Administrative Agency Civil Procedure Civil Remedies

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

ALJ Essex Elaborates an Evidence-Based Framework for Adjudicating the FRAND Defense

Administrative Law Judge Essex recently issued the public version of his Initial Determination on Remand in International Trade Commission investigation No. 337-TA-613, In the Matter of Certain 3G Mobile Handsets and...more

Federal Circuit Oral Arguments in Amgen v. Sandoz

On June 3, the parties in Amgen v. Sandoz presented oral arguments to the Federal Circuit as part of their dispute over the Biologics Price Competition and Innovation Act (BPCIA). The appeal is focused on two questions:...more

SEC Insider Trading Case Brought As Administrative Proceeding Enjoined

The SEC’s shift to administrative proceedings in recent months has spawned a series of suits against the agency challenging its forum selection authority. The suits have generally met with little success. Nevertheless,...more

NLRB Refuses to Approve Withdrawal of Charges Despite Settlement of Class Action Case

We know that, among many other common employer policies, the NLRB considers many mandatory arbitration agreements to be unlawful, particularly where they prohibit class or collective actions. See Murphy Oil USA, Inc., 361...more

CFPB Fines Worldwide Payment System $25 Million for Alleged Deceptive Practices

On May 19, the CFPB announced a stipulated final judgment against a California-based worldwide payment system company. According to the CFPB’s complaint, filed the same day, the defendant (i) failed to honor advertised...more

Abilify®’s Saga Continues: Otsuka’s Eight-Day Streak of Generic-Free Competition Ends, For Now

On May 27, 2015, the U.S. District Court for the District of Maryland granted FDA and the Defendant-Intervenors summary judgment against Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization,...more

Fees For Public Records Act Request Is Only Proper Where The Request Is "Clearly Frivolous"

In Bertoli v. City of Sebastopol, 2015 DJDAR 779, the California Court of Appeal for the First Appellate District decided a case involving a fee request under the California Public Records Act (“CPRA”)....more

Bad Faith Bargainer Beware: D.C. Circuit Enforces Award of Negotiation Costs

Last year the NLRB demonstrated an increased willingness to award negotiation costs as a remedy for bad faith bargaining in cases that are far less egregious than those where the remedy historically was given. Hospital of...more

Trademark Review | April 2015

The Supreme Court Rules TTAB Findings May Have Preclusive Effect in Later Federal Court Proceedings - B&B and Hargis have long contested each other’s rights in the mark "SEALTIGHT" for fasteners. B&B was the first to...more

Federal Circuit Patent Updates - April 2015

Biosig Instruments, Inc. v. Nautilus, Inc. (No. 2012-1289, 4/27/15) (Newman, Schall, Wallach) - April 27, 2015 11:12 AM. Wallach, J. On remand from the Supreme Court, reversing district court summary judgment...more

Amgen v. Sandoz BPCIA Dispute Heads to the Federal Circuit

After a series of preliminary skirmishes, the first full-fledged litigation under the Biologics Price Reduction and Innovation Act is Amgen’s lawsuit against Sandoz concerning Sandoz’s Zarxio, a biosimilar version of Amgen’s...more

District Court Declines to Lift Stay Even After Patent Trial and Appeal Board Issued Written Decision on CBM Petitions

The district court stayed several consolidated cases pending certain proceedings before the Patent Trial and Appeal Board ("PTAB"). In the order granting the stay, the district court stated: "Upon issuance of a final decision...more

From Dusk to Dawn: Battle Looming Over USDA Changes to Sunset Provision of Organic Rules

The USDA is facing a lawsuit in federal court stemming from its decision to unilaterally alter the process for exempting synthetic and non-organic substances used in producing organic food. Until September 2013, substances...more

Otsuka Files Amended Complaint and Motion for TRO/PI for Abilify®, Pointing to Congressional Intent to Argue Broad Exclusivity

As discussed in our April 13, 2015 blog, Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”) had until April 15, 2015...more

Amgen Receives No Help from the FDA -- A Biosimilar Update

Near the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and...more

District Court Lifts Stay After Covered Business Method Review Is Dismissed Because Federal Circuit Would Not Have Jurisdiction to...

Plaintiff GT Nexus, Inc. ("GT Nexus") filed a declaratory judgment action against Inttra, Inc. ("Inttra") seeking a declaration that four of Inttra's patents ("patents-in-suit") were invalid and have not been infringed....more

Australia: Perth Glory suspended, fined and going to Supreme Court

Perth Glory have been fined $269,000 and ejected from the finals series of the A-League after being found guilty of salary cap breaches....more

Don't Underestimate the Importance of TTAB Proceedings

A recent U.S. Supreme Court decision, B&B Hardware, Inc. v. Hargis Industries, Inc., heightens the importance of often-neglected trademark conflict administrative proceedings in the Trademark Trial and Appeal Board....more

€ 500 million VLT gaming fee confirmed?

The interim claim on the € 500 million video lottery fee has been rejected by Italian courts raising the question on whether the € 200 million payment due at the end of April shall be paid....more

Tenth Circuit Stays April 1 Effective Date of CPSC’s Magnets Safety Rule

Over the past year, we have blogged about the CPSC’s rulemaking process to regulate high-powered magnet sets via a safety standard as well as the administrative complaints brought by the agency to force multiple companies...more

FDA Denies Request to Make “Patent Dance” a Prerequisite for Biosimilar Approval

In a decision released on March 25, 2015, FDA denied a Citizen’s Petition that would have effectively made the information and patent exchange described in § 262 of the Biologics Price Competition and Innovation Act (“BPCIA”)...more

Amgen Inc. v. Sandoz Inc.

On March 19, 2015, the United States District Court for the Northern District of California issued its decision in Amgen Inc. v. Sandoz Inc., construing the patent negotiation provisions of the Biologics Price Competition and...more

California District Court Denies Amgen’s Motion for a Preliminary Injunction on BPCIA

On March 19, Judge Seeborg of the Northern District of California denied Amgen’s motion for a preliminary injunction in Amgen v. Sandoz. Sandoz recently won the first-ever FDA approval for a biosimilar for its product Zarxio,...more

Strike Two – FDA Rejects Amgen’s Certification Petition for Biosimilar Applicants

In parallel with the district court case where Amgen is asserting that Sandoz has not complied with the BPCIA because they have not provided Amgen with a copy of their biosimilar application, in October 2014 Amgen filed a...more

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