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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 “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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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