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IPR Enforcement Actions on Recombinant Factor VIII Products, Herbicide

Monday, April 20, 2015
Sandler, Travis & Rosenberg Trade Report

Recombinant Factor VIII Products. The International Trade Commission received April 16 on behalf of Baxter International Inc., Baxter Healthcare Corporation and Baxter Healthcare SA a petition requesting that it institute a Section 337 investigation regarding certain recombinant factor VIII products. The proposed respondents are located in Denmark and the U.S.

Section 337 investigations primarily involve claims regarding intellectual property rights violations by imported goods, including the infringement of patents, trademarks and copyrights. Other forms of unfair competition involving imported products, such as misappropriation of trade secrets or trade dress and false advertising, may also be asserted. The primary remedy available in Section 337 investigations is an exclusion order that directs U.S. Customs and Border Protection to stop infringing imports from entering the U.S. In addition, the ITC may issue cease and desist orders against named importers and other persons engaged in unfair acts that violate Section 337, including selling infringing imported articles out of U.S. inventory.

Herbicide. In patent infringement investigation 337-TA-914 of certain sulfentrazone (an herbicide), sulfentrazone compositions and processes for making sulfentrazone, the presiding administrative law judge has found no violation of Section 337 of the 1930 Tariff Act. However, the ALJ has recommended that if the ITC reverses that finding it should issue a limited exclusion order against the respondents.

The ITC is therefore soliciting through May 18 comments on whether the issuance of a limited exclusion order would affect the public health and welfare in the U.S., competitive conditions in the U.S. economy, the production of like or directly competitive articles in the U.S., or U.S. consumers. In particular, the ITC is interested in comments that:

- explain how the articles potentially subject to the recommended order are used in the U.S.;

- identify any public health, safety or welfare concerns in the U.S. relating to the recommended order;

- identify like or directly competitive articles that the complainant, its licensees or third parties make in the U.S. that could replace the subject articles if they were excluded;

- indicate whether the complainant, its licensees and/or third-party suppliers have the capacity to replace the volume of articles potentially subject to the recommended exclusion order within a commercially reasonable time; and

- explain how the limited exclusion order would impact consumers in the U.S.

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