On August 22, 2023, the U.S. Court of Appeals for the Federal Circuit issued yet another decision reinforcing what can only be described as the “lead compound” rule for challenging pharmaceutical and other chemical compound patents on the basis of obviousness…. The Federal Circuit has been utilizing the “lead compound” construct since around 2000. The Sun panel cited an earlier decision which couched the construct as something the court “ordinarily” employs. Otsuka Pharm. Co., Ltd. v. Sandoz Inc., 678 F. 3d 1280, 1289 (Fed. Cir. 2012). That earlier decision cited yet an earlier decision which stated that the “lead compound” methodology is used “in general.” Esai Co. v. Dr. Reddy’s Labs., Ltd., 533 F. 3d 1353, 1359 (Fed. Cir. 2008).
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