[Federal Register Volume 68, Number 229 (Friday, November 28, 2003)]
[Notices]
[Pages 66852-66853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29648]


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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 Finding a Violation of Section 337 and That the Domestic 
Industry Requirement Is Met; Schedule for Written Submissions on 
Remedy, Public Interest, and Bonding

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 
(``ID'') (Order No. 19) issued by the presiding administrative law 
judge (``ALJ'') finding a violation of section 337 and that the 
domestic industry requirement has been met in the above-captioned 
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

[[Page 66853]]

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, 
including 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. Of these, eleven were found to be in default. Two other 
respondents were never found to have been served with the complaint and 
notice of investigation, and have not otherwise participated in the 
investigation. Another respondent has been terminated from the 
investigation on the basis of a settlement agreement. One respondent is 
the subject of a motion to terminate the investigation on the basis of 
a consent order, which the ALJ has granted and which is currently 
before the Commission.
    On October 6, 2003, Pfizer filed a motion pursuant to Commission 
rule 210.18 (19 CFR 210.18) for summary determination on the issues of 
the existence of a domestic industry and violation of section 337. 
Pfizer's motion sought a general exclusion order and a cease and desist 
order against respondent 1 Aabaaca Viagra LLC (``Aabaaca''). 
On October 16, 2003, the Commission investigative attorney filed a 
response in support of Pfizer's motion. No other responses to the 
motion were filed.
    On October 27, 2003, the ALJ issued the subject ID finding that 
Pfizer has 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 the domestic 
industry requirement satisfied. As to remedy, the ALJ found that the 
legal framework for considering whether to issue a general exclusion 
order in the circumstances of this case is section 337(g)(2), not 
section 337(d)(2). He recommended the issuance of a general exclusion 
order, but did not recommend the issuance of a cease and desist order 
against respondent Aabaaca. He also recommended that the bond 
permitting temporary importation during the Presidential review period 
be set at 100 percent of entered value. No party petitioned for review 
of the ID.
    In connection with the final disposition of this investigation, the 
Commission may (1) issue an order that could result in the exclusion of 
the subject articles from entry into the United States, and/or issue 
one or more cease and desist orders that could result in respondents 
being required to cease and desist from engaging in unfair acts in the 
importation and sale of such articles. Accordingly, the Commission is 
interested in receiving written submissions that address the form of 
remedy, if any, that should be ordered. If a party seeks exclusion of 
an article from entry into the United States for purposes other than 
entry for consumption, it should so indicate and provide information 
establishing that activities involving other types of entry either are 
adversely affecting it or likely to do so. For background, see In the 
Matter of Certain Devices for Connecting Computers via Telephone Lines, 
Inv. No. 337-TA-360, USITC Pub. No. 2843 (December 1994) (Commission 
Opinion). The Commission considers the question of remedy to include 
the ALJ's finding that the legal framework for considering whether to 
issue a general exclusion order in the circumstances of this case is 
section 337(g)(2), not section 337(d)(2).
    If the Commission contemplates some form of remedy, it must 
consider the effects of that remedy upon the public interest. The 
factors the Commission will consider in this investigation include the 
effect that a remedial order would have on (1) the public health and 
welfare, (2) competitive conditions in the U.S. economy, (3) U.S. 
production of articles that are like or directly competitive with those 
that are subject to investigation, and (4) U.S. consumers. The 
Commission is therefore interested in receiving written submissions 
that address the aforementioned public interest factors in the context 
of this investigation.
    If the Commission orders some form of remedy, the President has 60 
days to approve or disapprove the Commission's action. During this 
period, the subject articles would be entitled to enter the United 
States under bond, in an amount determined by the Commission and 
prescribed by the Secretary of the Treasury. The Commission is 
therefore interested in receiving submissions concerning the amount of 
the bond that should be imposed.
    Written Submissions: The parties to the investigation, interested 
government agencies, and any other interested parties are encouraged to 
file written submissions on remedy, the public interest, and bonding. 
Such submissions should address the October 27, 2003, recommended 
determination by the ALJ on remedy and bonding. Complainant and the 
Commission investigative attorney are also requested to submit proposed 
orders for the Commission's consideration. The written submissions and 
proposed orders must be filed no later than close of business on 
December 12, 2003. Reply submissions, if any, must be filed no later 
than the close of business on December 19, 2003. No further submissions 
on these issues will be permitted unless otherwise ordered by the 
Commission.
    Persons filing written submissions must file with the Office of the 
Secretary the original document and 14 true copies thereof on or before 
the deadlines stated above. Any person desiring to submit a document 
(or portion thereof) to the Commission in confidence must request 
confidential treatment unless the information has already been granted 
such treatment during the proceedings. All such requests should be 
directed to the Secretary of the Commission and must include a full 
statement of the reasons why the Commission should grant such 
treatment. See section 201.6 of the Commission's Rules of Practice and 
Procedure, 19 CFR 201.6. Documents for which confidential treatment by 
the Commission is sought will be treated accordingly. All 
nonconfidential written submissions will be available for public 
inspection at the Office of the Secretary.
    This action is taken under the authority of section 337 of the 
Tariff Act of 1930, 19 U.S.C. 1337, and section 210.42 of the 
Commission's Rules of Practice and Procedure, 19 CFR 210.42.

    Issued: November 24, 2003.

    By order of the Commission.
Marilyn R. Abbott,
Secretary.
[FR Doc. 03-29648 Filed 11-26-03; 8:45 am]
BILLING CODE 7020-02-P