Supreme Court Turns Down Skinny Label Case
The U.S. Supreme court has declined to hear a closely watched appeal of a lower court’s ruling in a so-called “skinny label” case won by GlaxoSmithKline (GSK) against Teva over a generic form of GSK’s heart drug Coreg (carvedilol). The question at issue was: 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?
A recent U.S. government amicus brief saw FDA supporting the generic drug industry in the dispute. The brief noted that the issue warranted the high court’s review. “If allowed to stand, the decision below threatens significant harm to competition and to consumers,” it says. If Teva’s carved-out skinny labeling “supports a finding of intent to induce infringement, the section viii pathway will be seriously jeopardized,” further delaying generic competition on the market, it added.
In an earlier brief, Teva 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.”
GSK said in its brief that 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 subsequent brief that addressed the government’s position, GSK said the Supreme Court doesn’t have to rely on GSK’s, Teva’s, or the government’s word on any of the factual matters. It said a supplemental proceeding on remand is already slated to address these questions in the context of a Teva defense. “The government attempts to short-circuit this process by resolving contested issues against GSK and dispensing with evidence and law that does not fit its policy objectives,” GSK said. “This is no basis for recommending a grant of certiorari.”