No. 18-127

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

Lower Court: Federal Circuit
Docketed: 2018-07-27
Status: Denied
Type: Paid
Amici (1)Response RequestedRelisted (2) Experienced Counsel
Tags: 35-usc-112 biotechnology enablement federal-circuit innovation patent-law possession statutory-interpretation written-description
Key Terms:
Patent Privacy JusticiabilityDoctri
Latest Conference: 2019-01-04 (distributed 2 times)
Question Presented (AI Summary)

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 full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains * * * to make and use the same'—or whether court-created standards should control instead

Question Presented (OCR Extract)

QUESTION PRESENTED 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”). [bid. 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, Ta (quoting Aviad, 598 F.3d at 1850). The Federal Circuit has announced (and then modified or rescinded) various specialized “possession” sub-tests, as well as the evidence relevant to “possession.”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) ii full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains * * * to make and use the same”—or whether court-created standards should control instead.

Docket Entries

2019-01-07
Petition DENIED.
2018-12-05
DISTRIBUTED for Conference of 1/4/2019.
2018-12-04
Reply of petitioners Amgen Inc., et al. filed. (Distributed)
2018-11-19
Brief of respondents Sanofi, et al. in opposition filed.
2018-09-20
Motion to extend the time to file a response is granted and the time is extended to and including November 19, 2018
2018-09-20
Motion to extend the time to file a response from October 18, 2018 to November 17, 2018, submitted to The Clerk.
2018-09-18
Response Requested. (Due October 18, 2018)
2018-09-12
DISTRIBUTED for Conference of 10/5/2018.
2018-08-27
Brief amici curiae of Bristol-Myers Squibb Company, Morphosys AG, Bavarian Nordic A/S, and UCB Biopharma SPRL filed.
2018-07-23
Petition for a writ of certiorari filed. (Response due August 27, 2018)
2018-05-14
Application (17A1262) granted by The Chief Justice extending the time to file until July 23, 2018.
2018-05-11
Application (17A1262) to extend the time to file a petition for a writ of certiorari from May 24, 2018 to July 23, 2018, submitted to The Chief Justice.

Attorneys

Amgen Inc., et al.
Jeffrey Alan LamkenMoloLamken LLP, Petitioner
Jeffrey Alan LamkenMoloLamken LLP, Petitioner
Bristol-Myers Squibb Company, Morphosys AG, Bavarian Nordic A/S, and UCB Biopharma SPRL
Jorge Alberto GoldsteinSterne, Kessler, Goldstein & Fox, P.L.L.C., Amicus
Jorge Alberto GoldsteinSterne, Kessler, Goldstein & Fox, P.L.L.C., Amicus
Sanofi, et al.
Paul D. ClementKirkland & Ellis LLP, Respondent
Paul D. ClementKirkland & Ellis LLP, Respondent