The US District Court for the Western District of Pennsylvania has issued an opinion and order denying Pfizer's motion for summary judgment seeking the dismissal of Mylan's inequitable conduct claims in the amlodipine besylate patent litigation.

Pfizer had moved for the dismissal of Mylan's inequitable conduct claims against the two patents in the litigation, but the court ruled that both Pfizer and Mylan have raised a number of persuasive arguments as to the issues of the alleged inequitable conduct by the Pfizer patent applicants during the prosecution of both patents. The court ruling will allow Mylan to assert its inequitable conduct defenses on both patents at trial. In a separate ruling, the court also denied Mylan's motion for partial summary judgment of invalidity of one of the patents. Mylan will be able to assert its invalidity defense at trial, states a company release.

Amlodipine besylate tablets are the generic version of Pfizer's Norvasc tablets, which had US sales of approximately $2.5 billion for the 12-month period ended June 30, 2005, according to IMS Health. Mylan has already received final approval from the US FDA for its abbreviated new drug application (ANDA) for all strengths of amlodipine, and the FDA has confirmed that Mylan was the first generic company to file and is therefore eligible for 180 days of market exclusivity on all strengths. The exclusivity will begin to run from the earlier of the commercial launch of the Mylan product or a final court decision concerning the litigation with Pfizer.

Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. that develop, license, manufacture, market and distribute an extensive line of generic and proprietary products.