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IPR Import Restrictions Under Consideration for Drug Used to Treat Hemophilia

Tuesday, August 02, 2016
Sandler, Travis & Rosenberg Trade Report

In investigation 337-TA-956 of recombinant factor VIII products, the International Trade Commission has determined to review in part (a) a final initial determination finding no infringement of two patents asserted by complainants Baxter Healthcare Corporation and Baxter Healthcare SA, and (b) an initial determination granting a summary determination of infringement of one patent. Upon review the ITC has reversed the finding that the economic prong of the domestic industry requirement was not met for either asserted patent; other issues are still under review.

The presiding administrative law judge has recommended that (a) if the ITC does find patent infringement it should issue a limited exclusion order that excludes recombinant factor VIII products manufactured by processes that infringe the asserted claims; (b) such LEO should not extend to products imported to support clinical trials in the U.S.; (c) the respondent should be required to certify to U.S. Customs and Border Protection that any of one of its specific imported products will be used solely for such trials; (d) there should be a grace period of 60 days from the end of the presidential review period before the LEO is enforced; and (e) a cease and desist order containing the above exception and grace period should be directed to each respondent.

The ITC is accepting comments through Aug. 19 on (a) the form of remedy, if any, that should be ordered; (b) the effects of any such remedy on public health and welfare, competitive conditions in the U.S. economy, U.S. production of article that are like or directly competitive with those that are subject to investigation, and U.S. consumers; and (c) the amount of bond under which infringing articles could continue to enter the U.S. during the 60-day period the president has to review any ITC-ordered remedy.

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