Takeda Pharmaceuticals USA, Inc. v. West-Ward Pharmaceutical Corporation, et al., C.A. No. 14-1268-SLR, October 9, 2014.
Robinson, J. Plaintiff’s motion for a temporary restraining order is granted.
Defendants have launched a branded product, Mitigare, and intended to launch a generic version, for prophylaxis of gout. Defendants had not filed an ANDA with the FDA. Defendants’ product has the same active ingredient, route of administration, and strength as plaintiff’s patented product. Defendants omitted from their label mention of uses for which plaintiff has patent protection. The court concludes that it is not limited to patented uses approved by the FDA but may consider the realities of the marketplace in which the parties compete. In particular, the court considers the permissive attitude of the FDA toward the promotion of off-label uses of drugs. The court found there was sufficient evidence to allege direct and induced infringement. There is also sufficient evidence that a generic launch will significantly impact plaintiff’s market share. The balance of hardships weighs in plaintiff’s favor because defendants have “effectively side-stepped the ANDA regime in an effort to get its generic product to market without appropriate legal underpinnings.”