As the biopharma industry seeks clarity on so-called "skinny" labels, the United States’ top lawyer is calling on the Supreme Court to take up the long-running feud between Teva and GSK.
In a 29-page filing, the Biden administration’s solicitor general Elizabeth Prelogar told the justices that the case—which centers on GSK’s off-patent blood pressure med Coreg and Teva’s generic version—is a “suitable vehicle” to address the argument over skinny labels.
Skinny labels are a common generic carve-out that allow drugmakers to get their copycat medicines approved for one or several—but not all—approved indications of their brand-name counterparts.
In this case, Teva launched its generic version of GSK’s Coreg in two of the branded med’s three indications in 2007.
Four years later, the FDA told Teva to include the third indication for congestive heart failure in the generic's label, despite GSK holding a patent on that use through 2015. That prompted GSK to sue its generics rival in 2014. For its part, Teva argued it was simply following the FDA’s instructions.
GSK holds the upper edge in the litigation after winning a $235 million verdict in 2017 and getting that ruling upheld in appeals.
Teva petitioned the Supreme Court last summer to overturn the verdict. In October, the Supreme Court reached out to the Biden Administration for advice on whether or not to hear the case.
If GSK’s victory in appeals court is upheld, the decision could “seriously jeopardize” manufacturers’ ability to bring lower-cost generics to market, Prelogar wrote in a filing this week.
In Prelogar’s eyes, that decision was “incorrect.” She added that no “reasonable jury could have concluded that the carved-out labeling for [Teva’s] generic … was itself evidence of intent to produce infringement.”
GSK sees things differently, and the U.K.-based pharma urged the Supreme Court to reject Teva's High Court petition in August.
“Nothing about the potential legal consequences of this case warrants revisiting the fact-specific decision of the Federal Circuit or reversing the jury’s verdict,” GSK argued at the time.
While Teva has warned about the "enormous" implications of the case on the generics industry, GSK says the litigation poses no threat to copycat drugmakers who "operate properly under the law of induced infringement as applied to generic drug labels—'skinny' or not."
Branded drugmakers contend that strong patent protections are critical to protecting investments into research and development. If generics can reach the market with "skinny" labels, their off-label use threatens to take a chunk of sales from branded meds before patents expire.
The case has divided the industry and courts alike, Barnes & Thornburg partner and intellectual property attorney Ron Cahill told Fierce Pharma last fall. Ultimately, the lawyer said he doesn't expect the Supreme Court will take the case.
Generics makers have argued the ruling, if upheld, would set a precedent that makes it difficult for them to conduct their business. Generic medicines launch with skinny labels “almost half the time,” and the ruling puts all of those launches "at risk," Teva said in its Supreme Court appeal.
Editor's note: This story has been updated with additional details on GSK's position.