In the Matter of Certain Tadalafil or Any Salt or Solvate Thereof, and Products Containing Same; Notice of Investigation

AGENCY:

U.S. International Trade Commission.

ACTION:

Institution of investigation pursuant to 19 U.S.C. 1337.

SUMMARY:

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 8, 2005, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Lilly ICOS LLC of Wilmington, Delaware. A letter supplementing the complaint was filed on April 27, 2005. The complaint, as supplemented, alleges 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, and 12-13 of U.S. Patent No. 5,859,006. The complaint further alleges that there exists an industry in the United States as required by subsection (a)(2) of section 337.

The complainant requests that the Commission institute an investigation and, after the investigation, issue a permanent general exclusion order and permanent cease and desist orders.

ADDRESSES:

The complaint and supplemental letter, except for any confidential information contained therein, are 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., Room 112, Washington, DC 20436, telephone 202-205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at 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.

FOR FURTHER INFORMATION CONTACT:

Jay H. Reiziss, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, telephone 202-205-2579.

Authority: The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2004).

Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on May 9, 2005, Ordered that—

(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain tadalafil or any salt or solvate thereof, or products containing same, by reason of infringement of one or more of claims 1-4, 6-8, and 12-13 of U.S. Patent No. 5,859,006, and whether an industry in the United States exists as required by subsection (a)(2) of section 337.

(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:

(a) The complainant is—

Lilly ICOS LLC, 1209 Orange Street, Wilmington, DE 19801.

(b) The respondents are the following companies alleged to be in violation of section 337 and upon which the complaint is to be served:

Pharmacy4u.us, Attn: Dave Fox, 166 W. 44th Street, New York, NY 10282, Santovittorio Holdings Ltd, d/b/a Inhousepharmacy.co.uk.

Apartado 6-6305 El Dorado, El Dorado, Panama, Expressgeneric, 722 8th Cross, 11th Main H.A.L. 2nd Stage, Bangalore, Karnataka 560008 IN.

India, Stop4rx, Box 1246 Port-au-Prince, Port-au-Prince, FE 123182, Haiti.

Cutprice Pills, c/o Domains By Proxy, Inc., 15111 N. Hayden Road, Suite 160, PMB353, Scottsdale, AZ 85260.

Allpills.us, Attn: Gerard Gibson, Madisson 12, Beverly Hills, CA 90210.

Generic Cialis Pharmacy, Del Parque Central 200 N, Managua, Nicaragua, Rx Mex-Com, S.A. de C.V., Avenida Lazaro Cardenas #4207, Colonia Las Brisas, Monterrey 64780, Mexico.

Budget Medicines Pty Ltd., 2 Brierwood Place, French's Forest, Sydney, 2068, Australia.

www.nudewfds.info,, 838 Camp Street, Apartment C, New Orleans, LA 70130.

(c) Jay H. Reiziss, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street, SW., Suite 401, Washington, DC 20436, who shall be the Commission investigative attorney, party to this investigation; and

(3) For the investigation so instituted, the Honorable Charles E. Bullock is designated as the presiding administrative law judge.

Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(d) and 210.13(a), such responses will be considered by the Commission if received no later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting a response to the complaint will not be granted unless good cause therefor is shown.

Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter both an initial determination and a final determination containing such findings, and may result in the issuance of a limited exclusion order or a cease and desist order or both directed against such respondent.