Jazz takes on Watson at New Jersey court to protect Xyrem

Jazz Pharmaceuticals has sued Watson Laboratories for patent infringement in order to stop the company making a generic version of its flagship product Xyrem (sodium oxybate).

Watson bought Actavis in 2012, but the company retained the Actavis name. Earlier this month, the business was renamed Allergan after the latter was bought by Actavis.

Jazz filed suit at the US District Court for the District of New Jersey last Friday, June 26, after Watson filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) to make and sell a generic version of Xyrem before two Jazz-owned patents covering the drug expire.

Xyrem is used to treat patients with narcolepsy by reducing excessive daytime sleepiness. It is sold as an oral solution with a strength of 500mg/ml, and in 2014 it generated sales of $778 million.

It is one of the products whose patents have been challenged by Kyle Bass and his Coalition for Affordable Drugs under the inter-partes review system.

Watson has sought to make a sodium oxybate oral solution of 500mg/ml strength.

The two patents at suit, which are due to expire in December 2019, are both titled “Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy”.

Jazz asked the court to find that Watson infringed the patents by filing the ANDA, and that its manufacture and marketing of the generic Xyrem would also infringe the patents.

It has also asked that the FDA does not approve the ANDA before the two patents have expired, and for preliminary and permanent injunctions stopping Watson from making and selling its generic product until after the patents expire.

Neither Jazz nor Allergan had responded to a request for comment at the time of publication. But LSIPR will update the story should the companies get in touch.