Tag Archives: Personalized Medicine

Privacy Issues in the Sharing of Genetic Information

helix2
Low cost sequencing of a patient’s genome and advances in the interpretation of a patient’s genetic information is promised to transform the delivery of health care. To date, much of personalized medicine has focused on the use of genetics and data analytics to match a patient to the best treatment, especially in the area of … Continue reading this entry

Unlocking the Promise of Personalized Medicine: Reimbursement, Coverage, and Clinical Utility

243x200BPM
AmerisourceBergen, in connection with the Business of Personalized Medicine Summit, released “Unlocking the Promise of Personalized Medicine: Perspectives on Reimbursement, Coverage, and Clinical Utility” (“Report“). The Report explores the role of personalized medicine in today’s health care system with an overview of payer perspectives and provides recommendations to innovators to navigate the path to commercialization of … Continue reading this entry

Considering Sex-Specific Variation for Personalized Medicine

FDA
Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a particular cancer therapy. In some instances, the prediction of clinical outcome is related not only to the genetic variance … Continue reading this entry

Will the USPTO Respond to Public Feedback of Its Eligibility Guidance?

PatentEligibility-Abstract-Light
Periodically, the USPTO holds open meetings with the public to discuss its thinking on current topics relating to the patent procurement process. Late last week, the Biotechnology, Chemical and Pharmaceutical Customer Partnership of the USPTO announced the first bi-coastal meeting to be held via webcast in Washington, D.C. and San Jose, California on September 17th, 2014. … Continue reading this entry

Yamanaka iPSC Patent Challenged

cell
Dr. Shinya Yamanaka of Kyoto University shared the 2012 Nobel Prize in Physiology or Medicine with Dr. John B. Gurdon for their respective discoveries that mature, specialized cells can be reprogrammed to become immature cells capable of developing into all tissues of the body. In the 2012 Nobel announcement, the Nobel Assembly at Karolinka Institutet stated … Continue reading this entry

Managing IP Risk in the Age of Personalized Medicine

PersonalizedMedicine
As discussed on Foley’s Health Care Law Today blog, personalized medicine treatment trends and innovations are leading diagnostic and therapeutic companies to form complex arrangements and partnerships with the ultimate goal of delivering improved patient treatment. Diagnostics are married to a single or multiple treatments. Devices connect patients with providers. Health care systems may partner with … Continue reading this entry

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

FDA
Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that certain tests used by health care professionals that diagnose and treat patients are accurate, consistent and reliable, the U.S. Food and Drug … Continue reading this entry

Personalized Medicine Today: PMC Issues Fourth State of the Industry Report

PersonalizedMedicine
Personalized medicine is changing the paradigm of the research, development and delivery of health care. The Personalized Medicine Coalition (PMC), a consortium of interested stakeholders that seeks to promote the understanding and adoption of personalized medicine concepts, services and products, is a key driving force to removing roadblocks to the adoption of personalized medicine. Consistent … Continue reading this entry

Federal Circuit Dismisses WARF Stem Cell Case – A Missed Opportunity

Recently in Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 2013-1377 (Fed. Cir. 2014), the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) dismissed Appellant Consumer Watchdog’s appeal on the ground that as a party, it lacked Article III standing. While the court’s decision raises interesting issues regarding litigation strategy, dismissal of the appeal … Continue reading this entry

Is Next Generation Sequencing Ready for Personalized Medicine?

Next generation sequencing[1] (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application of the information obtained from NGS is as a companion diagnostic for a therapeutic.[2] A significant reduction in the overall cost to sequence the … Continue reading this entry

Patent-Eligibility of Stem Cells Under New USPTO "Myriad-Mayo" Guidance

In March, the U.S. Patent and Trademark Office (USPTO) implemented new procedures to address whether inventions that relate in whole or in part to laws of nature and naturally occurring products are patent-eligibility in light of recent U.S. Supreme Court decisions, notably Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) … Continue reading this entry

Recommendations for NextGen Health IT Infrastructure

Health care information technology (health IT) facilitates the delivery of personalized medicine by providing and supporting the infrastructure for patients, consumers and health care providers to communicate and distribute information. The Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) (collectively, the Office) acknowledge the importance of the … Continue reading this entry

