News & Analysis as of

Administrative Procedure Act New Guidance

Haug Partners LLP

The PTAB’s Overhaul of Its Discretionary Denial Procedures Signals a Pro-Patent Pivot

Haug Partners LLP on

Since Acting USPTO Director Coke Morgan Stewart took office in 2025, the Patent Trial and Appeal Board (PTAB) has overhauled its discretionary denial procedures for inter partes reviews (IPRs) and post-grant reviews (PGRs)....more

Shumaker, Loop & Kendrick, LLP

Client Alert: The Trump Administration Issues Guidance to Repeal Regulations

On April 9, 2025, the Trump Administration issued guidance that calls for the massive repeal of regulations throughout federal agencies. The guidance cites multiple Supreme Court decisions, including Loper Bright Enterprises...more

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

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In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

Sheppard Mullin Richter & Hampton LLP

Breaking Down the Bifurcated PTAB Review Process: What the USPTO’s Recent FAQ Drop Reveals

On March 26, 2025, the U.S. Patent and Trademark Office released a memorandum introducing a new interim process for handling institution decisions in inter partes reviews (IPRs) and post-grant reviews (PGRs). The Office just...more

Baker Botts L.L.P.

Impact of New USPTO Interim Procedures on Discretionary Denial of AIA Proceedings

Baker Botts L.L.P. on

Key Takeaway: The USPTO has reinstated earlier discretionary denial standards (including Fintiv) and introduced a new two-phase review process, which is expected to lead to more frequent denials of IPR petitions. Both patent...more

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

PTAB Issues Additional Information on New Pre-Institution Discretionary Briefing

On April 25, 2025, the USPTO issued additional information in response to frequently asked questions (FAQs) about the “Interim Processes for PTAB Workload Management” memorandum issued on March 26, 2025. As discussed in our...more

McGuireWoods LLP

Role of USPTO’s Delegated Rehearing Panel Changing With New Administration

McGuireWoods LLP on

Coke Morgan Stewart, named on Inauguration Day 2025 as deputy director of the U.S. Patent and Trademark Office (USPTO) and now serving as acting director of the USPTO, has already indicated that she will manage Director...more

Mayer Brown

Examining New Guidance from the USPTO on Discretionary Denials in AIA Post-Grant Proceedings

Mayer Brown on

Recent changes at the US Patent and Trademark Office (USPTO) concerning the Patent Trial and Appeal Board's (PTAB) discretion to deny institution of inter partes reviews (IPRs) or post-grant reviews (PGRs) based on parallel...more

Gibney Anthony & Flaherty, LLP

What Student Visa Holders and Employers Need to Know About Recent Student Visa Rescissions and Increased Scrutiny

The Department of State (DOS) has recently increased scrutiny of existing student visa holders and those requesting new student visas at U.S. consulates abroad. Some F-1 visas and SEVIS records have been rescinded or...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

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

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

BCLP

FinCEN Provides Guidance to Reporting Companies in Wake of Second Appeal to Fifth Circuit

BCLP on

As previously reported, the Supreme Court has already considered on an emergency basis whether to stay Corporate Transparency Act (“CTA”) enforcement deadlines. In that case, McHenry v. Texas Top Cop Shop, Inc., No. 24A653,...more

Ballard Spahr LLP

ABA issues white paper on agency guidance and sends letters to regulators commenting on recently-issued guidance

Ballard Spahr LLP on

The American Bankers Association (ABA) has issued a new white paper, “Effective Agency Guidance: Examining Bank Regulators’ Guidance Practices,” that is intended to help agencies issue guidance that complies with legal...more

King & Spalding

EPA Addresses Environmental Justice and Civil Rights in Permitting

King & Spalding on

The EPA’s External Rights Compliance Office recently released Interim Environmental Justice and Civil Rights in Permitting Frequently Asked Questions (“the FAQ”). Stressing “that it is time to use the full extent of its...more

ArentFox Schiff

EPA Issues New Policy on Its Use of Consent Decrees and Settlements

ArentFox Schiff on

The US Environmental Protection Agency (EPA) recently updated its guidance on “sue-and-settle” situations – a contentious approach to resolving claims alleging that the agency has failed to perform a required duty. Successive...more

Seyfarth Shaw LLP

Dreamers Face DACA Reboot

Seyfarth Shaw LLP on

Seyfarth Synopsis: In light of the recent Supreme Court decision, DHS continues the DACA program, but implements new guidance as it conducts a complete review of the program....more

McDermott Will & Emery

New Guidance on Medicare Payment Rule Enforcement

McDermott Will & Emery on

A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...more

Allen Matkins

White House Orders Agencies To Offer Opinion Letters Or Does It?

Allen Matkins on

Last month, the White House issued this fact sheet concerning two executive orders intended "to improve the transparency and fairness of government agencies and ensure that they are held accountable". The fact sheet describes...more

King & Spalding

President Trump Issues Executive Order Limiting Agency Use of Informal Guidance Documents

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On October 9, 2019, President Trump issued an Executive Order aimed to curb agencies, such as CMS, from using informal guidance documents as de facto rules that have the binding effect of law. In a press conference...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Beltway Buzz - October 2019 #2

Supreme Return. The Supreme Court of the United States kicked off its 2019 term this week with a few blockbuster oral arguments. On October 9, 2019, the Court heard oral argument in three cases concerning whether gender...more

Katten Muchin Rosenman LLP

SEC Warns Advisers to Up Their Game on Proxy Voting

On August 21, a sharply divided Securities and Exchange Commission (SEC) issued two interpretive releases addressing the proxy voting obligations of investment advisers and the obligations of proxy advisory firms....more

Stinson LLP

California Communities Against Toxics: The "Continuing Project" of Clarifying Administrative Law

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In California Communities Against Toxics v. EPA, the U.S. Court of Appeals for the DC Circuit issued an opinion that may have a lasting impact on administrative agencies’ use of guidance memos and policy statements. For...more

Downey Brand LLP

Cause for Concern Over Organic Fertilizer Made from Food Waste?

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In December 2016, the National Organic Program (NOP) issued guidance 5034-1 that can be interpreted as approving of food waste for use in organic crop production (for example, as an input in fertilizer) without regard to...more

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