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Allergan Announces Victory in Brimonidine Patent Infringement Case
Saturday, October 24, 2009 12:51 AM


(Source: Business Wire)trackingAllergan, Inc. (NYSE:AGN) announced today that the United States District Court for the District of Delaware ruled in favor of Allergan, Inc. in its patent infringement suit against Exela PharmSci, Inc., Exela PharmSci Pvt., Ltd. ("Exela"), Apotex, Inc. and Apotex Corp. ("Apotex") (collectively, the "Defendants") for seeking to market purported generic versions of Allergan's drugs ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% and 0.15%. Specifically, after a trial in March of 2009, the Court ruled today that all five patents (U.S. Patent Nos. 6,627,210; 6,641,834; 6,673,337; 6,562,873; and 5,424,078) asserted by Allergan are valid and enforceable, that Apotex's proposed generic versions of ALPHAGAN® P 0.1% and 0.15% infringe each of the five patents, and that Exela's proposed generic version of ALPHAGAN® P 0.15% infringes U.S. Patent No. 6,641,834, which was the only patent asserted against it. Pursuant to the Hatch-Waxman Act, the United States Food and Drug Administration is required to delay approval of Defendants' proposed generic products until the last to expire of the infringed patents, which is 2022.

"Innovation in medicine has improved lives, reduced suffering and advanced the quality of patient care, and our intellectual property embodies our commitment to and investment in medical innovation," said Douglas S. Ingram, Allergan's Executive Vice President, Chief Administrative Officer and Secretary. "It is only through a respect for intellectual property rights that the cost, time and risk of failure associated with new innovations is justified. Accordingly, this case is a victory not merely for Allergan but for the research and development process that brings new treatment choices to the medical community."

About ALPHAGAN® P

ALPHAGAN® P 0.1% and 0.15% are indicated for lowering elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension.

ALPHAGAN® P 0.1% and 0.15% are contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy. Although ALPHAGAN® P 0.1% and 0.15% ophthalmic solutions had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease. ALPHAGAN® P 0.1% and 0.15% should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans. Adverse events occurring in approximately 10-20 percent of the patients included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritus.



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