WOODCLIFF LAKE, N.J., Feb. 15 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the United States Court of Appeals for the Federal Circuit has affirmed a February 2005 lower court decision that granted summary judgment in favor of its wholly owned subsidiary, Barr Laboratories, Inc., in the Company’s challenge to the patent for DDAVP(R) (Desmopressin Acetate) Tablets, 0.1 mg and 0.2 mg. A three judge panel of the Federal Court affirmed, by a two to one majority, the earlier ruling by the U.S. District Court for the Southern District of New York that the patent asserted against Barr is unenforceable. Because it upheld the lower court’s decision that Barr’s product does not infringe the patent, the Federal Court did not address the lower court’s decision that Barr’s product does not infringe the patent.
“We are very pleased that the Federal Court has affirmed the lower court’s ruling that the patent is unenforceable,” said Bruce L. Downey, Barr’s Chairman and CEO. “We believed that our legal position was sound and chose to launch our generic version of DDAVP in July 2005 following the favorable lower court ruling and receipt of a final product approval from the FDA. Today’s ruling by the Federal Court reinforces our legal position and allows consumers to continue to have access to a lower cost version of DDAVP.”
Barr filed an Abbreviated New Drug Application (ANDA) for Desmopressin Acetate Tablets, 0.1 mg and 0.2 mg, with the U.S. Food & Drug Administration (FDA) in July 2002 and was sued on December 13, 2002, by Ferring B.V. and Aventis Pharmaceuticals, Inc. Ferring manufactures DDAVP Tablets for Aventis, which markets the product in the United States. Barr filed for summary judgment in April 2004 and summary judgment was granted in favor of the Company in February 2005. The court ruled that the patent alleged to cover DDAVP is unenforceable and not infringed by Barr’s product. The court’s decision ended the 30-month stay on FDA approval of Barr’s product, which was approved in July 2005. In February 2005, Ferring B.V. filed an appeal of the District Court’s decision. Today’s ruling by the Federal Court affirms the District Court’s ruling that the patent at issue is unenforceable.
DDAVP Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. They are also indicated for the management of primary nocturnal enuresis.
Barr Pharmaceuticals, Inc., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
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; 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 and products we acquire and implementing our new 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; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2004.
The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.
Barr Pharmaceuticals, Inc.
CONTACT: Carol A. Cox of Barr Pharmaceuticals, Inc., +1-201-930-3720,ccox@barrlabs.com
Web site: http://www.barrlabs.com/
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