USPTO Issues Guidance for Examining Process Patents

On March 4th, 2014, the U.S. Patent and Trademark Office (USPTO) issued “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as … Continue reading this entry

USPTO to Apply Myriad Beyond Isolated DNA

On March 4th, 2014, the United States Patent and Trademark Office (“USPTO”)  issued a Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as applied to patent-eligibility. See Assn. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. … Continue reading this entry

Genentech's Distribution of Prescribing Information to Physicians is Alleged to Infringe Method Patent

On January 31, 2014, Phigenix, Inc.  (“Phigenix”) filed a lawsuit in federal district court in Georgia alleging that the sale and use of the drug Kadcyla by Genentech, Inc. (“Genentech”) infringed U.S. Patent No. 8,080,534B2, assigned to Phigenix, under 35 U.S.C. Section 271. Particularly, Phigenix alleges that Genentech’s distribution of prescribing information to healthcare professionals such as … Continue reading this entry

Computer-Aided Selection Method Fails Patent-Eligibility

In SmartGene, Inc. v. Advanced Biological Labs., S.A., No. 2013-1186 (Fed. Cir., Jan. 24, 2014), the Federal Circuit held that a patent claiming the use of a computer to implement routine mental information-comparison and rule-application processes to select a treatment for a patient fails patent-eligibility because the claims are directed to an abstract idea. The … Continue reading this entry

Six Hot Opportunities in Genomic Medicine

Advances in DNA sequencing technology and the interpretation of the acquired data have fueled advances in genomics and its application in the delivery of personalized healthcare. Illumina recently announced a new milestone that will move the industry in ways that are yet to be realized, or even envisioned – a DNA sequencing super computer (HiSeqX) … Continue reading this entry

Task Force Recommendation for BRCA-Related Genetic Testing

The U.S. Preventive Services Task Force (“USPSTF”) recently issued a report regarding the effectiveness of BRCA1/BRCA2 genetic tests for women and within the report, issued recommendations for preventive screening for women with and without confirmed familial history of breast, ovarian, tubal, or peritoneal cancer (“BRCA-related cancers”). Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related … Continue reading this entry

FDA Issues Draft Guidance to Expedite Device Development

On November 14, 2013, the Food and Drug Administration (“FDA”) issued a draft guidance document - “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff”  (“Draft Guidance”) reporting a voluntary process for the qualification of medical device development tools (MDDT) used in device development and evaluation programs in the Center for Devices and … Continue reading this entry

11 New Biomarkers Identified for Alzheimer’s Disease

A two-stage meta-analysis of genome-wide association studies (GWAS) in individuals of European ancestry identified 11 new loci associated with Alzheimer’s disease. The multidisciplinary study, recently reported in Nature Genetics, (“Meta-analysis of 74,046 individuals 11 new susceptibility loci for Alzheimer’s disease”, published online on October 27, 2013), is a significant step toward identifying genetic risk factors … Continue reading this entry

Clinical Adoption of Personalized Medicine

A recent study published in the American Journal of Medical Genetics, “Barriers for Integrating Personalized Medicine into Clinical Practice:  A Qualitative Analysis” investigated physicians’ perceptions about the future of personalized medicine and identified factors that would influence their decisions in using genetic testing in their practice. The study is an interesting read for any innovator … Continue reading this entry

Risk-Sharing and Reimbursement of Diagnostic Tests

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 a move from a Fee-For-Service (FFS) system to a Pay-For-Value (PFV) model based on risk sharing among innovators, payors, physicians and … Continue reading this entry

Update on WARF Stem Cell Patent Challenge

As reported in my July 8, 2013 post, Consumer Watchdog (formerly known as The Foundation for Taxpayer and Consumer Rights) and the Public Patent Foundation (collectively “CW”) asked the Federal Circuit to determine if in vitro cultured human embryonic stem cells (hESCs) are patent-eligible. Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 13-1377 (Fed. Cir. … Continue reading this entry

Study Advances Personalized Medicine for Newborns

Earlier this year, the American Academy of Pediatrics (AAP) and the American College of Medical Genetics and Genomics (ACMG) issued recommendations and proposed best practices for genetic testing and screening of infants and children. In Ethical and Policy Issues in Genetic Testing and Screening of Children, the AAP and ACMG reviewed the scenarios in which genetic … Continue reading this entry