Teva Rebuts GSK Argument in ‘Skinny Label’ Case
Teva is urging the U.S. Supreme Court to dismiss a GlaxoSmithKline (GSK) argument that the high court should not hear Teva’s appeal of a “skinny label” case involving GSK’s heart drug Coreg (carvedilol). In its appeal, Teva framed the question for the high court as: If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages infringement of those carved-out uses?
An earlier GSK brief opposing the appeal says Teva “resorts to a blatantly misleading ‘question presented’ that relies on a premise — that Teva’s label carved out the patent use — rejected by the jury and the Federal Circuit Court of Appeals.” Glaxo argues that a properly-instructed jury and then the appeals court found liability because “Teva sold a generic drug with a patented use on its label and marketed the drug, with the intent to capture the sales for that patented use. Liability here under the law of induced patent infringement is clear.”
In a reply to the GSK brief, Teva urges the high court to hear the case because of a new Federal Circuit interpretation that now “permits inducement liability based on label language that does not recommend infringement and that the brand never identified as patented. That decision guts a key element of inducement law and distorts Hatch-Waxman’s careful balance.”
Teva argues that it did what “generic applicants routinely do — and Congress authorized — when a drug’s active ingredient is no longer patented: it adopted an FDA-drafted ‘skinny label’ that carved out the one indication GSK identified as patented in its sworn representations to FDA… Nevertheless, the Federal Circuit held that a jury could find Teva liable for ‘actively’ inducing infringement through information scattered across different portions of its label — portions GSK never identified to FDA. That is more than just a misapplication of settled precedent: it is an about-face, because it adopts what was previously a dissenting view and allows a jury to find active inducement in virtually any carve-out case.”
Additionally, Teva says that without the Supreme Court’s intervention, “no generic manufacturer can be confident it will avoid infringement liability by carving out everything the brand identifies to FDA…That risk will cause many generic manufacturers to forgo launching in the first place, as amici explain.
“Hatch-Waxman was designed to avoid exactly that result,” Teva continues. “Generic manufacturers are supposed to be able to obtain certainty pre-launch — either by resolving patent disputes before launch, without a jury trial or damages (if seeking approval for patented indications), or by avoiding patent litigation altogether (if seeking approval only for unpatented indications through a section viii pre-launch resolution)... The result will be precisely what Congress did not want: one narrow method patent holding generics off the market entirely.”