News & Analysis as of

Section 112 Enablement Inquiries Patents

Volpe Koenig

Artificial Ingenuity: Is Generative AI the New 'Person of Ordinary Skill' in Patent Law?

Volpe Koenig on

The concept of the "person of ordinary skill in the art" (POSITA) remains pivotal in patent law, particularly in evaluating obviousness under 35 U.S.C. § 103 and compliance with enablement and written description requirements...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Written Description and Enablement Depend on What a Patent 'Claims,' Not What the Claims Cover

The Federal Circuit recently reversed a district court decision that found a patent that did not describe after-arising technology failed to satisfy the written description requirement. In so doing, the Federal Circuit...more

Schwabe, Williamson & Wyatt PC

SUPREME COURT RULING: Amgen Inc. et al. v. Sanofi et al, May 18, 2023

Amgen Inc. et al. v. Sanofi et al, No. 21-757 (S. Ct. May 18, 2023) The Supreme Court issued a long-awaited decision today concerning the enablement requirement found in Section 112 of the Patent Act. Specifically, the...more

Bradley Arant Boult Cummings LLP

Supreme Court Delivers the Final Blow to Amgen

The questions from the high court during oral argument at the end of March 2023 were fairly telling of the 9-0 ruling that came down yesterday in Amgen, Inc. v. Sanofi (No. 21-757). In fact, it did not come as much of a...more

Morrison & Foerster LLP - Federal Circuitry

Last Week In The Federal Circuit (April 17 – April 21): Inherent Limits And Patent Enablement

We’re still waiting for the Supreme Court to issue its decision in Amgen v. Sanofi. But in the meantime, the Federal Circuit continues to provide insights into 35 U.S.C. § 112’s requirement to “enable” persons of skill in the...more

Bradley Arant Boult Cummings LLP

Is SCOTUS Looking to Change the Enablement Requirement for Patents?

The Supreme Court is set to hear oral arguments in Amgen, Inc. v. Sanofi (No. 21-757) on Monday, March 27, 2023. The highly contentious question before the high court focuses what an applicant must show to meet the enablement...more

McDonnell Boehnen Hulbert & Berghoff LLP

AbbVie Files Amicus Brief in Amgen v. Sanofi

The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sanofi and Regeneron File Respondents' Brief on Amgen v. Sanofi

Sanofi and Regeneron filed their brief at the Supreme Court in Amgen v. Sanofi, in which Amgen seeks to have the Court overturn the District Court's grant of JMOL in the issue of whether Amgen's claims were invalid for...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Files Its Principal Brief in Amgen v. Sanofi

Facing what is likely to be something of an uphill battle in seeking to have the Federal Circuit's decision against it in Amgen v Sanofi overturned before a not always patent-friendly Supreme Court, Amgen in late December...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Grants Certiorari in Amgen v. Sanofi: High Court Will Tackle Proper Enablement Standard

The Supreme Court on Friday, Nov. 3, granted Amgen’s petition for certiorari on the second of the Questions Presented in its petition...more

Haug Partners LLP

Has the Federal Circuit Just Put the Final Nail in the Coffin of Broad Functional Genus Claims?

Haug Partners LLP on

July 1, 2021 In a development having significant ramifications for many biopharma companies, the Federal Circuit has denied Amgen’s petition for rehearing en banc a decision invalidating a genus patent covering its antibody...more

Haug Partners LLP

Can Biopharma Functional Genus Patent Claims Be Resuscitated?

Haug Partners LLP on

An en banc rehearing petition to the Federal Circuit seeks to breathe life back into the widespread practice of patenting a genus of compounds by claiming their common functional characteristics. This claiming practice was...more

Proskauer - Minding Your Business

CAFC Tightens Enablement Standard for Functional Claiming of Antibodies

In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35...more

Knobbe Martens

Federal Circuit Review - October 2019

Knobbe Martens on

The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more

Knobbe Martens

Large Quantity of Routine Experimentation Can Be “Undue Experimentation”

Knobbe Martens on

IDENIX PHARMACEUTICALS LLC v. GILEAD SCIENCES INC. Before Prost, Newman, and Wallach. Appeal from the United States District Court for the District of Delaware. Summary: Synthesizing and screening tens of thousands of...more

WilmerHale

Federal Circuit Patent Updates - August 2018

WilmerHale on

Ericsson Inc. v. Intellectual Ventures I LLC (No. 2017-1521, 8/27/18) (Reyna, Taranto, Chen) Reyna, J. - Vacating and remanding the PTAB’s IPR decision because the PTAB erred in not considering portions of the petitioner’s...more

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