Barr Announces Favorable Ruling in Yasmin Patent Challenge
MONTVALE, N.J., March 3 -- Barr Pharmaceuticals today announced that the U.S. District Court for the District of New Jersey has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Bayer Schering Pharma, AG in connection with Bayer Schering's Yasmin(R) (drospirenone and ethinyl estradiol) oral contraceptive. In his ruling, Judge Peter G. Sheridan found that the patent at issue was invalid, because it was obvious.
"We are delighted that Judge Sheridan has invalidated the patent on Yasmin," said Bruce L. Downey, Barr's Chairman and CEO. "We are currently reviewing the opinion in the case and evaluating all of our options. Clearly, this is a positive development for the Company and we are evaluating what the potential impact could be on our earnings guidance for 2008."
Yasmin provides an oral contraceptive regimen consisting of 21 active tablets each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol and 7 inert tablets. Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. The product had annual sales of approximately $572 million for the twelve months ended December 2007, based on IMS sales data.
Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Yasmin product with the U.S. Food & Drug Administration (FDA) in January 2005, and received notification of the application's acceptance for filing in February 2005. Following receipt of the notice from the FDA, Barr notified Berlex, the New Drug Application (NDA) holder, and Schering AG, the patent owner. In April 2005, Schering AG and Berlex filed a patent infringement suit against Barr in the U.S. District for the District of New Jersey. In June 2006, Bayer AG acquired Schering AG. In November 2007, the patent infringement case was heard in front of Judge Sheridan.
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 26 proprietary products in the U.S. and approximately 1,025 products globally outside of the U.S. For more information, visit www.barrlabs.com.
Forward-Looking Statements
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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