In a potential indicator of the pharmaceutical industry’s increasing interest in the ITC as a litigation forum, on April 16 Baxter International Inc., Baxter Healthcare Corporation and Baxter Healthcare SA filed an ITC complaint against Novo Nordisk A/S, Denmark and Novo Nordisk Inc. concerning Novo’s forthcoming hemophilia treatment, Novoeight®.
Baxter’s ITC complaint comes less than a month after Novo Nordisk filed a declaratory judgment complaint against Baxter in the United States District Court, District of New Jersey. Apparently triggered by a letter sent by Baxter concerning Novoeight®, Novo Nordisk’s DJ complaint urged that seven Baxter patents are invalid and not infringed by Novoeight®. Baxter’s ITC complaint alleges infringement of two of those seven patents. The patents in the ITC case cover manufacturing techniques allegedly practiced in Novo Nordisk’s Denmark-based manufacture of Novoeight®.
ITC cases between pharmaceutical companies are historically rare. One reason is that the 30-month FDA stay available under the Hatch-Waxman Act for brand suits against generic manufacturers is not available for ITC cases. For cases such as this one between two brand companies, the ITC may be an increasingly-attractive forum where the alleged infringer manufactures overseas. Because the sole relief for ITC complainants is an order barring importation of infringing goods, the ITC has limited use as a forum against companies whose manufacturing is domestic. Further, to obtain relief, an ITC complainant must show a “domestic industry” in the asserted patent beyond simple sales of the patented product, e.g., licensed manufacturing of the product. In this case, Baxter alleges that it can satisfy the domestic industry requirement via activities in Thousand Oaks, California, in connection with the manufacture of its own anti-hemophilia treatment, Advate.
The ITC has requested comments no later than May 1 on any public interest issues raised by Baxter’s complaint. A decision on institution is expected no later than May 18, 2015.