Biden admin urges Supreme Court to hear 'skinny labels' case between
Teva, GSK
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[March 31, 2023]
By Blake Brittain
(Reuters) - The Biden Administration told the U.S. Supreme Court on
Wednesday that it should agree to hear a patent appeal over drug labels
involving Teva Pharmaceuticals USA Inc and GlaxoSmithKline LLC that
could have significant ramifications for the generic-drug industry.
The U.S. Solicitor General said Teva's generic version of GSK's heart
drug Coreg could not have violated GSK's patent rights because Teva
omitted the infringing use of the drug from its labeling.
Such "skinny labels" typically allow generic drugmakers to launch their
products earlier while avoiding liability for infringing brand-name
drugmakers' patents.
A Teva spokesperson said Thursday that the company was pleased with the
Solicitor General's recommendation on an "important issue impacting both
the pharmaceutical industry and U.S. patent law."
GSK declined to comment on the brief. The Solicitor General's office did
not immediately respond to a request for comment Thursday.
GSK sued Teva for patent infringement in Delaware federal court in 2014
over its generic version of Coreg. Teva argued that it followed U.S.
Food and Drug Administration instructions to "carve out" a patented
method for using the drug to treat heart failure from its label.
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The logo of Teva Pharmaceutical
Industries is seen in Tel Aviv, Israel February 19, 2019.
REUTERS/Amir Cohen
A jury sided with GSK and awarded it
$235 million in 2017.
The U.S. Court of Appeals for the Federal Circuit affirmed in 2021
that Teva's label, combined with its marketing materials, encouraged
doctors to prescribe the generic in an infringing way.
In its petition to the Supreme Court last year, Teva said the ruling
would cause "havoc" for skinny labels, which it said are
"extraordinarily common" and "save patients and the federal
government billions." GSK countered that the case does not threaten
generic drugmakers that "operate properly under the law."
The Biden Administration backed Teva on Wednesday, arguing generic
drugmakers should be entitled to rely on the FDA's carve-out
instructions, which are based on brand-name drugmakers' own
statements to the agency.
"The decision below subverts the balance struck by Congress, creates
significant uncertainty for FDA and generic manufacturers, and
invites gamesmanship by brand-name manufacturers," the government's
brief said.
(Reporting by Blake Brittain in Washington)
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