PITTSBURGH--(BUSINESS WIRE)--March 24, 2004--Mylan Laboratories Inc. (NYSE: MYL - News) announced today that it filed a lawsuit against Procter & Gamble and Watson Pharmaceuticals alleging that the distribution of Procter & Gamble’s Macrobid® product as a generic during Mylan’s 180-day exclusivity period violates the law.
The arrangement, according to the suit, undermines the Hatch-Waxman legislation which provides an incentive and various rights to a company that successfully challenges patents. The 180-day market exclusivity granted under the Hatch-Waxman statute compensates a company for the research, development and legal expenses incurred in challenging an invalid patent or developing a non-infringing product and contributes to the company’s ability to bring new generic products to the market through future challenges and new innovations.
Vice Chairman and CEO, Robert J. Coury, said, “In addition to undermining the 180-day exclusivity provision of the law, this practice of a branded company ‘authorizing’ a generic is completely misleading to consumers. Branded companies are utilizing a surrogate, to sell their branded product at a lower price, while the branded company continues to sell the same product at a higher price. Consumers and third party payors who are not aware of this practice and buy the branded product at the branded price are paying more than they should. The consumers and payors are being misled and should be entitled to have the difference in price returned to them.”
The lawsuit seeks declaratory and injunctive relief and restitution to consumers and third party payors.
For more information about Mylan, visit www.mylan.com.
This press release includes statements that constitute “forward-looking statements,” including with regard to the construction of Hatch-Waxman and the validity of “authorized generics.” These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: a decision by the court that the arrangements in question are permissible; other uncertainties and matters beyond the control of management inherent in litigation; the potential adverse effects that may result from the use of other legal, regulatory and legislative strategies by the Company’s competitors; and the other risks detailed in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release.
Contact:
Mylan Laboratories Inc. Heather Bresch, 724-514-1800
Source: Mylan Laboratories Inc.
