Preliminary Injunctions

News & Analysis as of

Federal Judge Puts Freeze on EPA’s Clean Water Act Rulemaking: Preliminary Injunction Halts Implementation of 'Waters of U.S.'...

In May of this year the U.S. Environmental Protection Agency (“EPA”) and the U.S. Army Corps of Engineers (“Corps”) issued the much-anticipated Waters of the United States rule (the “Rule”). The Rule redefines and expands...more

Advertising Law - August 2015 #4

In Case You Missed It: Possible Jail Time for TCPA Violations, Microsoft Gets Slammed With Solicitation Scam Class Action, and 'Do Not Disturb' Technology Gets Pushed on FCC - The world of the Telephone Consumer...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs

The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more

Judge Berman Deflates SEC’s ALJ Appointment Process

United States District Court Judge Richard M. Berman of the Southern District of New York has been making headlines in recent weeks as he presides over the highly publicized case between the National Football League (“NFL”)...more

Europe's Highest Court Recently Delivered a Judgment Imposing Affirmative Duties on SEP Holders

The EU Court of Justice sets out specific requirements with which an SEP holder needs to comply in order to be able to seek an injunction without abusing its dominant position (Huawei / ZTE)- Standards lie at the heart...more

Ninth Circuit Denies Requests to Stay Use of Enlist Duo Herbicide During Judicial Review

On August 11, 2015, the U.S. Court of Appeals for the Ninth Circuit denied a motion for a stay pending review filed on December 18, 2014, by the Natural Resources Defense Council (NRDC), as well as a subsequent stay motion...more

RLUIPA Round-UP

We’ve been monitoring news items involving local government, religion, and land use that may be of interest to our readers. Below is what has caught our attention. Livingston Daily reports that Genoa Charter Township...more

In Trademark Dispute, New Hampshire School Website Address Not Taken For Granite

New Hampshire is commonly referred to as the Granite State. In one recent trademark infringement case, however, a federal court in New Hampshire did not find a likelihood of consumer confusion between website addresses for...more

How Far Is Too Far? Court Rules for Amarin in Off-Label Marketing Fight against FDA

Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...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

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

Bridging the Week - August 2015 #3

Hackers and Traders Charged by SEC and Department of Justice in International Securities Fraud Scheme - The computer servers of three major newswire companies were allegedly hacked as part of an elaborate illicit...more

SDNY Enjoins SEC From Pursuing Administrative Hearing on Constitutional Grounds: Setback for Enforcement Strategy

The US District Court for the Southern District of New York, in Duka v. SEC, 15 Civ. 357, has preliminarily enjoined the SEC from pursuing a pending administrative hearing against Barbara Duka, a former managing director at...more

Second Federal Judge Enjoins “Likely Unconstitutional” SEC Admin Actions

Manhattan federal Judge Richard Berman yesterday (August 12) issued a preliminary injunction halting the SEC’s administrative action against former S&P executive Barbara Duka, holding the SEC’s in-house courts were “likely...more

Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc.

Case Name: Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc., Civ. No. 14-1078 (JBS/KMW), 2015 U.S. Dist. LEXIS 50082 (D.N.J. Apr. 16, 2015) (Simandle, C.J.) - Drug Product and Patent(s)-in-Suit: Abilify®...more

New York District Court Preliminarily Enjoins SEC Administrative Proceeding

We blogged last week about a New York federal court’s decision in Duka v. SEC conditionally sustaining a facial challenge to an administrative enforcement proceeding conducted by Administrative Law Judges (“ALJs”) of the...more

Second Circuit Denies Petition for Actavis Rehearing

We have previously posted about the New York Attorney General’s “product hopping” suit against Actavis and its subsidiary, Forest Laboratories LLC (together, “Actavis”), including our analysis of the District Court’s opinion...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

SDNY Enjoins SEC Administrative Proceeding

In Duka v. SEC, the District Court for the Southern District of New York entered a preliminary injunction to enjoin an SEC administrative proceeding because the proceeding is “likely unconstitutional.” The court gave the same...more

What Comes Next In Amarin Pharm v. FDA?

The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug...more

Practical Implications from Amarin

Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more

Amarin Obtains Preliminary Injunction Against FDA Regarding Off-Label and First Amendment Issues

In our prior posts about Amarin Pharma, Inc. v. FDA, we wondered what the Southern District of New York would make of Amarin’s request for an order prohibiting the FDA from taking enforcement actions against it over speech...more

No Copyright in Individual Contributions to a Film - 16 Casa Duse, LLC v. Merkin

Citing the U.S. Court of Appeals Ninth Circuit’s recent en banc decision in Garcia v. Google (IP Update, Vol. 18, No. 6), the United States Court of Appeals for the Second Circuit affirmed a summary judgment ruling that...more

Court Decries Ambiguity Of Terminology Used In Non-Compete Agreement And Injunction

A preliminary injunction was entered against a fired executive of a roofer who, immediately after he was discharged, went to work for an alleged competitor. The district court held, and the Seventh Circuit agreed, that his...more

Federal Court Grants First Amendment Injunction in Amarin Case

Federal Court Grants Requested Injunction in Amarin: Confirms Caronia Stands for Proposition that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the...more

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