Administrative Agency Civil Procedure Civil Remedies

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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

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

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

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

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

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