U.S. Gov’t Asked to Weigh in on Skinny Label Case
A Teva Pharmaceutical appeal to the U.S. Supreme of a U.S. Court of Appeals for the Federal Circuit decision in a case involving a so-called “skinny label” for a generic form of GlaxoSmithKline’s (GSK) heart drug Coreg (carvedilol) may be gaining traction now that the high court has invited the U.S. government to weigh in. In a 10/3 docket entry, the Supreme Court noted: “The Solicitor General is invited to file a brief in this case expressing the views of the United States.”
An earlier filing by Teva said that the question it wants the court to answer is: 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.?
In a filing last month, Teva urged the high court to dismiss a recent GSK argument that the court should not hear Teva’s appeal. GSK said 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 argued 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 urged 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 also argued 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 said 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 continued. “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.”