On April 16, 2015, Baxter International Inc. of Deerfield, Illinois, Baxter Healthcare Corp. of Deerfield, Illinois, and Baxter Healthcare SA of Switzerland (collectively, "Baxter") filed a complaint requesting that the ITC commence an investigation pursuant to Section 337.
The complaint alleges that Novo Nordisk A/S of Denmark and Novo Nordisk Inc. of Plainsboro, New Jersey (collectively, "Novo Nordisk") unlawfully import into the U.S., sell for importation, and/or sell or imminently sell within the U.S. after importation certain recombinant factor VIII products that infringe one or more claims of U.S. Patent Nos. 6,100,061 (the '061 patent), 6,936,441 (the '441 patent), and 8,084,252 (the '252 patent) (collectively, the "asserted patents").
According to the complaint, the asserted patents generally relate to novel processes for the manufacture of recombinant proteins in a serum- and protein-free environment, including recombinant factor VIII products, used by medical providers to treat patients with hemophilia A.
In the complaint, Baxter states that Novo Nordisk imports and sells products that infringe the asserted patents. The complaint specifically refers to Novo Nordisk recombinant factor VIII products such as Novoeight®.
Regarding domestic industry, Baxter states that it makes extensive use of the inventions claimed in the asserted patents in its recombinant protein products, including its recombinant factor VIII product Advate®. Baxter states that it manufactures such products in the U.S., including at a facility in Thousand Oaks, California. Baxter further states that it has nearly completed construction of a new U.S. facility. Further, Baxter states that its U.S.-based personnel and resources are involved in manufacturing, packaging, post-sale support, and patient education in connection with products that practice the asserted patents.
As to related litigation, Baxter states that on March 26, 2015, Novo Nordisk Inc. filed a declaratory judgment action in the U.S. District Court for the District of New Jersey seeking a declaratory judgment of non-infringement and invalidity of the asserted patents as well as other Baxter patents. Baxter also refers to a pending appeal in a European opposition proceeding on a European patent concerning related technology.
With respect to potential remedy, Baxter requests that the Commission issue a limited exclusion order and permanent cease and desist orders directed at Novo Nordisk and others acting on their behalf.