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NEWS RELEASE 98-030; MAY 7, 1998 May 7, 1998
News Release 98-030
Inv. No. 337-TA-408

ITC INSTITUTES SECTION 337 INVESTIGATION ON CERTAIN RECOMBINANTLY PRODUCED HEPATITIS B VACCINES AND PRODUCTS CONTAINING SAME

The U.S. International Trade Commission (ITC) has voted to institute an investigation of certain recombinantly produced Hepatitis B vaccines and products containing same. The products at issue in this investigation are vaccines, produced using recombinant DNA technology, that protect persons against infection by the Hepatitis B virus.

The investigation is based on a complaint filed by Chiron Corporation of Emeryville, CA, on April 3, 1998. The complaint, as amended and supplemented, alleges a violation of section 337 of the Tariff Act of 1930 in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain recombinantly produced Hepatitis B vaccines and products containing same that infringe a U.S. patent owned by Chiron. In its complaint, Chiron requests that the ITC issue a permanent exclusion order and permanent cease and desist orders barring the importation into and sale within the United States of the allegedly infringing products.

The ITC has identified the following companies as respondents in the investigation:

SmithKline Beecham Biologicals, S.A., of R.C. Nivelles, Belgium, and
SmithKline Beecham Corporation of Philadelphia, PA.

By instituting this investigation (337-TA-408), the ITC has not yet made any decision on the merits of the case. The case will be referred to an ITC administrative law judge, who will schedule and hold an evidentiary hearing. The administrative law judge will make an initial determination as to whether there is a violation of section 337; that initial determination is subject to review by the Commission.

The ITC will make a final determination in the investigation at the earliest practicable time. Within 45 days after institution of the investigation, the ITC will set a target date for completing the investigation. ITC remedial orders in section 337 cases are effective when issued and become final 60 days after issuance unless disapproved for policy reasons by the President of the United States within that 60-day period.

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