Skinny Labeling Post-GSK v. Teva: How the Decision Will Inform Biosimilar Carve-Outs



Date & Time

Start Date: 06/22/2021
Start Time: 1:00 pm
End Time: 2:00 pm EDT


Blake Coblentz will join a panel discussing skinny labeling on a pharmaceutical product. At the time of press, the Federal Circuit vacated its prior ruling finding induced infringement based on so-called skinny labeling on a pharmaceutical product in GSK v. Teva (Fed. Cir. Feb. 9, 2021). As we await a final decision, this panel will provide strategies and tactics in view of the decision, including:

  • Reevaluating claim and label language for optimal drafting
  • Analyzing what types of evidence should be used to prove infringement
  • Understanding second medical use patents and carve-out strategies
    • Clarifying the patentability of further medical use inventions
  • Outlining the implications of the Federal Circuit decision striking down labeling carve-outs
  • Determining whether post-filing evidence is admissible to show insufficient disclosure of further medical use
  • Balancing competing interests in promoting innovation v. permitting generic drugs


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W. Blake Coblentz

Co-Chair, Hatch-Waxman & Biologics
Vice Chair, Intellectual Property

(202) 912-4837

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