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Administrative Agency Updates

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

OCC Imposes $70 Million Fine Against National Bank for Failing to Fix Anti-Money-Laundering Issues

by Weiner Brodsky Kider PC on

On December 27, 2017, the Office of the Comptroller of Currency (OCC) entered a consent order with a national bank stemming from allegations that the bank violated a 2012 consent order related to Bank Secrecy Act/Anti-Money...more

PTAB Strategies and Insights - January 2018

The PTAB Strategies and Insights Newsletter is designed to be a valuable resource for all stakeholders in the global patent arena throughout the patent life cycle. To that end, articles will provide perspectives from both...more

Medicare 340B Drug Payment Policy Survives Legal Challenge; Hospitals Say, It's Not Over

by Baker Ober Health Law on

A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more

Petition Summary: Large Diameter Welded Pipe from Canada, Greece, India, China, Korea, and Turkey

by Husch Blackwell LLP on

On January 17, 2018, the American Line Pipe Producers Association filed a petition for the imposition of antidumping and countervailing duties on imports of Large Diameter Welded Pipe from Canada, Greece, India, the People’s...more

PTAB Designates Informative Decisions on Timeliness of IPR Petitions

by Knobbe Martens on

In wake of the Federal Circuit’s Wi-Fi One decision, the PTAB has designated two of its decisions as informative on the issue of IPR petition timeliness under § 315(b). This statute provides that an IPR may not be instituted...more

The Bubbler: January 2018

2017 is in the books and 2018 is now upon us. A dramatic close to 2017 on Capitol Hill ushered in sweeping changes to the tax code that will begin to impact both employers and employees in a number of ways – some more...more

How Much is That Issue Fee Payment in the Window?

by Foley & Lardner LLP on

A new USPTO fee schedule took effect on January 16, 2018, which usually means that all fees must be paid at the new (higher) rate. However, thanks to revisions to 35 USC § 151 effected by the Patent Law Treaties...more

Timeliness Determinations for Inter Partes Review Now Subject to Appellate Review

by Foley Hoag LLP on

On January 8, 2018, the en banc Federal Circuit, in Wi-Fi One, LLC v. Broadcom Corp., held that a PTAB decision upon institution as to whether a petition for inter partes review is timely under 35 U.S.C. § 315(b) is...more

Administrative Proceedings in Peril? Supreme Court Grants Certiorari in Lucia v. SEC

• On January 12, 2018, the Supreme Court granted certiorari in Lucia v. SEC, to resolve a circuit split over whether the SEC’s administrative law judges serve in violation of the Appointments Clause of the Constitution. •...more

EPA Memo Signals Plant Improvement Opportunities

by Jones Day on

A policy memorandum issued by the U.S. Environmental Protection Agency (“EPA”) during December 2017 clarifies how the agency will apply and enforce certain facets of the New Source Review regulations following a pair of...more

Supreme Court to Review SEC ALJs

by Burr & Forman on

On January 12, the US Supreme Court agreed to review the constitutionality of the SEC’s administrative law judges. On November 29, 2017, the SEC did an abrupt about-face, telling the Court it now regards its ALJs as...more

Supreme Court to Decide Who Can Appoint ALJs

The Supreme Court of the United States, on Friday, January 12, 2018, agreed to decide whether the former practice of the Securities and Exchange Commission (SEC) of having its chief judge appoint administrative law judges...more

The China Food and Drug Administration pushes forward on conditional approval and compassionate use of new drugs

by Hogan Lovells on

On December 20, 2017, the China Food and Drug Administration (“CFDA“) released two draft documents for public comment: (1) Conditional Approval for Urgently Needed Drugs Technical Guidance (the “Draft Conditional Approval...more

Supreme Court Will Hear Lucia’s Challenge to Appointment of SEC ALJs

by Ballard Spahr LLP on

On January 12, 2018, the U.S. Supreme Court agreed to hear the Lucia case in which Raymond J. Lucia is challenging how the SEC appoints administrative law judges (“ALJs”)....more

Court Upholds Procedural Validity of HHS's Outlier Reconciliation Instructions

by Baker Ober Health Law on

On December 26, 2017, the United States Court of Appeals for the District of Columbia Circuit upheld the procedural validity of 2010 manual instructions setting out the criteria by which Medicare outlier payments might be...more

NLRB Reverses Information Request Decision…After Court Reverses Board Decision

December saw a flurry of decisions by the NLRB as it briefly held a full complement. The Board currently has only four members and so law-changing decisions are less likely to occur until a new member is confirmed....more

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

The Supreme Court is taking another patent case, granting certiorari in WesternGeco v. Ion. A divided panel of the Circuit had ruled that the plaintiff was not entitled to lost profits as a result of the sale of components of...more

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

by Hogan Lovells on

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more

Wi-Fi, One v. Broadcom: En Banc Federal Circuit Held The Time-Bar Determinations (§ 315(b)) Appealable

n its first en banc decision of 2018, the Federal Circuit held that “judicial review is available for a patent owner to challenge the U.S. Patent and Trademark Office’s determination that the petitioner satisfied the...more

USITC Responds to Trade Representative’s Request to Identify ‘Unforeseen Developments’ That Led to Solar Cell Decision

by Morgan Lewis on

US International Trade Commission’s response to unforeseen developments signals strong administration action on solar cell tariffs....more

The Supreme Court Agrees To Review Appointment Requirements For SEC's In-House Judges

by Shearman & Sterling LLP on

On January 12, 2018, the U.S. Supreme Court granted certiorari in Lucia v. Securities and Exchange Commission, No. 17-130, agreeing to resolve a circuit split regarding the appointment process for Securities and Exchange...more

Justice Department reverses course on marijuana enforcement: What it means for employers

by Nexsen Pruet, PLLC on

Attorney General Jeff Sessions recently issued a guidance memorandum rescinding several Obama-era Justice Department memoranda regarding federal marijuana enforcement. ...more

US Tax Reform Impacts Roth Individual Retirement Account Conversions

by Morgan Lewis on

HR 1 makes Roth IRA conversion recharacterizations a thing of the past, but is silent on whether recharacterizing 2017 Roth IRA conversions in 2018 will be permitted....more

Four-Term Governor Jerry Brown: One Last Budget

This week, California Governor Jerry Brown, beginning the final year of his unprecedented four terms as governor, unveiled his 16th and last state budget proposal, which projects a $6.1 billion surplus, mostly a result of...more

PTAB Designates Two 35 U.S.C. §315(b) Cases Informative

by Jones Day on

On January 10, 2018, the PTAB designated two decisions weighing on 35 U.S.C. § 315(b) as informative: Luv N’ Care, Ltd. v. McGinley, IPR2017-01216, Paper 13 (P.T.A.B. Sept. 18, 2017) (AIA § 315(b), insufficient funds at...more

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