News & Analysis as of

Administrative Procedure

Goodwin

Charting a Conditional Approval Pathway for Rare Disease Drugs - A Top Priority for a Revamped FDA?

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On April 18, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced plans to roll-out a new approval pathway for rare disease drugs. ...more

Latham & Watkins LLP

European Commission Announces Simplifications to the Implementation of the EU Deforestation Regulation

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The updated guidance includes simplification measures allowing due diligence statements’ reuse, annual submission, and management by authorised representatives on behalf of companies....more

Jones Day

PTAB Announces a Bifurcated Process for Consideration of IPR and PGR Petitions

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A new interim process for the acting 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...more

Latham & Watkins LLP

USPTO Implements Interim Procedures Bifurcating Decisions to Institute AIA Trials

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On March 26, 2025, Acting Director of the United States Patent and Trademark Office (USPTO) Coke Morgan Stewart issued a memorandum (the Workload Memorandum) to all Administrative Patent Judges (APJs) of the Patent Trial and...more

Holland & Knight LLP

New York Court Strikes Down CDPAP Reimbursement Changes

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In a significant development for fiscal intermediaries (FIs) and the Consumer Directed Personal Assistance Program (CDPAP), a New York Supreme Court Justice ruled on March 20, 2025, that the New York State Department of...more

Fish & Richardson

EPRx 101: Getting to Know Ex Parte Reexamination

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Ex parte reexamination (EPRx) is a powerful tool that allows any party — including the patent owner — to request that the United States Patent and Trademark Office (USPTO) reassess the validity of an issued patent based on...more

White & Case LLP

Amendments to the Amparo Law

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On March 13, 2025, the Federal Official Gazette published the decree amending and repealing various provisions of the Amparo Law (the "Amendment"). Substance and Objectives of the Amendment - This amendment to the Amparo...more

BCLP

Patent Office Withdraws Previous Discretionary Denial Guidance for Post-Grant Proceedings

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On Friday afternoon, February 28, 2025, the United States Patent and Trademark Office (USPTO) issued a brief “bulletin” rescinding a memorandum issued by the former Director Kathy Vidal (“Vidal Memo”) providing guidance on...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

Morrison & Foerster LLP

Federal Circuit Significantly Broadens Qualifying Expenses for Economic Domestic Industry at the ITC

On March 5, the Federal Circuit held that sales, marketing, warehousing, quality control, or distribution expenditures may count as “employment of labor or capital” for purposes of satisfying the economic domestic industry...more

Smart & Biggar

Canadian Patent Office resumes granting of patents and is temporarily publishing list of pre-grant patents

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The Canadian Patent Office (CIPO) has advised that as of January 14, 2025, it had granted patents for which final fees were processed in the old system. CIPO has started to process applications where final fees were paid in...more

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

OSH Law Primer, Part XI (Continued): Understanding and Contesting OSHA Citations - The Whys and Hows

This is a continuation of the eleventh installment in a series of articles intended to provide the reader with a very high-level overview of the Occupational Safety and Health (OSH) Act of 1970 and the Occupational Safety and...more

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

Supreme Court Says Alabama’s Exhaustion of State Processes Rule Unlawfully Blocked Due Process Claims

On February 21, 2025, the Supreme Court of the United States ruled that an Alabama rule requiring claimants to first exhaust the state administrative appeals process before bringing due process claims over delays in their...more

Dorsey & Whitney LLP

The Supreme Court Update - February 21, 2025

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The Supreme Court of the United States issued three decisions today: Wisconsin Bell, Inc. v. United States, ex rel. Heath, No. 23-1127: This case considers whether reimbursement requests submitted to the Federal...more

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

State Department Updates Criteria for Nonimmigrant Visa Interview Waivers

On February 18, 2025, the U.S. Department of State updated visa interview waiver (“drop box”) eligibility criteria for individuals renewing their visa stamps, resulting in sudden drop box appointment cancellations and...more

ArentFox Schiff

Navigating Changes at the USPTO: Impact of New Government Cost-Reduction Initiatives

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The new presidential Administration’s cost-reduction initiatives, including a hiring freeze and return-to-office mandate for federal employees, are poised to impact the efficiency of the US Patent and Trademark Office...more

WilmerHale

Preparing for EDGAR Next

WilmerHale on

On March 24, 2025, enrollment for EDGAR Next will open. All EDGAR filers, including existing reporting entities, Section 16 reporting persons, and Section 13 filers, are required to transition to the new system by September...more

Cozen O'Connor

Amendments to Trademarks Regulations Prompt Changes at Trademarks Opposition Board

Cozen O'Connor on

On January 29, 2025, the Canadian Intellectual Property Office (CIPO) announced that the long-awaited amendments to the Trademarks Regulations (SOR/2018-227) and new practice notices implementing cost awards, confidentiality...more

Tonkon Torp LLP

The Return of Extreme Vetting: Impact on Cases Filed with USCIS and Visa Processing at U.S. Embassies and Consulates

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The slew of executive orders published by the Trump Administration in January included references to: •Vetting and screening to the maximum degree across agencies - •Reestablishing a uniform baseline for screening and...more

Dorsey & Whitney LLP

Has Uncle Sam Terminated Your Federal Grant? You Have Rights (and Maybe a Financial Claim)

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The first weeks of the Trump Administration have created substantial uncertainty within Dorsey’s client base, with many clients assessing their partnerships with the United States government and asking whether they have legal...more

Miller Canfield

IRS Fast-Track Settlement Has Been Refined to Improve Accessibility

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Taxpayers whose tax returns the IRS examines may experience long administrative delays in working with the IRS to resolve unagreed issues. About twenty years ago, the IRS developed a procedure – fast track settlement – to...more

Bricker Graydon LLP

Ohio’s Virtual Meeting Law Brings Modernization to Public Governance

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Ohio’s new virtual meeting law revolutionizes public governance, making accessibility, transparency, and efficiency the new standard for certain public bodies statewide. On January 8th, Governor DeWine signed House Bill 257...more

BCLP

Government’s Bold Move to Reduce Legal Challenges to NSIPs

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The Government has confirmed it will introduce legislation to reduce the number of attempts claimants have to secure permission to legally challenge a DCO....more

Venable LLP

The NLRB's Race to Turn Student Athletes into Employees Faces Its Next Hurdle - A Change in Administration

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We previously reported that the National Labor Relations Board (NLRB) heard a complaint earlier this year against the NCAA, the University of Southern California, and the Pac-12 Conference for failing to classify student...more

Dorsey & Whitney LLP

The Supreme Court Update - January 13, 2025

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On January 10, 2025, the Supreme Court of the United States granted certiorari in three cases: Becerra v. Braidwood Management, Inc., No. 24-316: This case addresses the constitutionality of the U.S. Preventive Services...more

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