17
Jul
By Eric Schweibenz and Alex Englehart
On July 7, 2017, Bioverativ Inc., Bioverativ Therapeutics Inc., and Bioverativ U.S. LLC (collectively, “Bioverativ”)—all of Waltham, Massachusetts—filed a complaint requesting that the ITC commence an investigation pursuant to Section 337.

The complaint alleges that CSL Behring LLC of King of Prussia, Pennsylvania, CSL Behring GmbH of Germany, and CSL Behring Recombinant Facility AG of Switzerland (collectively, “CSL”) unlawfully import into the U.S., sell for importation, and/or sell within the U.S. after importation certain recombinant Factor IX products that infringe one or more claims of U.S. Patent Nos. 9,670,475 (the ’475 patent), 9,623,091 (the ’091 patent), and 9,629,903 (the ’903 patent) (collectively, the “asserted patents”).

According to the complaint, the asserted patents generally relate to the control and prevention of bleeding episodes, perioperative (surgical) management, and routine prophylaxis in adults and children with hemophilia B. In particular, the ’475 patent relates to methods of controlling a bleeding episode in a human subject by administering multiple doses of about 25 IU/kg to about 50 IU/kg of a chimeric Factor IX polypeptide comprising Factor IX and an FcRn binding partner (e.g., Fc or albumin) at a dosing interval of about 7 days between two doses in order to maintain the plasma Factor IX activity of the subject above 1 IU/dL during the dosing interval. The ’091 patent relates to methods of treating hemophilia B in a human subject by intravenously administering multiple doses of about 50 IU/kg to about 100 IU/kg of chimeric Factor IX polypeptide comprising Factor IX and an FcRn binding partner (e.g., Fc or albumin) at a dosing interval of about 10 days to about 14 days between two doses in order to maintain the plasma Factor IX activity of the subject above 1 IU/dL and reduce the frequency of spontaneous bleeding. Lastly, the ’903 patent relates to methods of treating hemophilia B in a human subject by intravenously administering multiple doses of about 50 IU/kg to about 100 IU/kg of a chimeric Factor IX polypeptide comprising Factor IX and an FcRn binding partner (e.g., Fc or albumin) at a dosing interval of about 10 days to about 14 days between two doses in order to maintain a trough level of plasma Factor IX activity of at least 3 IU/dL after six days and reduce the frequency of spontaneous bleeding.

In the complaint, Bioverativ states that CSL imports and sells products that infringe the asserted patents. The complaint specifically refers to CSL’s Idelvion product as an infringing product.

Regarding domestic industry, Bioverativ states that its Alprolix product practices at least one claim of each asserted patent. Bioverativ further states that it, its contract manufacturer Biogen Inc. (“Biogen”), and third-party logistics providers employ U.S.-based personnel and resources in the manufacture, packaging, sale, and post-sale support of Alprolix. Bioverativ states in particular that Biogen manufactures Alprolix drug substance in North Carolina. Bioverativ further states that its U.S.-based personnel are involved in post-approval clinical studies and efforts to educate and support the medical community, patients using Alprolix, and the broader hemophilia community.

As to related litigation, Bioverativ states that, concurrently with the filing of the instant ITC complaint, it also filed a complaint against CSL in the U.S. District Court for the District of Delaware alleging infringement of the asserted patents.

With respect to potential remedy, Bioverativ requests that the Commission issue a limited exclusion order and cease and desist orders directed at CSL and related entities.
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