Tag Archives: Personalized Medicine

New Report Outlines 5 Year Plan to Achieve Cancer Moonshot

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The Cancer Moonshot Task Force has just released its 5 year plan for implementing President Obama’s “Cancer Moonshot” program (“Report”). The initiative, announced during President Obama’s 2016 State of the Union Address, is a national effort to dramatically accelerate efforts to prevent, diagnose and treat cancer that take advantage of recent advances in molecular medicine … Continue reading this entry

Personalized Medicine: Insights Into Current Legal Issues

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Guest Post by:  Nate Beaver, Esq.; Gary Koch, Esq.; Antoinette Konski, Esq.; and Judy Waltz, Esq., Foley & Lardner, LLP. In his January 20, 2015 State of the Union address, President Obama brought to the nation’s attention the promise of personalized medicine when he announced the Precision Medicine Initiative (the “PMI”). In announcing this initiative during … Continue reading this entry

USPTO ANNOUNCES CANCER MOONSHOT CHALLENGE

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The USPTO announced a public challenge in support of the National Cancer Moonshot Initiative. The USPTO is asking the public to investigate and leverage the intellectual property data within the USPTO and combine it with other economic and funding data (e.g., SEC filings, FDA reporting, National Science Foundation grants and other funding sources) to “reveal new insights … Continue reading this entry

Advancing Personalized Medicine Through Cross-sector Collaboration and Innovation

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Since 2013, thought leaders, innovators, and health care specialists have convened for a one day summit to discuss the business of personalized medicine. The Business of Personalized Medicine Summit, explores the economic, legal and regulatory barriers to making personalized medicine a reality for patients everywhere while sharing strategies for success. This year’s Summit – Strategies for Partnering … Continue reading this entry

Breakthrough Business Solutions to Advance Personalized or Precision Medicine

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In today’s era of unprecedented opportunities and complexity within personalized medicine, it has become critical innovators in the space to adopt a collaborative approach with outside experts in order to quickly and affordably bring new products and services to market. And, as it turns out, collaboration may also be the key to achieving mainstream clinical … Continue reading this entry

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

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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 insight into the diagnosis, prediction and treatment of disease, and will continue to do so as more genetic information is collected and … Continue reading this entry

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

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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 information on one or at most, several variants at a time. Advances in DNA sequencing technology, notably Next Generation Sequencing (NGS), permit the analysis of millions of variants … Continue reading this entry

FEDERAL CIRCUIT’S RECENT PRIMER ON PATENT-ELIGIBILITY

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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 (Fed. Cir., July 5th 2016). The decision provides much needed guidance to the life science industry that had yet to receive positive guidance from … Continue reading this entry

Supreme Court Declines Sequenom Review

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Last week the United States Supreme Court denied Sequenom’s petition to review the Federal Circuit’s holding in Sequenom Inc. v. Ariosa Diagnostic Inc., 788 F.3d 1371 (2015) that claims directed to detecting fetal DNA in maternal blood were invalid for failing to recite patent eligible subject matter. Therefore by default, the Court let stand the … Continue reading this entry

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 where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply … Continue reading this entry

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

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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 goal of developing and laying out appropriate genomic methodologies for use during the development and life-cycle of a drug. Past issues and problems that have been encountered … Continue reading this entry

DESPITE BARRIERS, COMMUNITY SPECIALTY CLINICIANS ARE EAGER TO ADOPT PRECISION MEDICINE TOOLS

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GUEST POST BY Vicki Albrecht, Ph.D., Senior Vice President and General Manager of ION Solutions 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 patient care, PM can improve patient outcomes and increase the effectiveness of … Continue reading this entry

USPTO RELEASES PATENT ELIGIBILITY UPDATE

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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 to that rejection. The USPTO concurrently released new life science examples to assist examiners and applicants evaluate whether claimed discoveries satisfy 35 U.S.C. … Continue reading this entry

ANOTHER DIAGNOSTIC PATENT FALLS UNDER 101

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In Genetic Techs Ltd v Merial LLC (Fed. Cir., April 8, 2016), the Federal Circuit invalidated yet another diagnostic patent for failing to satisfy 35 U.S.C. § 101 on the ground that the claims recite nothing more than a law of nature. The claim’s recitation of the term “to detect the allele” was insufficient to … Continue reading this entry

Capitalizing on Collaboration – The President’s Precision Medicine Initiative

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Last week President Obama marked the one year anniversary of his Precision Medicine Initiative (“PMI”) by holding a web-accessible panel discussion where he and interested stakeholders discussed his PMI initiative, its progress and future direction. The President also announced a series of awards, funded by the National Institutes of Health (“NIH”), to build the infrastructure … Continue reading this entry

Data Transmission, Personalized Medicine, and Privacy

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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 January 26, 2016) has rolled out a program to collect health data from one million volunteers to inform and guide future research. Consumers … Continue reading this entry

The President’s Precision Medicine Initiative – The First Annual Check-Up

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Watching President Obama’s recent 2016 State of the Union Address reminded me that one year has passed since the President announced a new “precision” or personalized medicine initiative to advance personalized, effective therapies for the American public. It was during his 2015 State of the Union Address that the President stated:[1] “[T]onight, I’m launching a … Continue reading this entry

3 Pressing Challenges for Personalized Medicine

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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 their unique genetic or clinical profiles. According to an article published by the FDA in the spring of 2015 (FDA Continues to Lead … Continue reading this entry

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 key takeaway was that while diagnostics hold the promise of getting the right medicine to the right patient at the right time, much … Continue reading this entry

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

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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 consider if their diagnostic test may be subject to FDA oversight, either as a moderate risk (Class II) or high-risk (Class III) … Continue reading this entry

Patent Subject Matter Eligibility – Impact on Litigation and Prosecution

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Personalized medicine relies on diagnostic technologies to accurately evaluate a patient’s clinical or genetic signature to guide treatment decisions. Protecting innovation by patenting the diagnostic methods and tools that inform clinical intervention and treatment has been the traditional means to protect investment in these important technologies. Recent U.S. Supreme Court decisions have challenged inventors’ ability … Continue reading this entry

Breaking Through to Business Solutions for Personalized Medicine: A Thought-Provoking, Can’t-Miss Industry Event

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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, so it should come as no surprise that each demands a distinct business strategy that can evolve alongside the industry. The annual Business of Personalized Medicine … Continue reading this entry

Nautilus Standard Sinks Dow Patents

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Dow Chemical Company (“Dow”) lost a ruling that competitor NOVA Chemical Corporation and NOVA Chemicals Inc. (collectively “NOVA”) infringed claims of two Dow patents when the Federal Circuit applied the U.S. Supreme Court’s new definiteness standard set forth in Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014)(“Nautilus”). Dow Chemical Co. v. NOVA Chemicals … Continue reading this entry

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

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Guest Post by Amy Grogg, PharmD, Senior Vice President of Strategy and Commercialization, AmerisourceBergen Specialty Group The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is for you.” The promise of personalized medicine … Continue reading this entry