US Supreme Court Preview: ‘Skinny’ Labels, FTC, And FCA – But No Tecfidera As Biogen Loses Bid
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.
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High court will consider the standard for determining if a patent covering a group of related chemicals is enabled in Amgen v. Sanofi. It denies Juno petition seeking review of standard for written description of an invention in CAR T-cell patent suit against Kite.
As the US Supreme Court deliberates on whether to grant Teva’s petition to review its litigation with GSK over “skinny label” generics that carve out patented indications, Aziz Burgy, partner at Axinn, Veltrop & Harkrider LLP, talks to Generics Bulletin about the key issues at stake.
ANDA sponsors targeting Novartis’s Gilenya have been informed by the US Court of Appeals for the Federal Circuit that at an ‘at-risk’ launch is possible, after the originator’s latest petition to the court was denied as it seeks a ruling from the US Supreme Court.