Allergan Announces Victory in Brimonidine Patent Infringement Case.IRVINE, Calif. -- Allergan, Inc. (NYSE NYSE See: New York Stock Exchange :AGN AGN Again (Amateur Radio) AGN Active Galactic Nucleus AGN Acute Glomerulonephritis AGN Accountants Global Network AGN Air Gabon (ICAO code) ) announced today that the United States District Court for the District of Delaware The United States District Court for the District of Delaware is the Federal district court having jurisdiction over the entire state of Delaware. The Court sits in Wilmington. Currently, three judges and two magistrate judges preside over the court. ruled in favor of Allergan, Inc. in its patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. 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([R]) P (brimonidine tartrate tartrate /tar·trate/ (tahr´trat) a salt of tartaric acid. tar·trate n. A salt or ester of tartaric acid. tartrate a salt of tartaric acid. ophthalmic solution ophthalmic solution n. A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops. ) 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([R]) P 0.1% and 0.15% infringe each of the five patents, and that Exela's proposed generic version of ALPHAGAN([R]) 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 United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. 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 A chief administrative officer (CAO) is responsible for administrative management of private, public or governmental corporations. The CAO is one of the highest ranking members of an organization, managing daily operations and usually reporting directly to the chief executive 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([R]) P ALPHAGAN([R]) P 0.1% and 0.15% are indicated for lowering elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension. ALPHAGAN([R]) P 0.1% and 0.15% are contraindicated in patients receiving monoamine oxidase (MAO MAO - An early symbolic mathematics system. [A. Rom, Celest Mech 1:309-319 (1969)]. ) inhibitor therapy. Although ALPHAGAN([R]) 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([R]) 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 con·junc·ti·val adj. Relating to the conjunctiva. conjunctival pertaining to or emanating from conjunctiva. congenital conjunctival membrane hyperemia hyperemia /hy·per·emia/ (-e´me-ah) engorgement; an excess of blood in a part.hypere´mic active hyperemia , arterial hyperemia that due to local or general relaxation of arterioles. , and eye pruritus pruritus /pru·ri·tus/ (proo-ri´tus) itching.prurit´ic pruritus a´ni intense chronic itching in the anal region. pruritus hiema´lis xerotic eczema. . Full prescribing information for ALPHAGAN([R]) P 0.1% and 0.15% can be found at www.allergan.com or www.alphaganp.com. About Allergan, Inc. Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The Company employs more than 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries. Forward-Looking Statements This press release contains "forward-looking statements" including, but not limited to, the statements by Mr. Ingram, statements regarding litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. objectives and outcomes and other statements regarding the safety, effectiveness and adverse events associated with ALPHAGAN([R]) P 0.1% and 0.15%. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, the uncertainties associated with the litigation and appeal process; general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing; inconsistency of treatment results among patients; potential difficulties in manufacturing a product; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2008 Form 10-K and Allergan's Form 10-Qs for the quarters ended March 31, 2009, and June 30, 2009. Copies of Allergan's press releases and additional information about Allergan are available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636. ([c]) 2009 Allergan, Inc. Irvine, CA 92612. ([R]) marks owned by Allergan, Inc. |
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