In the lengthy legal back-and-forth over the heart drug Coreg, GlaxoSmithKline has scored another victory against generic rival Teva. The decision could have far-reaching implications for the generics market and the practice of “skinny labeling.”
By a 2-1 vote, a U.S. Federal Circuit appeals panel ruled that Teva infringed a GSK patent by urging doctors to prescribe its generic version of Coreg for congestive heart failure, a use that was still protected by GSK's patent at the time.
In 2007, Teva launched its generic version of GSK's Coreg but for only two of its three indications—hypertension and ventricular dysfunction after heart attack. Four years later, the FDA instructed Teva to add the indication for congestive heart failure even though GSK held a patent for that use through 2015.
In 2014, GSK sued claiming Teva induced doctors to prescribe the generic for congestive heart failure. Teva argued it was merely following the FDA's instructions for the drug's label.
Three years later, a jury ruled for GSK and ordered the $235 million judgement. Teva later convinced a district court judge to overturn the verdict.
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The latest decision is a blow to generic drugmakers. After the October ruling in GSK’s favor, eight other generic manufacturers, including Novartis’ Sandoz and Mylan, banded together backing Teva and urging the court for a review.
Pitching in with support was former California Rep. Henry Waxman, co-author of the 1984 Hatch-Waxman Act. In a court filing, Waxman said the Teva decision was inconsistent with the act and could have a “devastating impact on the Hatch-Waxman Act’s generic drug program.”
Meanwhile, lawsuits are now in the works against other generic manufacturers who have used skinny labels, Bloomberg reported in December.
RELATED: ‘Skinny labeling’ under fire: GSK, Teva federal court decision undermines common practice
In rendering its decision on Thursday, the court acknowledged the confusion the ruling would create over skinny labels.
“It is unclear what Teva even did wrong—or, put it another way, what another generic in its shoes should do differently," the court wrote.