-----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, EZNq1jfqTkNnRp5vNP5ogZxj8hJyicV0ZA90lPvn5+8p5ain2D49dBMLt3vNf+6C hHd+e1ZXyMN4TkNS/dwHCQ== 0001104659-09-062546.txt : 20091104 0001104659-09-062546.hdr.sgml : 20091104 20091104164508 ACCESSION NUMBER: 0001104659-09-062546 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20091102 ITEM INFORMATION: Other Events FILED AS OF DATE: 20091104 DATE AS OF CHANGE: 20091104 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: 091158233 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 a09-32847_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)  November 2, 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 November 2, 2009 (the “Actavis Notice Date”), Cephalon, Inc. (“Cephalon”) received a Paragraph IV certification notice letter (the “Actavis Notice Letter”) regarding an Abbreviated New Drug Application (“ANDA”) submitted to the U.S. Food and Drug Administration (the “FDA”) by Actavis Pharma Manufacturing Pvt Ltd., by and through its agent Actavis Inc. (collectively, “Actavis”), requesting approval to market and sell a generic version of NUVIGIL® (armodafinil) Tablets [C-IV].

 

On November 3, 2009 (the “Mylan Notice Date”, and together with the Actavis Notice Date, the “Notice Dates”), Cephalon received a Paragraph IV certification notice letter (the “Mylan Notice Letter”, and together with the Actavis Notice Letter, the “Notice Letters” ) regarding an ANDA submitted to the FDA by Mylan Pharmaceuticals, Inc. (“Mylan”) requesting approval to market and sell a generic version of NUVIGIL.

 

In their Notice Letters, Actavis and Mylan each claim that U.S. Patent Nos. RE37,516  (“the ‘516 patent”), 7,297,346 (“the ‘346 patent”) and 7,132,570 (“the ‘570 patent”) issued to Cephalon are invalid, unenforceable and/or will not be infringed by the respective party’s manufacture, use or sale of the products described in the applicable ANDA. Cephalon has a three-year period of marketing exclusivity for NUVIGIL that extends until June 15, 2010. In addition, including the six-month pediatric extension, the ‘516 Patent, the ‘346 Patent, and the ‘570 Patent expire on April 6, 2015, May 29, 2024, and June 18, 2024, respectively. The Notice Letters do not challenge Orange Book-listed U.S. Patent No. 4,927,855 (the “‘855 Patent”), which provides additional protection until October 22, 2010, the expiration date of the ‘855 Patent.

 

Cephalon is currently reviewing the Notice Letters. By statute, if Cephalon initiates a patent infringement lawsuit against Actavis and/or Mylan within 45 days of the applicable Notice Date, then the FDA would be automatically precluded from approving the applicable party’s ANDA until the earlier of entry of a district court decision finding the patents invalid or not infringed or 30 months from the applicable Notice Date.

 

As disclosed in Cephalon’s Current Report on Form 8-K filed October 22, 2009, Cephalon previously received a Paragraph IV certification notice letter relating to an ANDA submitted to the FDA by Teva Pharmaceuticals USA, Inc. requesting approval to market and sell a generic version of NUVIGIL.

 

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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: November 4, 2009

By:

/s/ Gerald J. Pappert

 

 

Gerald J. Pappert

 

 

Executive Vice President and General Counsel

 

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