Amgen Inc., et al. v. Sanofi, et al.

The 1952 Patent Act requires patents to “contain a written description of the invention, and of the manner and process of making and using it.” 35 U.S.C. § 112(a). The “written description” must be “in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” Ibid. “The object of the statute is to require the patentee to describe his invention so that others may construct and use it after the expiration of the patent.” Schriber-Schroth Co. v. Cleveland Tr. Co., 305 U.S. 47, 57 (1938). The Federal Circuit has construed § 112(a) as imposing separate “written description” and “enablement” requirements subject to different standards. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1344 (Fed. Cir. 2010) (en banc). The Federal Circuit holds that the standard in § 112(a)—“in such full, clear, concise, and exact terms as to enable” skilled artisans “to make and use” the invention—does not govern written description of the invention; it applies only to the “enablement” requirement (“the manner and process of making and using”). Ibid. For “written description of the invention,” the Federal Circuit applies its own standard: The patent disclosure must demonstrate that the inventor “ ‘had possession’ ” of the invention “ ‘as of the filing date.’ ” App., infra, 7a (quoting Ariad, 598 F.3d at 1350). The Federal Circuit has announced (and then modified or rescinded) various specialized “possession” sub-tests, as well as the evidence relevant to “possession.” The question presented is: Whether the standard for determining the adequacy of the “written description of the invention” should be as the statute says—that the description must be “in such (i)