OasisLMS

From Lab to Clinic: What Restoring Patent Eligibility for Genetic Material Means for the Genetics Community and Patient Care

Sponsored by the ACMG Ethical, Legal, and Social Issues and Advocacy and Government Affairs Committees

Tuesday, August 18, 2026 | 2:00 – 3:00 pm ET

1.0 AMA PRA Category 1 Credits™ and P.A.C.E.^®

Credit Claiming by September 18, 2026

Session Description

This genetics academy session will provide information about the current and historical legal landscape of human DNA and
its patent eligibility. Current and potential future legislative initiatives could alter the legal framework and allow for the
patenting of human DNA. We will discuss the implications of genetic material that has been isolated, purified, enriched, or
otherwise altered by human activity becoming patent eligible in the genetics community, clinical care, and patient outcomes.

Learning Objectives

At the conclusion of this activity, participants should be able to:

1. Identify the changes to current law that would be in place if DNA sequences and their correlation to disease
   became patent eligible under S.1546 PERA 2025.
2. Examine the potential effects that allowing patents on genetic material that has been isolated, purified, 
   enriched, or otherwise altered by human activity would have on patient experience and outcome.
3. Summarize the implications of genetic material that has been isolated, purified, enriched, or otherwise
   altered by human activity becoming patent eligible.

Target Audience

This activity is designed for clinical geneticists, genetic counselors, laboratory geneticists, genetic counselors, and other
healthcare providers who provide comprehensive diagnostic, management, and counseling services for patients
with, or at risk for, genetically influenced health problems.

Agenda

Topic / Session

• 1:00pm – 1:05 pm Opening Remarks & Introduction — Tatum Vilaboy, MS, CGC
• 1:05pm – 1:20pm Legal Landscape of DNA Patents – Jorge Contreras, JD
  • History of current DNA patent law and key court decisions
  • Overview of the Patent Eligibility Restoration Act (PERA) of 2025 and prior similar legislation
  • How current law would change if PERA (or similar) were enacted and prior Supreme Court
    decisions overturned
    • What would become patent-eligible under this scenario
  • Status of S.1546 (PERA 2025)
• 1:20pm – 1:35pm Patent Eligibility of Human DNA and Patient Outcomes – Lisa Schlager, BS
  • Historical evidence that broad gene patents have more often hindered than helped collaborative
    research and clinical care
  • Effects on patient outcomes
  • Effects on research and innovation (e.g., genetic tests, testing technology, gene therapies, vaccines)
  • Patent-eligibility concerns even where challenged patents wouldn't survive under other sections of patent law
  • Patent-eligibility concerns even before patents are formally granted

• 1:35pm – 1:50pm Implications on Access, Equity, and Innovation – Bob Cook-Deegan, MD
  • Tension between access and innovation
  • Increased legal and economic uncertainty and resulting inequality
  • Ethical tension with global norms
• 1:50pm – 2:00pm Q&A

Meet the Faculty

Jorge Contreras, JD

Distinguished University Professor and Adjunct Associate Professor
College of Law and Department Human Genetics, School of Medicine
The University of Utah

Jorge Contreras is a Distinguished University Professor, the James T. Jensen Endowed Professor for

Transactional Law and the Director of the Program on Intellectual Property and Technology Law at the University of Utah

S.J. Quinney College of Law and holds an adjunct appointment in the Department of Human Genetics in the University of

Utah School of Medicine. Professor Contreras’s research focuses on intellectual property law and science policy. He has

published more than 200 scholarly articles and has written or edited 15 books including The Genome Defense: Inside the

Epic Legal Battle to Determine Who Owns Your DNA (Hachette/Algonquin, 2021), which was recognized by the New York

Times as one of the top nonfiction books of the season and has received praise from news outlets ranging

from the Wall Street Journal to Nature. He has testified before committees of the U.S. Senate and House of Representatives,

the Federal Trade Commission and the European Commission, and has served on advisory councils of the National Human

Genome Research Institute (NHGRI), the National Center for Advancing Translational Science (NCATS) and the NIH

Council of Councils. He received his JD from Harvard Law School and earned his BSEE and BA in English at Rice University.

Bob Cook-Deegan, MD
Professor
School for the Future of Innovation in Society and Consortium for
Science, Policy and Outcomes
College of Global Futures and Global Futures Laboratory
Arizona State University

Dr. Robert Cook-Deegan, MD, is a professor at Arizona State University in the School for the Future of Innovation in Society and the Consortium for Science, Policy & Outcomes. He was at Duke University 2002-2016, after a career in Washington at the National Academies of Science, Engineering and Medicine (1991-2002); National Center for Human Genome Research (1989-1990); and the congressional Office of Technology Assessment (1982-1988). His research interests include science policy, health policy, biomedical research, cancer, and intellectual property. He is the author of "The Gene Wars: Science, Politics, and the Human Genome" and more than 350 other publications.

