Hi-Tech Pharmacal announced that the United States District Court denied Hi-Tech's motion for a preliminary injunction, permanent injunction, and declaratory judgment, and granted Apotex's motion for summary judgment, and entered summary judgment in favor of the USFDA.
Hi-Tech had challenged the FDA's ruling that the Company had forfeited an exclusive generic marketing period for the Company's Dorzolamide and Timolol ophthalmic solution ANDA. Hi-Tech launched Dorzolamide and Timolol on October 28, 2008 and continues to market the product.
Update
Hi-tech was first ANDA filer for Trusopt (Dorzolamide) & Cosopt (Dorzolamide & Timolol) by filing Para IV against following Orange Book listed patents on Oct 11, 2005.
US4797413 (Expiry: Oct 28, 2008)
US6248735 (Disclaimed)
US6316443 (Disclaimed)
Earlier on January 18, 2006 innovator Merck sued Hi-tech for the infringement of ‘413 patent (the other two patents were disclaimed by innovator under 35 USC 253) . On April 2006, court gave decision in favor of innovator Merck (which was also affirmed by CAFC on March 29,2007) and delayed ANDA proval of Hi-tech till expiry of ‘413 patent. However, Hitech got 180 days exclusivity based on Para IV filing agiant ‘735 and ‘443 patents. The USFDA has denied Hitech pharma 180 days exclusivity for Cosopt (Dorzolamide hydrochloride & Timolol maleate) due to failure to market provision.Apotex also filed ANDA against innovator’s Orange Book listed patent ‘413 but it also sought to file Para IV against ‘735 and ‘443, which were disclaimed by innovator at the time of Apotex’s ANDA filing. Apotex was sued by innovator on December 4, 2006 for he infringement of ‘413 patent. However, Apotex counter claimed for declaratory judgment of noninfringement/invalidity w.r.t disclaimed patents ‘735 and ‘443.The CAFC concluded that there is no article III controversy and dismissed Apotex’s complaint and its attempt to trigger Hitech’s 180 days exclusivity
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