Category Archives: Personalized Medicine

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Medical Treatment Patent Claims Held Patentable Subject Matter Under the Alice/Mayo Section 101 Test

In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd, Slip Op. (Nos. 2016-2707, 2016-2708, April 13, 2018) the U.S. Court of Appeals for the Federal Circuit provided useful guidance for patentees seeking to survive a patent-eligibility challenge under Section 101.… Continue reading this entry

All of Us Research Program Opens May 6th

The National Institutes of Health (NIH) opened national enrollment today, May 6th, for the All of Us research program. Initially branded as the “Precision Medicine Initiative Cohort Program,” All of Us is the largest health and medical research program on precision medicine, aiming to enroll 1 million or more diverse volunteers. Any adult age 18 … Continue reading this entry

Advancing Access to Precision Medicine Act - A Bipartisan Bill

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

Over 30% of New Drug Approvals in 2017 were Personalized Medicines

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

FDA Releases Stem Cell Guidance Documents

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient, for example, as done in bone marrow transplants or peripheral blood stem cell transplantation, has provided benefits to many patients and are effective treatments for leukemia, … Continue reading this entry

NIH Begins Beta Test of Million Patient Cohort

The National Institutes of Health announced the enrollment of the first participants as beta testers of the “All of Us” research program. Initially branded as the “Precision Medicine Initiative®” Cohort Program, “All of Us” will be the largest health and medical research program on precision medicine. The mission of the All of Us Research Program … Continue reading this entry

Breaking Down Barriers Between Pre-clinical and Clinical Adoption of Personalized Medicine

Personalized medicine will change how health care is delivered and disease is prevented and treated. But first, how disease and health is defined, as well as the clinical development and adoption of new therapies must align with current theories of disease and treatment.… Continue reading this entry

Proving Utility, Demonstrating Value: How to Align the Moving Parts in Personalized Medicine Reimbursement

Of the many business, operational, legal, regulatory and clinical obstacles standing in the way of widespread delivery of personalized medicine, the single greatest challenge may lie in solving the reimbursement puzzle. Advocates of personalized medicine contend that it results in better care for the patient, as therapy is targeted specific to an individual, and that … Continue reading this entry

Forget Bigger Data – Personalized Medicine Needs Smarter Data to Reach its Full Potential

The advent of big data has helped enable the growth of personalized medicine. But if machine learning and analytics are to truly help transform health care, it won’t be through bigger data, but through harmonized, smarter data.… Continue reading this entry

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air.  Learn what you need to know quickly with these seven questions and answers. What do I Need to Know?… Continue reading this entry

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

FEDERAL CIRCUIT KNOCKS OUT PATENTS AFTER CBM CHALLENGE

Guest Post by Jocelyn Yu, Foley & Lardner, LLP. Apple successfully invalidated three patents for failure to recite patent eligible subject matter. Apple, Inc. v. Ameranth, Inc., 2015-1792, 2015-1793 (Fed. Cir. 2016). The patents relate to synchronous communication systems for electronically generating and transmitting menu selections. While the covered technology is not directly related to … Continue reading this entry

Precision Medicine - Obama’s Health Care Legacy

As we come to the end of President Obama’s administration, it is time to look back on the past eight years and the administration’s impact on the delivery of the nation’s health care. While the Affordable Care Act (signed into law early in the President’s administration on March 23rd, 2010) is a significant achievement in … Continue reading this entry

New Report Outlines 5 Year Plan to Achieve Cancer Moonshot

The Cancer Moonshot Task Force has just released its 5 year plan for implementing President Obama’s “Cancer Moonshot” program (“Report”). The initiative, announced during President Obama’s 2016 State of the Union Address, is a national effort to dramatically accelerate efforts to prevent, diagnose and treat cancer that take advantage of recent advances in molecular medicine … Continue reading this entry

Personalized Medicine: Insights Into Current Legal Issues

Guest Post by:  Nate Beaver, Esq.; Gary Koch, Esq.; Antoinette Konski, Esq.; and Judy Waltz, Esq., Foley & Lardner, LLP. In his January 20, 2015 State of the Union address, President Obama brought to the nation’s attention the promise of personalized medicine when he announced the Precision Medicine Initiative (the “PMI”). In announcing this initiative during … Continue reading this entry

Ariosa Loses Verinata Patent Challenge

Fetal diagnostic pioneer Ariosa Diagnostics lost its latest attempt to invalidate competitor Verinata Health’s U.S. Patent No. 8,318,430, “Methods of Fetal Abnormality Detection.” The USPTO’s Patent Trial and Appeal Board (PTAB) concluded that Petitioner Ariosa Diagnostics (Ariosa) failed to demonstrate the unpatentability of challenged claims 1-30. Ariosa Diagnostics, Inc. v. Verinata Health, Inc., IPR2013-0027/-00277 (PTAB … Continue reading this entry

Advancing Personalized Medicine Through Cross-sector Collaboration and Innovation

Since 2013, thought leaders, innovators, and health care specialists have convened for a one day summit to discuss the business of personalized medicine. The Business of Personalized Medicine Summit, explores the economic, legal and regulatory barriers to making personalized medicine a reality for patients everywhere while sharing strategies for success. This year’s Summit – Strategies for Partnering … Continue reading this entry

FDA Issues Guidance on Use of Public Human Genetic Variant Databases and Their Use in Personalized Medicine

Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine. Analysis of whole genomes is providing insight into the diagnosis, prediction and treatment of disease, and will continue to do so as more genetic information is collected and … Continue reading this entry

FDA Issues Draft Guidance To Streamline Regulatory Oversight Of NGS-Based Tests For Diagnosing Germline Diseases

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

FEDERAL CIRCUIT’S RECENT PRIMER ON PATENT-ELIGIBILITY

A method of producing a desired population of multi-cryopreserved hepatocytes was held to be patent-eligible because the challenged claims did not recite a judicial exception. Rapid Litig. v. CellzDirect, Inc.., 2015-1570 (Fed. Cir., July 5th 2016). The decision provides much needed guidance to the life science industry that had yet to receive positive guidance from … 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

EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated goal of developing and laying out appropriate genomic methodologies for use during the development and life-cycle of a drug. Past issues and problems that have been encountered … Continue reading this entry

USPTO RELEASES PATENT ELIGIBILITY UPDATE

PatentEligibility
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