A US court of appeals in Washington D.C. has hit the pause button temporarily on MSN’s US Food and Drug Administration-approved generic version of Novartis’ Entresto (sacubitril/valsartan) blockbuster, following the originator’s eleventh-hour emergency plea for an administrative stay and further suspension of proceedings.
MSN Hit With Temporary Pause On Entresto Generic As US Patent Runs Its Course
D.C. Appeals Court Issues Administrative Stay As It Weighs Novartis’ Petition For Relief
A lot can happen in 24 hours, as Novartis can attest. The Swiss originator has managed to win a court order temporarily putting the brakes on MSN’s Entresto ANDA product – just hours after a lower court refused a similar request.
More from Legal & IP
• By
A UK High Court justice came down on the side of Glenmark in AstraZeneca’s bid to enjoin the firm from launching a generic version of its Forxiga blockbuster before judgment is delivered in the firms’ patent-litigation clash.
• By
Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
• By
In a precedential decision, the US Court of Appeals for the Federal Circuit has determined the meaning of the language “the patent” as it applies to patent-term extensions for reissued patents, in the context of Aurobindo’s bid to wipe out a reissued patent shielding Merck & Co’s Bridion (sugammadex) injectable.
• By
Novartis’ multi-front legal battle against MSN Laboratories over its Entresto blockbuster in the US has taken yet another twist, with a federal district court in New Jersey finding that a preliminary injunction was warranted against MSN’s product on the basis of infringement of Novartis’ trade dress.
More from Generics Bulletin
• By
Off-patent drug trade groups expressed their concerns that personnel and expertise cuts will affect the agency’s ability to review and approve generics and biosimilars.
• By
Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.
• By
FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.