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2015 IP Law Year In Review

Commil USA, LLC v. Cisco Systems, Inc., 135 S. Ct. 1920 (May 26, 2015) - ..Does a defendant’s belief that a patent is invalid serve as a defense to charges of inducing infringement? NO - ..Inducement requires...more

DOJ Acknowledges in Proposed Jury Instructions That Dissemination of Truthful and Non-Misleading Off-Label Use Information Is Not...

For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more

Latest First Amendment Off-Label Notes - Has DoJ Finally Come Around?

As we mentioned before (when we provided a discount) Bexis spoke earlier this week at the ACI Promotional Review Summit on the “Brave New World . . . Post-Amarin” – that is to say, about the First Amendment and off-label...more

A New Year’s Resolution: Avoid The Rising Tide of Defamation Claims In The Health Care Arena

In college and graduate school, we all had professors that had “non-attribution/academic freedom” policies designed to foster open debate, critical thinking and robust discussion. To state the obvious, we are a long way from...more

Lessons from Latham & Watkins’ Representation of Pacira Pharmaceuticals In Ground-Breaking Settlement with FDA

FDA rescinds warning letter and admits to incorrect interpretation of drug’s labelling. What can the life sciences industry learn? On December 15, 2015, Pacira Pharmaceuticals, Inc. (Pacira) announced that the US Food &...more

Top Posts of 2015

In descending order, here were the top posts from 2015. #7 Will Net Neutrality Kill the Internet 3.0? In February, the FCC passed the net neutrality rules. This seems like one of those issues, like most, that seemed...more

Poetic Justice – 2015 Wrap Up (Part 1 of 2)

This is the time of year to anxiously look forward to all that is anticipated to come in 2016. But it is also the time to look back at all that has happened in 2015. Rather than simply give you links to all of my stimulating...more

New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion

In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic...more

Breaking News – Pacira First Amendment Case Settles

We learned about it yesterday from a reporter, but were sworn to secrecy until today. Pacira Pharmaceuticals and the FDA settled their litigation with Pacira getting essentially everything it wanted – what the company calls...more

When They Don’t Have Anything, They’ll Try Anything

The rumblings began shortly after the industry First Amendment victory over the FDA in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015). A couple of anonymous, obviously plaintiff-side,...more

November 2015: Life Sciences Litigation Update

Amarin Wins Injunction Against FDA over Off-Label Marketing. Historically, FDA-approved drug products have only been promoted for their expressly approved uses. On August 7, 2015, the Southern District of New York granted...more

The FTC Pressures Press Interactions, Defies Commercial Speech Doctrine

On Tuesday, the FTC joined the Department of Justice and several other federal agencies in announcing numerous recent and ongoing actions against dietary supplement marketers. The FTC, in its discussions, highlighted a case...more

California Enacts Electronic Communication Privacy Statute, Connected Television Privacy Statute

The California legislature recently enacted the California Electronic Communications Privacy Act (“CalECPA”) (Senate Bill 178), which provides greater protections against governmental searches for persons’ electronic...more

Supreme Court denies cert in case involving cell location privacy rights

On July 31, 2015, Quartavious Davis petitioned for certiorari in Davis v. United States, No. 15-146 asking (1) whether the acquisition of a cell phone user’s location data from his cellular service provider constitutes a...more

California Gives the Fourth Amendment a 21st Century Makeover

The average American today generates more media than they did at any other point in history, and the ease with which our communications, photos, and videos are sent and stored digitally means most of us have more media stored...more

Risky times for some Internet lenders

A recent decision by the Minnesota Supreme Court serves as a painful reminder to Internet lenders of the perils of relying on choice-of-law provisions or arguments citing the Commerce Clause of the U.S. Constitution to avoid...more

Commerce Clause Does Not Prevent Minnesota from Regulating Internet Loans Made to State Residents, Minnesota Supreme Court Rules

The Minnesota Supreme Court has ruled that the Commerce Clause of the U.S. Constitution does not preclude Minnesota from applying its payday lending law to loans consummated in Delaware that are made to Minnesota residents...more

First Amendment Notes: Amicus Briefs In Pacira & Application of IMS v. Sorrell

Here we discuss a couple of developments involving (actually or potentially) the application of the First Amendment to the FDA’s increasingly battered prohibition against truthful promotion of off-label use....more

Updates Regarding the Pacira Pharmaceutical Inc. v. FDA Lawsuit Regarding First Amendment and Off-Label Promotion Issues

As readers of this blog know, following Amarin’s success in obtaining a preliminary injunction limiting FDA enforcement action against it for truthful, non-misleading off-label promotion of its prescription drug Vascepa,...more

Change Coming to FDA’s “Intended Use” Regulations?

Over at the Drug And Device Law Blog, our colleagues call attention to proposed changes to the “intended use” regulations for prescription drugs and devices, 21 C.F.R. §201.128 and 21 C.F.R. §804.1, somewhat hidden within a...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

It’s Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case

To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more

Arizona’s Revenge Porn Law Remains on Indefinite Hold

Earlier this year, the Arizona Legislature made major revisions to Arizona’s revenge porn law, Arizona Revised Statutes § 13-1425. Arizona is neither the first nor the only state to prohibit the unauthorized disclosure...more

First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA

The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved...more

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