Novartis Pharms. Corp. v. Hetero USA Inc.

Case Name: Novartis Pharms. Corp. v. Hetero USA Inc., Civ. No. 20-md-2930-RGA, 2024 WL 3757086 (D. Del. Aug. 12, 2024)

Drug Product and Patent(s)-in-Suit: Entresto® (sacubitril/valsartan); U.S. Patent No. 8,101,659 (“the ’659 patent”)

Nature of the Case and Issue(s) Presented: Like the prior MSN Labs case in D. Delaware, this case is another Hatch-Waxman patent infringement action by Novartis against multiple ANDA filers. Following a bench trial, the court found the ’659 patent invalid for lack of written description. Novartis appealed. MSN received final approval from FDA to market its ANDA product. Novartis moved for an injunction pending appeal to prevent MSN from launching. Again, the court denied the injunction.

Why MSN Prevailed: The court, not surprisingly, did not agree with Novartis that the Federal Circuit is likely to reverse the district court’s judgment. And as in its other order denying Novartis’s injunctive relief, Judge Andrews was “skeptical” about Novartis’s purported irreparable harm, noting that “I do not find it reasonable to attribute harm resulting from the actions taken by other generic drug makers to MSN’s decision to launch its own individual product,” nor “do I think it fair to attribute to MSN the harm of impaired promotion of Novartis’s other cardiovascular drugs, which would result from Novartis’s own profit-maximizing business decision to decrease its cardiovascular product salesforce in response to MSN’s launch.” Once more, the court did not believe that Novartis had shown that money could not remedy the alleged harm. The court denied the injunction but granted a temporary stay to allow Novartis to seek injunctive relief from the Federal Circuit.