HAYWARD, CA - IMPAX Laboratories Inc. announced in a press release that the US District Court for the District of Delaware has ruled that Aventis Pharmaceutical's patent 5,527,814 related to the use of Rilutek for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is not invalid on the grounds of anticipation.
This decision comes following a remand from the Court of Appeals for the Federal Circuit in November 2006, in which the Court of Appeals had vacated an earlier decision of patent validity and remanded for further findings relating to a specific validity issue of anticipation by a prior art patent.
IMPAX's ANDA for its generic version of Rilutek (riluzole) 50mg tablets was approved on January 29, 2003 by the US Food and Drug Administration (FDA), but the product has never been sold due to an injunction entered in this patent litigation and therefore the ultimate outcome of this litigation is not expected to have a material impact on the Company's financial results.
According to Wolters Kluwer Health, US sales of Rilutek were $39 million in the 12 months ended May 31, 2007.
IMPAX Laboratories Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.
ag-ip news
