Category Archives: Genetic Testing

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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

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

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

Expanding Access to, and Development of, Personalized Medicine

In a July 8th, 2013 letter to the Centers for Medicare & Medicaid Services (CMS), the Personalized Medicine Coalition (PMC) advised that proposed reimbursement schedules for diagnostic medicine will  threaten the development of, and access to, personalized medicine and reduce the quality of patient care.… Continue reading this entry

Patents, Genetic Testing and Federal Funding

In a July 12, 2013 letter to Dr. Francis S. Collins of the National Institutes of Health (“NIH”), Senator Patrick J. Leahy urged the NIH to exercise its march-in rights under the Bayh-Dole Act to directly license the genetic testing patents held by Myriad Genetics, Inc. (“Myriad”) that have been the subject of on-going litigation. … Continue reading this entry

Isolated DNA Is Not Patent-Eligible

Today the U.S. Supreme Court in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., __ U.S. __ (2013) (opinion here), held that genes and DNA fragments merely isolated from nature without alteration are not patent-eligible. Justice Thomas, who delivered the opinion of the Court, stated that claims to isolated DNA (in this case, isolated BRCA1 and BRCA2 … Continue reading this entry

Personalized Medicine and the Gene Patenting Debate

The transcript for today’s Supreme Court oral argument in The Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (2013) has been released, and the importance of the gene patenting debate to personalized medicine was discussed. The Court was well briefed on the issues and questioned the parties and U.S. government regarding why isolated genes should or should not be patent-eligible, the … Continue reading this entry

"Human Genes" and Patents

At 10:00 A.M. on April 15th, the U.S. Supreme Court will entertain oral arguments in the dispute now known as the human “gene patenting” case. The Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (2013) is likely the highest profile patent dispute before the Supreme Court in recent history, arguably because it touches on issues concerning invention, innovation, investment, … Continue reading this entry

Business Models for Personalized Medicine

Personalized medicine is moving from concept to reality, fueled in part by advances in sequencing technology and data analysis. However, significant business challenges remain that hinder growth and adoption of personalized health care. One such challenge how to is pay for the research and development of new diagnostics and therapies when the target patient population does not … Continue reading this entry

Australian "Gene Patenting" Case to be Appealed

The patenting of human genes in Australia remains under court review. As reported in the blog Patentology, an appeal of the Australian decision, Cancer Voices et al. v. Myriad Genetics Inc. et al., was filed on March 4, 2013 to a Full Bench of the Federal Court of Australia by the law firm of Maurice … Continue reading this entry

Preparing to Comply With the HITECH Final Rule

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

Genetic Testing and Screening of Children: Ethics and Best Practices

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

Petitioners File Supreme Court "Gene Patenting" Brief

Petitioners (The Association for Molecular Pathology et al., represented by the American Civil Liberties Union or “Petitioner” or “ACLU”) filed their brief with the U.S. Supreme Court yesterday urging the Court to reverse the Federal Circuit’s decision and the USPTO’s decades long practice of granting patents on isolated DNA. Similar to their arguments in all prior … Continue reading this entry

HIPAA/HITECH Regs Implement GINA Genetic Privacy Provisions

On January 17, 2013, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) issued the long-awaited 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 Clinical Health Act … Continue reading this entry

Amici Urge Reversal of “Gene Patenting” Decision

On November 30th, 2012, the U.S. Supreme Court will conference and consider whether to review the patent-eligibility of isolated DNA sequences. Our prior post of September 25, 2012 addressed Petitioners’ brief and request for review of the Federal Circuit’s decision that upheld the patent-eligibility of isolated DNA. On October 31st, 2012, Myriad Genetics, Inc. et al. … Continue reading this entry

Genetic Data, Patents, and Trade Secrets

Patents protect proprietary information but are of limited duration. After expiration, the patented technology becomes part of the public domain. Trade secrets, in contrast, never expire and therefore are not accessible to the public as long as the information remains secret. Thus, the authors of “The Next Controversy in Genetic Testing: Clinical Data as Trade Secrets?”  … Continue reading this entry

Patent Pool Simplifies Development of Personalized Medicine

One argument often cited against patenting is that multiple patents can cover one product, its preparation and use, creating a so-called “patent thicket” that must be unwound like a bowl of spaghetti before a new technology is free of potential liability. Cooperation and collaboration among patent holders in the form of a patent pool is one means … Continue reading this entry

More on Myriad -- "Gene Patenting" Debate Continues

As promised in my earlier post, today our firm issued its review of the much anticipated decision regarding the “gene patenting” case (formally known as The Association For Molecular Pathology. et al. v. USPTO et al.) The case was before the Federal Circuit on remand from the U.S. Supreme Court’s March 20, 2012 decision in Mayo Collaborative Services … Continue reading this entry

Federal Circuit - Non-Naturally DNA Patent-Eligible

Today, in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 2010-1406 (Fed. Cir. 2012), the Federal Circuit held that non-naturally occurring DNA is patent eligible as well as the use of a transformed, non-naturally occurring cell for screening drug candidates. Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences were held to be patent-ineligible. A … Continue reading this entry

ACLU "Gene Patenting" Case Argued at Federal Circuit

On July 20th, 2012, the parties in the Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 10-1406 (Fed. Cir. 2011)(also known as the “ACLU gene patenting” case) argued (again) before the Federal Circuit. Recall, the U.S. Supreme Court had asked the court to reconsider its prior ruling as to the patent-eligibility of claims to … Continue reading this entry

What's Patentable After Prometheus? USPTO Issues Interim Response

The USPTO has just issued guidelines for its patent examining corps to assist them in determining whether a process claim is patent-eligible in light of the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (“Prometheus”) decision. A copy of the guidance document (“Guidance Document”) is attached. [2012_interim_guidance] The examiners are … Continue reading this entry