Novartis Pharms. Corp. v. Alembic Pharms. Ltd.

Entresto® (sacubitril/valsartan)

September 29, 2023

GENERICally Speaking

Case Name: Novartis Pharms. Corp. v. Alembic Pharms. Ltd., Civ. No. 22-1395-RGA, 2023 WL 6387975 (D. Del. Sept. 29, 2023) (Andrews, J.)

Drug Product and Patent(s)-in-Suit: Entresto® (sacubitril/valsartan); U.S. Patent No. 11,096,918 (“the ’918 patent”)

Nature of the Case and Issue(s) Presented: Previously, Novartis sued Noratech, MSN, and other defendants, alleging that each defendant’s ANDA products infringed various patents. As part of that previous litigation, Noratech and MSN provided to Novartis their ANDAs, product samples, and other confidential information subject to the protective order entered in that case. Novartis ultimately dismissed its infringement claims.

Novartis then filed this case asserting, “on information and belief,” that Noratech’s and MSN’s ANDA products (the same ANDA products accused in the previous case) infringe the ’918 patent. Noratech filed a motion to dismiss for failure to state a claim, and the MSN defendants filed a motion for judgment on the pleadings. Defendants argued that Novartis’s “on information and belief” allegations were insufficient, and that Novartis should have to plead infringement with greater specificity based on ANDAs, testing data, and other documents it obtained during the previous litigation. The court denied both motions.

Why Novartis Prevailed: The court had previously interpreted the protective order governing Defendants’ disclosures in the previous litigation as preventing use of that information to initiate other litigation. Thus, Novartis could not plead infringement with the additional detail that Defendants demanded. Moreover, the court reaffirmed application of the more “relaxed” Belcher pleading standard in ANDA infringement cases, including those asserting only non-OB-listed patents, like this one—ANDA infringement plaintiffs are held to a lower level of specificity than plaintiffs in other patent infringement cases.

MSN also moved for judgment of non-infringement, arguing that the ’918 patent claims an amorphous form of the claimed compound and its ANDA product requires a crystalline form. Consistent with recent trends, the court determined that it could not adjudicate infringement at this early stage—in particular, without expert testimony—and pleading that the ANDA product infringes was sufficient. The court went so far as to state that “an ANDA does not provide a complete answer to infringement.”

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