Generic Manufacturers Face Uphill Climb After Federal Circuit’s ‘Skinny Label’ Decision
Split appeals court denies en banc review of GSK v. Teva ruling, but suggests the district court could consider GSK’s patent declarations in determining whether Teva’s label is evidence of inducement to infringe. Teva plans to file petition for Supreme Court review.
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Teva’s carve-out fight with GSK over generic Coreg will see the Solicitor General weigh in. Amgen and Juno’s patent petitions remain pending, and the high court stays a Federal Circuit decision invalidating Novartis’ Gilenya patent.
The two agencies are pursuing initiatives to address instances of patents being used improperly to delay competition. FDA may play greater role in PTAB proceedings and training patent examiners.
Supreme Court nominee issued three decisions on Hatch-Waxman regime as district court judge, including case in which she ruled against the FDA’s denial of orphan drug designation and another in which she deferred to the agency’s view on exclusivity. Her analysis of facts may play a role if the court takes up a case on administrative agency deference.