Lupin Pharmaceuticals Sued After Filing Cataplexy Treatment ANDA

Jazz Pharmaceuticals Ireland Limited filed a complaint for patent infringement Wednesday in the District of New Jersey against Lupin Pharmaceuticals and affiliated entities. The complaint specifies the issue Jazz Pharmaceuticals has taken with the defendant’s filing of an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA), which the plaintiff claims will violate multiple existing patents if approved.

The ANDA filed by Lupin Pharmaceuticals was filed in an effort to gain approval to produce and market a generic version of Jazz Pharmaceutical’s Xywav drug prior to the expiration of the patents that protect Xywav, the complaint said. Xywav is a calcium, magnesium, potassium, and sodium oxybates oral solution. It is used for the treatment of cataplexy or “excessive daytime sleepiness in patients with narcolepsy.” The plaintiff believes that if Lupin gains FDA approval to make the generic version of Xywav, they will begin the immediate production and marketing which will be in violation of the patents-in-suit.

The patents that protect Xywav include the ‘922 patent, ‘306 patent, ‘173 patent, ‘302 patent, ‘107 patent, ‘426 patent, ‘168 patent, ‘400 patent, ‘258 patent, and ‘181 patent, collectively referred to as the patents-in-suit. They protect both the method by which Xywav is produced and the product itself. All the patents were issued within the last 9 years, with some being issued just last year.

Lupin provided notice to Jazz Pharmaceuticals of its filing of an ANDA through a notice letter. In the letter, they expanded on their belief that the patents-in-suit protecting Xywav are either invalid and unenforceable or will not be infringed upon by the defendant’s product.

The complaint cites ten counts of patent infringement. The plaintiff is represented by Saul Ewing Arnstein & Lehr.