Barr Announces Favorable Ruling in Mirapex(R) Patent Challenge
In his ruling, District Court Judge Joseph J. Farnan, Jr. found that thepatent claims at issue in the litigation were invalid on the grounds ofnonstatutory double patenting.
Barr's Abbreviated New Drug Application (ANDA) for a generic Mirapexproduct received final approval from the U.S. Food and Drug Administration(FDA) in February 2008. Barr believes that it is the first company to file anANDA with a paragraph IV certification for Mirapex Tablets, 0.125mg, 0.25mg,0.5mg, 1mg & 1.5mg.
"We are very pleased with the Court's favorable decision regarding thepatent on Mirapex, and are currently reviewing the opinion in the case andevaluating our options," said Bruce L. Downey, Barr's Chairman and CEO.
Barr filed its ANDA for generic Mirapex Tablets, 0.25mg containing aparagraph IV certification with the FDA in May 2005 and in June 2005 amendedits application to include the tablet strengths 0.125mg, 0.5mg, 1mg, and1.5mg. Following receipt of the notice from the FDA of the application'sacceptance for filing, Barr notified the New Drug Application (NDA) holder andpatent owner. On September 26, 2005, Boehringer Ingelheim filed suit in theU.S. District Court in Delaware to prevent Barr from proceeding with thecommercialization of its product, formally initiating the patent challengeprocess under the Hatch-Waxman Act. In March 2008, the patent infringementcase was heard in front of Judge Farnan.
Mirapex (pramipexole dihydrochloride) had annualized sales ofapproximately $381 million for the twelve months ended April 2008, based onIMS sales data.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical companythat operates in more than 30 countries worldwide and is engaged in thedevelopment, manufacture and marketing of generic and proprietarypharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. Aholding company, Barr operates through its principal subsidiaries: BarrLaboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and itssubsidiaries. The Barr Group of companies markets more than 120 generic and 27proprietary products in the U.S. and approximately 1,025 products globallyoutside of the U.S. For more information, visit www.barrlabs.com.
Except for the historical information contained herein, the statementsmade in this press release constitute forward-looking statements within themeaning of Section 27A of the Securities Act of 1933 and Section 21E of theSecurities Exchange Act of 1934. Forward-looking statements can be identifiedby their use of words such as "expects," "plans," "projects," "will," "may,""anticipates," "believes," "should," "intends," "estimates" and other words ofsimilar meaning. Because such statements inherently involve risks anduncertainties that cannot be predicted or quantified, actual results maydiffer materially from those expressed or implied by such forward-lookingstatements depending upon a number of factors affecting the Company'sbusiness. These factors include, among others: the difficulty in predictingthe timing and outcome of legal proceedings, including patent-related matterssuch as patent challenge settlements and patent infringement cases; theoutcome of litigation arising from challenging the validity ornon-infringement of patents covering our products; the difficulty ofpredicting the timing of FDA approvals; court and FDA decisions on exclusivityperiods; the ability of competitors to exten
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