-----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, N44UG2J+NT9qpeH4brPPW44pmmAFMIcx2w4U3E6p4C0wqV90y8bvzaimdOiVGsMi pX2eRDf3O7+4GiazBAqzbw== 0000950123-08-002413.txt : 20080303 0000950123-08-002413.hdr.sgml : 20080303 20080303124310 ACCESSION NUMBER: 0000950123-08-002413 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080227 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080303 DATE AS OF CHANGE: 20080303 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OSI PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000729922 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 133159796 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15190 FILM NUMBER: 08658670 BUSINESS ADDRESS: STREET 1: 41 PINELAWN ROAD CITY: MELVILLE STATE: NY ZIP: 11747 BUSINESS PHONE: 631-962-2000 MAIL ADDRESS: STREET 1: 41 PINELAWN ROAD CITY: MELVILLE STATE: NY ZIP: 11747 FORMER COMPANY: FORMER CONFORMED NAME: ONCOGENE SCIENCE INC DATE OF NAME CHANGE: 19920703 8-K 1 y50716e8vk.htm FORM 8-K 8-K
Table of Contents

 
 
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) February 27, 2008
OSI PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
         
Delaware   0-15190   13-3159796
         
(State or other jurisdiction of
incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)
41 Pinelawn Road
Melville, NY 11747
 
(Address of principal executive offices)
(631) 962-2000
 
(Registrant’s telephone number, including area code)
N/A
 
(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:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a- 12)
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
 
 

 


TABLE OF CONTENTS

Item 8.01. Other Events.
Item 9.01. Financial Statements and Exhibits.
SIGNATURE
EXHIBIT INDEX
EX-99.1: PRESS RELEASE


Table of Contents

Item 8.01.   Other Events.
On February 27, 2008, OSI Pharmaceuticals, Inc. (“OSI”) announced that it filed an application to reissue its composition of matter patent for Tarceva® (erlotinib) (U.S. Patent No. 5,747,498) with the U.S. Patent and Trademark Office. The application seeks to correct certain errors relating to the claiming of compounds, other than Tarceva, which fall outside of the scope of the main claim in the patent. A copy of OSI’s press release, dated February 27, 2008, is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01.   Financial Statements and Exhibits.
         
Exhibit No.   Description
       
 
  99.1    
Press release dated February 27, 2008.

 


Table of Contents

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.
         
Date: March 3, 2008   OSI PHARMACEUTICALS, INC.
 
 
  By:   /s/ Barbara A. Wood    
    Barbara A. Wood   
    Senior Vice President, General Counsel and Secretary   
 

 


Table of Contents

EXHIBIT INDEX
         
Exhibit No.   Description
       
 
  99.1    
Press release dated February 27, 2008.
       
 

 

EX-99.1 2 y50716exv99w1.htm EX-99.1: PRESS RELEASE EX-99.1
 

Exhibit 99.1
(OSI PHARMACEUTICALS LOGO)
NEWS RELEASE
     
Contacts:
   
OSI Pharmaceuticals, Inc.
  Burns McClellan, Inc. (representing OSI)
Kathy Galante (investors/media)
  Justin Jackson (media)
Senior Director
  Kathy Nugent (media)
Kim Wittig (media)
  (212) 213-0006
Director
   
631-962-2000
   
OSI Pharmaceuticals Seeks to Strengthen Tarceva Patent by Filing Re-Issue
Application with the U.S. Patent and Trademark Office
MELVILLE, NEW YORK — February 27, 2008 — OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that it has filed with the U.S. Patent and Trademark Office an application to reissue its composition of matter patent for Tarceva® (erlotinib), U.S. Patent No. 5,747,498 (the ‘498 patent), in order to correct certain errors relating to the claiming of compounds, other than Tarceva, which fall outside of the scope of the main claim in the patent. OSI’s reissue application seeks to correct these errors by deleting surplus compounds from the claims. Like most composition of matter patents, the ‘498 patent claims many compounds in addition to Tarceva. Tarceva itself is accurately described in the ‘498 patent. While the reissue application is pending, the ‘498 patent remains listed in the Orange Book with the FDA and enforceable against any infringer.
“The generic industry is employing increasingly aggressive tactics toward innovator intellectual property rights, with challenges to IP around the world becoming increasingly common,” stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. “We view eliminating these errors as soon as possible as the best approach to defending against any challenge to our Tarceva intellectual property position and have settled on a strategy to reissue the core ‘498 patent. We remain confident in the ultimate core composition of matter protection of Tarceva and view the reissue filing as a prudent step, given the current environment, in order to manage any prospective generic challenge to the patent estate and to address concerns associated with any possible future litigation.”
OSI-together with Genentech, Inc. and Roche — has continually assessed the Tarceva intellectual property estate around the world, with particular attention to the United States, where the five year data exclusivity under Hatch-Waxman expires on November 18, 2009. Under U.S. law, a generic manufacturer can file an Abbreviated New Drug Application

 


 

(ANDA) with the FDA on the fourth anniversary of the original approval (November 18, 2008 for Tarceva), provided it asserts that it does not infringe the innovator IP or that IP is invalid or unenforceable.
“Should any ANDA filing occur we would, of course, file suit and aggressively assert our rights. We believe we have a strong case for the inventiveness of Tarceva and are confident that a favorable outcome will be achieved,” added Dr. Goddard.
About OSI Pharmaceuticals
OSI Pharmaceuticals is committed to “shaping medicine and changing lives” by discovering, developing and commercializing high-quality and novel pharmaceutical products designed to extend life and/or improve the quality of life for patients with cancer and diabetes/obesity. The Company’s oncology programs are focused on developing molecular targeted therapies designed to change the paradigm of cancer care. OSI’s diabetes/obesity efforts are committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI’s flagship product, Tarceva® (erlotinib), is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients in certain settings. OSI markets Tarceva through partnerships with Genentech, Inc. in the United States and with Roche throughout the rest of the world.
This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, a rejection of the reissue application, challenges to OSI’s intellectual property, any adverse litigation decisions , competition from other pharmaceutical companies, the ability to effectively market products, OSI’s and its collaborators’ abilities to successfully develop and commercialize drug candidates, the completion of clinical trials, the FDA review process and other governmental regulation, and other factors described in OSI Pharmaceuticals’ filings with the Securities and Exchange Commission.
###

 

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