Category Archives: Genetic Testing

Subscribe to Genetic Testing RSS Feed

HHS and Medicare Asked to Expand Coverage for Genetic Tests

Fifteen members of Congress have asked the Department of Health and Human Services (HHS) and the Medicare Payment Advisory Commission (Medicare) to examine how the federal government can help improve patient access to genetic testing. In a March 7, 2017 letter to Secretary Price of HHS and Dr. Crosson, Chairman of Medicare, the congressmen seek a … Continue reading this entry

One is Not Enough – Infringement Liability under § 271(f)(1)

In Life Technologies Corp. v. Promega Corp., Slip Op. 14-1538 (Feb. 22, 2017), the U.S. Supreme Court held that the supply of a single component of a multicomponent invention for manufacture abroad does not give rise to liability under 35 U.S.C. § 271(f)(1). The Court’s decision is important for manufacturers of kit components and those that … Continue reading this entry

FDA Hits “Pause” on Regulation of LDTs

On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion Paper). The Discussion Paper follows FDA’s late 2016 announcement that, contrary to the Agency’s earlier reports, it would not issue a final guidance on its proposed oversight of LDTs to allow “for further … Continue reading this entry

More Than 25% of New Molecular Entities Approved in 2016 Are Personalized Medicines

The Personalized Medicine Coalition (PMC) recently reported that for the third year in a row, personalized medicines accounted for more than 25% of all new molecular entities (NMEs) approved by the US Food & Drug Administration (FDA). Personalized Medicine at FDA, 2016 Progress Report (Report). Personalized medicines are new drugs, agents or therapeutic biologics where … Continue reading this entry

Supreme Court Declines Sequenom Review

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

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

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

ANOTHER DIAGNOSTIC PATENT FALLS UNDER 101

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

3 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 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

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

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

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

FDA Considering New Regulatory Approaches for NGS – Part I

The Food and Drug Administration (“FDA”) announced a workshop to be held February 20th, 2015, entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to obtain public input regarding its regulation of next generation sequencing (“NGS”). Specifically, the agency seeks public comment and feedback on the issues and questions raised in its discussion … Continue reading this entry

An Early Test for the USPTO’S Eligibility Analysis

Just last week, the USPTO released its revised subject matter eligibility guidance (2014 Interim Guidance on Patent Subject Matter Eligibility “Interim Guidance” reviewed in my prior post of December 16th, 2014). The Interim Guidance replaced the March 2014 Guidance that was much-criticized for its expansive application of U.S. Supreme Court jurisprudence relating to the judicial … Continue reading this entry

Canada Joins the Gene Patenting Debate

Canada has joined the gene patenting debate. Children’s Hospital of Eastern Ontario (“Children’s”) sued the University of Utah Research Foundation, Genzyme Genetics, and Yale University (“Defendants”) in Canada’s Federal Court asserting that 5 patents[1] assigned to Defendants (collectively the “Long QT Patents”) for compositions and methods useful in the diagnosis and/or assessment of Long QT syndrome … Continue reading this entry

Myriad’s Continuing Patent Debate

On October 6, 2014, the U.S. Court of Appeals for the Federal Circuit entertained oral argument in the interlocutory appeal of the district court’s denial of Myriad’s motion for preliminary injunction against Ambry Genetics. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. If you missed oral argument, the … Continue reading this entry

Privacy Issues in the Sharing of Genetic Information

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

Myriad Set for Another Round

On Monday, October 6th, the U.S. Court of Appeals for the Federal Circuit will entertain oral argument in another case involving Myriad’s BRCA1/BRCA2 diagnostic tests. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. In the words of Myriad “[t]his appeal … presents this Court with one of the … Continue reading this entry

USPTO Releases Examiner Post-"Myriad" Training Slides – Points to Ponder

The United States Patent and Trademark Office (USPTO) published its examiner training materials (Training Materials) for applying “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” (Guidance), that advised U.S. patent examiners and the public of the factors for determining whether a patent claim satisfies 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

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

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