Teva asks Fed Circ for ‘skinny label’ redo
Teva Pharmaceuticals has once again petitioned the US Court of Appeals for the Federal Circuit to reconsider its decision in a dispute over generic drug labelling which held that the drugmaker infringed GlaxoSmithKline’s (GSK) Coreg heart drug (Carvedilol).
Reiterating its argument, Teva claims that the February ruling will lead to a “wave of lawsuits” against generic drug manufacturers that exclude patent-protected indications from generic labels, a process referred to as “carving-out”.
The practice is commonplace for generic drug manufacturers and remained unchallenged for years prior to Teva v GSK made its way to the Federal Circuit.
The petition for rehearing en banc, dated October 7, claims “the panel’s decision contradicts settled precedent,” and eviscerates the carve-out statute, and throws inducement doctrine into disarray.”
“Because the background facts here will seemingly persist in most skinny-label cases, Dissent 35, the effects of the decision will be seismic.”
Creating liability
Teva was found twice to have infringed GSK’s Coreg patents, with the Federal Circuit panel indicating that drug makers were free to sell generic treatments, as long as they don’t promote uses for the drug that were pioneered by the original manufacturer.
But Teva argued that it was protected because the generic’s “skinny label” had excluded patent-protected uses of Coreg, but the Circuit held that, as the drug had been prescribed for the infringing purposes.
On the second consideration of the $235 million rulings, the Federal Circuit the three-judge panel indicated that it wanted to ensure drug makers can produce and sell generic medicines, provided they don’t promote novel uses pioneered by brand-name companies.
But Federal Circuit chief judge Sharron Prost dissented the panel’s decision, claiming that it “creat[ed] infringement liability for any generic entering the market with a skinny label” and permitted liability for labels that “did not actually cause any direct infringement”.
Breaking precedent
Among the core argument presented in Teva’s petition is that the Federal Circuit had drawn a consistent line between “encouraging” and “describing” an infringing use in a precedential ruling in Bayer Schering Pharma AG v Lupin.
The verdict made a clear distinction between the two, ruling that elements that may be “described” outside of the indications and usages section on labels cannot be found to “encourage” the uses unless it “required” or “recommended” the patented method, according to Teva.
“The majority somehow ends up at encouragement but fails to justify how it got there,” Teva argues. “In particular, it never meaningfully engages with the legal distinction between encouraging, recommending, or promoting an infringing use and describing it.”
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