In its “skinny label” legal saga with Teva, GSK has hit back following the U.S. solicitor general’s call for the Supreme Court to rehear the years-long case.
In a supplemental brief filed this week, GSK argued the government has taken a myopic view on the issue, homing in on Teva’s label for its generic of GSK’s heart med Coreg “to the exclusion of everything else.”
Skinny labels are par for the course in the generics industry. They allow manufacturers to get their copycat medicines approved for one or several—but not necessarily all—approved indications of their brand-name counterparts.
In Teva and GSK’s Coreg feud, Teva launched its generic version of the GSK medicine in two of Coreg’s three indications back in 2007. GSK subsequently sued Teva in 2014 after Teva tacked a third indication for congestive heart failure onto the generic’s label, despite GSK holding a patent on that use through 2015. Teva, for its part, argues it was simply following the guidance of the U.S. Food and Drug Administration.
GSK currently holds the upper hand in the litigation after winning a $235 million verdict in 2017 and getting that ruling upheld on appeal.
Teva, in turn, petitioned the Supreme Court last summer to overturn the verdict.
In its latest argument, GSK pointed to communications from Teva “lumping” indications together and describing its product as a Coreg generic writ large, “without any hint Teva’s product had a skinny label.”
GSK accuses the government of “rewriting” statutes to “relieve Teva of the consequences of its actions,” which the drugmaker argues “flies in the face of long-standing precedent, practice and guidance.”
The Biden Administration’s top lawyer, solicitor general Elizabeth Prelogar, sees things differently. Last month, she told the Supreme Court the case was a suitable venue to address the broader issue of skinny labels.
She contends that if GSK’s victory in appeals court is upheld, the decision could “seriously jeopardize” manufacturers’ ability to bring more affordable generics to market. She called the thinking behind GSK’s victory “incorrect” and suggested no “reasonable jury could have concluded that the carved-out labeling for [Teva’s] generic … was itself evidence of intent to produce infringement.”
For its part, Teva has warned the case could have “enormous” implications for the generics industry. GSK has countered by suggesting 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.”