Court Of Appeals For Federal Circuit (CAFC) in asignificant decision thwarted Apotex’s attempt for triggring generic rival Hi-tech’s 180 days exclusivity on Dorzolamide. 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)
US 6248735 (Disclaimed)
US 6316443 (Disclaimed)
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 aagiants ‘735 and ‘443 patents.
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
Trusopt (dorzolamide hydrochloride ophthalmic solution) is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Trusopt is used to lower increased intraocular pressure in open-angle glaucoma and ocular hypertension.
US4797413 (Expiry: Oct 28, 2008)
US 6248735 (Disclaimed)
US 6316443 (Disclaimed)
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 aagiants ‘735 and ‘443 patents.
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
Trusopt (dorzolamide hydrochloride ophthalmic solution) is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Trusopt is used to lower increased intraocular pressure in open-angle glaucoma and ocular hypertension.
Cosopt (Dorzolamide hydrochloride & Timolol maleate) is a drug for lowering pressure in the eye to normal levels, and a treatment for glaucoma.
Opinion of court
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