Barr Subsidiary Sues Watson for SEASONIQUE Patent Infringement
MONTVALE, N.J., March 5 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its wholly-owned subsidiary, Duramed Pharmaceuticals, Inc., has filed suit against Watson Pharmaceuticals (NYSE: WPI) and its subsidiary, Watson Laboratories, Inc., for infringement of the patent protecting Duramed's SEASONIQUE(R) extended-cycle oral contraceptive product. The Company's SEASONIQUE Patent No. 7,320,969 is due to expire on January 30, 2024. In addition to the patent, the Company also has 3-year New Product Exclusivity for its SEASONIQUE product until May 25, 2009.
"We remain committed to enforcing our patent on our SEASONIQUE extended-cycle oral contraceptive product and will pursue all legal means necessary to prevent Watson from launching a generic product prior to patent expiry in 2024," said Bruce L. Downey, Barr's Chairman and CEO.
On January 22, 2008, the U.S. Patent and Trademark Office issued the patent for the Company's SEASONIQUE extended-cycle oral contraceptive. The Company immediately submitted the patent to the U.S. Food and Drug Administration (FDA) for listing in the Orange Book. On January 22, 2008, Watson notified the Company pursuant to the Hatch-Waxman Act that Watson had filed an Abbreviated New Drug Application (ANDA) with the FDA for SEASONIQUE and that Watson had amended its application to include a paragraph IV certification asserting that the SEASONIQUE patent is invalid, unenforceable or not infringed by Watson's ANDA product. Barr has filed to enforce the patent and prevent Watson from marketing a competing product prior to patent expiry in 2024. If Barr is unsuccessful in this litigation, the Company may face generic competition for SEASONIQUE as early as May 25, 2009, the date of expiration of our existing new product regulatory exclusivity for SEASONIQUE.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of companies markets more than 120 generic and 27 proprietary products in the U.S. and approximately 1,025 products globally outside of the U.S. For more information, visit www.barrlabs.com.
Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non-infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment in the markets where we operate; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies (such as PLIVA d.d.) and products we acquire and implementing our new SAP enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; our expansion into international markets through our PLIVA acquisition, and the resulting currency, governmental, regulatory and other risks involved with international operations; our ability to service our significantly increased debt obligations as a result of the PLIVA acquisition; changes in generally accepted accounting principles; and other risks detailed in our SEC filings, including in our Transition Report on Form 10-K/T for the six months ended December 31, 2006.
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