Biosimilar Litigation: Janssen Vs. Samsung Anticipates Supreme Court Decision
Hoping to hold off a biosimilar to Remicade, Janssen challenges Samsung's decision not to participate in patent dance as it claims infringement of three manufacturing patents.
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During oral arguments in Sandoz v Amgen, justices suggest FDA issue rule-making on whether biosimilar sponsors can give early notification of launches and need to follow all the steps in the patent dance. The agency has explicitly said it wants to be left out of it.
Infliximab-abda gains FDA licensure without having faced an advisory committee review; under current case law, launch could come as early as mid-October.
US court dismisses Genentech suit over Amgen's patent dance moves; Janssen v. Celltrion trial is postponed as parties fight over Janssen's standing to sue; and Amgen wants to bar AbbVie citizen petition filers from seeing its Amjevita information.