-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, BkFTb9M6q7Z0f3UnaooAIC3MZtOpi5T0ZsygfCyrvmTJ286NjEU/bOkhUtLFNRlb ygMvA6sdXVfvMsdPQl/FRw== 0001104659-09-070108.txt : 20091215 0001104659-09-070108.hdr.sgml : 20091215 20091215170228 ACCESSION NUMBER: 0001104659-09-070108 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20091211 ITEM INFORMATION: Other Events FILED AS OF DATE: 20091215 DATE AS OF CHANGE: 20091215 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CEPHALON INC CENTRAL INDEX KEY: 0000873364 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 232484489 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19119 FILM NUMBER: 091242301 BUSINESS ADDRESS: STREET 1: 41 MOORES ROAD CITY: FRAZER STATE: PA ZIP: 19355 BUSINESS PHONE: 6103440200 MAIL ADDRESS: STREET 1: 41 MOORES ROAD CITY: FRAZER STATE: PA ZIP: 19355 8-K 1 a09-35366_18k.htm 8-K

 

 

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)  December 11, 2009

 

Cephalon, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

0-19119

 

23-2484489

(State or Other Jurisdiction

 

(Commission

 

(IRS Employer

of Incorporation)

 

File Number)

 

Identification No.)

 

41 Moores Road

 

 

Frazer, Pennsylvania

 

19355

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code  (610) 344-0200

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


 

Item 8.01               Other Events.

 

On December 11, 2009, Cephalon, Inc. (“Cephalon”) filed a lawsuit in U.S. District Court in Delaware against Mylan Pharmaceuticals, Inc., Mylan Inc., Matrix Laboratories Limited and Matrix Laboratories Inc. (collectively, “Mylan”) for infringement of U.S. Patent Nos. 7,132,570 and RE37,516 for the Cephalon product NUVIGIL® (armodafinil) Tablets [C-IV].  The lawsuit is based upon an Abbreviated New Drug Application (“ANDA”) filed by Mylan seeking approval from the U.S. Food and Drug Administration (“FDA”) for a generic equivalent of armodafinil to be sold in the United States.  Mylan alleges that the above NUVIGIL patents are invalid, unenforceable and/or will not be infringed by Mylan’s manufacture, use or sale of the product described in its ANDA.

 

The filing of this lawsuit is provided for by the Hatch-Waxman Act, a federal statute governing certain aspects of generic drug approvals.  Under that statute, the filing of the lawsuit stays any FDA approval of the Mylan ANDA until the earlier of entry of a district court judgment in favor of Mylan or 30 months from Cephalon’s November 2009 receipt of a Paragraph IV certification letter from Mylan.

 

2


 

SIGNATURES

 

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.

 

 

 

CEPHALON, INC.

 

 

 

 

Date: December 15, 2009

By:

/s/ Gerald J. Pappert

 

 

Gerald J. Pappert

 

 

Executive Vice President, General Counsel

 

3

 -----END PRIVACY-ENHANCED MESSAGE-----