80 FR 29745 - Certain Recombinant Factor VIII Products; Institution of Investigation

INTERNATIONAL TRADE COMMISSION

Federal Register Volume 80, Issue 99 (May 22, 2015)

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 16, 2015, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Baxter International Inc. of Deerfield, Illinois; Baxter Healthcare Corporation of Deerfield, Illinois; and Baxter Healthcare SA, of Switzerland. Letters supplementing the complaint were filed on April 21, 2015; May 1, 2015; and May 4, 2015. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain recombinant factor VIII products by reason of infringement of certain claims of U.S. Patent No. 6,100,061 (``the '061 patent''); U.S. Patent No. 6,936,441 (``the '441 patent''); and U.S. Patent No. 8,084,252 (``the '252 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29745-29746]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12390]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-956]


Certain Recombinant Factor VIII Products; Institution of 
Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that a complaint was filed with the 
U.S. International Trade Commission on April 16, 2015, under section 
337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of 
Baxter International Inc. of Deerfield, Illinois; Baxter Healthcare 
Corporation of Deerfield, Illinois; and Baxter Healthcare SA, of 
Switzerland. Letters supplementing the complaint were filed on April 
21, 2015; May 1, 2015; and May 4, 2015. The complaint alleges 
violations of section 337 based upon the importation into the United 
States, the sale for importation, and the sale within the United States 
after importation of certain recombinant factor VIII products by reason 
of infringement of certain claims of U.S. Patent No. 6,100,061 (``the 
'061 patent''); U.S. Patent No. 6,936,441 (``the '441 patent''); and 
U.S. Patent No. 8,084,252 (``the '252 patent''). The complaint further 
alleges that an industry in the United States exists as required by 
subsection (a)(2) of section 337.
    The complainants request that the Commission institute an 
investigation and, after the investigation, issue a limited exclusion 
order and cease and desist orders.

ADDRESSES: The 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: The Office of Unfair Import 
Investigations, U.S. International Trade Commission, telephone (202) 
205-2560.


[[Page 29746]]


    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 (2015).

    Scope of Investigation: Having considered the complaint, the U.S. 
International Trade Commission, on May 15, 2015, 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 recombinant 
factor VIII products by reason of infringement of one or more of claims 
19-21, 36, 37, and 39 of the '061 patent; claims 20 and 21 of the '441 
patent; claims 1, 5, 8, 10, 14, and 18 of the '252 patent, and whether 
an industry in the United States exists as required by subsection 
(a)(2) of section 337;
    (2) Pursuant to Commission Rule 210.50(b)(1), 19 CFR 210.50(b)(1), 
the presiding administrative law judge shall take evidence or other 
information and hear arguments from the parties and other interested 
persons with respect to the public interest in this investigation, as 
appropriate, and provide the Commission with findings of fact and a 
recommended determination on this issue, which shall be limited to the 
statutory public interest factors set forth in 19 U.S.C. 1337(d)(1), 
(f)(1), (g)(1)
    (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 complainants are:

Baxter International Inc., One Baxter Parkway, Deerfield, IL 60015-
4625.
Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015-
4625.
Baxter Healthcare SA, Thursgauerstrasse 130, Glattpark 
(Opfikon),Switzerland.

    (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:

Novo Nordisk A/S, Novo All[eacute], 2880 Bagsvaerd, Denmark.
Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536.

    (c) The 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 Chief Administrative 
Law Judge, U.S. International Trade Commission, shall designate 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(e) 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 respondent, 
to find the facts to be as alleged in the complaint and this notice and 
to enter an initial determination and a final determination containing 
such findings, and may result in the issuance of an exclusion order or 
a cease and desist order or both directed against the respondent.

    By order of the Commission.

    Issued: May 18, 2015.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2015-12390 Filed 5-21-15; 8:45 am]
BILLING CODE 7020-02-P