Personalized Medicine

News & Analysis as of

Inherent Disclosure Satisfied Written Description

In Yeda Research and Development Co., Ltd. v. Abbott GMBH & Co. KG, Slip Op. 2015-1662 (Fed. Cir. 2016), the Federal Circuit held that a claim to an isolated protein described by its partial amino acid sequence satisfies 35...more

FDA Issues Guidance on Use of Public Human Genetic Variant Databases and Their Use in Personalized Medicine

Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine. Analysis of whole genomes is providing...more

FDA Issues Draft Guidance To Streamline Regulatory Oversight Of NGS-Based Tests For Diagnosing Germline Diseases

Personalized or Precision Medicine needs reliable and accurate diagnostic tests to guide clinical intervention and treatment decisions. Traditional testing of germline variants is site-specific and therefore only provides...more

Federal Circuit’s Recent Primer on Patent-Eligibility

A method of producing a desired population of multi-cryopreserved hepatocytes was held to be patent-eligible because the challenged claims did not recite a judicial exception. Rapid Litig. v. CellzDirect, Inc.., 2015-1570...more

Supreme Court Deals Blow To Diagnostic Method Patents, Denies Cert In Sequenom

“If you can’t say something nice, don’t say anything at all” can be good words to live by, but in the context of the Supreme Court’s denial of certiorari in Sequenom, the silence is deafening–and could have a chilling impact...more

Will the Supreme Court Clarify Patent-Eligibility?

The United States Supreme Court is set to render its decision on the grant or denial of Sequenom, Inc.’s (“Sequenom’s”) petition for writ of certiorari that posed the issue: ..Whether a novel method is patent-eligible...more

EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated...more

IP Developments In Biotechnology And Trade Secrets

2016 has been a year of IP changes and these changes have had an effect upon biotechnology as well as trade secrets. Patents: Will the U.S. Supreme Court Grant Cert. In Ariosa v. Sequenom? Ariosa v. Sequenom was...more

Despite Barriers, Community Speciality Clinics are Eager to Adopt Precision Medicine Tools

Fueled by technological advances, scientific breakthroughs and significant financial investments, precision medicine (PM) has emerged as a promising approach to disease prevention and treatment. A multi-faceted solution to...more

USPTO Releases Patent Eligibility Update

On May 4, 2016, the USPTO released a “May 2016 Subject Matter Eligibility Update” (“Update”) providing guidance to patent examiners on formulating a subject matter eligibility rejection and evaluating an applicant’s response...more

Data Transmission, Personalized Medicine, and Privacy

Health care analytics make use of patient data to inform treatment decisions and is increasingly moving front and center in personalized medicine. For example, the President’s Precision Medicine Initiative (see post of...more

European Life Sciences Review: Issue 1

Welcome to the first issue of our EU Life Sciences Review . It is produced by our life sciences lawyers in London, Brussels, Frankfurt, Moscow, and Paris and covers some of the most critical developments in the pharmaceutical...more

Laboratory Developed Tests Emerging in FDA Regulation

Health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease state management such as for cancer,...more

Looking Ahead to 2016 and Beyond: Could the Precision Medical Initiative Revolutionize the Way Patients Receive Medical Treatment?

The Precision Medicine Initiative (“PMI”) was officially unveiled in President Obama’s January 2015 State of the Union address. Precision medicine is an emerging approach for disease prevention and treatment that considers an...more

FDA Legal and Regulatory – 2015 Year In Review

Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on...more

Prometheus Labs., Inc. v. Roxane Labs., Inc. (Fed. Cir. 2015)

The Federal Circuit affirmed a judgment of invalidity based on obviousness in a decision rendered in Prometheus v Roxane. In doing so, the Court might also have given an indication of the types of claims for "personalized...more

Genetic Testing, Genome Sequencing, and the FDA

In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) – any test that detects a disease, condition, or infection – to the...more

Life lines: Life sciences M&A and the rise of personalised medicine

The second report in our Deal Dimensions series, written in collaboration with Mergermarket and launched today, reveals that 94 per cent of life sciences companies are planning an acquisition in the next year, with more than...more

Three Pressing Challenges for Personalized Medicine

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

National Geographic Considers Technology and Its Threat to Humanity

Progress, and faith in progress to improve human lives, has been a cornerstone belief in American civilization (and, indeed, Western civilization generally, at least since St Augustine argued that Christ's death put an arrow...more

Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

Navigating the Diagnostic Commercialization Process

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

Highlights from the Tenth CEO/Innovators Roundtable: June 4 – 5, 2015

This past June, leaders from health systems, outpatient services companies, health insurers, IT and equipment suppliers, health retailers, home care providers, pharmaceutical companies, and investors gathered in Chicago for...more

[Event] 2015 Business of Personalized Medicine Summit - Oct. 7, San Francisco, CA

Just as with patient treatments, one size does not fit all when it comes to companies involved in personalized medicine. Each is unique in its mission, culture, and capabilities, and so it should come as no surprise that each...more

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

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