issue a skinny label and carve out the use of its generic product.

Three years later, the US Food and Drug Administration (FDA) ordered Teva to update its label so it could be “identical in content to the approved [GSK Coreg] labelling” and include the indication for treatment of heart failure, after GSK patents covering other uses of Coreg were delisted from the Orange Book.

In 2014, GSK sued Teva and, a jury at the US District Court for the District of Delaware found that Teva had infringed the patent and was liable for $234.1 million for lost profits and $1.4 million in royalties.

The dispute has already gone through the Federal Circuit twice. Most recently, in August 2021, the Federal Circuit reinstated the $235 million verdict against Teva after a 2-1 majority found that Teva had induced infringement by failing to carve-out a patent-protected use of the drug on its generic label.

At the time, 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”.

Last week’s decision featured four sets of opinions, three of which were dissents.

In a concurring opinion written by Chief Circuit Judge Kimberly Moore, the six judges said that the dissents focused on arguments Teva hadn't asserted.

Moore said: “Ultimately, it is a sense of fairness that drives the dissents to advance these positions. They believe Teva’s partial label cannot be evidence of the intent required for active encouragement when Teva ‘play[ed] by the skinny-label rules.’.”

Circuit judges Sharon Prost, Timothy Dyk, and Jimmie Reyna dissented from the order denying Teva's petition.

“Now, no skinny-label generic is safe. Using this statutory pathway—and following the brand’s directions—becomes just another fact thrown into the mix when assessing a generic’s intent,” said Prost, in her dissent.

She added: “And, as amici observe, because most skinny labels contain language that (with clever expert testimony) could be pieced together to satisfy a patent claim, essentially all of these cases will now go to trial.”

According to Prost, where a generic plays by the skinny-label rules, the FDA-required label can’t be evidence of intent.

“Indeed, the panel majority’s decision doesn’t just eliminate a generic’s ability to depend on the skinny-label system; it also gives brands a powerful tactic: neglect to identify language as patent-covered, then sue a generic for including that very language,” warned Prost.

Both Dyk and Reyna also submitted separate dissents.

According to Reuters, Teva plans to appeal against the decision to the Supreme Court.

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