Skinny Label Carve-Outs: Essential Considerations


Under the Hatch-Waxman Act, section viii carve-outs, also known as "skinny labels," have provided a pathway for generic drug manufacturers to seek approval to market their drugs by carving out the branded drug's patented methods of use. On Wednesday, April 19th, join Fish Principals Juanita Brooks and Betsy Flanagan for an introduction to skinny label carve-outs and a discussion addressing the following questions and more:

  • What are the policy reasons for allowing carve-outs?
  • What is the interplay between carve-outs and the law of inducement?
  • What does a true carve-out look like?
  • What does an insufficient carve-out look like?
  • What remedies does an innovator have when there's an insufficient carve-out?
  • Are the generics right? Will the GSK v. Teva opinion bring an end to carve-outs?  

Fish & Richardson will apply for 1.0 hour of CLE credit.

If you have any questions, please contact eventsteam@fr.com.

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