Novartis Pharmaceuticals sued Ranbaxy, Inc. and Ranbaxy Laboratories, Ltd., on Dec. 29 over allegations of patent infringement.
The suit followed the defendants' submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) to pursue the creation of a generic form of the Gleevec drug.
U.S. Patent No. 6,894,051 (051 Patent) was issued on May 17, 2005 to Jürg Zimmerman, et al. It grants an exclusive license for Gleevec to Novartis. The Gleevec tablets consist of 100 mg and 400 mg forms of imatinib sesylate, which is used as a treatment for multiple types of cancer.
Novartis alleged in the suit that Ranbaxy, Inc. and Ranbaxy Laboratories, Ltd. submitted their ANDA request before the expiration date of the Gleevec patent. Ranbaxy countered by saying the patents are either invalid, unenforceable or would not be infringed upon.
The plaintiffs asked the court to enforce the patent until its expiration date, acknowledge that the ANDA submitted by the defendant is infringement upon the patent and bar the defendant from manufacturing and selling imatinib mesylate tablets until after the Gleevec patent has expired. They also asked for the payment of legal fees and further relief as deemed necessary.
Novartis is represented by Michael Kelly, Daniel Silver and Benjamin Smyth, of McCarter & English, LLP.
U.S. District Court of Delaware case no. 1:14-cv-01526-LPS.