Blake Coblentz will be speaking at the American Conference Institute's Biosimilars & Innovator Biologics conference. Subsequent to the Federal Circuit’s skinny label ruling in GSK v. Teva, the District of Delaware in Amarin v. Hikma (D. Del. 2022) embraced a narrower approach in dismissing an induced infringement claim based on an allegedly inadequate skinny label carve out. The Delaware court also examined the novel question of whether a health insurer’s formulary placement of the drug in question induced infringement of method-of-use patents. Further, confirming that without any bright line rules, and absent a decision from the U.S. Supreme Court or legislation, the fate of the skinny label remains in the balance.
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Considering whether the language of press releases, web pages and other marketing materials require more scrutiny
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Analyzing potential liability faced by insurers for placement of skinny label on formularies
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Does liability exist for induced infringement by listing a skinny label on a formulary
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Taking stock of the potential impact to patients
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Understanding when information can put you at risk for infringement claims regardless of labeling revisions have been approved by FDA as part of a skinny label