Civil Remedies Administrative Agency

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DOT Revises Its “Mistaken Fares” Enforcement Policy

DOT’s Office of Aviation Enforcement and Proceedings issued a notice temporarily amending its enforcement policy regarding airlines’ obligation to honor “mistaken fares.” Until now, DOT’s Enforcement Office has generally...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

Amgen v. Sandoz: Federal Circuit Grants Injunction Pending Appeal

Yesterday the Federal Circuit granted Amgen’s motion for an injunction pending appeal in Amgen v. Sandoz, the first appeal to squarely address the patent litigation provisions of the Biologics Price Competition and Innovation...more

The High Price of Challenging a Refusal to Register a Trademark in District Court

Applicants who challenge in a federal district court a Trademark Trial and Appeal Board decision that upholds a PTO refusal to register a trademark may be required to reimburse the government for PTO attorney fees, even if...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

Whistleblowers to be Rewarded, Protected under OSC Proposal

Staff of the Ontario Securities Commission (OSC) has released for public comment a consultation paper on a proposed whistleblower program (Program), under which whistleblowers would be eligible for a financial reward of up to...more

SDNY Judge Deals Rejects Constitutional Challenge to SEC’s Use of Administrative Proceedings

A former executive of Standard & Poor’s (S&P) Rating Services has lost an early constitutional challenge to the SEC’s use of administrative proceedings....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

EEOC Consent Decrees are its Most Powerful Enforcement Mechanisms

The vast majority of settlements between an employer and the Equal Employment Opportunity Commission (“EEOC”) take the form of a court-approved consent decree. This document is a public record designed to highlight and...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

FCC Enforcement Bureau Stays Pole Attachment Complaint Proceeding Pending Completion of Arbitration

In a March 16, 2015 Letter Ruling, the Market Disputes Resolution Division of the FCC’s Enforcement Bureau granted a request by Duke Energy Carolinas, LLC (“Duke”) for a stay in a pole attachment complaint proceeding brought...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

Dutch judge: online operator does not have to refund gambling losses

Through its website, the remote gambling operator gave the opportunity to participate in remote games of chance. Now that it is still not legally permitted to offer remote games of chance targeted to the Dutch market, the...more

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