Tag Archives: Personalized Medicine

Perspectives on the President’s Precision Medicine Initiative

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President Obama’s “precision medicine initiative” earmarked over $200 million from his proposed 2016 budget to “bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”[1] The National Institutes of Health (“NIH”) and the National … Continue reading this entry

Direct-to-Consumer Genetic Test Authorized by FDA

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23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order fashion. For ninety-nine dollars, customers only needed to send in a saliva sample and the company would analyze the customer’s genetic information, … Continue reading this entry

President Obama Revisits Interest in Personalized Medicine

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President Obama announced during his 2015 State of the Union Address that he is launching a new “precision” or personalized medicine initiative to advance personalized, effective therapies for the American public. As reported by the Personalized Medicine Coalition, President Obama stated: “21st century businesses will rely on American science, technology, research and development. I want … Continue reading this entry

FDA Considering New Regulatory Approaches for NGS – Part II

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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

FDA Considering New Regulatory Approaches for NGS – Part I

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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

Fetal Diagnostics Patent Claims Fall in Inter Partes Review

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Post grant inter partes review proceedings have lowered the hurdle to invalidate U.S. patents. The “broadest reasonable construction” of the claims and the lower burden to prove invalidity (by a preponderance of the evidence) of inter partes review proceedings have resulted in many successful challenges. Indeed, the Patent Trial and Appeal Board (PTAB) of the … Continue reading this entry

USPTO Releases Revised Subject Matter Eligibility Guidance

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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

Canada Joins the Gene Patenting Debate

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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

Federal Circuit’s Post-Alice Eligibility Analysis of Business Methods

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The Federal Circuit in Ultramercial, Inc. v. WildTangent, Inc., held that an “entrepreneurial” multi-step process for distributing copyrighted media products over the Internet to consumers is not patent-eligible under 35 U.S.C. § 101 even though the specific method of advertising and content distribution was neither previously known nor employed on the Internet. Although the patent … Continue reading this entry

Supreme Court Asked to Review Standing in Stem Cell Challenge

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The Public Patent Foundation and Consumer Watchdog (collectively “CW”) petitioned the U.S. Supreme Court on October 31, 2014, seeking reversal of the Federal Circuit’s dismissal of its appeal from a decision of the USPTO that upheld the validity of Wisconsin Alumni Research Foundation’s (WARF’s) patent regarding in vitro cultured human embryonic stem cells. The case … Continue reading this entry

Myriad’s Continuing Patent Debate

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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

FDA Issues Draft Guidance for Regulation of LDTs

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On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance“). The publication of the draft Guidance is the next step in FDA’s implementation of its risk based approach to oversight of LDTs. In addition to noting FDA’s intention for bringing under … Continue reading this entry

Privacy Issues in the Sharing of Genetic Information

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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

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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

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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?

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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

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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

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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

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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

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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