International Trade Commission June 10, 2016 – Federal Register Recent Federal Regulation Documents
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Certain Recombinant Factor VIII Products
Notice is hereby given that the presiding administrative law judge (ALJ) has issued a final initial determination on May 27, 2016, and a recommended determination on remedy and bonding on June 3, 2016. The ALJ found no violation of Section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337). Should the Commission, however, find a violation of Section 337, the ALJ recommends that the Commission issue a limited exclusion order that excludes from importation into the United States certain recombinant factor VIII products manufactured by processes that infringe certain claims of U.S. Patent Nos. 6,100,061 and 8,084,252. The respondents are Novo Nordisk A/S of Bagsvaerd, Denmark, and Novo Nordisk Inc. of Plainsboro, N.J. Upon a finding of a violation, the ALJ further recommends that cease and desist orders issue to respondents and be directed to respondents' domestic inventories. This notice is soliciting public interest comments only from the public. Parties are to file public interest submissions pursuant to 19 CFR 210.50(a)(4) within 30 days from service of the recommended determination.
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