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Federal Circuit Review - November 2014

Japan Airlines Activities For US Government Cannot Infringe - In IRIS CORP. v. JAPAN AIRLINES CORP., Appeal No. 2010-1051, the Federal Circuit affirmed a decision to dismiss due to a conflict of laws. IRIS owns...more

FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act

Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing...more

"Generic" Logic Helps Branded Drug Achieve Dismissal

A federal district court has held that design defect claims against a brand pharmaceutical manufacturer are preempted by federal law. Booker v. Johnson & Johnson, No. 3:12 oe 40000, 2014 WL 5113305 (N.D. Ohio Oct. 10,...more

Beginning to Close the POM Circle? – POM Wonderful and Drug Advertising: JHP Pharmaceuticals

Earlier this year, in POM Wonderful LLC v. Coca-Cola Co.,[1] the Supreme Court examined the interaction between the Lanham Act’s prohibition against false advertising and the FDCA’s prohibition against food, drug and...more

Ninth Circuit Upholds Alameda Safe Drug Disposal Ordinance, Triggering Implementation of King County Secure Medicine Return Rule

On September 30, 2014, the Ninth Circuit affirmed the Northern District of California’s summary judgment that the Alameda Safe Drug Disposal Ordinance (the “Ordinance”) does not violate the dormant Commerce Clause of the...more

Patent Protection for Isolated Genetic Sequences Upheld in Australia

Last year in AMP v Myriad Genetics, the U.S. Supreme Court concluded that isolated, naturally occuring DNA are not patent eligible, which caused considerable consternation in the biotech community. However, this does not...more

The USPTO Patent Subject Matter Eligibility Guidance TRIPS Over Treaty Requirements

The “Myriad-Mayo” patent subject matter eligibility guidance issued March 4, 2014 reflects the USPTO’s interpretation of Supreme Court cases interpreting and applying 35 USC § 101 to claims involving laws of nature, natural...more

Supreme Court Reinforces Need for Robust Adverse Event Reporting Process

On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more

UK High Court confirms jurisdiction to grant cross-border declaration of non-infringement

In Actavis Group HF v. Eli Lilly & Co. the UK High Court has granted a declaration of non-infringement in the UK, France, Italy and Spain. A jurisdictional challenge in relation to the French, Italian and Spanish...more

Help Wanted: Supreme Court Looking for Expert to Fill In The Right Words for Patent Eligibility Test

There's a new job opening at the Supreme Court: Job Description: Complete test of patent eligiblity sketched out by this Court’s decisions in Bilski v. Kappos and Mayo v. Prometheus. Self starter required: must be...more

A Brief Overview of the Case Law Regarding "Failure to Train" Claims - And Its Implications for Medical Device Manufacturers

In recent years, causes of action for “failure to train,” or allegations predicated on a duty to train, have been on the rise in cases against medical device manufacturers. Historically, however, such claims and allegations...more

$4 Billion Price Tag for Pleasing Plaintiffs' Bar? New Study Estimates Costs of FDA's Proposed Rule on Generic Drug Labeling

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more

Judicial Notice of FDA Website Documents Can Be a Powerful Lever in a Medical Device Manufacturer’s Motion to Dismiss

A motion to dismiss can be a powerful tool in the hands of medical device companies to eliminate cases that should be dismissed from the outset on preemption grounds, before engaging in costly discovery. Oftentimes, however,...more

Fourth Circuit Limits Scope of Employers’ Claims Under Computer Fraud and Abuse Act

In July 2012, the United States Court of Appeals for the Fourth Circuit issued an important decision limiting the claims employers can bring against disloyal current and former employees under the federal Computer Fraud and...more

District Courts Staying Cases Pending CLS Bank, but the Federal Circuit Decides One

In December, the Supreme Court granted certiorari in CLS Bank Int’l v. Alice Corp., No. 13-298, in which the question presented by the petitioner is “[w]hether claims to computer-implemented inventions — including claims to...more

New Jersey punitive damages analysis ignores established precedent

Since 2008 New Jersey law has effectively granted pharmaceutical manufacturers immunity from punitive damages claims. While New Jersey state courts continue to recognise and enforce that immunity, some recent federal court...more

Allergan, Inc. v. Athena Cosmetics, Inc. (Fed. Cir. 2013) -- FDCA Does Not Preempt State Unfair Competition Laws

If you have ever wondered how popular eyelash enhancers like RevitaLash and Latisse produce their effects, Allergan, Inc. v. Athena Cosmetics, Inc. provides the answer: these products comprise prostaglandin derivatives. The...more

Industry Group To Weigh In On GMO Labeling Debate

With the rise in state legislative efforts to require labeling for foods produced using genetic engineering or “GMOs,” the Grocery Manufacturers Association (GMA) is poised to enter the labeling debate by working with federal...more

A Short-Lived Victory for Generic Manufacturers? – Part 2

In our prior blog post of the same title on July 5, 2013, we predicted that the protection from product liability/failure to warn litigation for generic manufacturers as a result of the Supreme Court decision in Mutual...more

Careful What You Say – No Preemption for Statements Made in Operating Room

Makers of medical devices marketed pursuant to the Food and Drug Administration’s (FDA) premarket approval process are generally relieved from defending state law failure to warn claims by operation of express preemption, a...more

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

Goodbye to Generic Preemption? FDA Publishes Proposed Rule

Today, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule in the Federal Register in an effort to “create parity” between brand-name and generic manufacturers for their labeling obligations. 78...more

Second Circuit Holds In-House Lawyer Precluded from Blowing Whistle on Former Employer

The Second Circuit issued an opinion tackling the interplay between an attorney's ethical obligation to maintain client confidences and the ability to act as a "whistleblower" to report unlawful conduct to the government. The...more

Thoughts on the Stored Communications Act, Federal Preemption and Supremacy, and State Laws on Fiduciary Access to Digital...

As of the date of this posting, seven states have recently passed laws and at least eighteen other states are considering new laws granting fiduciary access to an incapacitated or deceased person’s online accounts and other...more

International Patent Laws – Interview with Julian Crump, Managing Member, Mintz Levin's London, UK Office  [Video]

Attorney Julian Crump, Managing Member of Mintz Levin's London, UK office, talks about the differences between patent laws in the US and the EU and the importance of identifying those differences at the outset of the...more

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