News & Analysis as of

Diagnostic Method Diagnostic Tests

J.S. Held

Accuracy of 2016-2022 EDRs in IIHS Crash Tests

J.S. Held on

Abstract - Event data recorders (EDRs) were harvested and imaged after Insurance Institute for Highway Safety (IIHS) 56 km/hr frontal and 64.4 km/hr frontal offset crashes of 15 different brands of 2016-2022 vehicles. The...more

Napoli Shkolnik

Diagnostic Errors Claim Nearly 800,000 American Lives Per Year, Study Finds

Napoli Shkolnik on

A new study shows that approximately 371,000 people die and 424,000 sustain permanent disabilities due to diagnostic error, including brain damage, blindness, loss of limbs or organs or metastasized cancer....more

Foley & Lardner LLP

2019 FDA Precision Medicine Approvals: Progress At FDA

Foley & Lardner LLP on

On February 21, 2020, the Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: The Scope and Significance of Progress in 2019” (Report) that monitors FDA approvals of precision medicine...more

Kramer Levin Naftalis & Frankel LLP

Supreme Court Won’t Take Up Patent Eligibility for Medical Diagnostics

The cloud of uncertainty over patent eligibility of patents for medical diagnostic methods remains. On Monday, the Supreme Court declined the opportunity to revisit patent eligibility under its two-step Mayo test when it...more

King & Spalding

Federal Circuit Continues Trend of Finding Diagnostic Inventions to Be Patent-Ineligible

King & Spalding on

On August 9, 2019, the Federal Circuit issued a public opinion in Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH & Co. KG, finding claims directed to methods for detecting a genetic marker for a canine hereditary disease...more

Foley & Lardner LLP

Australia Holds The Line On Patent Eligibility Of Diagnostic Methods

Foley & Lardner LLP on

In a decision underscoring that the U.S. stands (nearly) alone in holding most diagnostic methods to be not eligible for patenting, the Federal Court of Australia upheld Sequenom’s Australian patent directed to prenatal...more

Bradley Arant Boult Cummings LLP

Patenting Diagnostics and Biomarkers Six Years After Mayo

In 2012, the U.S. Supreme Court decided the landmark case of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), which was hailed by some as banning patents on methods of medical diagnosis. It...more

Foley & Lardner LLP

Three Pressing Challenges for Personalized Medicine

Foley & Lardner LLP on

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Dorsey & Whitney LLP

Patent for Technology that “Revolutionized Prenatal Care” Nonetheless Invalid as Patent Ineligible

Dorsey & Whitney LLP on

The Federal Circuit Friday held in Ariosa Diagnostics, Inc. v. Sequenom, Inc. that Sequenom’s patent directed toward its MaterniT21 test—involving methods of detecting and using cell-free fetal DNA— was invalid for lack of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Patent Profile: National Tsing Hua University Receives Patent for Method for Early Diagnosis of Liver Cancer

Last week, the U.S. Patent and Trademark Office issued U.S. Patent No. 8,628,920, which is entitled "Method for early diagnosis of liver cancer and prediction of metastasis." The '920 patent, which is assigned to National...more

Foley & Lardner LLP

Risk-Sharing and Reimbursement of Diagnostic Tests

Foley & Lardner LLP on

Five industry executives argue for an overhaul of the current approval and reimbursement framework for diagnostic tests. In A Pay-For-Value, Data-Driven Approach for the Coverage of Innovative Genetic Tests a case is made for...more

Foley & Lardner LLP

Supreme Court Asked for Further Clarity on Patent-Eligibility of Diagnostic Claims

Foley & Lardner LLP on

Did the Federal Circuit incorrectly interpret and apply the holding of the U.S. Supreme Court’s decision regarding patent-eligibility of medical methods as set forth in Mayo Collaborative Services v. Prometheus Laboratories,...more

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