USITC Institutes Section 337 Investigation of Certain Recombinant Factor IX Products

August 8, 2017
News Release 17-116
Inv. No. 337-TA-1066
Contact: Peg O'Laughlin, 202-205-1819
USITC Institutes Section 337 Investigation of Certain Recombinant Factor IX Products

The U.S. International Trade Commission (USITC) has voted to institute an investigation of certain recombinant Factor IX products.  The products at issue in the investigation are certain recombinant Factor IX products for treatment of hemophilia B.

The investigation is based on a complaint filed by Bioverativ Inc., Bioverativ Therapeutics Inc., and Bioverativ U.S. LLC, all of Waltham, MA, on July 7, 2017.  The complaint alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States and sale of certain recombinant Factor IX products that infringe patents asserted by the complainants.  The complainants request that the USITC issue a limited exclusion order and cease and desist orders.

The USITC has identified the following as respondents in this investigation:

CSL Behring LLC of King of Prussia, PA;
CSL Behring GmbH of Marburg, Hessen, Germany; and
CSL Behring Recombinant Facility AG of Bern, Switzerland.

By instituting this investigation (337-TA-1066), the USITC has not yet made any decision on the merits of the case.  The USITC’s Chief Administrative Law Judge will assign the case to one of the USITC’s administrative law judges (ALJ), who will schedule and hold an evidentiary hearing.  The ALJ 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 USITC will make a final determination in the investigation at the earliest practicable time.  Within 45 days after institution of the investigation, the USITC will set a target date for completing the investigation.  USITC remedial orders in section 337 cases are effective when issued and become final 60 days after issuance unless disapproved for policy reasons by the U.S. Trade Representative within that 60-day period.

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