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

This is an ANDA litigation in which plaintiffs CIMA Labs Inc., Azur Pharma Limited, and Azur Pharma International III Limited, assert infringement of U.S. Patent Nos. 6,024,981 (the “‘981 patent”) and 6,222,392 (the “‘392 patent”) (together, the “patents-in-suit”).  The defendant is Mylan Pharmaceuticals, Inc. On June 16, 2010, plaintiffs received defendant’s Paragraph IV notice letter informing them of Mylan’s ANDA No. 201824, in which Mylan seeks FDA approval to market a generic orally disintegrating clozapine product.  On July 23, 2010, plaintiff’s initiated this lawsuit.  On December 3, 2010, the defendant filed its answer and counterclaim.  On January 7, 2011, plaintiffs filed their answer to defendant’s counterclaim and filed a motion to stay the lawsuit pending reexamination of the patents-in-suit.  On January 31, 2011, the Court held a Fed. R. Civ. P. 16 scheduling conference, but refrained from entering a scheduling order until resolution of the motion to stay.  On April 19, 2011, after the completion of briefing and oral argument, the Court granted the plaintiffs’ motion to stay and ordered the parties to submit a status report on the reexamination and the necessity for continued stay of the action every ninety (90) days until the stay is lifted. In reaching its decision, the Court reasoned that the six (6) related litigations were stayed pending conclusion of reexamination, many of the claims of the patents-in-suit were already rejected and awaiting appeal, and reexamination had progressed for several years and the instant case was in its early stages.  The Court further reasoned that a stay would pose no undue prejudice to defendant.  Although the Court recognized that the defendant could conceivably be prejudiced from its inability to lift the automatic 30-month stay by achieving an early non-appealable judgment of non-infringement, the Court reasoned that a finding of prejudice in the instant case was premised on four assumptions: the accused product does not infringe the patents-in-suit; a forfeiture of the 180-day exclusivity period by two previous ANDA applicants; a resolution of the instant lawsuit before expiration of the 30-month stay; and approval of the ANDA application before expiration of the 30-month stay.  The Court was not persuaded to deny the motion for stay on defendant’s willingness to proceed only with an infringement action and assertion that this would simplify the matter, reasoning, inter alia, that claim construction positions are disputed and a denial might prompt an attempt to lift the stay in the related cases and a consolidation of the cases.