Civil Remedies Civil Procedure Administrative Agency

Read Civil Remedies updates, alerts, news, and legal analysis from leading lawyers and law firms:
News & Analysis as of

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 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

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

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

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

364 Results
View per page
Page: of 15

Follow Civil Remedies Updates on:

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.