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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): August 30, 2004
MYLAN LABORATORIES INC.
(Exact name of registrant as specified in its charter)
Pennsylvania 1-9114 25-1211621 (State or other (Commission File (I.R.S. Employer jurisdiction of Number) Identification No.) incorporation)
1500 Corporate Drive Canonsburg, PA 15317 (Address of principal executive offices)
(724) 514-1800 (Registrant’s telephone number, including area code)
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Item 8.01 Other Events. Item 9.01 Financial Statements and Exhibits. SIGNATURE EXHIBIT INDEX EXHIBIT 99.1 PRESS RELEASE DATED AUGUST 30, 2004 EXHIBIT 99.2 LETTER DATED AUGUST 30, 2004 (MYLAN TO US DIST. CT Table of Contents
Item 8.01 Other Events.
On August 30, 2004, Mylan Laboratories Inc., a Pennsylvania corporation, issued a press release announcing that Mylan Pharmaceuticals Inc. has filed a notice of voluntary dismissal without prejudice in the U.S. District Court for the Northern District of West Virginia in its lawsuit against the Food and Drug Administration on the issue of authorized generics. A copy of the press release is attached hereto as Exhibit 99.1, and the August 30, 2004 letter to the court, as referred to in the release, is attached as Exhibit 99.2.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits.
Exhibit No. Description
99.1 Press release of the registrant, dated August 30, 2004.
99.2 Letter dated August 30, 2004, from counsel to Mylan Pharmaceuticals Inc. to the U.S. District Court for the Northern District of West Virginia.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
MYLAN LABORATORIES INC.
Date: August 30, 2004 By: /s/ Edward J. Borkowski Edward J. Borkowski Chief Financial Officer
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EXHIBIT INDEX
Exhibit No. Description
99.1 Press release of the registrant, dated August 30, 2004.
99.2 Letter dated August 30, 2004, from counsel to Mylan Pharmaceuticals Inc. to the U.S. District Court for the Northern District of West Virginia.
Exhibit 99.1
For Immediate Release CONTACTS: Heather Bresch (Media) Mylan Laboratories Inc. 724.514.1800
Kris King (Investors) Mylan Laboratories Inc. 724.514.1800
Mylan Withdraws Lawsuit In Order to Consider Additional Authorized Generics Claims
Pittsburgh, PA — August 30, 2004 — Mylan Laboratories Inc. (NYSE: MYL) today announced that Mylan Pharmaceuticals Inc. has filed a notice of voluntary dismissal without prejudice in the United States District Court for the Northern District of West Virginia in its lawsuit against the Food and Drug Administration (“FDA”) on the issue of authorized generics. In a letter to the court submitted along with the dismissal notice, counsel for Mylan noted that counsel for both FDA and Procter & Gamble disclosed facts and positions that have a significant bearing on the “authorized generic” question and the considerable anticompetitive effects of authorized generics on the pharmaceutical industry. Mylan now believes that additional potential claims may be available to the industry.
Mylan Vice Chairman and CEO, Robert J. Coury, stated “Mylan dismissed this lawsuit without prejudice in order to have the ability to refile the lawsuit taking into consideration the additional facts presented during oral argument. We have every intention of taking all necessary steps to end this practice.” Mr. Coury added, “The FDA by its actions has eliminated the 180-day exclusivity reward specifically provided to generic companies in the Hatch Waxman Amendments. Congress could not have intended such a result.”
A copy of Mylan’s August 30th letter to the Court will be filed with the SEC with a Current Report on Form 8-K.
Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc. and Mylan Bertek Pharmaceuticals Inc., that develop, license, manufacture, market and distribute an extensive line of generic and proprietary products.
For more information about Mylan, visit www.mylan.com.
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This press release includes statements that constitute “forward-looking statements”, including with regard to the practice of authorized generics, additional potential claims available to the industry, Congressional intent and Mylan’s future actions with regard to 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: uncertainties inherent in litigation as well as in legislative, judicial and governmental matters; the rendering of a decision or ruling contrary to the Company’s position with regard to authorized generics; the potential costs, interruptions and delays that may result from the use of legal, regulatory and legislative strategies by the Company’s competitors or other third parties; 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.
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August 30, 2004
William A. Rakoczy
312.222.6301 telephone 312.222.6321 facsimile [email protected]
VIA HAND-DELIVERY
The Honorable Irene M. Keeley Chief Judge United States District Court 500 West Pike Street P.O. Box 2808 Clarksburg, West Virginia 26302-2808
Re: Mylan Pharmaceuticals Inc. v. FDA et al., Civil Action No. 1:04cv00174 (N.D. W. Va.)
Dear Judge Keeley:
On behalf of Mylan Pharmaceuticals Inc., the purpose of this letter is to notify the Court of, and explain to the Court the reason for, the attached notice of voluntary dismissal without prejudice that Mylan has today filed with the Clerk.
During the proceedings at the preliminary injunction hearing, counsel for both FDA and P&G disclosed facts and positions that have a significant bearing on related aspects of the “authorized generic” question and the considerable anticompetitive effects of authorized generics on the industry. The importance of these issues to Mylan and the entire generic pharmaceutical industry has led Mylan to conclude that all potential claims and aspects of the problems raised by authorized generics should be presented for review together in one action. In these circumstances, and because of potential preclusion concerns, Mylan feels compelled to withdraw its action without prejudice at this time in order to evaluate all of the potential issues and claims concerning authorized generics arising out of the recent hearing.
312-527-2157 main phone 312-527-4205 main fax
www.rmmlegal.com 6 WEST HUBBARD STREET , SUITE 500, CHICAGO , IL 60610
The Honorable Irene M. Keeley Chief Judge United States District Court August 30,2004 Page 2
Mylan is, of course, aware that the Court has committed significant time and effort to the issues raised to date. Mylan is deeply appreciative of those efforts and thankful for’the Court’s continuing courtesy and cooperation.
Very truly yours,
RAKOCZY MOLINO MAZZOCHI LLP
By: /s/ William A. Rakoczy
William A. Rakoczy
Enclosure cc: All Counsel of Record