Takeda Pharma., U.S.A. v. Hikma Am., Inc., No. 15-1139 (Fed. Cir. 2015)Annotate this Case
Takeda owns several asserted patents that cover several methods of administering colchicine products to treat gout. Colchicine itself, which has been used for centuries, is not covered by Takeda’s patents. Takeda has patents directed to treating acute gout flares and others directed to methods for administering colchicine for prophylaxis of gout in patients who are concomitantly taking certain drug inhibitors known as “CYP3A4” and “P-gp” inhibitors. In 2010, Hikma sought FDA approval of a colchicine product for prophylaxis of gout flares. It submitted an New Drug Application under the Hatch Waxman Act, 21 U.S.C. 355(b)(2). In 2014, the FDA granted Hikma approval to market its Mitigare colchicine capsule. Hikma launched Mitigare, and Takeda filed suit, asserting induced infringement under 35 U.S.C. 271(b) based on Hikma’s labeling of the Mitigare product. Hikma planned on launching an authorized generic version of Mitigare in October 2014. The district court granted Takeda’s request for a temporary restraining order, but later denied a preliminary injunction. The Federal Circuit affirmed. Takeda acknowledged that evidence of mere knowledge of infringing uses is not sufficient and did not establish a probability of success on the issue of infringement.