News & Analysis as of

Section 112

American Conference Institute (ACI)

[Event] 23rd Advanced Summit on Life Sciences Patents - May 19th - 20th, New York, NY

At ACI’s 23rd Advanced Summit on Life Sciences Patents, you can expect informational overviews and thorough discussion of every facet of the industry. In a time of major legislative, regulatory, and judicial change, you can't...more

Sheppard Mullin Richter & Hampton LLP

2024 Federal Circuit Case Summaries - Intellectual Property: Year End Report

We are excited to present the second edition of Sheppard Mullin’s “Year in Review” report, which provides a comprehensive summary of the key precedential Federal Circuit decisions related to patent law in 2024. Building on...more

Polsinelli

Judge Connolly (D. Del.) Overturns $96 Million Molecular Diagnostics Jury Verdict, Finds Patents Invalid Under § 112

Polsinelli on

Synopsis: In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera,...more

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

Latest Federal Court Cases: Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) Our Case of the Week is a 31-page decision that touches on a variety of issues, including...more

Baker Botts L.L.P.

35 U.S.C. § 112 in IPR: I know you cannot use it to invalidate a claim, but how about breaking the priority chain?

Baker Botts L.L.P. on

It is well established that “a petitioner in an inter partes review … is not permitted to assert a ground of unpatentability under 35 U.S.C. § 112.” Dexcowin Golabl, Inc. v. Aribex, Inc., IPR2016-00436, Paper 12 (PTAB July 7,...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2024 #3

Vascular Solutions LLC v. Medtronic, Inc., Appeal No. 24-1398 (Fed. Cir. Sept. 16, 2024) In our Case of the Week, the Federal Circuit evaluated certain heavily litigated claims directed to guide catheters. The patents...more

Goldberg Segalla

Big Wheel Keep on Turnin’, EPA Keep on Churnin’ Out Regulations

Goldberg Segalla on

Stationary combustion turbines, often referred to as gas turbines, are used to generate high volumes of electricity at power stations, dams, and industrial centers. Despite their size, noise, and prodigious output, these...more

Jones Day

Petition Denied for Lacking Section 112(f) Construction and Fintiv

Jones Day on

On March 7, 2024, the PTAB denied institution in 10x Genomics, Inc. v. President and Fellows of Harvard College, IPR2023-01299, Paper 15 (PTAB Mar. 7, 2024) (“Decision”). The PTAB denied institution on two separate grounds:...more

Sheppard Mullin Richter & Hampton LLP

2023 Federal Circuit Case Summaries - Intellectual Property: Year End Report

We are pleased to share Sheppard Mullin’s inaugural “Year in Review” report that collects and reports on most key patent law-related Federal Circuit decisions for 2023. This is a follow up to the quarterly report we...more

American Conference Institute (ACI)

[Event] 20th Paragraph IV Disputes - April 25th - 26th, New York, NY

Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...more

McDermott Will & Emery

PTO Continues to Wave Wands in Assessing Enablement

McDermott Will & Emery on

In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance...more

Mitchell, Williams, Selig, Gates & Woodyard,...

112(r)/Air Enforcement: U.S. Environmental Protection Agency and Downington Town, Pennsylvania, Water Authority Enter into...

The United States Environmental Protection Agency (“EPA”) and Downington Regional Water Authority (“DRWA”) entered into an Expedited Settlement Agreement (“ESA”) addressing alleged violations of Section 112(r) of the Clean...more

Bradley Arant Boult Cummings LLP

More Antibody Claims Falling Under Post-Amgen Scrutiny

With only two precedential IP decisions coming down from the Federal Circuit in the second half of September, pickings were a little slim for blogging. That said, the opinion in Baxalta v. Genentech (2022-1461) — drafted by...more

Venable LLP

[Ongoing Program] Life Sciences Series - Current Trends in ANDA Litigation - October 31st, 1:00 pm - 2:00 pm ET

Venable LLP on

We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2023 #4

United Therapeutics Corporation v. Liquidia Technologies, Inc., Appeal Nos. 2022-2217, 2023-1021 (Fed. Cir. July 24, 2023) In the Federal Circuit’s only precedential patent case this week, the Court considered questions...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

Sheppard Mullin Richter & Hampton LLP

2023 Federal Circuit Case Summaries

We are excited to share Sheppard Mullin’s inaugural quarterly report on key Federal Circuit decisions. The Spring 2023 Quarterly Report provides summaries of most key patent law-related decisions from January 1, 2023 to March...more

Bradley Arant Boult Cummings LLP

Searching for Claim Support in a Patent Specification? You Better Blaze a Trail

Last month the Federal Circuit affirmed a PTAB inter partes review (IPR) decision finding that the University of Minnesota’s patent claim directed to the anti-cancer drug sofosbuvir was not adequately supported by the written...more

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more

Morgan Lewis

USPTO Director Vidal: Decision on Treatment of Multiple Dependent Claims Is Precedential

Morgan Lewis on

US Patent and Trademark Office (USPTO) Director Katherine K. Vidal recently designated as precedential a decision by the Patent Trial and Appeal Board (PTAB or Board) in IPR2020-01234, which granted rehearing and modified 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

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