-----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, Vplskf/eDW5PzcVoM9XPq92XqnDPzkFBhLoM24R4wKZQ46yr8TCaP8HcX3MbFiPD sNB6Nmu/vc1O5ngKZCnFEQ== 0000950135-04-004830.txt : 20041019 0000950135-04-004830.hdr.sgml : 20041019 20041019101805 ACCESSION NUMBER: 0000950135-04-004830 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20041015 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041019 DATE AS OF CHANGE: 20041019 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TRANSKARYOTIC THERAPIES INC CENTRAL INDEX KEY: 0000885259 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 043027191 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21481 FILM NUMBER: 041084406 BUSINESS ADDRESS: STREET 1: 195 ALBANY ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6173490200 8-K 1 b52205tke8vk.htm TRANSKARYOTIC THERAPIES, INC. e8vk
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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) October 15, 2004


Transkaryotic Therapies, Inc.


(Exact Name of Registrant as Specified in Its Charter)

Delaware


(State or Other Jurisdiction of Incorporation)
         
000-21481
      04-3027191

 
(Commission File Number)
      (IRS Employer Identification No.)
 
       
700 Main Street, Cambridge, MA
      02139

 
(Address of Principal Executive Offices)
      (Zip Code)

(617) 349-0200


(Registrant’s Telephone Number, Including Area Code)

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 (see General Instruction A.2. below):

     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))



 


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Item 7.01 Regulation FD Disclosure
Item 8.01 Other Events
Item 9.01. Financial Statements and Exhibits
SIGNATURE
EXHIBIT INDEX
Ex-99.1 Press Release, dated October 15, 2004


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Item 7.01 Regulation FD Disclosure

     The website of The United Kingdom Parliament (www.parliament.uk/judicial_work/judicial_work4.cfm) provides that the House of Lords will announce on Thursday, October 21, 2004 at 9:45a.m. (London, England time), its judgment on the appeal of Kirin-Amgen, Inc. (“Kirin-Amgen”) in the patent infringement proceedings between Kirin-Amgen and Transkaryotic Therapies, Inc. (“TKT”) and Sanofi-Aventis SA (“Sanofi-Aventis”).

     TKT and Sanofi-Aventis have been engaged in legal proceedings with Kirin-Amgen since July 1999 with respect to whether Dynepo ™ (epoetin delta), TKT’s Gene-Activated erythropoietin product for the treatment of anemia, which was developed in collaboration with Sanofi-Aventis, infringes a patent of Kirin-Amgen. In July 2002, the Court of Appeals in the United Kindom ruled that Dynepo did not infringe Kirin-Amgen’s patent. Kirin-Amgen appealed this decision to the House of Lords.

Item 8.01 Other Events

     On October 15, 2004, TKT announced that the U.S. District Court of Massachusetts (the “District Court”) issued a ruling in a patent infringement suit in the United States involving Dynepo. The District Court found that certain claims of four patents held by Amgen Inc. are valid and infringed. TKT intends to appeal the District Court’s decision to the U.S. Court of Appeals for the Federal Circuit.

     The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits

     (c) Exhibits

     
99.1
  Press Release entitled “TKT to Appeal Dynepo Ruling to Federal Circuit”, issued by TKT on October 15, 2004.

 


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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: October 19, 2004  REGISTRANT


TRANSKARYOTIC THERAPIES, INC.
 
 
  By:   /s/Michael J. Astrue    
    Michael J. Astrue  
    President and Chief Executive Officer   
 

 


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EXHIBIT INDEX

     
Exhibit No.
  Description
99.1
  Press Release entitled “TKT to Appeal Dynepo Ruling to Federal Circuit”, issued by TKT on October 15, 2004.

