After the Supreme Court invited the Solicitor General to file a brief expressing the views of the United States regarding Teva Pharms USA, Inc. v. GlaxoSmithKline LLC, et al., the Solicitor General filed its brief amicus curiae on March 29, 2023. The Solicitor General urged the Supreme Court to grant Teva’s petition for a writ of certiorari. The Solicitor General indicated that even after an outcry of amici in response to the Federal Circuit’s initial decision, the Federal Circuit’s holding that a reasonable jury could view petitioner’s carved-out labeling as evidence of intent to induce infringement of respondents’ method-of-use patent further exacerbated the practical concerns raised by the court’s initial opinion. Specifically, the Solicitor General warned that under the Federal Circuit’s holding, a generic manufacturer that follows the Hatch-Waxman Amendments by marketing an FDA-approved label that carves out the brand-name indications claimed by a method-of-use patent can still be liable for intent to induce infringement.
Additionally, the Solicitor General echoed Judge Prost’s dissent,[1] noting that “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.” Under the governing statutes, the FDA cannot authorize a generic drug that would infringe a patent, but it also lacks both the expertise and the authority to review patent claims. As such, it is the brand-name manufacturer’s responsibility to identify the portions of the approved labeling that correspond to the method of use claimed by the patent. Additionally, a generic manufacturer is not free to omit additional portions of the brand-name labeling beyond the omissions approved by the FDA. This uncertainty will deter generic manufacturers from invoking the section viii pathway, which may threaten the availability of lower-cost drugs. Further, the Solicitor General found that the Federal Circuit’s holding that “when a label instructs or teaches a patented use, it can be considered evidence of intent to encourage that use” as inappropriate here, as Teva’s labeling was driven by FDA regulatory requirements and GSK’s own identification of the indication that should be excised.
Finally, in response to the Federal Circuit’s description of Teva’s marketing efforts, catalogs, and press releases that contributed to the finding of intent to induce infringement, the Solicitor General noted that this literature presented to doctors advised the doctors to read the labels and prescribe the drug as indicated by the labels. The Solicitor General stated, “Absent independent evidence that petitioner understood its carved-out labeling to encompass patented uses, proof that petitioner expected and encouraged doctors to rely on the labeling cannot support an inference of intent to induce infringement.”
In light of the Supreme Court’s request that the Solicitor General file its brief amicus curiae, and the Solicitor General’s recommendation that the Supreme Court grant Teva’s petition for a writ of certiorari, it appears that the Supreme Court may agree to hear this case. We will provide additional updates on this case if this happens.
[1] GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 7 F.4th 1320, 1342-1361 (Fed. Cir. 2021) (Prost, J., dissenting).