Healthcare Industry News: Barr Laboratories
News Release - September 18, 2006
U.S. Court of Appeals Denies Rehearing Request in Dismissal of Tamoxifen Citrate Antitrust Lawsuits
Decision Ends the Litigation Before the Second CircuitWOODCLIFF LAKE, N.J., Sept. 18 (HSMN NewsFeed) -- Barr Pharmaceuticals, Inc. (NYSE: BRL ) today announced that the United States Court of Appeals for the Second Circuit has denied the plaintiffs' petitions for rehearing and rehearing en banc in the Tamoxifen Citrate antitrust lawsuits. The denial of the petitions follows the Court's November 2005 affirmation of the dismissal of the cases for failure to state a viable antitrust claim. The Court's ruling ends the litigation before the Second Circuit.
On November 2, 2005, a three-member panel of circuit judges of the Court of Appeals for the Second Circuit affirmed the May 2003 dismissal by U.S. District Judge I. Leo Glasser of all of the plaintiffs' claims against Barr and AstraZeneca in the Tamoxifen Citrate antitrust litigation. The ruling affirmed that the 1993 settlement agreement between Barr and AstraZeneca did not violate federal antitrust statutes or the antitrust and/or consumer protection statutes of various states. On November 30, 2005, plaintiffs petitioned the Court for rehearing and rehearing en banc. The Court denied the plaintiffs' petition on September 15, 2006.
"The Court's denial of the rehearing petitions re-enforces the growing body of judicial authority in the Second Circuit and elsewhere that companies can lawfully settle Hatch-Waxman patent challenge cases," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "We are pleased that our patent challenge settlement related to Tamoxifen Citrate has been upheld as being pro-consumer and pro-competitive."
In 1993, as a result of a patent challenge, Barr and AstraZeneca entered into an agreement that resulted in the distribution by Barr of a more affordable version of AstraZeneca's Nolvadex® (Tamoxifen Citrate) treatment for breast cancer. That agreement expired in August 2002. AstraZeneca's pediatric exclusivity, which prevented generic competition, expired in February 2003. Barr launched its generic version of Tamoxifen Citrate in February 2003. Approximately 30 class action complaints were filed by consumers and/or third party payors in state and federal courts against Barr and AstraZeneca arguing that the settlement insulated Barr and AstraZeneca from generic competition, and resulted in artificially inflated Tamoxifen Citrate prices. All complaints were consolidated in the U.S. District Court for the Eastern District of New York. In May 2003, Judge Glasser issued an order in the case dismissing both the state and federal claims. The plaintiffs appealed Judge Glasser's order to U.S. Court of Appeals for the Second Circuit, which affirmed his order on November 2, 2005. On November 30, 2005, plaintiffs petitioned the Court for rehearing and rehearing en banc, which was denied on September 16, 2006.
Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market 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, 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
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