Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. · ¶12

The second option is to submit a “section viii statement,” and assert “that the generic manufacturer will market the drug for one or more methods of use not covered by the brand’s patents.” Id., at 406; see 21 U. S. C. §355(j)(2)(A)(viii). This less confrontational path may be available if, for example, “the brand’s patent on the drug compound has expired and the brand holds patents on only some approved methods of using the drug.” Caraco, 566 U. S., at 406. A manufacturer that selects the section viii option must file with its ANDA a proposed “skinny label” that “‘carves out’ from the brand’s approved label the still- patented methods of use.” Ibid.; see 21 CFR §314.94(a)(8)(iv) (2025). In other words, the skinny label may not give instructions for uses that would infringe the patented methods of use.

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