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 personalized medicine, the Federal Circuit’s review of the patents’ specifications and the court’s claim constructions in the context of a 35 U.S.C. § 101 challenge is instructive to patent applicants seeking to patent methods that may be characterized as an abstract idea, such as methods linking treatment options or clinical trials to potential patients. Continue reading this entry

FDA Hits “Pause” on Regulation of LDTs


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 public discussion on an appropriate oversight approach, and to give our congressional authorizing committees the opportunity to develop a legislative solution.” Discussion Paper at page 1. Continue reading this entry

More Than 25% of New Molecular Entities Approved in 2016 Are Personalized Medicines


The Personalized Medicine Coalition (PMC) recently reported that for the third year in a row, personalized medicines accounted for more than 25% of all new molecular entities (NMEs) approved by the US Food & Drug Administration (FDA). Personalized Medicine at FDA, 2016 Progress Report (Report). Personalized medicines are new drugs, agents or therapeutic biologics where a diagnostic test is used to determine which medical treatments will work best for a specific patient. For purposes of the Report, the PMC categorized personalized medicines as those therapeutic products for which the label includes reference to specific biological markers.

PMCs Report specifically indicates that of the 22 NMEs approved by the FDA in 2016, 6 of them are personalized medicines, half of which are oncology drugs. This continues the 3-year trend that the PMC first documented in 2014 when it reported that 9 of the 41 approved NMEs were personalized medicines.

The 6 new FDA-approved drugs are:

  1. Rubraca (rucaparib) for the treatment of advanced ovarian cancer;
  2. Exondys 51 (eteplirsen) for the treatment of Duchenne muscular dystrophy;
  3. Epclusa (sofosbuvir and velpatasvir) for the treatment of chronic hepatitis C infection;
  4. Tecentriq (atezolizumab) for the treatment of advanced or metastatic urotherlian cancer and metastatic non-small cell lung cancer;
  5. Venclexta (venetoclax) for the treatment of chronic lymphocytic leukemia; and
  6. Zepatier (elbasvir and grazoprevir) for the treatment of chronic hepatitis C infection.

The Report concludes that while challenges in the areas of diagnostic regulatory policy, reimbursement, and clinical adoption remain, the FDAs approval of these new drugs that rely on diagnostic medicine signals a shift toward a more personalized health care system.


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 that it provided many Americans access to health care, one cannot dismiss the President’s transformative commitment to precision or personalized medicine.

In 2006 as a then junior senator, President Obama introduced the Genomics and Personalized Medicine Act to improve access to and utilization of valid, reliable genetic tests and to secure the promise of personalized medicine for all Americans. While neither President Obama’s bill nor subsequent versions were enacted into law, many of the elements of the bills were incorporated into, and expanded upon, in the recently enacted 21st Century Cures Act (the “Act”).  Signed into law by the President on December 13th, 2016, the Act passed the House of Representatives (392-26) and Senate (94-5) with overwhelming bipartisan support.

The Act secures $4.8 billion in funding for the necessary infrastructure to advance precision medicine. This includes funding to the National Institutes of Health to support the President’s Precision Medicine Initiative ($1.5 billion) and to Vice President Biden’s “Cancer Moonshot” initiative ($1.8 billion). Spending under the Act will advance precision medicine more specifically by developing:

  • New approaches for addressing scientific, medical, public health and regulatory issues;
  • New genomic-based technologies;
  • New private-public partnerships to better leverage data sources and interpretation;
  • New expanded sources of genetic and clinical information; and
  • Improved regulations and laws to protect human participants and their private health care information.

We can all look back with gratitude to President Obama’s leadership in the advancement of personalized medicine and the modernization of the tools necessary to advance its promise.

A copy of the Bill and a concise summary provided by The Energy and Commerce Committee can be found here.

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 and information sciences. This initiative is unique in its emphasis on public and private collaboration:

“The Cancer Moonshot aims to realize this promise by leveraging public and private efforts focused on building a system in which patients, researchers, and clinicians can seamlessly share information on treatments and outcomes to accelerate research, guide treatment decisions, and improve cancer outcomes for people across the Nation, and ultimately the world.”

Report at page 2.

Five Goal Approach

The Report, authored by the Moonshot Task Force, noted the need to have an organizational framework for addressing and uniting efforts to reach the goal of improving cancer diagnosis and therapy. Five goals emerged, each of which is noted to be critical to the overall mission, but also intended to build on and augment the success of the other goals. Report at page 5.

Strategic Goal 1: Catalyze New Scientific Breakthroughs

New scientific breakthroughs will be accelerated by: 1) promoting interdisciplinary approaches for elucidating the biological mechanism underlying cancer onset and treatment; 2) aligning research and care as a seamless and iterative process; and 3) maximizing the collection and research use of longitudinal data and biospecimens.

Strategic Goal 2: Unleash the Power of Data

A stated goal of the Task Force is to maximize access to and usability of data now available due to advances in genomic information and health record information.  This will be achieved by: 1) enabling a seamless data environment; 2) supporting open publication and storage platforms; and 3) developing a workforce that can take advantage of the open and connected environment.

Strategic Goal 3: Accelerate Bringing New Therapies to Patients

New effective therapies are the ultimate goal of the President’s initiative. The Task Force seeks to remove impediments by: 1) finding efficiencies in regulatory review and licensing processes; 2) enhance data sharing and incentivize pre-competitive collaborations; and 3) strengthen oncology clinical research.

Strategic Goal 4: Strengthen Prevention and Diagnosis

Cancer prevention and diagnosis can be strengthened by: 1) promoting public access to health programs, policies and outreach; 2) gaining a better understanding of the environmental determinants of cancer; and 3) enhancing cancer screening and testing.

Strategic Goal 5: Improve Patient Access and Care

Strategic goal 5 seeks to build on the improved access to health care provided by the Affordable Care Act. The Task Force seeks to identify areas with the greatest potential for meaningful patient impact by: 1) improve efficiencies of current programs; 2) improve cancer prevention, treatment and quality of care by applying current knowledge into workable policies; and 3) ensuring each patient receives quality care.

Creating New Paradigms

The Report sets out a blueprint with a series of activities to accelerate gains for cancer diagnosis and therapy – that is, to achieve ten years of progress in five. The Report summarizes the aspirations, conceptual and practical, that can be achieved:

“Ultimately, through the creation of new paradigms for generating, sharing, and integrating research and clinical data to enhance patient care, the Cancer Moonshot can accelerate the delivery of effective cancer prevention strategies, diagnostics, and treatments to patients in communities around the world.”

Report at page 29.