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

This is an ANDA litigation involving Entocort®, which has budesonide as its active ingredient, and involving U.S. Patent No. 5,643,602 (“the ‘602 Patent”).  Plaintiffs, AstraZeneca LP, Aktiebolaget Draco, KBI Inc., and KBI-E Inc., initiated litigation in 2008 and tried the case to the bench in May of 2010.  Defendant, Mylan Pharmaceuticals Inc., is owner of an ANDA seeking approval to sell budesonide enteric coated capsules in three (3) milligram strength prior to the expiration of the ‘602 Patent.  The parties submitted post-trial proposed findings of fact and conclusions of law concerning the validity and enforceability of the ‘602 Patent and whether the defendant’s proposed product infringes the patent.  Defendant was found not to infringe the asserted claims of the ‘602 Patent because the evidence at trial, including expert testimony and manufacturing process evidence, demonstrated, inter alia, “Mylan’s product consists solely of: 1) an active core in which budesonide is homogenously distributed and 2) an enteric coating, and further finds that the lactose particles in the active core are not enclosed on all sides by a glucocorticosteroid/polymer coating.”  The court’s findings of fact and law and order did not address the validity and enforceability of the ‘602 Patent.