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Administrative Agency Updates

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

PTAB Designates as “Informative” Expanded PTAB Panel Decision Adopting the Seven NVIDIA Factors For Evaluating Follow-On Petitions...

by Knobbe Martens on

The PTAB’s Chief Administrative Patent Judge and Deputy Chief Administrative Patent Judge joined an expanded PTAB panel that adopted the seven NVIDIA factors and denied institution of the Petitioner’s follow-on petitions in...more

Air Enforcement: Arkansas Department of Environmental Quality and Garland County, Arkansas Rubber Products Manufacturing Facility...

The Arkansas Department of Environmental Quality (“ADEQ”) and Alliance Rubber Company (“ARC”) entered into a September 13th Consent Administrative Order (“CAO”) addressing an alleged violation of an air permit. See LIS No....more

PTAB Grants Rare Rehearing Due To Insufficient Evidence Of Obviousness

by Jones Day on

In Coalition For Affordable Drugs VI, LLC v. Celgene Corp. (2015-01096, -01102, -01103), the PTAB granted Patent Owner Celgene’s request for rehearing of a final written decision that had found the challenged claims invalid...more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In In Re Cray, the panel grants Cray’s petition for a writ of mandamus, ruling that the district court’s handling of the case is not consistent with its case law regarding what is “a regular and established place of...more

Doctrine of Equivalents and Prosecution History Estoppel Around the World

Please see full Doctrine of Equivalents Chart for Countries around the World. ...more

Shaking Things Up – The Trump Administration, Regulatory Change, and Administrative Law: Allan Gates (Mitchell Williams) National...

My law firm colleague Allan Gates undertook a webinar presentation for the National Association of Clean Water Agencies (“NACWA”) titled: - Shaking Things Up – The Trump Administration, Regulatory Change, and...more

Patent Trial and Appeal Board Activity in the First Five Years+

by Knobbe Martens on

September 16, 2017 marked five years since the Patent Trial and Appeal Board (PTAB) was created. Some of the notable statistics and trends of the previous 5 years are shown here....more

Department of Education Rescinds Obama-Era Title IX Guidance in Advance of New Rulemaking

This morning, the Office for Civil Rights of the Department of Education issued a “Dear Colleague” letter rescinding the Obama administration’s school sexual assault guidance. The Department also issued a new set of...more

Trump Nominates Peter Robb as the General Counsel for the NLRB

by Seyfarth Shaw LLP on

After being reportedly close to nominating retired Jones Day partner Roger King for the role, the White House announced last Friday that President Donald Trump will nominate Peter Robb, a management-side labor and employment...more

Air Modeling and Effects Review Applicability: Texas Commission on Environmental Quality Updates Guidance

The Texas Commission on Environmental Quality (“TCEQ”) announced the release of an updated Modeling and Effects Review Applicability guidance document (“Guidance”). See APDG 5874. TCEQ intends for the document to provide a...more

Celgene Notches Rare Win On PTAB Request For Rehearing

by Foley & Lardner LLP on

The recent decisions of the USPTO Patent Trial and Appeal Board (PTAB) granting Celgene’s requests for rehearing in parallel Inter Partes Review proceedings brought by Kyle Bass’s Coalition for Affordable Drugs (CFAD) are...more

Calculating Patent Term Adjustment: Part 2

This article is second in a series focusing on various issues related to Patent Term Adjustment for U.S. patent applications. While Part 1 is a general overview of how to calculate patent term adjustment (“PTA”), this...more

New California Tax Agencies’ Roles Clarified

On September 16, 2017, California Governor Jerry Brown signed Assembly Bill (A.B.) 131 into law, making various changes to the Taxpayer Transparency and Fairness Act of 2017 (Act) enacted on June 27, 2017. The Act overhauled...more

Pensions Round-Up - July/August 2017 (UK)

by DLA Piper on

Welcome to the latest edition of Pensions Round-Up which provides an overview of developments in pension legislation, case law and regulatory guidance. In this edition we look at key developments from the second half of July...more

Surviving Alice with an Appeal

by Fenwick & West LLP on

This third article in the “Surviving Alice” series examines how the USPTO’s Patent Trial and Appeal Board has responded to the U.S. Supreme Court’s June 2014 Alice decision. It also shows how applicants can use the PTAB’s...more

Statutory Waivers Under the New School Funding Bill

by Franczek Radelet P.C. on

As reported in an earlier alert, the State’s new school funding bill, Senate Bill 1947 (Public Act 100-0465), provides new mandate relief. School districts have been eligible to petition the General Assembly for waivers from...more

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

by Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

D.C. Circuit Strikes Down FAA’s Recreational UAS Rule

by Benesch on

The Federal Aviation Administration (“FAA”) has long set standards for the operation of aircraft in the United States, including extensive requirements for aircraft registration. Historically, the FAA did not interpret the...more

Advanced Weather Data: Vital for the Future of Commercial Drone Operations

Back in December 2016, Amazon executed its first customer delivery by drone in the United Kingdom. Now, as Amazon, and other large retailers, aim for widespread deployment of drones for the delivery of goods to consumers, it...more

FDA Announces Biosimilar User Fee Act Rates for FY2018

by Goodwin on

Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2018 federal fiscal year, which runs from October 2017 through September 2018. The FDA determined these rates pursuant to the Food and Drug...more

Proposed 2016 “White Collar” Regulations Struck Down; DOL Starts Work on New Regulations

The winding legal path of the 2016 “white collar” regulations has come to an end. On August 31, 2017, the Honorable Amos L. Mazzant of the U.S. District Court for the Eastern District of Texas struck down the U.S. Department...more

Am I Being Clear Enough? – PTAB Reaffirms Lower Pre-Issuance Threshold for Indefiniteness in Ex Parte McAward

On August 25, 2017, the Patent Trial and Appeal Board issued a precedential opinion in Ex Parte McAward, reaffirming the Patent Office’s use of a lower pre-issuance threshold for indefiniteness distinct from the Supreme...more

Look (At The PTAB Factors) Before You Leap Into Your Follow-On IPR Petition

by Orrick - IP Landscape on

Decision Denying Petitioner’s Requests For Rehearing, General Plastic Industrial Co., Ltd. v. Canon Kabushiki Kaisha, Nos. Case IPR2016-01357, 01358, 01359, 01360, 01361 (P.T.A.B. September 6, 2017) (expanded panel) - Last...more

UK Publishes Draft Legislation Prohibiting the Manufacture and Supply of Cosmetic Products Containing Microbeads

by Hogan Lovells on

On 11 September 2017, the UK Department for Environment, Food and Rural Affairs (DEFRA) published draft regulations prohibiting the manufacture and supply of rinse-off personal care products containing microbeads. The draft...more

New FDA Final Guidance on Medical Device Panel Meetings Provides Certain Changes to Timelines and Procedures

by Hogan Lovells on

On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical Device Advisory Committee meetings (or, panel meetings). The document,...more

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