Lisa Schlager, BA
Vice President, Public Policy
FORCE: Facing Our Risk of Cancer Empowered

Lisa Schlager is a recognized patient advocacy leader in the cancer community. A BRCA1 mutation carrier, she is personally and professionally invested in representing people with or at risk of hereditary cancer. As Vice President of Public Policy for FORCE (Facing Our Risk of Cancer Empowered), she spearheads the organization’s legislative and regulatory policy efforts, advocating for the unique needs of the high-risk, hereditary cancer community.

Well-versed in healthcare and genetic privacy laws, Schlager is the point person on national guidelines and advocacy issues impacting people with or at risk of hereditary cancers due to BRCA, Lynch syndrome or other genetic mutations. She possesses expert knowledge on policies affecting individuals at increased risk of cancer, insurance coverage of genetic, screening and preventive services, and targeted treatments for those diagnosed with hereditary cancer.

Ms. Schlager holds leadership positions with several cancer and healthcare initiatives in the government, nonprofit, and private sectors. She represents FORCE and the hereditary cancer community as an expert speaker at conferences, events, and in the media.

Tatum Vilaboy, MS, CGC
University of Utah

Tatum Vilaboy is a pediatric and research genetic counselor for the University of Utah 

Department of Pediatrics, working in both the inpatient and outpatient setting. She sees a wide variety of patients there in general medical genetics, cardiology, and vascular anomalies. She also works on the research side, developing protocols and consenting patients into a broad genomics research study at Primary Children's Hospital. She is a member of the ACMG Ethical, Legal, and Social Issues Committee (ELSI) and has a particular interest in the ELSI issues that affect genetics patients.

Translating Genes into Health Webinar Series Planners

Henry J. Mroczkowski, MD, PhD, FACMG (Chair)

University of TN Health Science Ctr

Mari Mori, MD, MS, FACMG

The Ohio State University

Georgianne L. Arnold, MD, FACMG

University of Pittsburgh

Roya M. Mostafavi, MGC

University of Washington School of Medicine

Catherine A. Ziats, MD, FACMG

Cook Children's

Damara Ortiz, MD, FACMG

Children's Hospital of Pittsburgh of UPMC

Daniel Schecter, MD, MS

Mount Sinai School of Medicine

Staff

Jane Radford, MHA, CHCP

Director of Education - ACMG

Accredited Continuing Education Information:

AMA PRA Category 1 Credit^TM, ASCLS P.A.C.E.^®

Accreditation

The American College of Medical Genetics and Genomics is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation
The American College of Medical Genetics and Genomics designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The American Medical Association (AMA) defines physicians as those individuals who have obtained an MD, DO, or equivalent medical degree from another country. Non-physicians may request a certificate of attendance for their participation.

ASCLS P.A.C.E.® CEU's 

ACMG is approved as a provider of continuing education programs in the clinical laboratory sciences by the American Society for Clinical Laboratory Science (ASCLS) Professional Acknowledgment for Continuing Education (P.A.C.E.®) Program.

ACMG is approved by the Florida Board of Clinical Laboratory Personnel as CE Provider (50-11878). ACMG is approved by the California Department of Health Services through the ASCLS P.A.C.E.® (275-200-26-05). This activity has been approved for 0.10 P.A.C.E.® CEU's.

Claiming your Educational Credits

Complete the activity and carefully complete the evaluation form. The deadline to claim educational credits is within 30 days from the date of the activity. Educational credit requests after this date will not be accepted.

Learner Data Consent

ACMG Education reports learner data to respective agency boards and you will be asked for consent during the evaluation process. Your compliance with deadlines and completing evaluations are part of the process in meeting learner needs and ACMG’s education mission.

Technical Support:
You can reach us by email at education@acmg.net or call 301-718-9603.
Support Center Hours: Monday – Friday, 9:00 AM – 5:00 PM Eastern Time.

Accredited Continuing Education Financial Disclosure

The American College of Medical Genetics and Genomics (ACMG) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide Accredited Continuing Education (ACE) for physicians. ACMG is an organization committed to improvement of patient care and general health by the incorporation of genetics and genomics into clinical practice.

ACMG has implemented the following procedures to ensure the independence of ACE activities from commercial influence/promotional bias, the Accreditation Council for Continuing Medical Education (ACCME) requires that providers (ACMG) must be able to demonstrate that: 1) everyone in a position to control the content of an ACE activity has disclosed all financial relationships that they have had in the past 24 months with ineligible* companies; 2) ACMG has implemented a mechanism to mitigate relevant financial relationships; and 3) all financial relationships with ineligible companies are disclosed to the learners before the beginning of the educational activity. The learners must also be informed if no relevant financial relationships exist.

*Ineligible companies are defined as those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

All relevant financial relationships listed have been mitigated.