Justices Refuse to Hear ‘Skinny Label’ Drug Patent Case
WASHINGTON — The Supreme Court on Monday declined to review a 2020 decision by the U.S. Circuit Court of Appeals for the Federal Circuit that resulted in Teva Pharmaceuticals being found liable for $235 million for infringing on a GlaxoSmithKline heart drug patent.
The case placed a spotlight on the use of so-called “skinny labels” for generic drugs, and justices refused to weigh in on the controversy despite a request from the U.S. solicitor general.
The underlying case began in 2014 when GlaxoSmithKline sued Teva Pharmaceuticals USA over its generic version of the Glaxo heart drug Coreg, a prescription medicine used to treat the symptoms of heart failure and high blood pressure.
Teva argued in court that it followed Food and Drug Administration instructions to “carve out” from its label a single use for the drug that would not infringe on any existing patent.
The “carve out” is a key provision of the Hatch-Waxman Act of the mid-1980s, whose drafters sought to create an innovative pathway to bring low-cost generic drugs to market.
When a brand-name drug has both patented and unpatented uses, its manufacturer must tell the FDA the specific sections of its labeling that describe the patented uses.
That allows generic manufacturers to carve out those sections and adopt a “skinny label” — one labeled for only unpatented uses.
Teva maintains it did just that. Nevertheless, in 2017, a jury awarded GlaxoSmithKline $235 million on its patent infringement claim.
A federal judge then overturned the verdict, but the U.S. Court of Appeals for the Federal Circuit, which specializes in patent cases, reinstated it in 2020, holding that the label, coupled with Teva’s marketing materials, did encourage doctors to prescribe its drug in a way that infringed on GlaxoSmithKline’s patent.
In its petition for a Supreme Court review of the case, Teva argued that the appeals court’s “controversial” opinion would “upend the legal rules facing the modern prescription-drug marketplace, wreaking doctrinal havoc.”
“Where there was previously clarity and ‘equilibrium to the skinny-label system,’ there is now confusion and uncertainty,” Teva said. “That uncertainty discourages generics from using carve-outs, which ‘throw[s] a wrench into Congress’ design for enabling quick public access to generic versions of unpatented drugs with unpatented uses.’”
“The ramifications of such an outcome are enormous — skinny-label launches are extraordinarily common, and they save patients and the federal government billions,” it said.
Solicitor General Elizabeth Prelogar also urged the justices to hear the case, arguing the Federal Circuit’s decision created “significant uncertainty” for generic drugmakers.
As is their custom, the justices did not explain their rationale for rejecting the case. However, the court did note that Justice Brett Kavanaugh would have granted it a review.
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