Is Next Generation Sequencing Ready for Personalized Medicine?

sequencingNext 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 complete genome, most notably Illumina’s announcement of the “$1,000 genome,” makes NGS an attractive alternative to current locus-by-locus genetic analysis, and raises the prospect of near-term adoption of NGS in clinical medicine. This post will review some current opinions on NGS and whether the technology is ready for use in diagnostic and therapeutic development. Continue reading this entry

Federal Circuit Adds to Section 101 Jurisprudence

Federal Circuit Adds to Section 101 JurisprudenceThe U.S. Court of Appeals for the Federal Circuit, relying on U.S. Supreme Court patent-eligibility precedent, held that a claim to a live-born clone of a pre-existing, non-embryonic, donor mammal is not patent-eligible. The Court reasoned that because the clone is genetically identical to its donor parent, it is not markedly different from that found in nature and therefore not eligible for patent protection. See In re Roslin Institute (Edinburgh), Slip Op. No. 2013-1407 (Fed. Cir. May 8, 2014).

A Sheep Named Dolly

In the mid-1990′s, Campbell and Wilmut, two scientists from The Roslin Institute of Edinburgh, Scotland (Roslin) were the first to successfully clone a mammal from an adult somatic cell – Dolly the Sheep. The method, called somatic cell transfer, requires removing the nucleus of a somatic cell and implanting that nucleus into an oocyte from which the nucleus has been removed. To create Dolly, the nucleus of an adult, somatic mammary cell was fused with an enucleated oocyte. The resulting fused oocyte develops into an embryo which can then be implanted into a surrogate mammal, where it develops into a fetus. The resulting mammal is an exact genetic replica of the adult mammal from which the somatic cell nucleus was taken. Continue reading this entry

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

StemCells-Abstract_DarkIn 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) and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012). See 2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products (Guidance) (reviewed in my prior posts of March 5th, 2014; March 7th, 2014 and March 20th, 2014). While not explicitly noted as falling within the scope of the Guidance, technologies related to stem cells and regenerative medicine are natural products that will be examined pursuant to the Guidance. Continue reading this entry

Recommendations for NextGen Health IT Infrastructure

mHealthHealth 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 technology and the risks to the public if this infrastructure is not adequately maintained. In its report “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework” (Report), the Office has proposed a strategy and offered recommendations to maintain the integrity of health IT while supporting innovation. The proposed strategy and recommendations are based on the premise that risk and corresponding controls should focus on health IT functionality and not the platform(s) on which such functionality resides or the product name/description of which it is a part. Embedded within the Report are several points that may be relevant to those involved with the development of products and services that support the delivery of personalized health care information that clinical decisions. 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 U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as applied to products and processes that might fall under one of the judicial exceptions to patentable subject matter (see my prior posts of March 5th and March 7th for a review of the Guidance). A few points raised in the Training Materials bear close attention. Continue reading this entry