[Federal Register Volume 71, Number 92 (Friday, May 12, 2006)]
[Notices]
[Pages 27742-27743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7307]


=======================================================================
-----------------------------------------------------------------------

INTERNATIONAL TRADE COMMISSION

[Inv. No. 337-TA-568]


In the Matter of Certain Products and Pharmaceutical Compositions 
Containing Recombinant Human Erythropoietin; Notice of Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Institution of investigation pursuant to 19 U.S.C. 1337.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that a complaint was filed with the 
U.S. International Trade Commission on April 11, 2006, under section 
337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of 
Amgen Inc. of Thousand Oaks, California. Amgen filed an amended 
complaint and a supplement on April 27, 2006. The amended complaint 
alleges violations of section 337 in the importation into the United 
States of certain products and pharmaceutical compositions containing 
recombinant human erythropoietin by reason of infringement of claims 1 
and 2 of U.S. Patent No. 5,441,868, claims 3, 4, 5, and 11 of U.S. 
Patent No. 5,547,933, claims 4-9 of U.S. Patent No. 5,618,698, claims 4 
and 6 of U.S. Patent No. 5,621,080, claim 7 of U.S. Patent No. 
5,756,349, and claim 1 of U.S. Patent No. 5,955,422. The complaint 
further alleges that an industry in the United States exists as 
required by subsection (a)(2) of section 337.
    The complainant requests that the Commission institute an 
investigation and, after the investigation, issue a permanent exclusion 
order and permanent cease and desist orders.

ADDRESSES: The amended complaint, except for any confidential 
information contained therein, is available for inspection during 
official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the 
Secretary, U.S. International Trade Commission, 500 E Street, SW., Room 
112, Washington, DC 20436, telephone 202-205-2000. Hearing impaired 
individuals are advised that information on this matter can be obtained 
by contacting the Commission's TDD terminal on 202-205-1810. Persons 
with mobility impairments who will need special assistance in gaining 
access to the Commission should contact the Office of the Secretary at 
202-205-2000. General information concerning the Commission may also be 
obtained by accessing its Internet server at http://www.usitc.gov. The 
public record for this investigation may be viewed on the Commission's 
electronic docket (EDIS) at http://edis.usitc.gov.

FOR FURTHER INFORMATION CONTACT: Anne Goalwin, Office of Unfair Import 
Investigations, U.S. International Trade Commission, telephone (202) 
205-2574.

    Authority: The authority for institution of this investigation 
is contained in section 337 of the Tariff Act of 1930, as amended, 
and in section 210.10 of the Commission's Rules of Practice and 
Procedure, 19 CFR 210.10 (2005).
    Scope of Investigation: Having considered the complaint, the U.S. 
International Trade Commission, on May 8, 2006, ordered that--
    (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 
1930, as amended, an investigation be instituted to determine whether 
there is a violation of subsection (a)(1)(B) of section 337 in the 
importation into the United States, the sale for importation, or the 
sale within the United States after importation of certain products and 
pharmaceutical compositions containing recombinant human

[[Page 27743]]

erythropoietin by reason of infringement of one or more of claims 1 and 
2 of U.S. Patent No. 5,441,868, claims 3, 4, 5, and 11 of U.S. Patent 
No. 5,547,933, claims 4-9 of U.S. Patent No. 5,618,698, claims 4 and 6 
of U.S. Patent No. 5,621,080, claim 7 of U.S. Patent No. 5,756,349, and 
claim 1 of U.S. Patent No. 5,955,422, and whether an industry in the 
United States exists as required by subsection (a)(2) of section 337.
    (2) In instituting this investigation, the Commission is mindful of 
the provision of 35 U.S.C. 271(e), which states that ``[i]t shall not 
be an act of infringement to make, use, offer to sell, or sell within 
the United States or import into the United States a patented invention 
* * * solely for uses reasonably related to the development and 
submission of information under a Federal law which regulates the 
manufacture, use, or sale of drugs * * *.'' Accordingly, the Commission 
directs the presiding administrative law judge to consider at an early 
date any motions for summary determination based upon 35 U.S.C. 271(e). 
Any decision granting or denying such motions should be issued in the 
form of an initial determination (ID) under Rule 210.42(c), 19 CFR 
210.42(c). The ID will become the Commission's final determination 45 
days after the date of service of the ID unless the Commission 
determines to review the ID. Any such review will be conducted in 
accordance with Commission Rules 210.43, 210.44 and 210.45, 19 CFR 
210.43, 210.44, and 210.45.
    (3) For the purpose of the investigation so instituted, the 
following are hereby named as parties upon which this notice of 
investigation shall be served:
    (a) The complainant is--

Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320.

    (b) The respondents are the following entities alleged to be in 
violation of section 337, and are the parties upon which the complaint 
is to be served:

Roche Holding Ltd., Grenzacherstrasse 124, CH-4070, Basel, Switzerland.
F. Hoffmann-La Roche, Ltd., Grenzacherstrasse 124, CH-4070, Basel, 
Switzerland.
Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305, Mannheim, 
Germany.
Hoffmann La Roche, Inc., 340 Kingsland Street, Nutley, New Jersey 
07110.

    (c) The Commission investigative attorney, party to this 
investigation, is Anne Goalwin, Esq., Office of Unfair Import 
Investigations, U.S. International Trade Commission, 500 E Street, SW., 
Suite 401, Washington, DC 20436; and
    (4) For the investigation so instituted, the Honorable Paul J. 
Luckern is designated as the presiding administrative law judge.
    Responses to the complaint and the notice of investigation must be 
submitted by the named respondents in accordance with section 210.13 of 
the Commission's Rules of Practice and Procedure, 19 CFR 210.13. 
Pursuant to 19 CFR 201.16(d) and 210.13(a), such responses will be 
considered by the Commission if received not later than 20 days after 
the date of service by the Commission of the complaint and the notice 
of investigation. Extensions of time for submitting responses to the 
complaint and the notice of investigation will not be granted unless 
good cause therefor is shown.
    Failure of a respondent to file a timely response to each 
allegation in the complaint and in this notice may be deemed to 
constitute a waiver of the right to appear and contest the allegations 
of the complaint and this notice, and to authorize the administrative 
law judge and the Commission, without further notice to the 
respondents, to find the facts to be as alleged in the complaint and 
this notice and to enter a final determination containing such 
findings, and may result in the issuance of a limited exclusion order 
or cease and desist order or both directed against the respondent.

    Issued: May 9, 2006.

    By order of the Commission.
Marilyn R. Abbott,
Secretary to the Commission.
[FR Doc. E6-7307 Filed 5-11-06; 8:45 am]
BILLING CODE 7020-02-P