New Legislative Effort Could Wipe Out Laws Preventing Gene Patents
June 2019 - Members of Congress recently released draft legislation to amend Sec. 101 of the Patent Act which permits issuing patents on new and useful processes, machines, etc. As currently written, this legislation is extremely concerning as it would establish a completely new patent eligibility framework and, as a result, would overturn significant Supreme Court decisions that have fostered affordable access to genetic tests including the AMP v. Myriad decision, which said that naturally occurring DNA sequences cannot be patented.
For over a century, the Supreme Court has held that laws of nature, natural phenomena, and abstract ideas are not eligible for patents. Recent cases from 2012-2014 (Mayo Collaborative Services v. Prometheus Laboratories, Association for Molecular Pathology v. Myriad Genetics, and Alice Corp v. CLS Bank) affirm and clarify these important exceptions to patent-eligibility.
These cases have created a legal foundation that promotes innovation. The Myriad case was especially significant for FORCE and the hereditary cancer community. Prior to 2013, Myriad Genetics held patents on two human genes–BRCA1 and BRCA2–mutations that are associated with significantly increased risk of certain cancers (breast, ovarian, prostate, pancreatic, and others). These patents gave Myriad a monopoly on the genes, and exclusive rights to testing of the BRCA genes–which stifled competition and resulted in exceptionally high costs for BRCA genetic testing.
If enacted, the legislation would wipe out prior court decisions and allow for the patenting of products and laws of nature, abstract ideas, and other general fields of knowledge. Whether intended or not, it would ultimately permit patenting of human genes and naturally-occurring associations between genes and diseases. This could drive up costs and hinder advancements in genetic testing.
FORCE and other concerned parties understand that there are problems with the current application of the law that must be solved, but narrower paths to addressing them are preferable to rewriting section 101 in its entirety. FORCE has participated in meetings with congressional staff about this issue and joined the ACLU, AMP and numerous other organizations in a letter expressing concern to the sponsors of this legislation.
Beginning June 4, the Senate Judiciary Committee is holding a series of hearings on the draft legislation and patent reform.
Update: September 2020
The bill is still active but movement has been slow due to competing priorities. We continue to follow this issue closely and will post updates as they are available.
4/25/2022 - FORCE added its support to an effort spearheaded by SNMMI asking the House Energy and Commerce and Ways and Means Committee Leadership to schedule a hearing on the Facilitating Innovative Nuclear Diagnostics (FIND) Act.
5/2022 - Joined a coalition letter to the HHS Secretary emphasizing that regulatory reform of the framework for clinical laboratory diagnostics is essential to protect patients and ensure access to innovative, high-quality diagnostic tests.
3/29/2022 - Signed on in support of the Right Drug Dose Now (Right) Act, which will advance utilization of evidence-based pharmacogenomic (PGx) information in clinical practice, advance precision medicine, and improve quality of care.