[Federal Register Volume 69, Number 31 (Tuesday, February 17, 2004)]
[Notices]
[Page 7497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3306]


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INTERNATIONAL TRADE COMMISSION

[Inv. No. 337-TA-489]


In the Matter of Certain Sildenafil or any Pharmaceutically 
Acceptable Salt Thereof, Such as Sildenafil Citrate, and Products 
Containing Same; Notice of Commission Decision Not to Review an Initial 
Determination Terminating Investigation as to One Respondent on the 
Basis of a Settlement Agreement; Notice of Issuance of General 
Exclusion Order; Termination of the Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has determined not to review an initial determination (Order 
No. 22) issued by the presiding administrative law judge (``ALJ'') 
terminating the investigation as to respondent Biovea on the basis of a 
settlement agreement. Notice is also hereby given that, having 
previously found a violation of section 337 of the Tariff Act of 1930, 
19 U.S.C. 1337, the Commission has issued a general exclusion order 
under section 337(d)(2) and terminated the investigation.

FOR FURTHER INFORMATION CONTACT: Wayne Herrington, Esq., Office of the 
General Counsel, U.S. International Trade Commission, 500 E Street, 
SW., Washington, DC 20436, telephone 202-205-3090. Copies of all 
nonconfidential documents filed in connection with this investigation 
are or will be 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., Washington, DC 20436, 
telephone 202-205-2000. General information concerning the Commission 
may also be obtained by accessing its Internet server (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. 
Hearing-impaired persons are advised that information on the matter can 
be obtained by contacting the Commission's TDD terminal on 202-205-
1810.

SUPPLEMENTARY INFORMATION: The Commission instituted this investigation 
on March 6, 2003, based on a complaint filed by Pfizer, Inc. 
(``Pfizer'') of New York, New York. 68 FR 10749 (March 6, 2003). The 
complaint, as supplemented, alleged violations of section 337 of the 
Tariff Act of 1930 in the importation into the United States, sale for 
importation, and sale within the United States after importation of 
certain sildenafil or any pharmaceutically acceptable salt thereof, 
such as sildenafil citrate, and products containing same by reason of 
infringement of claims 1-5 of Pfizer's U.S. Patent No. 5,250,534 (``the 
'534 patent'').
    Fifteen respondents were named in the Commission's notice of 
investigation. Thirteen of these were successfully served with the 
complaint and notice of investigation. One respondent has previously 
been terminated from the investigation on the basis of a settlement 
agreement.
    Eleven respondents were found to be in default, including 
respondent 1 Aabaaca Viagra LLC (``Aabaaca''). On October 27, 
2003, the ALJ issued an initial determination (``ID'') (Order No. 19) 
finding that Pfizer had demonstrated that there is a violation of 
section 337 by reason of the defaulting respondents' importation and 
sale of sildenafil, sildenafil salts, or sildenafil products that 
infringe one or more of claims 1-5 of the '534 patent. He also found 
that Pfizer had established the existence of a domestic industry. He 
recommended the issuance of a general exclusion order, but did not 
recommend the issuance of a cease and desist order against defaulting 
respondent Aabaaca, as had been requested by Pfizer. The ALJ also 
recommended that the bond permitting temporary importation during the 
Presidential review period be set at 100 per cent of entered value. On 
November 24, 2003, the Commission issued notice that it had determined 
not to review the ALJ's ID and set a schedule for written submissions 
on remedy, the public interest, and bonding. Both Pfizer and the 
Commission investigative attorney timely filed initial submissions on 
remedy, the public interest, and bonding. The Commission investigative 
attorney filed a reply submission.
    On January 6, 2004, the ALJ issued an initial determination (Order 
No. 22) terminating respondent Biovea on the basis of a settlement 
agreement. No petitions for review of Order No. 22 were filed.
    Having reviewed the record in this investigation, including the 
recommended determination of the ALJ and the written submissions of the 
parties, the Commission determined (1) to not review Order No. 22, 
terminating respondent Biovea on the basis of a settlement agreement 
and (2) to terminate the investigation with the issuance of a general 
exclusion order under section 337(d)(2) prohibiting the unlicensed 
entry for consumption of sildenafil or any pharmaceutically acceptable 
salt thereof, such as sildenafil citrate, and products containing same 
which infringe one or more of claims 1-5 of the '534 patent.
    The Commission also determined that the public interest factors 
enumerated in section 337(d) do not preclude the issuance of the 
aforementioned general exclusion order and that the bond during the 
Presidential review period shall be 100 percent of the entered value of 
the articles in question.
    This action is taken under the authority of section 337 of the 
Tariff Act of 1930, 19 U.S.C. 1337, the Administrative Procedure Act, 
and Sec.Sec. 210.41-210.51 of the Commission's Rules of Practice and 
Procedure, 19 CFR 210.41-210.51.

    Issued: February 6, 2004.

    By order of the Commission.
Marilyn R. Abbott,
Secretary.
[FR Doc. 04-3306 Filed 2-13-04; 8:45 am]
BILLING CODE 7020-02-P