E6-9003. In the Matter of Certain Insulin Delivery Devices, Including Cartridges Having Adaptor Tops, and Components Thereof; 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 May 8, 2006, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Novo Nordisk A/S, Novo Nordisk Inc., and Novo Nordisk Pharmaceuticals Industries, Inc. Supplemental letters were filed on May 11 and 23, 2006. 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 insulin delivery devices, including cartridges having adaptor tops, and components thereof, by reason of infringement of claims 1-3, 5-7, 11, 18, and 19 of U.S. Patent 5,693,027. The complaint further alleges that an industry in the United States exists or is in the process of being established 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 exclusion order and a permanent cease and desist order.

ADDRESSES:

The complaint, except for any confidential information contained therein, is 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 [phone]. 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:

Juan Cockburn, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, telephone [phone].

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 (2005).

Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on June 5, 2006, 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 insulin delivery devices, including cartridges having adaptor tops, or components thereof, by reason of infringement of claims 1-3, 5-7, 11, 18, or 19 of U.S. Patent 5,693,027, and whether an industry in the United States exists or is in the process of being established 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 complainants are—

Novo Nordisk A/S, Novo Alle, 2880 Bagsvaerd, Denmark.

Novo Nordisk Inc., 100 College Road West, Princeton, NJ 08540.

Novo Nordisk Pharmaceuticals Industries, Inc., 3612 Powhatan Road, Clayton, NC 27527.

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

Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst, D-65926, Frankfurt am Main, Germany.

Sanofi-Aventis, 174/180 Avenue de France, Paris, Cedex 75013 France.

Aventis Pharmaceuticals, Inc., 300 Somerset Corporate Blvd., Bridgewater, NJ 08807.

(c) The Commission investigative attorney, party to this investigation, is Juan Cockburn, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street, SW., Suite 401, Washington, DC 20436; and

(3) For the investigation so instituted, the Honorable Sidney Harris 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 not 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 responses to the complaint and the notice of investigation 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 this notice, 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 an initial determination and a final determination containing such findings, and may result in the issuance of a limited exclusion order or cease and desist order or both directed against the respondent.

By order of the Commission.

Issued: June 6, 2006.

Marilyn R. Abbott,

Secretary to the Commission.