In the Matter of Certain Tadalafil or Any Salt or Solvate Thereof and Products Containing Same; Notice of Commission Decision Not To Review an Initial Determination Finding a Violation of Section 337; Schedule for Written Submissions on Remedy, Public Interest, and Bonding, 1452-1453 [E6-63]

Agencies

• INTERNATIONAL TRADE COMMISSION

[Federal Register Volume 71, Number 5 (Monday, January 9, 2006)]
[Notices]
[Pages 1452-1453]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-63]


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INTERNATIONAL TRADE COMMISSION

[Inv. No. 337-TA-539]


In the Matter of Certain Tadalafil or Any Salt or Solvate Thereof 
and Products Containing Same; Notice of Commission Decision Not To 
Review an Initial Determination Finding a Violation of Section 337; 
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. 10) issued by the presiding administrative law 
judge (``ALJ'') finding a violation of section 337 in the subject 
investigation.

FOR FURTHER INFORMATION CONTACT: Steven Crabb, Esq., Office of the 
General Counsel, U.S. International Trade Commission, 500 E Street, 
SW., Washington, DC 20436, telephone (202) 708-5432. Copies of non-
confidential 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 
(https://www.usitc.gov). The public record for this investigation may be 
viewed on the Commission's electronic docket (EDIS) at https://
edis.usitc.gov. Hearing-impaired persons are advised that information 
on this matter can be obtained by contacting the Commission's TDD 
terminal on (202) 205-1810.

SUPPLEMENTARY INFORMATION: This investigation was instituted by the 
Commission based on a complaint filed

[[Page 1453]]

by Lilly ICOS LLC (``Lilly'') of Wilmington, DE under section 337 of 
the Tariff Act of 1930, as amended, 19 U.S.C. 1337. 70 FR 25601 (May 
13, 2005). The complainant alleged violations of section 337 in the 
importation into the United States, the sale for importation, and the 
sale within the United States after importation of certain tadalafil or 
any salt or solvate thereof, and products containing same by reason of 
infringement of claims 1-4, 6-8, 12, and 13 of U.S. Patent No. 
5,859,006. The complaint and notice of investigation named ten 
respondents.
    On September 12, 2005, the Commission issued a notice indicating 
that it had determined not to review an ID (Order No. 5) finding 
respondents Santovittorio Holdings Ltd. d/b/a Inhousepharmacy.co.uk of 
El Dorado, Panama, Stop4Rx of Port-au-Prince, Haiti, Rx Mex-Com, S.A. 
de C.V. of Colonia Las Brisas, Mexico, and https://www.Nudewfds.info of 
New Orleans, LA, in default. The ALJ also found that respondent Express 
Generic had not been properly served with the complaint.
    On November 17, 2005, the Commission issued a notice that it had 
determined not to review an ID (Order No. 9) finding an additional five 
of the originally named respondents in default. The additional five 
respondents were Budget Medicines Pty Ltd., of Sydney, Australia, 
Generic Cialis Pharmacy of Managua, Nicaragua, Cutprice Pills of 
Scottsdale, AZ, Allpills.us of Beverly Hills, CA, and Pharmacy4u.us of 
New York, NY.
    On October 28, 2005, Lilly filed a motion for summary determination 
on the issues of the existence of a domestic industry and violation of 
section 337 with respect to the nine respondents that were found in 
default. On November 14, 2005, the Commission Investigative Attorney 
(``IA'') filed a response to Lilly's motion.
    On December 6, 2005, the ALJ issued the subject ID (Order No. 10) 
granting Lilly's motion for a summary determination of a violation of 
section 337. With respect to the remedy, the ALJ recommended the 
issuance of a general exclusion order under section 337(g)(2), 19 
U.S.C. 1337(g)(2). The ALJ also recommended that the bond permitting 
importation during the Presidential review period be set at 100 percent 
of the value of the infringing imported products. No party petitioned 
for review of the subject ID. The Commission has determined not to 
review this ID with respect to the finding of a violation of section 
337, and to request written submissions with respect to remedy, 
bonding, and the public interest.
    In connection with the final disposition of this investigation, the 
Commission may issue an order that could result in the exclusion of the 
subject articles from entry into the United States. 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).
    When 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 an exclusion 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 a 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, bonding, and the public interest. 
Such submissions should address the December 6, 2005, recommended 
determination (Order No. 10) by the ALJ on remedy and bonding. 
Complainants and the Commission's investigative attorney are also 
requested to submit proposed orders for the Commission's consideration. 
Complainants are further requested to state the expiration date of the 
patent at issue and the HTSUS numbers under which the infringing goods 
are imported. Main written submissions and proposed orders must be 
filed no later than close of business on January 17, 2006. Reply 
submissions, if any, must be filed no later than the close of business 
on January 24, 2006. 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 that 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.
    The authority for the Commission's determination is contained in 
section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and 
in section 210.42 and 210.50 of the Commission's Rules of Practice and 
Procedure (19 CFR 210.42 and 210.50).

    By order of the Commission.

    Issued: January 4, 2006.
Marilyn R. Abbott,
Secretary to the Commission.
[FR Doc. E6-63 Filed 1-6-06; 8:45 am]
BILLING CODE 7020-02-P