[Federal Register: November 28, 2003 (Volume 68, Number 229)]
[Notices]
[Page 66852-66853]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28no03-93]
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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