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Trade secrets law in the Internet age

How do you maintain a trade secret in the Internet age? As in the punch line to an old joke, “VERY CAREFULLY.”...more

The Supreme Court Sends Spokeo Back

Today, the U.S. Supreme Court decided one of the Term’s most closely watched cases: Spokeo, Inc. v. Robins. The 6-2 decision, while far from sweeping, creates a hurdle for plaintiffs in “no-injury” class actions....more

In Onboard Wi-Fi Case, Covenant Not To Sue Has Wide Range

Judge Jeffrey Alker Meyer of the District of Connecticut recently released an opinion that is significant to litigants on either side of a covenant not to sue. In a complex case with a host of claims and counterclaims...more

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

The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more

Federal Circuit Review | March 2016

Under O2 Micro, a District Court Must Provide a Claim Construction if the Parties Dispute the Meaning of a Claim Term - In Eon Corp. IP Holdings LLC v. Silver Springs Networks, Inc., Appeal No. 2015-1237, the Federal...more

The Supreme Court - March 2016 #3

The Supreme Court of the United States issued one per curiam decision on March 21, 2016: Caetano v. Massachusetts, No. 14-10078: Massachusetts enacted a law prohibiting the possession of stun guns. That law was upheld...more

Early Settlement of the Home Depot Consumer Data Breach Claims – The Start of a Trend?

Last week, a federal court in Atlanta issued an order preliminarily approving a proposed settlement – valued up to $19.5 million – of the consumer claims arising from the 2014 theft of payment card data from Home Depot. The...more

Fight the Good Fight Every Moment: Do Recent First Amendment Court Developments Deal a Blow to the Government?

In the last month, the Food and Drug Administration has suffered setbacks relating to off-label promotion oversight. In both cases, one involving a pharmaceutical company and the other a medical device firm and its Chief...more

Amarin Settles Off-Label Promotion Case Against the FDA

The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion. On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more

Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing

On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to...more

Amarin Pharma Settles First Amendment Claims Against FDA: Potential Implications

Irish drug company Amarin Pharma, Inc. (Amarin) and the U.S. Food and Drug Administration (FDA) agreed, on March 8, 2016, to settle claims that FDA regulations barring Amarin from making “truthful” and “non-misleading”...more

A Proposed End to “Amarin Pharm v. FDA” has FDA Agreeing to Abide by District Court’s Order

We have been closely following Amarin Pharm, Inc. v. FDA with respect to the preliminary injunction granted by the Southern District of New York that prohibited the FDA from taking action against Amarin over truthful,...more

Post-Grant PTAB Procedures Are Constitutional - MCM Portfolio LLC v. Hewlett-Packard Co.

In a case of first impression, the U.S. Court of Appeals for the Federal Circuit upheld the constitutionality of inter partes review (IPR) proceedings. The Federal Circuit ruled that because patents were a public right,...more

Ropes & Gray Advises Pacira Pharmaceuticals in Reaching Landmark Settlement Agreement with FDA

A cross-disciplinary team of Ropes & Gray attorneys advised Pacira Pharmaceuticals on its December 14 settlement agreement with FDA. On behalf of Pacira, Ropes & Gray had filed suit against FDA in September 2015 in the U.S...more

Post-Grant Challenges in Life Sciences: A Midyear Assessment

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

Reply Brief filed in Spokeo v. Robins – Oral Argument next on Nov. 2

In its reply brief in Spokeo v. Robins, petitioner Spokeo comes out of the gate with the consequential argument that for Robins to prevail, the Supreme Court must accept his position that every violation of a statutory right...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

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

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

Blog: Significant Court Decision Issued Today re: Off-Label Promotion

A highly anticipated decision was issued today in the U.S. District Court for the Southern District of New York in the case, Amarin Pharma Inc. et al. v. Food and Drug Administration et al. (case no. 1:15-cv-03588). See this...more

Breaking News - Amarin Hits First Amendment Home Run Off FDA

Here’s a copy of today’s 71-page decision in Amarin Pharma, Inc v. FDA, No. 15 Civ. 3588 (PAE), slip op. (S.D.N.Y. Aug.7, 2015), in which the court granted a First Amendment-related injunction against the FDA’s prohibition...more

Federal Circuit Review | July 2015

Nunc Pro Tunc Assignments Insufficient To Confer Retroactive Standing - In ALPS SOUTH, LLC v. OHIO WILLOW WOOD CO., Appeal Nos. 2013-1452, 2013-1488, 2014-1147, and 2014-1426, the Federal Circuit reversed the denial of a...more

Barbarians at the Gate: Seventh Circuit Finds Article III Standing for Data Breach Class Actions

As a result of the Supreme Court’s decision in Clapper v. Amnesty Int’l USA, 133 S. Ct. 1138, 1147 (2013), data breach class actions were largely considered dead in the water. The overwhelming majority of courts, relying...more

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers...more

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