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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

$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

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

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

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

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

Supreme Court May Decide Issue of the Level of Specificity Required Under Rule 9(b) in FCA Whistleblower Suits

The United States Supreme Court recently indicated its potential interest in hearing arguments in a key False Claims Act (FCA) case that would address a circuit split over the important issue of the level of specificity of...more

Federal Preemption Rules and Insufficient Pleading Results in Dismissal of Plaintiff’s Off-Label Claims

In a recent decision issuing from the Central District of California, the court evaluated requirements pertaining to federal preemption and pleading, and granted Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc.’s...more

A victory for generics suppliers

In late June the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more

Pre-Emption of State-Law Design-Defect Claim Against Generic Drug Company

On June 24, 2013, in a 5-4 decision, the U.S. Supreme Court in Mutual Pharmaceutical Co., Inc. v. Bartlett held that state-law design-defect claims based on the inadequacy of a generic drug’s labeled warnings are pre-empted...more

Generic Drug Preemption Expanded by Supreme Court's Bartlett Decision

Not surprisingly, the Supreme Court reaffirmed the broad preemptive scope of PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and further extended the reach of impossibility preemption to design defect claims, in issuing its...more

Supreme Court Rejects ‘Stop-Selling’ Argument in Conflict Preemption Cases

In a 5-4 decision, the U.S. Supreme Court rejected the notion that a manufacturer’s option to stop selling its product resolves preemption concerns raised by conflicting state and federal laws....more

U.S. Supreme Court Bartlett Decision in Favor of Generic Drug Manufacturers

In a 5-4 decision, the United States Supreme Court held that state law design defect claims against manufacturers of generic pharmaceuticals are preempted by federal law when the claim hinges on the adequacy of the drug's...more

Mutual v. Bartlett Further Shields Generic Drug Manufacturers from Liability

Yesterday, the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more

"Supreme Court’s Bartlett Decision Reaffirms Broad Scope of Generic Drug Preemption"

In a significant victory for generic drug companies, the Supreme Court today issued its decision in Mutual Pharmaceutical Co. v. Bartlett, reversing the decision of the First Circuit, which had affirmed a multimillion dollar...more

First Circuit Deepens Circuit Split On Question Concerning the False Claims Act’s First-to-File Bar

On May 31, 2013, the First Circuit weighed in on a question concerning application of the False Claims Act’s first-to-file bar that has split the circuits. In United States ex rel. Heineman Guta v. Guidant Corp., et al.,...more

Supreme Court Hears Bartlett, Will Resolve Liability Questions for “Design-Defect” of Generic Drugs

In March, the U.S. Supreme Court held oral argument in Mutual Pharmaceutical Co. v. Bartlett, concerning whether design-defect claims against generic drug companies are preempted by federal law. Although the case addresses...more

Delta Finds Reprieve in State Court, but Not Everyone Will Get to Fly the Friendly Skies

California Attorney General Kamala Harris’ attempt to bring an enforcement action against Delta Air Lines, Inc. won’t be leaving the runway. California Superior Court Judge Marla J. Miller has dismissed a data privacy...more

Privacy Litigation Alert: California Court Dismisses Attorney General's Mobile App Privacy Suit Against Delta, Offers Little...

A California Superior Court judge has dismissed with prejudice a privacy suit brought by California Attorney General Kamala Harris against Delta Airlines. The complaint, filed in December of 2012, alleged that Atlanta-based...more

Compounding Animal Drugs from Bulk Ingredients

Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). In the world of...more

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