Patent Owners Would Get Better Shot At Quashing IPR Petitions Under USPTO Rule
Proposed rule would eliminate petitioner advantage when patent board is deciding whether to institute inter partes review of patent claims.
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But Patent Trial and Appeals Board must issue final written decision on all claims raised by challenger – not just some of them, court says; rulings in two closely watched cases mean that IPR proceedings can continue unabated, but generic drug and biosimilar sponsors may need to rethink how they go about challenging innovator patent claims.
Brand pharma gets a few wins in final rule on Patent Trial and Appeal Board practices, but not the big shift it was seeking.
Existing emergency use authorizations to remain in effect and FDA may continue to issue new ones. Pfizer and Merck are moving to transition Paxlovid and Lagevrio to full approval as FDA allows prescribing without a positive COVID test first.