Delaware Patent Litigation Report : Delaware Intellectual Property Lawyer & Attorney : Morris James Law Firm : Delaware Patent Litigation Report

This case is multi-district consolidated ANDA litigation involving a generic version of the muscle relaxant drug AMRIX®, which has the active ingredient cyclobenzaprine hydrochloride in extended release formulation.  A bench trial was held September 29 to October 7, 2010. On May 12, 2011, the Court issued its findings of fact and conclusions of law.  The Court found the patents-in-suit infringed and not invalid for failure to disclose the best mode. However, the Court found the patents-in-suit invalid for being obvious.  The Court reasoned, inter alia, cyclobenzaprine existed in immediate release form well before the issuance of the patents-in-suit, the delivery system and claimed dissolution profile were disclosed in the prior art, and the optimization of the immediate release profile into the claimed extended release form was routine for one of ordinary skill in the art at the time of the invention.  The failure of ALIZA to make an extended release version of cyclobenzaprine is not evidence of failure of others because that company’s goals were different from those of plaintiff.  Plaintiff failed to prove commercial success where its costs exceed sales by more than $55 million despite an aggressive marketing campaign.  Fulfillment of long-felt need was not established where plaintiffs relied on the immediate release version of the drug rather than disputed extended release version.  With respect to inequitable conduct, the court holds that it cannot find intent to deceive when the only evidence is the fact that a particular patent, although material, was not disclosed to the examiner.