Administrative Agency Updates

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.
News & Analysis as of

FDA Issued Draft Guidance on Interchangeability

Today, the FDA announced the availability of a draft guidance on biosimilar interchangeability, entitled “Considerations in Demonstrating Interchangeability With a Reference Product,” which is currently available on FDA’s...more

Federal Circuit Requires Standing To Appeal An IPR Decision

In the case of Phygenix, Inc. v. ImmunoGen, Inc., the Court of Appeals for the Federal Circuit (CAFC) held that the petitioner (Phygenix) that had unsuccessfully challenged certain claims of ImmunoGen’s U.S. Patent No....more

Delaware Moves to Revamp Its Unclaimed Property Law

On January 12, 2017, the Delaware Senate introduced legislation that represents a complete rewrite of the state’s Escheats Law, currently codified at 12 Del. Code Ann. § 1130 et seq. The bill – SB 13 – is...more

FDA Finalizes Guidance on Postmarket Management of Medical Device Cybersecurity

On December 28, 2016, the Food and Drug Administration (FDA) issued final guidance on the postmarket management of cybersecurity in medical devices. The guidance outlines nonbinding recommendations on how device manufacturers...more

HUD Publishes Further Revisions to RAD Notice

In an announcement on January 12th, the U.S. Department of Housing and Urban Development (HUD) published a significant third revision to the Rental Assistance Demonstration (RAD) Notice (PIH 2012-32/ H 2017-03 Rev-3)....more

Antennas up, Employers: Are ALJs History?

The Supreme Court of the United States is, of course, known for landmark decisions affecting the lives of Americans. When we hear "SCOTUS" we think of famous civil rights cases such as Marbury v. Madison, (1803) which...more

OSHA’s New Electronic Reporting and Anti-Retaliation Rule Challenged By Industry Groups in Oklahoma

Seyfarth Synopsis: Business organizations have once again brought suit against OSHA’s new electronic reporting and retaliation rule, arguing that the proposed online database violates employers’ First and Fifth Amendment...more

The White House’s Revisions to its Breach Response Policy For Federal Agencies and Departments Also Affect Contractors

On January 3, 2017, the Obama Administration issued a memorandum to all executive departments and agencies setting for a comprehensive policy for handling breaches of personally identifiable information (the “Memorandum”),...more

Birmingham Medical News: End in Sight for Medicare ALJ Backlog?

As providers who are currently undergoing a Medicare claims appeal know, there is a lengthy delay to having an appeal actually heard by an Administrative Law Judge (“ALJ”). Some estimates indicate that it will currently take...more

Supreme Court of Illinois Says Courts Can Decide ARES Rate Disputes

Courts – not the ICC – have jurisdiction over rate cases involving an ARES, said the Supreme Court of Illinois.[1] In a unanimous opinion written by Chief Justice Karmeier, the Court in December answered the Seventh Circuit’s...more

Another view on Presidential authority to remove Director Cordray

As rumors swirl that President-elect Trump is planning to remove Director Cordray immediately after January 20th, conflicting views have emerged about his authority to do so before the appeal in PHH is resolved. We...more

D.C. Circuit grants PHH’s motion for leave to file supplemental response

Last Friday, the D.C. Circuit entered an order granting PHH’s motion for leave to file a supplemental response to the CFPB’s petition for rehearing en banc.  On December 22, PHH and the United States filed responses to the...more

HHS Ordered To Eliminate Medicare Appeals Backlog By 2021

On January 4, 2017, the U.S. District Court for the District of Columbia rejected a request by the Secretary of HHS asking the court to reconsider its decision that requires HHS to eliminate the backlog of Medicare claims...more

Supreme Court to Review SEC Enforcement Limitations

On Friday, January 13, the Supreme Court granted certiorari to resolve a Circuit split on the extent to which SEC enforcement actions are restricted by the five-year statute of limitations in 28 U.S.C. § 2462. Section...more

Making Tequila and Pisco Shots Safe From Confusion

The United States Patent and Trademark Office, Trademark Trial and Appeal Board (the “Board”) cancelled the registration for the mark PORTÓN last week, finding it to be confusingly similar to the senior mark PATRÓN. Patrón...more

Minnesota Discovers Limits To Its Regulator’s Power Over Insurers

In Minnesota, the Commissioner of the Department of Commerce regulates the insurance industry, and he has a statutory right to conduct investigations “related to the duties and responsibilities entrusted to” him. Last month,...more

A Family Victory! Victory! Just Not for Little Caesars

The United States Patent and Trademark Office, Trademark Trial and Appeal Board (the “Board”) modified its treatment of the “family of trademarks” doctrine in the recent case In re LC Trademarks, Inc., Serial No. 85890412...more

FAA Updates the Public on Drones with “A Story of Revolution and Evolution”

At the CES Unmanned Systems conference in Las Vegas last week, Administrator of the Federal Aviation Administration (FAA), Michael Huerta, provided the public with an update on the state of our unmanned aircraft systems (UAS)...more

[Webinar] 2017 MSHA Enforcement Initiatives and Rulemaking Outlook - Jan. 26th, 1:00pm EST

As we begin a new calendar year and look ahead to a new administration, industry should continue to stay informed as to MSHA’s regulatory agenda and enforcement initiatives. While MSHA will soon have new decision makers in...more

CBM Review Standard

Whether a patent qualifies for a CBM review has been a moving target. Early decisions held that the claims do not need to be directed to a “financial product or service,” since a reference in the specification to a financial...more

Covered Business Methods Patents — Not So Broad!

The Federal Circuit Court of Appeals has reminded the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office in no uncertain terms that covered business method review has limits. In Unwired Planet, LLC v....more

An IPR Does Not Necessarily Have Standing to Appeal if it Loses

In Phigenix, Inc. v. ImmunoGen, Inc., [2016-1544] (January 9, 2017), the Federal Circuit held that Phigenix, the losing petitioner in an IPR, lacked standing to appeal the PTAB’s decision that claims 1–8 of U.S. Patent No....more

Mississippi CON Report

Certificates of Need Approved and Staff Recommendations – December 2016 - 1. CON – Final Orders - a. CON Review Number: HG-A-0715-015 – Singing River Health System d/b/a Singing River Hospital – Amendment and Cost...more

Beacon Navigation GmbH v. Ford Motor Company

Case Name: Beacon Navigation GmbH v. Ford Motor Company - Docket Number: 2:13-cv-11381-PJD-MAR - Date Filed: 3/28/2013 - Judge: Hon. Victoria A. Roberts - Status: Stayed 01/07/2016 - On March 28, 2013, Beacon...more

To Be or Not To Be: The SEC Administrative Court — Are They Constitutional or Not

Seyfarth Synopsis: What, if any, steps the government will take to appeal the Tenth Circuit’s Bandimer’s decision remains to be seen. The government may elect to petition the entire Tenth Circuit to hear the case en banc. Or...more

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