PITTSBURGH, Oct. 19 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today reported that the U.S. District Court for the Western District of Pennsylvania granted Mylan Pharmaceuticals’ motion to dismiss the ‘909 patent from the patent infringement litigation between Pfizer and Mylan concerning Amlodipine Besylate Tablets and thereby removes the ‘909 as a patent that Pfizer can assert against Mylan. The ‘909 patent was one of two patents covered in the litigation scheduled to begin on Nov. 28, 2006, in Pittsburgh.
In a decision with far-reaching implications for the generic industry, the court denied Pfizer’s attempt to include the ‘909 patent in the litigation notwithstanding the fact that the patent has already expired. In the decision, the court ruled that “because the ‘909 patent has now expired, the rights secured by the patent are no longer protectable and entitlement to injunctive relief becomes moot because such relief is no longer available.” Pfizer had sought to continue to include the ‘909 patent in the litigation in an attempt to reinstate pediatric exclusivity as to Mylan.
Amlodipine Besylate Tablets are the generic version of Pfizer’s Norvasc(R) Tablets, which had U.S. sales of approximately $2.7 billion for the 12-month period ended June 30, 2006, according to IMS Health.
As previously announced, the U.S. Food and Drug Administration (FDA) has granted Mylan final approval for its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base). The FDA also confirmed that Mylan was the first generic company to file on all strengths of Norvasc(R) Tablets and is therefore eligible for 180 days of market exclusivity. The FDA has indicated that the exclusivity will begin to run from the earlier of the commercial launch of the Mylan product or a final court decision concerning the pending litigation between Pfizer and Mylan.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries: Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.
This press release includes statements that constitute “forward-looking statements,” including with regard to the pending litigation with Pfizer and the implications of the recent court ruling, as well as market exclusivity for the products. 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: risks inherent in legal proceedings; the effects of regulatory proceedings, actions or changes; the use of legal, regulatory and legislative strategies by competitors or other third parties to delay or prevent product introductions; 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.
For more information about Mylan, please visit www.mylan.com.
Mylan Laboratories Inc.
CONTACT: Patrick Fitzgerald or Kris King of Mylan Laboratories Inc.,+1-724-514-1800
Web site: http://www.mylan.com//
