Section viii Carve-Outs: Federal Circuit Holds Argument in Amarin v. Hikma

Last week, the Federal Circuit held an oral argument that may have future implications for Section viii Carve-Outs in Amarin Pharmaceuticals, Inc. v. Hikma Pharmaceuticals USA Inc. (Appeal No. 23-1169), where Hikma carved out a portion of its label under Section viii to address two patented methods of using Vascepa® to reduce the risk of cardiovascular events, covered by U.S. Patent Nos. 9,700,537 and 10,568,861.

The district court evaluated the skinny label and found that its listing of side effects was insufficient to constitute inducement. The district court then evaluated Hikma’s public statements and found that the statements alone did not constitute inducement to infringe either. On appeal, Amarin argued that Hikma’s website and marketing materials outside of the label encouraged physicians to replace Amarin’s brand-name medication with Hikma’s generic version. The Federal Circuit is reviewing the District of Delaware’s decision to grant Hikma’s motion to dismiss Amarin’s induced infringement claims under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim.

Both sides presented compelling arguments, with the three-judge panel posing equally difficult questions for each side. The Court suggested on the issue of Section viii Carve Outs that generics could avoid future litigation by stating in their marketing statements that they have a generic version that can be used for the approved indication in the same fashion as the branded version. The Court further suggested that this would not unravel Section viii — it doesn’t make it so generics can’t sell; it would just make it so that generics, when they are planning their generic, have to explain what they are generic for.