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IPR Import Restrictions Considered for Drug Used to Treat Hemophilia

Thursday, June 09, 2016
Sandler, Travis & Rosenberg Trade Report

In investigation 337-TA-956 of recombinant factor VIII products, the International Trade Commission’s presiding administrative law judge has found no Section 337 violation. However, the ALJ has also recommended that if the ITC does find a violation it should issue (a) a limited exclusion order that excludes from importation subject goods manufactured by processes that infringe certain patent claims asserted by the complainant and (b) cease and desist orders directed to the respondents’ domestic inventories.

The ITC is now seeking comments by June 29 on whether the issuance of an LEO and/or cease and desist orders 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 orders are used in the U.S.;

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

- 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 to be 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 requested orders within a commercially reasonable time; and

- explain how the requested orders would impact U.S. consumers.

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