Novartis wins at the CAFC

Novartis prevailed on the appeal by HEC:




On appeal, HEC challenges the district court’s decisions concerning the ’405 patent’s written description of the 0.5 mg daily dose limitation and the no-loading-dose negative limitation. “Whether a claim satisfies the written description requirement is a question of fact that, on appeal from a bench trial, we review for clear error.” Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1308 (Fed. Cir. 2015) (quoting Alcon Rsch. Ltd. v. Barr Lab’ys, Inc., 745 F.3d 1180, 1190 (Fed. Cir. 2014)). Under the clear error standard, we will not overturn the district court’s factual finding unless we have a “‘definite and firm conviction’ that a mistake has been made.” Nuvo Pharms. (Ireland) Designated Activity Co. v. Dr. Reddy’s Lab’ys Inc., 923 F.3d 1368, 1376 (Fed. Cir. 2019) (quoting Scanner Techs. Corp. v. ICOS Vision Sys. Corp. N.V., 528 F.3d 1365, 1374 (Fed. Cir. 2008)). The written description requirement is found in section 112 of the patent statute, which provides that the patent’s specification must contain “a written description of the invention, and of the manner and process of making and using it.”5 35 U.S.C. § 112(a). A specification that “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” has adequate written description of the claimed invention. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). “[T]he test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. HEC challenges the district court’s decisions concerning the ’405 patent’s written description of two limitations: the 0.5 mg daily dose limitation and the no-loading-dose negative limitation. Despite arguing that the inventors did not possess the claimed subject matter in 2006, HEC bases its arguments, not on the 2006 priority application’s written description, but on the ’405 patent’s specification—leaving it to this court to independently search the 2006 priority application for written description of the claims. HEC’s confusion is ultimately of no moment, as we find that the claims have adequate written description support in portions of the ’405 specification which also appear in the 2006 priority application.6


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Written description in this case, as in all cases, is a factual issue. In deciding that the district court did not clearly err in finding written description for the negative limitation in the ’405 patent, we do not establish a new legal standard that silence is disclosure, as the dissent asserts. Instead, we merely hold that, on this record, the district court did not clearly err in finding that a skilled artisan would read the ’405 patent’s disclosure to describe the “absent an immediately preceding loading dose” negative limitation. Written description in this case, as in all cases, is a factual issue. In deciding that the district court did not clearly err in finding written description for the negative limitation in the ’405 patent, we do not establish a new legal standard that silence is disclosure, as the dissent asserts. Instead, we merely hold that, on this record, the district court did not clearly err in finding that a skilled artisan would read the ’405 patent’s disclosure to describe the “absent an immediately preceding loading dose” negative limitation.