On February 15, 2018, representatives Eric Swalwell (CA-15), John Shimkus (IL-15), Scott Peters (CA-52), Erik Paulson (MN-03), and Juan Vargas (CA-51), introduced the Advancing Access to Precision Medicine Act (H.R. 5062)(“Bill”) to “provide a study by the National Academy of Medicine on the use of genetic and genomic testing to improve health care, and for other purposes.” (Bill, … Continue reading this entry
Tags: Genetic Test, Genetic Testing, Personalized Medicine, Personalized Medicine Coalition
The Personalized Medicine Coalition (PMC) recently published its “Personalized Medicine at FDA: 2017 Progress Report” (Report) that highlights drug approval developments and milestones achieved in 2017. Last year was notable for a record number of personalized medicine approvals by the FDA, and 5 “firsts” for the industry: Three gene therapies were approved; A tissue agnostic … Continue reading this entry
Tags: Genetic Test, Genetic Testing, Personalized Medicine, Personalized Medicine Coalition, U.S. Food and Drug Administration (FDA)
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
Tags: Genetic Test, Genetic Testing, Personalized Medicine
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
Tags: 35 U.S.C. 101, Genetic Test, U.S. Food and Drug Administration (FDA)
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
Tags: Genetic Test, Personalized Medicine, Precision Medicine Initiative, U.S. Food and Drug Administration (FDA)
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
Tags: Genetic Test, Genetic Testing, Personalized Medicine, Subject Matter Patent Eligibility
On December 15th, 2014, the USPTO released its much anticipated revised subject matter eligibility examination guidance to assist patent examiners to evaluate inventions that may be related to any one of the three judicial exceptions to subject matter eligibility under 35 U.S.C. § 101 – law of nature, natural phenomena, and/or an abstract idea. 2014 … Continue reading this entry
Tags: 35 U.S.C. 101, Gene Patenting, Genetic Test, Isolated DNA Claims, Myriad, Patent Eligibility, Personalized Medicine, Subject Matter Patent Eligibility, USPTO
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
Tags: Genetic Test, Genetic Testing, Personalized Medicine
Earlier this week, I had the opportunity to speak again with Colin O’Keefe of LXBN regarding last week’s oral arguments in Association for Molecular Pathology v. Myriad Genetics. In the interview, I share some quick observations on the oral arguments and offer my thoughts why I believe the Justices will “split the baby” with their ruling.… Continue reading this entry
Tags: 35 U.S.C. 101, Assn. Molec. Path. et al. v. USPTO et al., Gene Patent, Gene Patenting, Genetic Test, Subject Matter Patent Eligibility
As reported in my January 24th, 2013 post, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) issued an omnibus final rule (the Rule) implementing changes in current regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), pursuant to the Health Information Technology for Economic and … Continue reading this entry
Tags: Genetic Test, Genetic Testing, Health Care IT
The application of medical technology in the pediatric setting must serve the best interest of the child. Genetic testing of children and infants presents unique challenges. In contrast to the testing of adult patients, most children cannot understand the risks and benefits or provide informed consent. The American Academy of Pediatrics (AAP) and the American College of Medical Genetics and … Continue reading this entry
Tags: Genetic Test, Genetic Testing, Personalized Medicine
Those seeking to conduct research involving human genetic material within the People’s Republic of China or to import into China such material should review China’s recently issued draft regulations (“Draft”) for the management of its human genetic resources. The regulations apply to the collection, preservation, research, development, immigration and other activities involving human genetic material. The Draft … Continue reading this entry
Tags: Genetic Test, Genetic Tests, Personalized Medicine
The U.S. Patent Office recently announced that it will not be delivering its report on Genetic Testing as required under Section 27 of the America Invents Act (“AIA”) by the June 16, 2012 deadline.… Continue reading this entry
