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Both Parties Seek En Banc Intervention in Amgen v. Sandoz

Last month, a divided panel of the Federal Circuit issued a split decision in Amgen v. Sandoz (summary; opinion). Amgen (in which Patterson Belknap represented one of the amici supporting Amgen) is the court’s first decision...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

Target Reaches $67 Million Settlement with Visa over Data Breach Claims

More than a year-and-a-half after Target’s December 2013 announcement of a massive data breach, the retailer has reached an agreement with Visa, whereby it will reimburse Visa and certain affected card issuers up to $67...more

Will New PTAB Rules Impact IPRs Filed By Kyle Bass Hedge Fund?

On August 19th, the USPTO released a new set of proposed rules related to post-grant proceedings before the Patent Trial and Appeal Board (PTAB). Among the many offered rules was the addition of a “Rule 11-type certification”...more

Target and Visa Announce $67 Million Settlement

Last winter, following a well-publicized data breach, a group of financial institutions sued Target, arguing that Target should be held responsible for the damages that they had experienced as a result of the data breach...more

Address Businesses Liabilities With Sound Compliance, Experienced Litigation Counsel

One of the points we mention fairly frequently on this blog is that proactive regulatory compliance is critical for businesses. One reason for this is that the costs for failing to comply with federal laws and regulations can...more

Breaking News: Target to Settle Data Breach Claims of Visa Card Issuers for $67 Million

Target has announced that it has entered into a settlement with Visa to resolve claims of issuers of Visa credit and debit cards arising from Target’s November 2013 data breach. The proposed settlement will pay issuers of...more

Divided Federal Circuit Says U.S.I.T.C. May Exclude Indirectly Infringing Items

The U.S. International Trade Commission (ITC) is a powerful tool for enforcing intellectual property rights. The U.S. Court of Appeals for the Federal Circuit recently expanded that power – at least for the time being,...more

IP Newsflash - August 2015 #2

FEDERAL CIRCUIT CASES - Federal Circuit Quashes $287 Million Enhanced Damages Award Finding Objectively Reasonable Defenses Raised During Litigation - The Federal Circuit has reversed a district court’s award of...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

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

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

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

Ninth Circuit is the First Appeals Court to Rule on RAND/SEP Licensing

In a decision written by Judge Marsha S. Berzon, a three-judge panel of the U.S. Court of Appels for the Ninth Circuit affirmed a first-of-its-kind district court judgment relating to royalty rates for standard-essential...more

What is a RAND Licensing Rate? The Ninth Circuit Weighs in.

July has just ended, and SEP and FRAND issues are in the air. On July 8, the Japan Fair Trade Commission (JFTC) sought public comments on its proposed amendments to its Guidelines for the Use of Intellectual Property under...more

Sony Data Breach Class Action Survives Motion to Dismiss Suit

As previously reported upon by PK Law, Michael Corona and eight other individuals (“Plaintiffs”) filed a class action on March 2, 2015 against Sony Pictures Entertainment, Inc. (“Sony”). (U.S. District Court, Central District...more

Empowering Customers to Sell an Exonerated Accused Product - Speedtrack Inc. v. Office Depot, Inc.

In a decision that expands a customer’s right to defend itself under the Kessler doctrine, the Federal Circuit clarified that a customer is not subject to liability for a product that has already been cleared of patent...more

Ninth Circuit Affirms District Court Decision Regarding Reasonable and Non-Discriminatory (RAND) Obligations in Patent Licensing...

In a recent decision, the Ninth Circuit affirmed a jury verdict awarding Microsoft $14.5 million for Motorola's breach of its obligation to offer Microsoft reasonable and non-discriminatory (RAND) licenses for certain...more

Amendment to the Personal Information Protection Act Passed in the National Assembly July 6, 2015

On July 6, 2015, the Korean National Assembly passed a bill containing several amendments to the Personal Information Protection Act (PIPA). This bill (the Amendment Bill) combines a number of major provisions from nine...more

Individual Inventor Alleges Eli Lilly and BDA Overdosed on Patented Dosage Adherence Tool

In the latest chapter of a year-long battle between an individual inventor and two companies, Lisa Duer (“Duer”), a resident of Woodstock, Georgia, filed her Third Amended Complaint alleging patent infringement, trademark...more

IP Newsflash - July 2015 #4

FEDERAL CIRCUIT CASES - Federal Circuit Grants Mandamus Disallowing Use of U.S. Discovery in Foreign Proceedings - The Federal Circuit has granted mandamus vacating a New Jersey district court’s order that allowed...more

Ninth Circuit Upholds First District Court Determination of FRAND Licensing Rate and Affirms $14.5 Million Damage Award

The Ninth Circuit has affirmed Microsoft’s $14.5 million jury verdict against Motorola, upholding the first federal bench trial decision setting a fair, reasonable, and non-discriminatory (FRAND) licensing rate. Armed with...more

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