Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc. et al

On January 21, 2022, Novartis Pharmaceuticals Corporation (hereinafter “Plaintiff” or “Novartis”), represented by Alexandra M. Joyce and Daniel M. Silver of McCarter & English, LLP, filed an intellectual property lawsuit against Teva Pharmaceuticals Usa, Inc., and Teva Pharmaceutical Industries Ltd. (collectively, “Defendants”) seeking injunctive relief, damages, attorney’s fees, costs, and interest, among other relief, for the alleged infringement of United States Patents owned by Plaintiff. This case was filed in the United States District Court in the District of Delaware.

Plaintiff filed this complaint for the alleged infringement of United States Patent No. 11,058,667 titled “Sacubitril-Valsartan Dosage Regimen for Treating Heart Failure” (the “’667 patent” or “Patent-in-Suit”) owned by Plaintiff.

In the complaint Plaintiff alleged that, “On information and belief, Teva Pharmaceuticals USA, Inc., by itself or in concert with Teva Pharmaceutical Industries Ltd., submitted to the FDA ANDA No. 213577 under the provisions of 21 U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Teva ANDA Products prior to the expiration of the ’667 patent.” Further, Plaintiff alleged that, “[o]n information and belief, the use of the Teva ANDA Products in the United States in accordance with and as directed by Teva’s labeling for those products, if approved, will directly infringe one or more claims of the ’667 patent.”

Plaintiff further alleged that, “On information and belief, if the Teva ANDA Products are approved, physicians, other medical providers, caregivers and/or patients following said instructions will directly infringe one or more claims of the ’667 patent. On information and belief, if the Teva ANDA Products are approved, Teva Pharmaceuticals USA, Inc. and/or Teva Pharmaceutical Industries Ltd. will actively encourage, recommend, or promote this infringement with knowledge of the ’667 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’667 patent.”

The Plaintiff also alleged that, “On information and belief, if the Teva ANDA Products are approved, physicians, caregivers and/or patients following the approved instructions in the Teva ANDA Products will directly infringe one or more claims of the ’667 patent. On information and belief, if the Teva ANDA Products are approved, Teva Pharmaceuticals USA, Inc. and/or Teva Pharmaceutical Industries Ltd. will contributorily infringe one or more claims of the ’667 patent and will do so with knowledge of the ’667 patent, and that the Teva ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’667 patent and are not suitable for substantial non-infringing use.”

There is one claim for relief laid down by Plaintiff which deals with the alleged infringement of the Patent owned by Plaintiff.

In its prayer for relief Plaintiff has requested the court for an award of permanent injunctive relief together with damages or other monetary relief from Defendants Teva Pharmaceuticals USA, Inc. and/or Teva Pharmaceutical Industries Ltd. for the infringement, inducement of infringement, and contributory infringement of the ’667 patent. Further, Plaintiff requested the court for an award of attorney’s fees, expenses, and costs, and equitable relief as the court deems just and proper.

This case summary may not reflect the current position of the parties to this litigation or the status of this case. Sign up to view the latest case updates and court documents.