MSN Seeks FDA Delisting of Novartis’ Revived Entresto Patent

A Novartis AG patent for Entresto revived this month doesn’t cover the blockbuster heart-failure drug’s valsartan-sacubitril complex and should be pulled from the FDA’s registry of approved drugs, MSN Laboratories Pvt. Ltd. said in a court filing.

A judgment that Novartis’ US Patent No. 8,101,659 is improperly listed in the US Food and Drug Administration’s Orange Book entry for Entresto “will remove any independent barriers to MSN’s launch of its” generic version of the drug “and competition that may exist by virtue of” Novartis’ maintenance of the listing, according to MSN’s answer to the complaint and counterclaims filed Wednesday in ...