 

EX-99.1 2 b52205tkexv99w1.htm EX-99.1 PRESS RELEASE, DATED OCTOBER 15, 2004 Ex-99.1 Press Release, dated October 15, 2004
 

Exhibit 99.1

TKT to Appeal Dynepo Ruling to Federal Circuit

CAMBRIDGE, Mass., Oct. 15 /PRNewswire-FirstCall/ — Transkaryotic Therapies, Inc. (Nasdaq: TKTX) announced today that the U.S. District Court of Massachusetts issued a ruling in a patent infringement suit involving Dynepo™ (epoetin delta), its Gene-Activated® erythropoietin product for the treatment of anemia, which is being developed with Sanofi-Aventis in the United States. The District Court found that certain claims of four patents held by Amgen Inc. are valid and infringed. TKT intends to appeal the District Court’s decision to the U.S. Court of Appeals for the Federal Circuit.

“Courts should not create thirty-five year monopolies by allowing companies to radically expand their patent claims more than a decade after filing an application. I believe today’s decision misreads the law, discourages innovation, exports biotechnology manufacturing jobs overseas, and denies patients in the United States an important alternative product,” said Michael J. Astrue, President and Chief Executive Officer of TKT. “We will appeal.”

In January 2003, the Federal Circuit issued a decision affirming in part and reversing in part the District Court’s initial January 2001 decision and remanding the case for further proceedings. The Federal Circuit instructed the District Court to reconsider infringement and validity of certain of Amgen’s patents.

     The District Court on remand found with respect to:

    U.S. Patent No. 5,955,422, that the patent is valid. The Federal Circuit had affirmed the District Court’s finding of infringement of one claim, but remanded to reconsider validity of the patent.
 
    U.S. Patent No. 5,756,349, that the patent is valid and is literally infringed. The Federal Circuit had affirmed the District Court’s finding of infringement of certain claims, and remanded to reconsider validity of the patent and infringement of certain other claims.
 
    U.S. Patent No. 5,618,698, that Aventis’ and TKT’s process infringes certain claims. The Federal Circuit had remanded to reconsider infringement.
 
    U.S. Patent No. 5,621,080, that the claims of the patent are valid. The District Court issued an opinion in October 2003 that Aventis and TKT infringed under the doctrine of equivalents. The Federal Circuit had remanded to reconsider validity and infringement under the doctrine of equivalents.

Additional information on the patent litigation involving Dynepo can be accessed online at: http://www.tktx.com/legal/index.htm.

 


 

About TKT

Transkaryotic Therapies, Inc. is a biopharmaceutical company primarily focused on researching, developing and commercializing treatments for rare diseases caused by protein deficiencies. Within this focus, the company markets Replagal™, an enzyme replacement therapy for Fabry disease, and is developing treatments for Hunter syndrome and Gaucher disease. Outside its focus on rare diseases, TKT intends to commercialize Dynepo™, its Gene- Activated® erythropoietin product for anemia related to kidney disease, in the European Union. TKT was founded in 1988 and is headquartered in Cambridge, Massachusetts, with additional operations in Europe, Canada and South America. Additional information about TKT is available on the company’s website at http://www.tktx.com.

This press release contains forward-looking statements regarding TKT’s patent litigation with Amgen involving Dynepo, as well as statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “should,” “could,” “will,” “may,” and similar expressions. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the timing of appeal of the District Court’s decision to the Federal Circuit, whether the Federal Circuit agrees with TKT’s arguments in the appeal, the timing of a decision from the Federal Circuit, and other factors set forth under the caption “Certain Factors Which May Affect Future Results” in the company’s Quarterly Report on Form 10-Q filed August 9, 2004, which is on file with the Securities and Exchange Commission and are incorporated herein by reference. While the company may elect to update forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so, even if its expectations change.

Gene-Activated® is a registered trademark and Replagal™ is a trademark of Transkaryotic Therapies, Inc. Dynepo™ is a trademark of Sanofi-Aventis SA.

For More Information Contact:
Justine E. Koenigsberg
Senior Director, Corporate Communications
(617) 349-0271

 

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