[Federal Register Volume 71, Number 116 (Friday, June 16, 2006)]
[Notices]
[Pages 34966-34967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9467]


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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 Issuance of General 
Exclusion Order; Decision To Grant Motion To File a Surreply; 
Termination of the Investigation

AGENCY: International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has found a violation of section 337 of the Tariff Act of 
1930, as amended, 19 U.S.C. 1337, and has issued a general exclusion 
order under section 337(g)(2), 19 U.S.C. 1337(g)(2), and terminated the 
investigation. The Commission has decided to grant complainant's motion 
to file a surreply.

FOR FURTHER INFORMATION CONTACT: Jean Jackson, Esq., Office of the 
General Counsel, U.S. International Trade Commission, 500 E Street, 
SW., Washington, DC 20436, telephone (202) 205-3104. 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 
(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 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 by Lilly ICOS LLC (``Lilly'') of 
Wilmington, Delaware, 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 `006 patent''). 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 initial determination (``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 
http://www.Nudewfds.info of New Orleans, Louisiana; in default. The ID 
further 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 are Budget Medicines Pty Ltd., of Sydney, Australia; 
Generic Cialis Pharmacy of Managua, Nicaragua; Cutprice Pills of 
Scottsdale, Arizona; Allpills.us of Beverly Hills, California; and 
Pharmacy4u.us of New York, New York.
    On October 28, 2005, Lilly filed a motion for summary determination 
on the issues of the existence of a domestic

[[Page 34967]]

industry and violation of section 337 by reason of patent infringement 
with respect to the nine respondents that were found in default. On 
November 14, 2005, the Commission investigative attorney (``IA'') filed 
a response in support of Lilly's motion.
    On December 6, 2005, the presiding administrative law judge 
(``ALJ'') issued an ID (Order No. 10) granting Lilly's motion for a 
summary determination of violation of section 337. At the same time the 
ALJ made his recommendations on remedy and the amount of bond to be 
imposed during the Presidential period of review provided for in 
section 337(j), 19 U.S.C. 1337(j). No party petitioned for review of 
the ID. On January 4, 2006, the Commission determined not to review the 
ID, thereby allowing it to become the Commission's final determination 
on violation. 71 FR 1452 (Jan. 9, 2006). With respect to 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.
    Pursuant to the Commission's notice, Lilly and the IA submitted 
main briefs on the issues of remedy, the public interest, and bonding 
on January 17, 2006, with draft general exclusion orders attached. The 
IA filed a reply submission on January 24, 2006. Lilly filed a motion 
to file a surreply with surreply attached on February 9, 2006. The 
Commission has determined to grant Lilly's motion to file a surreply.
    Having reviewed the record in this investigation, including the 
recommended determination of the ALJ and the written submissions of the 
parties, the Commission has determined that the public interest factors 
listed in section 337(d)(2) do not preclude issuance of a general 
exclusion order that prohibits the unlicensed entry for consumption of 
tadalafil salt or solvate thereof and products containing same that 
infringe one or more of claims 1-4, 6-8, 12, and 13 of the `006 patent 
during the term of that patent. The Commission has further determined 
that the appropriate bond during the period of Presidential review 
pursuant to section 337(j) should be set at 100 percent of the value of 
the infringing products. The Commission's general exclusion order was 
delivered on the date of its issuance to the President and to the 
United States Trade Representative, pursuant to the Presidential 
Memorandum of July 21, 2005. 70 FR 43251 (July 26, 2005).
    This action is taken under authority of section 337 of the Tariff 
Act of 1930, 19 U.S.C. Sec.  1337, and sections 210.41, 210.49, and 
210.50 of the Commission's Rules of Practice and Procedure, 19 CFR 
210.41, 210.49, and 210.50.

    Issued: June 13, 2006.

    By order of the Commission.
Marilyn R. Abbott,
Secretary to the Commission.
 [FR Doc. E6-9467 Filed 6-15-06; 8:45 am]
BILLING CODE 7020-02-P