No. 20-380

Idenix Pharmaceuticals LLC, et al. v. Gilead Sciences, Inc.

Lower Court: Federal Circuit
Docketed: 2020-09-24
Status: Denied
Type: Paid
Amici (3)Response RequestedResponse WaivedRelisted (2) Experienced Counsel
Tags: 35-usc-112a enablement genus-claim genus-claims patent patent-law pharmaceutical-innovation pharmaceuticals statutory-interpretation written-description
Key Terms:
Patent JusticiabilityDoctri
Latest Conference: 2021-01-15 (distributed 2 times)
Question Presented (AI Summary)

Whether the Federal Circuit's genus-claim-specific enablement rule and separate 'possession' requirement are consistent with 35 U.S.C. § 112(a)

Question Presented (OCR Extract)

QUESTIONS PRESENTED The Patent Act provides that patents must “contain a written description of the invention” 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.” 35 U.S.C. § 112(a). The law has long recognized that patents including “genus” claims—i.e., claims that identify a class of substances—can satisfy § 112(a). In the field of pharmaceuticals, inventing a genus of compounds is often the key to lifesaving medical innovation, and spelling out each potential embodiment—that is, every chemical variant with the same property—can be practically impossible. This petition presents two related questions: 1. Whether, as the Federal Circuit has held, a genus claim is not enabled “as a matter of law” if it encompasses a large number of compounds—or whether, as this Court has_ recognized, enablement is a context-specific jury question; and 2. Whether, as the Federal Circuit has held, §112(a) contains a _ separate “possession” requirement—or whether, as the _ statute provides, § 112(a) sets forth a single substantive requirement of “a written description of the invention” sufficient “to enable any person skilled in the art ... to make and use the same.”

Docket Entries

2021-01-19
Petition DENIED.
2020-12-30
DISTRIBUTED for Conference of 1/15/2021.
2020-12-30
Reply of petitioners Universita Degli Studi di Cagliari filed. (Distributed)
2020-12-16
Brief of respondent Gilead Sciences, Inc. in opposition filed.
2020-11-16
Brief amicus curiae of GLAXOSMITHKLINE PLC. filed.
2020-11-16
Brief amicus curiae of Intellectual Property Professors filed.
2020-11-16
Brief amicus curiae of Amgen Inc. filed.
2020-11-02
Motion to extend the time to file a response is granted and the time is extended to and including December 16, 2020.
2020-10-30
Motion to extend the time to file a response from November 16, 2020 to December 16, 2020, submitted to The Clerk.
2020-10-16
Response Requested. (Due November 16, 2020)
2020-10-14
DISTRIBUTED for Conference of 10/30/2020.
2020-10-09
Waiver of right of respondent Gilead Sciences, Inc. to respond filed.
2020-09-21
Petition for a writ of certiorari filed. (Response due October 26, 2020)

Attorneys

Amgen Inc.
Roy T. Englert Jr.Robbins, Russell, et al., Amicus
Roy T. Englert Jr.Robbins, Russell, et al., Amicus
Gilead Sciences, Inc.
E. Joshua RosenkranzOrrick, Herrington & Sutcliffe LLP, Respondent
E. Joshua RosenkranzOrrick, Herrington & Sutcliffe LLP, Respondent
GLAXOSMITHKLINE PLC.
John M. DesmaraisDesmarais LLP, Amicus
John M. DesmaraisDesmarais LLP, Amicus
Idenix Pharmaceuticals LLC
Shay DvoretzkySkadden, Arps, Slate, Meagher & Flom LLP, Petitioner
Shay DvoretzkySkadden, Arps, Slate, Meagher & Flom LLP, Petitioner
Intellectual Property Professors
Mark A. LemleyStanford Law School, Amicus
Mark A. LemleyStanford Law School, Amicus
Universita Degli Studi di Cagliari
Gregory Andrew CastaniasJones Day, Petitioner
Gregory Andrew CastaniasJones Day, Petitioner