The Federal Circuit's August 5, 2021 ruling in GlaxoSmithKline LLC v. Teva Pharm. USA, Inc. (link to issued opinion), is an important development in the law of "skinny" generic pharmaceutical labels and induced infringement claims. See GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021) ("GSK II") (Google Scholar link). Read on for important aspects of the majority's opinion and Judge Prost's dissent.
Background on Section viii Carve Outs. ANDA filers can seek approval for generic products with labels that "carve out" patented indications. Those labels are commonly referred to as "skinny labels" or "section viii carve outs" (the applications require a statement under Section 505(j)(2)(A)(viii) of the FDCA, 21 U.S.C. ' 355(j)(2)(A)(viii)).
FDA accepts a carved-out label if the omissions "do not render the proposed drug product less safe or effective than the listed drug for all remaining, nonprotected conditions of use." 21 CFR 314.127(a)(7). Courts have also recognized the viability of this labeling practice. In 2003, for example, the Federal Circuit explained that a Hatch-Waxman infringement case is "limited to an analysis of whether what the generic drug maker is requesting authorization for in the ANDA would be an act of infringement if performed." Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1360, 1364-65 (Fed. Cir. 2003) (explaining that an ANDA applicant's "'paragraph IV certification[]' . . . was effectively a statement of non-applicable use pursuant to 21 U.S.C. ' 355(j)(2)(A)(viii)" and holding that "the request to make and sell a drug labeled with a permissible (non-infringing) use cannot reasonably be interpreted as an act of infringement (induced or otherwise) with respect to a patent on an unapproved use, as the ANDA does not induce anyone to perform the unapproved acts required to infringe").
But since 2010, the Federal Circuit has issued several decisions upholding induced infringement claims against skinny labels for infringement of the carved-out uses. See, e.g.,AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed. Cir. 2010) (finding induced infringement where "despite being aware of the infringement problem presented by the proposed label, Apotex nonetheless proceeded with its plans to distribute its generic drug product"); Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 845 F.3d 1357, 1369 (Fed. Cir. 2017) ("[E]vidence that the product labeling that Defendants seek would inevitably lead some physicians...
