News & Analysis as of

Administrative Procedure Act Patents

Robins Kaplan LLP

Vanda Pharms., Inc. v. FDA

Robins Kaplan LLP on

Hetlioz® (tasimelteon) - Case Name: Vanda Pharms., Inc. v. FDA, Civ. No. 23-280 (TSC), 2025 WL 485401 (D.D.C. Feb. 13, 2025) (Chutkan, J.) Drug Product and Patent(s)-in-Suit: Hetlioz® (tasimelteon); U.S. Patent No. , a...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Recent Updates at the U.S. Patent Trial and Appeal Board

Recent changes at the U.S. Patent Trial and Appeal Board (PTAB) have brought uncertainty to inter partes review and post-grant review practitioners before the U.S. Patent and Trademark Office (PTO). These procedural and...more

Jones Day

PTAB Pendulum Swings in Favor of Discretionary Denial

Jones Day on

Recent developments at the USPTO suggest a significant shift in favor of the PTAB exercising discretionary denial and uncertainty on behalf of parties to PTAB proceedings.  ...more

McDermott Will & Emery

Detour Ahead: New Approach to Assessing Prior Art Rejections Under § 102(e)

The US Court of Appeals for the Federal Circuit established a more demanding test for determining whether a published patent application claiming priority to a provisional application is considered prior art under pre-America...more

Jones Day

PTAB Announces Bifurcated Process for Consideration of Discretionary Denial Issues

Jones Day on

A new interim process for the Director to exercise discretion as to whether to institute an inter partes review(IPR) or a post grant review (PGR) was announced on March 26, 2025, in which discretionary considerations and...more

Foley Hoag LLP

PTAB Changes Procedure for Determining Discretionary Denials

Foley Hoag LLP on

Key Takeaways: - The Director, in consultation with at least three APJs, will now decide the discretionary denial question, rather than having the merits panel decide the issue. - Discretionary denial will have separate...more

Kilpatrick

Pre-Institution Overhaul: Unpacking the PTAB’s New Briefing Procedures

Kilpatrick on

Hot on the heels of rescinding former Director Vidal’s June 2022 memo providing guidance on discretionary denials, Acting Director of the USPTO, Coke Morgan Stewart, issued a memo yesterday outlining new “Interim Processes...more

Morrison & Foerster LLP

Pivot At The PTAB: The Acting Director Bifurcates Review

With two memoranda this week, the United States Patent and Trademark Office (“USPTO”) has made significant changes to trials at the Patent Trial and Appeal Board (“PTAB”). Those trials—introduced in 2012 by the Leahy-Smith...more

Knobbe Martens

IPR Standing Arguments Not Presented to the Board Are Forfeited

Knobbe Martens on

APPLE INC. v. GESTURE TECHNOLOGY PARTNERS, LLC - Before Moore, Prost, and Stoll. Appeal from the Patent Trial And Appeal Board. A patent owner forfeits its argument that an IPR petitioner lacks standing under 35 U.S.C....more

McDermott Will & Emery

PTO Reverts to Prior Post-Grant Guidelines for Cases Involving Parallel District Court Litigation

McDermott Will & Emery on

On February 28, 2025, the acting director of the US Patent & Trademark Office (PTO) announced that the agency will revert to previous guidelines for discretionary denials of petitions for post-grant proceedings where there is...more

McDermott Will & Emery

An Odyssey of Timeliness: Appointments Clause Arguments Must Be Preserved

McDermott Will & Emery on

Citing forfeiture, the US Court of Appeals for the Federal Circuit upheld the dismissal of a complaint against the US Patent & Trademark Office (PTO). The complaint sought director review of a 2018 Patent Trial & Appeal Board...more

Rothwell, Figg, Ernst & Manbeck, P.C.

USPTO Withdraws June 2022 Guidance on Fintiv Denials

On Friday, February 28, 2025, the United States Patent and Trademark Office (USPTO) announced the withdrawal of the June 2022 memorandum titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with...more

Venable LLP

USPTO Rescinds 2022 Fintiv Memorandum

Venable LLP on

On February 28, 2025, the USPTO issued a Notice rescinding a Memorandum issued by former Director Kathy Vidal, which, since June 21, 2022, had defined USPTO guidance regarding whether to discretionarily deny a post-grant...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Resolving Claim Ambiguity via Reissue

Takeaways - -Intra-patent claim inconsistencies are errors correctible via reissue. -Subtle legal distinctions in reissue may require PTAB appeals. Patent prosecution errors occur. One such error that occurs is...more

Womble Bond Dickinson

USPTO’s Proposed Terminal Disclaimer Practice: What Happened and What Comes Next?

Womble Bond Dickinson on

On May 10, 2024, the United States Patent and Trademark Office (“USPTO”) published a new proposed rule that would require when a patent applicant submits a terminal disclaimer to obviate non statutory double patenting that...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2024 PTAB Year in Review: Analysis & Trends

The Patent Trial and Appeal Board (PTAB) continues to play a pivotal role in shaping the intellectual property landscape. In 2024, several developments affecting PTAB practice emerged, from new rulemaking at the USPTO to key...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Director Review Codified as Director Vidal Steps Down—What is this Power and How Did Vidal Wield It?

With U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal’s return to private practice in December 2024 and the future permanent Director yet to be tapped for nomination, it is a good time to reflect on one of the...more

Jones Day

Prior Art Asserted in Second Petition Should Have Been Asserted in the First

Jones Day on

The PTAB denied institution of a second inter partes review (“IPR”) petition filed by Aylo Freesites (“Petitioner”) after having previously instituted inter partes review of Petitioner’s first petition related to the same...more

Erise IP

Eye on IPRs: January 2025: USPTO Fee Increases; Patent Challengers Can't Dismiss Fed. Cir. Appeal After Decision

Erise IP on

Effective January 19, 2025, the USPTO is increasing various patent filing fees, including an across-the-board fee increase as well as specific increases for America Invents Act trials, Director Review, and other procedures....more

Rothwell, Figg, Ernst & Manbeck, P.C.

Reviewing 2024's Crucial Patent Law Developments

As 2024 draws to a close, several crucial developments — some aimed at modernizing long-standing legal practices, others addressing emerging challenges — have reached patent law. Originally published in Law360 - December...more

Fuerst Ittleman David & Joseph

Compounded GLP-1 Drugs: is the Party Over? These Are the Legal and Regulatory Issues for Game Changing Weight Loss Products and...

Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more

McDermott Will & Emery

Got Pillaged? Not If You Didn’t Follow the APA and FTCA

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a district court decision dismissing claims under the Administrative Procedure Act (APA) and Federal Tort Claims Act (FTCA) against the US Patent & Trademark Office...more

Flaster Greenberg PC

Chevron’s Demise and Its Effect on Intellectual Property & Its Governing Agencies

Flaster Greenberg PC on

For many, the demise of Chevron – the doctrine by which agencies enjoy deference in interpreting ambiguous statutes – has long been coming. While Chevron’s demise, and the resulting resurgence of Skidmore, is likely to lead...more

Fenwick & West LLP

En banc Hearing Petition Filed on Recent Fed. Circ. Collateral Estoppel Decision

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The Court of Appeals for the Federal Circuit has sparked debate following a recent ruling on the Patent Trial and Appeal Board's (PTAB) application of estoppel provisions in invalidating amended claims in inter partes...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Reexamination Petition Practice Is a Critical Tool for Patent Owner Success

Takeaways: 1. Nontraditional and unique issue petitions are common for patent owners to properly prosecute reexamination proceedings. 2. Well-drafted petitions influence outcomes and preserve PTAB, District Court, and/or...more

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