Allergan Announces Its Intention to File Expedited Appeal With the Federal Circuit.Business Editors & Health/Medical Writers IRVINE, Calif.--(BW HealthWire)--May 9, 2002 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 it will file an expedited appeal with the Federal Circuit Court of Appeal to overturn an order granting Alcon's motion for summary judgment motion for summary judgment n. a written request for a judgment in the moving party's favor before a lawsuit goes to trial and based on recorded (testimony outside court) affidavits (or declarations under penalty of perjury), depositions, admissions of fact, answers in Allergan's lawsuit against Alcon for infringement of certain of Allergan's method of use patents relating to Alphagan(R) (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. ) 0.2%. "This order does not end the 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. ," explained Douglas S. Ingram, Allergan's Corporate Vice President, General Counsel, and Secretary. "The primary issue presented by the motion for summary judgment was a narrow but significant legal one regarding 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. lawsuits involving pharmaceutical method of use patents. Although the other Federal District Courts that have considered the issue have concluded otherwise, in this case the District Court for the Central District of California -- Southern Division -- ruled that holders of pharmaceutical method of use patents cannot sue for inducement of patent infringement under 35 U.S.C. Section 271(e)(2)(A). This ruling is, in Allergan's opinion, inconsistent with applicable federal statutes, contrary to the applicable federal case law, and if allowed to stand will have a negative impact on pharmaceutical innovation by potentially removing from pharmaceutical companies a motivation to seek new patented uses for existing products." A similar legal issue is already before the Federal Circuit in a matter entitled Warner-Lambert v. Apotex, No. 02-1073. That matter should be fully briefed by the end of May 2002 and a ruling from the Federal Circuit is expected as early as the summer of 2002. Additionally, it is Allergan's understanding that Allergan's matter could be briefed, heard and decided by the Federal Circuit on an expedited basis and before an 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 ("ANDA ANDA abbr. abbreviated new drug application ") could reasonably be expected to issue for any generic product. Allergan is hopeful that the Federal Circuit will follow the other District Courts that have examined this legal issue and reverse the order for summary judgment. If so, the matter would proceed in the District Court and any ANDA approval for generic brimonidine tartrate ophthalmic solution 0.2% would not be approved until the sooner of an unfavorable decision in the litigation or the expiration of 30 months from the original ANDA filing. This ruling does not expedite the approval of an ANDA for generic brimonidine tartrate ophthalmic solution 0.2%. Consistent with Allergan's prior analysis, in the absence of a ruling in Allergan's favor in its patent infringement lawsuit against Alcon and Bausch & Lomb, the Company, relying on average ANDA approval times published by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , still does not expect an ANDA for generic brimonidine tartrate ophthalmic solution 0.2% until some time after the first quarter of 2003. Additionally, this ruling does not in any way involve and has no effect on the timing of a generic version of Alphagan(R) P (brimonidine tartrate ophthalmic solution, 0.15%), Allergan's next-generation Alphagan(R) product that has an equivalent efficacy to original Alphagan(R), but with a lower effective dose, a greater tolerability, and a lower incidence of adverse events than original Alphagan(R). Allergan has FDA marketing exclusivity for Alphagan(R) P through September of 2004. Forward-Looking Statements This press release contains "forward-looking statements," including, but not limited to, statements regarding the possible outcomes of the litigation and appeal process and the timing of FDA approval for generic versions of the Company'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 the uncertainties associated with the litigation and appeal process; general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; the uncertainties regarding the regulatory approval process and the timing associated therewith there·with adv. 1. With that, this, or it. 2. In addition to that. 3. Archaic Immediately thereafter. Adv. 1. ; potential legislative changes and health care reforms; trends toward managed care and health care cost containment cost containment, n the features of a dental benefits program or of the administration of the program designed to reduce or eliminate certain charges to the plan. ; and other governmental laws and regulations affecting domestic and foreign operations. The reader is thus cautioned not to rely on these forward-looking statements. 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 " Certain Factors and Trends Affecting Business" in Allergan's 2001 Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2001. Copies of Allergan 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 Investor relations The process by which the corporation communicates with its investors. Department by calling 714-246-4636. About Allergan, Inc. Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing eye care and specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the ophthalmic, neurological and dermatological markets that deliver value to our customers, satisfy unmet medical needs, and improve patients' lives. |
|
||||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion