AbbVie, Genentech Raise New Constitutional Challenge To Inter Partes Review
Firms contend that IPR should not apply to patents filed before America Invents Act was enacted, objecting to IPR decisions invalidating Humira, Avastin and Herceptin patents.
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Past year was the high-water mark for product approvals and launches, but complete response letters remain a frequent occurrence. FDA’s ability to deliver on its promise of further clarity on transition products, interchangeability and indication carve-outs/carve-ins may take a hit from the ongoing partial government shutdown. On the legal side, look for more patent settlements with staggered entry dates and new antitrust scrutiny.
Sandoz joins list of companies that opt to settle rather than challenge AbbVie's hefty patent portfolio; staggered launches offer model for future deals.
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.