U.S. Federal Circuit Court Affirms Judgment for Allergan, Inc. and Roche Palo Alto, LLC against Apotex, Inc., Apotex Corp., and Novex Pharma in Ketorolac Patent Infringement Lawsuit.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 Court of Appeals for the Federal Circuit The United States Court of Appeals for the Federal Circuit is a United States court of appeals. The Federal Circuit was created by Congress with passage of the Federal Courts Improvement Act of 1982. The court is headquartered in Washington, D.C., and occupies the Howard T. has affirmed a favorable ruling for Allergan and Roche Palo Alto, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control , formerly known as Syntex (U.S.A.) LLC, in a 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. lawsuit against Apotex, Inc., Apotex Corp., and Novex Pharma (the "Defendants") preventing the Defendants from obtaining U.S. Food and Drug Administration approval to market a generic version of Allergan's product ACULAR([R]) (ketorolac tromethamine ketorolac tromethamine Acular, Acular LS Pharmacologic class: Nonsteroidal anti-inflammatory drug (NSAID) Therapeutic class: Analgesic, antipyretic, anti-inflammatory Pregnancy risk category C ophthalmic solution ophthalmic solution n. A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops. ) 0.5% and enjoining en·join tr.v. en·joined, en·join·ing, en·joins 1. To direct or impose with authority and emphasis. 2. To prohibit or forbid. See Synonyms at forbid. the Defendants from manufacturing or selling the same. In 2006, the Defendants appealed a ruling by the United States District Court for the Northern District of California The United States District Court for the Northern District of California is the Federal district court whose jurisdiction comprises following counties: Alameda, Contra Costa, Del Norte, Humboldt, Lake, Marin, Mendocino, Monterey, Napa, San Benito, San Francisco, San Mateo, Santa that the Defendants' proposed generic product infringed a valid and enforceable patent owned by Roche Palo Alto, LLC and licensed to Allergan. The District Court's ruling provided that the effective date of any approval of the Defendants' Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar may not occur before U.S. Patent No. 5,110,493 expires in 2009 and that the Defendants, together with all persons and entities acting in concert with the Defendants, are enjoined from making any preparations that make, use, sell, or offer for sale ketorolac tromethamine ophthalmic solution 0.5% in the United States. The Federal Circuit affirmed the District Court's ruling in all regards. "This ruling is a triumph for the value of intellectual property rights and their protection," 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 , General Counsel and Secretary. "It is only through continuing innovation that new and improved medicines are made available to health care providers and their patients. The development of, and equally importantly the respect for, intellectual property are essential for life-enhancing innovation. As we have repeatedly stated, Allergan will fiercely defend its intellectual property rights against those who would trade on the hard work and creativity of our scientists and R&D professionals." ACULAR([R]) is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis allergic conjunctivitis n. Conjunctivitis caused by an allergic reaction to a substance. Also called atopic conjunctivitis. allergic conjunctivitis and the treatment of post-operative inflammation in patients who have undergone cataract surgery. The most frequently reported adverse event is transient burning and stinging upon instillation. Full prescribing information for ACULAR([R]) is available at www.allergan.com. About Allergan, Inc. With more than 55 years of experience providing high-quality, science-based products, Allergan, Inc., with headquarters in Irvine, California, discovers, develops and commercializes products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics, obesity intervention and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives. Forward-Looking Statements This press release contains "forward-looking statements" including, but not limited to, the statements by Mr. Ingram and 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. outcomes and the timing of generic versions of Allergan's products. 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; general domestic and international economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents obtained by competitors; challenges inherent in product marketing such as the unpredictability of market acceptance for new pharmaceutical and biologic products and/or the acceptance of new indications for such products; domestic and foreign health care reforms; the timing and uncertainty of the research and development and regulatory processes; trends toward managed care and health care cost containment; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law. 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 2006 Form 10-K. Copies of Allergan's press releases and additional information about Allergan is 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. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion