Administrative Agency Civil Remedies

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.
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Apotex Follows the BPCIA “Patent Dance” Again

The first biosimilar makers to file regulatory applications with FDA attempted to bypass all or a subset of the patent litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Apotex, the...more

Nearly Two Years After Dismissal of its Declaratory Judgment Action, FDA Accepts for Review Sandoz’s Application for a Biosimilar...

Sandoz Inc. announced on October 2, 2015 that FDA accepted its regulatory application for a proposed biosimilar of Amgen Inc.’s biologic arthritis drug Enbrel for review. The acceptance comes years after Sandoz attempted to...more

Federal Court Halts Implementation of BLM Fracking Rules

On September 30, 2015, the U.S. District Court for the District of Wyoming held that the Interior Department's Bureau of Land Management ("BLM") did not have Congressional authority to promulgate and finalize hydraulic...more

Federal Circuit Review | September 2015

Federal Circuit Remands Record Damages Award For New Trial On Extraterritorial Sales - In Carnegie Mellon University v. Marvell Technology Group, Ltd., Appeal No. 2014-1492, the Federal Circuit reversed a damages award...more

Complaint To Administrative Agency Does Not Support Abuse of Process Claim But May Be A Nuisance

Bonnie Springs Ranch sits below towering and very picturesque Aztec Sandstone cliffs a few miles outside of Las Vegas, Nevada.  After terminating a contract to sell some adjacent land, Bonnie Springs alleged that that buyer...more

Blog: District Court Compels SEC To Provide “Expedited Schedule” For Issuing Dodd-Frank Resource Extraction Rule — Will Other Rule...

A U.S. District Court has handed a victory to Oxfam America in its efforts to compel the SEC to complete rulemaking on the Dodd-Frank mandate regarding resource extraction disclosures (Section 1504). ...more

Federal Judge Halts Implementation of Waters of the United States Rule

Injunction Applies Only to 13 States That Are Parties to the Case On Thursday, U.S. District Judge Ralph Erickson in Fargo, N.D. issued a temporary injunction requested by North Dakota and 12 other states prohibiting the...more

District Court Enjoins Federal Regulations Revising Scope of Clean Water Act Jurisdiction

North Dakota v. U.S. Environmental Protection Agency, No. 3:15-cv-00059 (D.N.D. Aug. 27, 2015) - A federal judge, Ralph R. Erickson, in North Dakota today granted several states’ request for a preliminary injunction to...more

Federal Judge Enjoins Implementation of EPA and USACE's New Clean Water Rule

On Thursday, August 27, 2015, the U.S. District Court for the District of North Dakota enjoined the U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers (USACE) from implementing the recently...more

Trope Doctrine Does Not Apply In Public Records Act Proceeding

In Law Offices of Marc Grossman v. Victor Elementary School District, 2015 DJDAR 8356, the California Court of Appeal for the Fourth Appellate District ruled that the Trope Doctrine did not apply in litigation under the...more

Federal Court Deflates, For Now, SEC’s Efforts to Proceed Before Its In-house Courts

A federal judge in Manhattan recently granted a preliminary injunction against the Securities and Exchange Commission in the latest of a series of rulings raising issues with the SEC’s use of in-house proceedings before its...more

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

Be Careful What You Say: Allegations Of Worker Misconduct Might Be Defamation

Healthcare institutions have a moral and legal obligation to promote patient safety as an essential component of patient care. Supervisors and managers must be supportive of their staffs while remaining vigilant about the...more

Bass Opposes Sanctions and Defends His Actions at the PTAB

On July 28, 2015, Celgene filed a motion for sanctions in IPR Nos. 2015-01092 and 2015-01103, proceedings challenging the validity of Celgene patents covering Thalomid®, Revlimid® and Pomalyst®. Celgene specifically...more

How Will the FCC’s TCPA Declaratory Ruling and Order Affect Your Business?

In a previous blog post, we reported on the FCC’s new pro-consumer TCPA ruling. On July 10, 2015, the FCC officially released the Declaratory Ruling and Order, which became effective immediately. The ruling creates new and...more

Courts Will Go Above and Beyond to Award Attorneys’ Fees for Unreasonably Withholding Public Records

In a novel and somewhat convoluted fact pattern, the California Court of Appeal yet again sent a loud and clear message: The purpose of the California Public Records Act ("CPRA") is to monitor governmental activities despite...more

More on the CFPB’s administrative law judge job posting

We reported earlier this week that the CFPB had recently posted a job opening for an administrative law judge (ALJ) and that the government jobs website indicated that the position was closed. We saw this as suggesting that...more

National Companies Considering Commercial Drones Must Consider State Privacy Laws

On Feb. 15, the Federal Aviation Administration proposed a regulatory framework applicable to small commercial drones, or unmanned aircraft systems, meaning those weighing less than 55 pounds. The comment period on this...more

CFPB seeks to hire administrative law judge

The CFPB recently posted a job opening for an administrative law judge (ALJ). According to the government jobs website, the position is closed which suggests that it has been filled. A recent Politico article indicated that...more

CPUC Judge Finds Uber in Contempt, Threatens Suspension of Service

Uber may have to suspend service in California and pay a $7.3 million fine as a penalty for withholding information from state regulators, according to a ruling this week by a CPUC administrative law judge. The decision found...more

Court Shoots Down The EEOC At “Mach” Speed Based On “Sham” Conciliation Process

Amid the flurry of major U.S. Supreme Court decisions that were decided towards the end of the 2014-2015 term, the landmark decision in Mach Mining v. EEOC, No. 13-1019 (U.S. April 29, 2015), seems like ancient history. As we...more

Appellate Court Notes

- Supreme Court Advance Release Opinions: - SC19422 - Awdziewicz v. Meriden Certain police officers retired, entitling them to pension benefits under the City Charter as previously modified in a separate lawsuit...more

Cancelled Solicitation: What Can A Government Contractor Do?

Proposal preparation can be a difficult and expensive process. On top of the normal challenges of spending thousands of dollars preparing what a contractor hopes is a successful proposal, they also face the risk of an agency...more

PTAB to Consider Motion for “Abuse of Process” Sanctions Against Kyle Bass Hedge Fund IPR Petition

In a recent order, the Patent Trial and Appeals Board (PTAB) indicated that it will consider a motion for sanctions based on a claim of “abuse of process” in Inter Partes Review (IPR) proceedings filed by the Coalition for...more

District court says appointment of SEC administrative law judge was likely unconstitutional

Recently, in Hill v. Securities Exchange Commission, the United States District Court for the Northern District of Georgia preliminarily enjoined the SEC from conducting the administrative proceeding brought against Charles...more

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