No. 21-1567

Biogen International GmbH, et al. v. Mylan Pharmaceuticals Inc.

Lower Court: Federal Circuit
Docketed: 2022-06-15
Status: Denied
Type: Paid
Amici (2) Experienced Counsel
Tags: 35-usc-112 effective-dose efficacy-requirement federal-circuit multiple-sclerosis patent patent-law patent-specification statutory-interpretation written-description
Key Terms:
Patent JusticiabilityDoctri
Latest Conference: 2022-09-28
Question Presented (AI Summary)

Is 35 U.S.C. § 112's written-description requirement met when the specification describes the invention?

Question Presented (from Petition)

QUESTION PRESENTED Biogen’s asserted patent, which claims methods of treating multiple sclerosis by orally administering 480 mg/day of dimethyl fumarate (DMF), expressly states that “an effective dose of DMF ... to be administered to a subject orally can be from ... about 480 mg to about 720 mg per day.” Over a dissent from the panel decision and the dissent of three additional judges from the denial of rehearing en banc, the Federal Circuit nonetheless held that Biogen’s patent did not satisfy 35 U.S.C. §112’s requirement to provide a “written description of the invention” because the patent’s description of the claimed dose did not include data proving the 480 mg/day dose’s efficacy, the claimed effective dose was “listed only once” in the specification, and the patent disclosed other inventions as well. The question presented is: Is 35 U.S.C. § 112’s requirement that a patent specification “contain a written description of the invention” met when the specification describes the invention, or must the specification also disclose data that demonstrates the claimed invention is “effective” and emphasize the claimed invention by singling it out and describing it more than once? @

Docket Entries

2022-10-03
Petition DENIED.
2022-08-31
DISTRIBUTED for Conference of 9/28/2022.
2022-08-30
Reply of petitioners Biogen International GmbH and Biogen MA Inc. filed. (Distributed)
2022-08-15
Brief of respondent Mylan Pharmaceuticals Inc. in opposition filed.
2022-07-15
Brief amici curiae of Pharmaceutical Research and Manufacturers of America, et al.
2022-07-14
Brief amicus curiae of New England Legal Foundation filed.
2022-07-11
Brief amicus curiae of Chemistry and the Law Division of the American Chemical Society filed.
2022-07-01
Motion to extend the time to file a response is granted and the time is extended to and including August 15, 2022.
2022-06-30
Motion to extend the time to file a response from July 15, 2022 to August 15, 2022, submitted to The Clerk.
2022-06-14
Petition for a writ of certiorari filed. (Response due July 15, 2022)

Attorneys

Biogen International GmbH and Biogen MA Inc.
Seth P. WaxmanWilmer Cutler Pickering Hale and Dorr LLP, Petitioner
Seth P. WaxmanWilmer Cutler Pickering Hale and Dorr LLP, Petitioner
Chemistry and the Law Division of the American Chemical Society
James Clark CarverThe Carver Law Firm, Amicus
James Clark CarverThe Carver Law Firm, Amicus
Mylan Pharmaceuticals Inc.
Nathan Kip KelleyPerkins Coie LLP, Respondent
Nathan Kip KelleyPerkins Coie LLP, Respondent
New England Legal Foundation
Daniel Bradford WinslowNew England Legal Foundation, Amicus
Daniel Bradford WinslowNew England Legal Foundation, Amicus
Pharmaceutical Research and Manufacturers of America; Biotechnology Innovation Organization
Jeffrey P. KushanSidley Austin LLP, Amicus
Jeffrey P. KushanSidley Austin LLP, Amicus