Tags: Diagnostic Method Claims, Genetic Test, Genetic Testing, Personalized Medicine, USPTO
Tags: Genetic Test, Genetic Testing, Health Care Costs, Personalized Medicine
The Canadian Patent Office released today practice guidelines regarding the patent-eligibility of medical diagnostic methods and medical methods. The practice guidance are in effect immediately and until further notice, and in place of any contrary guidance presently in the Canadian Manual of Patent Office Practice (MOPOP, the Canadian equivalent to the US MPEP, setting forth … Continue reading this entry
Tags: 35 U.S.C. 101, Companion Diagnostics, Diagnostic Method Claims, Genetic Test, Genetic Testing, Personalized Medicine, Prometheus
The other day I had the opportunity to speak with Colin O’Keefe of LXBN TV on the subject of Mayo Collaborative Services v. Prometheus Laboratories, Inc. In the short interview, I explain the background of the case, offer my thoughts on why Prometheus’ patent wouldn’t have a detrimental impact on medical research and give my thoughts … Continue reading this entry
Tags: Assn. Molec. Path. et al. v. USPTO et al., Companion Diagnostics, Diagnostic Method Claim, Diagnostic Test, Gene Patent, Genetic Test, Genetic Testing, Isolated DNA Claims, Myriad, Personalized Medicine, Prometheus
On November 24, 2009, President Obama established the Presidential Commission for the Study of Bioethical Issues (Commission) to advise him on bioethical issues generated by novel and emerging research in biomedical and related areas of science and technology. As part of this initiative, the Commission issued a Notice on March 27, 2012 (Federal Register) seeking comments … Continue reading this entry
Tags: Bioethics, Gene Patent, Genetic Test, Genetic Testing, Personalized Medicine, Privacy
The U.S. Supreme Court has sent the ACLU “gene patenting” case back to the Federal Circuit for reconsideration in light of its unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (S. Ct. 2012). For a review of the issues, please see Foley & Lardner’s client alert “Supreme Court Tells Federal Circuit to … Continue reading this entry
Tags: Gene Patent, Gene Patenting, Genetic Test
On the same day that the personalized medicine testing market was reported to have exceeded $28 billion in 2011, the New England Journal of Medicine (NEJM) also reported a perceived stumble to the use of genomic tests that serve personalized medicine.… Continue reading this entry
Tags: Diagnostic Test, Genetic Test, Patents, Personalized Medicine
On June 23, 2011, the United States House of Representatives passed the “Leahy-Smith America Invents Act” (H.R. 1249) to amend title 35 of the United States Code, to provide for patent reform. Within the numerous provisions related to the examination, administration and enforcement of U.S. patents is a proposed amendment that may affect the value … Continue reading this entry
Tags: Gene Patent, Genetic Test, Patent Eligibility, Patent Reform
Even for patent attorneys who specialize in personalized medicine, confusion still exists as to the best way to pursue and enforce diagnostic method patent claims in light of patent eligibility considerations under 35 U.S.C. §101. While the Supreme Court and Federal Circuit have provided some guidance regarding patent eligibility of certain method claims, details of … Continue reading this entry
Tags: 35 U.S.C. 101, AMP, Biogen, Classen, Diagnostic Method Claim, Diagnostic Test, Genetic Test, In re Grams, Lab Corp., Mayo, Metabolite, Myriad, Personalized Medicine, Prometheus, Subject Matter Patent Eligibility, USPTO
In Billups-Rothenberg, Inc. v. Associated Regional and University Pathologists, Inc. (ARUP) and Bio-Rad Labs., Inc., the Federal Circuit affirmed a district court summary judgment that diagnostic method claims in two patents were invalid as either failing the written description requirement under 35 U.S.C. §112, or being anticipated under 35 U.S.C. §102 by a patent owned … Continue reading this entry
Tags: ARUP, Billups-Rothenberg, Bio-Rad, Diagnostic Method Claim, Diagnostic Test, Enablement, Genetic Test, Personalized Medicine, Written Description
Posted in DTC Genetic Test; FDA; Personalized Medicine
