In August 2021, the United States Court of Appeals for the Federal Circuit issued a decision in GlaxoSmithKline, LLC, SmithKline Beecham (Cork) Ltd. (“GSK”) v. Teva Pharmaceuticals USA, Inc. (“Teva”) regarding claims Teva infringed on GSK’s Patent. GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., No. 2018-1976, 2021 WL 3412496 (Fed. Cir. Aug. 5, 2021). In the Appeal of this October 2020 infringement decision, the Federal Circuit throws into question the fate of skinny labels and access to generic drugs. In 2013, GlaxoSmithKline, LLC sued Teva for inducing infringement by encouraging doctors to prescribe a generic version of GSK’s cardiovascular drug. In 2017, the jury sided with GSK and awarded an eye-opening $235 million in damages. Despite the jury’s decision, the District Court granted judgment as a matter of law to Teva stating that GSK failed to prove that Teva’s actions caused doctors to infringe on GSK’s patented use. Even though Teva argues that this was allowed by Teva carving out the patented use of GSK’s cardiovascular drug, the Federal Circuit, on appeal, found sufficient evidence that Teva’s labelling encouraged doctors to infringe on the patented use. Thus, throwing into question whether skinny labels under Section VIII of the Hatch-Waxman Act are sufficient for generic products to come into the market.
A “skinny” (or a carved out) label is a pharmaceutical product label that has an unpatented indication and at least one patented indication omitted. Upon approval of a skinny label, a generic product is able to reach the market before the patent associated with the patented indication expires, thereby allowing the unpatented product to be sold, but not for the specific purpose, method, or indication covered by the patent. Under the Hatch-Waxman Act, an Abbreviated New Drug Application (“ANDA”) applicant with a skinny label is not liable for infringement of the patented indication. See 35 U.S.C. §156
Section 505(j)(2)(A)(viii) of the Food, Drug, and Cosmetic Act protects generic drug companies such as Teva from infringement lawsuits as long as the ANDA applicant’s drug uses are not covered by the patent(s), or the ANDA applicant acknowledges that the patent is listed in the Orange Book and states that it does not claim the same condition of use or otherwise carves out from its label the patented use. Federal Food, Drug, and Cosmetic Act, § 505(j)(2)(A)(viii), 21 U.S.C. § 355(j)(2)(A)(viii).
In 1998, the United States Patent and Trademark Office granted GSK a patent, U.S. Patent No. 5,760,069, which claimed a method of administering its carvedilol compound to decrease mortality caused by congestive heart failure. GlaxoSmithKline, 2021 WL 3412496. In 2002, GSK sought a reissue of its 1998 patent and was reissued as U.S. Patent No. RE40,000 in 2008. Id. In 2003, Teva updated its label to include the indication decreasing mortality caused by congestive heart failure, the indication covered by GSK’s reissued patent. Id. However, just before Teva launched its generic carvedilol, it removed the indication from its label. Id.
At trial, Teva argued it need not provide certification to GSK’s reissued patent because its ANDA was approved before GSK’s patent reissued. However, the court focused on Teva’s marketing of the generic drug. Id. Specifically, it honed-in on the fact that Teva continued to take action that began before the patent was reissued in 2008, intending to cause physicians to directly infringe GSK’s Patent by administering Teva’s generic carvedilol product. The Federal Circuit stated that Teva encouraged physicians to use the generic carvedilol product for an infringing purpose during the full label period. Id.
Although the majority clarified its decision and stated that claiming a drug to be generic is insufficient evidence of inducing infringement, in a lengthy thirty page argument, the court was not without dissent.
Judge Prost dissented stating that “[b]efore today, there was an equilibrium to the skinny-label system—one that allowed companies to make informed, responsible decisions in this area. If a generic wanted to avoid patented uses, it had the simple expedient of omitting from its label the uses the brand identified. And if a brand wanted to block a skinny label containing a use it thought was patented, it had the simple expedient of including that use in its FDA patent declaration. That equilibrium is no more.” Id. at *32 With this opinion, the law of infringment and practice of skinny labeling may have become even more unsettled than before.