WOODCLIFF LAKE, N.J., April 9 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL - News) today announced that the U.S. Patent and Trademark Office (PTO) has issued a Notice of Allowance for the reissuance of U.S. Patent 5,895,032 (‘032), relating to Barr’s SEASONALE® extended-cycle oral contraceptive. The issuance of the Notice of Allowance confirms that Barr’s reissue patent application has satisfied statutory requirements of patentability and indicates that the PTO will issue the reissue patent in the future.
“The PTO Notice of Allowance is the first step in a two step process. The next step will be formal reissuance of the SEASONALE patent which we can then list in the U.S. Food and Drug Administration’s (FDA) Orange Book with a patent term expiration of 2017,” said Bruce L. Downey, Barr’s Chairman and CEO. “The reissued patent confirms our position that we have the exclusive right to market SEASONALE.”
Barr filed its application seeking reissuance of the ‘032 patent with the PTO in July 2004. Since this date, the application has been rejected three times, and each time the Company responded with arguments to counter the rejections. The PTO issued the notice of allowance after receiving the Company’s third response and a supplement to this response. The PTO has not provided a timeframe for reissuance. When the patent is formally reissued, the reissued patent will replace the ‘032 patent in FDA’s Orange Book and will have the same remaining term as the ‘032 patent, which expires in 2017.
In June 2004 Barr announced that it had been notified that Watson Laboratories had filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification asserting that the patent covering SEASONALE was invalid, unenforceable or would not be infringed by Watson’s generic product. Barr did not initiate patent infringement litigation with respect to Watson’s ANDA. In September 2006, Watson launched a generic version of SEASONALE following final approval from the U.S. Food & Drug Administration (FDA).
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 245 generic and 25 proprietary products in the U.S. and more than 1,200 products globally outside of the U.S.
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.
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.
Source: Barr Pharmaceuticals, Inc.
