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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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

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

Supreme Court Holds That TTAB Rulings Can Have Preclusive Effect in Court

On Tuesday, the Supreme Court issued its decision in B&B Hardware v. Hargis Industries, ruling that decisions of the Trademark Trial and Appeal Board (TTAB) on “likelihood of confusion” in trademark opposition proceedings can...more

Supreme Court: An Administrative Ruling on Confusion Can Be the Last Word in Trademark Litigation

Trademark disputes often focus on whether two marks create a “likelihood of confusion” with one another. That issue can come up before a court considering trademark infringement; before the Trademark Trial and Appeal Board...more

Supreme Court Seals Tight a TTAB Decision

In a recent case that will raise the stakes for companies involved in contentious administrative trademark proceedings, the U.S. Supreme Court held that the administrative tribunal, the Trademark Trial and Appeal Board...more

The Pitfalls of Settling Qui Tam Lawsuits

In a recent federal court case, the federal government and the State of California successfully enforced an oral settlement agreement of a qui tam lawsuit against a health care provider. United States v. North East Medical...more

The Tyranny of the Judiciary

There has always been a tension between the need for a final arbiter of the law and the inherent power associated with such a role placed in the judicial branch. Jefferson himself was wary of this tendency, writing in a...more

Alert - Biologics Price Competition and Innovation Act (BPCIA) Developments

The Evolving World of Biosimilars - Amgen, Inc. v. Sandoz, Inc. Addressing two new issues in the Biologics Price Competition and Innovation Act (BPCIA), the Northern District of California issued an order, on...more

One More Hurdle Cleared – Amgen’s Preliminary Injunction Motion for Filgrastim is Denied

On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more

FTC Rule Change Simplifies Process Following a Denial of a Preliminary Injunction Motion

On March 14, 2015, the Federal Trade Commission (FTC) announced procedural revisions governing the FTC process when it loses an injunction bid in federal court, to block the consummation of a merger pending its in-house...more

Pomegranate Health Benefit Claims Were False, Misleading - POM Wonderful, LLC, et al. v. Federal Trade Commission

In an opinion addressing the amount and type of scientific evidence required to substantiate disease treatment and prevention claims, the U.S. Court of Appeals for the District of Columbia upheld the Federal Trade...more

ITC Section 337 Update - March 2015

Commission Files Brief In 833 Investigation Appeal Regarding Digital Models Qualifying As “Articles” – On February 18, 2015, the International Trade Commission filed its brief in an appeal to the Federal Circuit of the...more

LYNX Surveillance Footage Exempt from Public Inspection

In a surprising opinion issued on January 30, 2015, which promises to have a wide-reaching effect, the Fifth District Court of Appeal overturned a declaratory judgment entered in favor of WKMG-TV Local 6, and determined that...more

Food Litigation Newsletter - March 2015

In This Issue: - RECENT SIGNIFICANT RULINGS ..Summary Judgment For Defendants In Juice False Advertising Suit ..Partial Class Certification Granted in “100% Natural” Cooking Oil Action ...more

Uber and Lyft Face Class Action Suit in Memphis for Ride Sharing Services

The City of Memphis is the site of the latest legal challenge to the peer-to-peer ride sharing services offered by Uber and Lyft. On March 4th, a federal class action lawsuit was filed against Uber and Lyft on behalf of all...more

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