Novartis Alleges Apotex Infringed on Zometa Patent

Novartis has filed a complaint in federal court alleging Apotex infringed on its patent by seeking to manufacture, market and sell a generic version of cancer drug Zometa.

In Novartis Pharmaceuticals Corporation v. Apotex, Inc. et al., the brandmaker accuses Apotex of seeking ANDA approval for 4 mg/100 ml vials of zoledronic acid, the active ingredient in Zometa, and threatening Novartis’ exclusivity in the U.S.

Specifically, Novartis notes that the ’189 patent calls for Zometa to be administered as an intravenous infusion over no less than 15 minutes. Since Apotex hasn’t filed a suitability petition seeking FDA approval to deviate from the label’s infusion time instruction, one must assume that the generic maker plans to administer its version as described in the patent, the brandmaker claims.

Novartis obtained the patent on Dec. 4, 2012, according to the complaint filed in U.S. district court in New Jersey. The Orange Book shows the patent expiring on May 29, 2025.

The Swiss drugmaker is asking the court to prevent Apotex from making, using, selling or importing its generic version of Zometa until the patent expires. The suit also seeks unspecified damages and monetary relief.

The lawsuit is one of several alleging infringement of the ’189 patent. The case, In re: Certain Consolidated Zoledronic Acid Cases, is pending in federal court in New Jersey.

Zometa is indicated for the treatment of multiple myeloma, bone metastases from solid tumors and high blood calcium levels associated with cancers.

Novartis declined to comment. Apotex did not respond to a request for comment by press time. — Jonathon Shacat