The proposal, which could become a bill, would overturn decisions in two landmark Supreme Court cases.
In the 2013 decision in Association for Molecular Biology v. Myriad Genetics, Inc.,the Court denied a patent for the discovery of the BRCA gene mutation for breast cancer. In the 2012 decision in Mayo Collaborative Services v. Prometheus Laboratories Inc., the Court invalidated a patent on an adjusted drug dose based on a particular quality identified in a patient’s blood.
In both cases, the Court ruled patent eligibility cannot be extended to “abstract ideas, laws of nature, and natural phenomena.”
The draft legislation proposal, released by Sen. Thom Tillis (R-NC) and Sen. Chris Coons (D-DE), would “statutorily abrogate judicially created exceptions” to patent eligibility, limiting them to “fundamental scientific principles, products that exist solely and exclusively in nature, pure mathematical formulas, economic or commercial principles, and mental activities.”
The Senate Judiciary Subcommittee on Intellectual Property, of which Tillis is chair and Coons is a ranking member, held hearings on the proposal on June 5 and June 11.
Patenting Natural Phenomena
The proposal is extreme and would create big problems, says Roger Klein, M.D, J.D., a board member of the Association for Molecular Pathology (AMP), precision medicine specialist, and policy advisor to The Heartland Institute, which publishes Health Care News. Klein’s organization challenged the Myriad Genetics patents on the BRCA1 and BRCA2 genes.
“What it does is reverse over 150 years of patent law,” Klein said on the Heartland Daily Podcast. “Any case since 1853 that relied on the Court saying something was a natural phenomenon would be abrogated, reversed. It removes the ability of the Court to create these exceptions.”
The first time the Court weighed in on patent eligibility was in 1854, when Samuel Morse, the inventor of the telegraph, tried to patent the use of an electromagnetic force to communicate characters.
“If you allowed a patent on the use of electricity, anybody who would come up with any invention couldn’t use it, because they are really patenting the natural phenomenon underlying the process,” said Klein.
Gene sequencing also involves natural phenomena, says Klein.
“Myriad claimed that by removing these genes from the body so that you could read the information, you were creating a product and it was no longer natural, making it patent-eligible,” said Klein. “Our contention was the information was the same. You removed it from the body just so you could read it, much like a page in a book.”
In addition to AMP, 169 other organizations and companies oppose the proposal. Opponents signed a letter sent to lawmakers on June 3.
The Biotechnology Innovation Organization trade group supports the proposal. The group’s vice president of government relations, Chuck Ludlam, says the current state of patent law under the two Court decisions makes it difficult for companies to attract investors and partners for research. Without patent protection on discoveries in “natural phenomena” and without a clear legal definition of what that term covers, companies may move abroad, costing the United States its technology edge, Ludlam says.
Affecting Medical Diagnostics
Klein says a further area of concern is clinical genetic and genomic testing.
“Impacts on research are important and highly relevant, but the effects on testing performed for medical purposes, much more so,” said Klein. “Molecular pathology and molecular genetic tests are performed on hundreds of thousands of patients each year; for example, to select therapies for people with cancer or to diagnose individuals and families with inherited disorders,” said Klein.
Today, much work in precision medicine is done through large-scale gene sequencing, and often at affordable prices.
“This would have been impossible without the Mayoand Myriad decisions,” said Klein. “The diagnostic world would be a much different place without those decisions, and the impacts on care in these areas would have been profound.”
Defining the Terms
The draft, known as Section 101 Reform, requires a discovery be “useful,” not “new and useful,” to be patent-eligible. Tillis says the term “useful” will not include laws of nature.
“If we get sufficient input from legal scholars and others that we may not be clear on that, then we’ll draft language that makes it very clear,” Tillis told Sciencemagazine.
Klein says he wants to make sure only true innovations are protected.
“We need to look at proposals that would focus on providing intellectual property protections for natural substances that are used in medical therapy,” said Klein. “If you discover something and make a medicine out of it, it is a very different thing than [as in the case of genetic testing] you use it just to look at the information [it contains].”
The patent discussion could also have an effect on the Food and Drug Administration’s drug approval process, says Ed Hudgins, research director at The Heartland Institute and author of the study “A Modern System for Improving the Cures of the Future.”
“We may need to draw a distinction between information about a genome that can be discovered by researchers and techniques for making use of the information,” said Hudgins.
“It’s important we highlight the potential of exponential medical treatments and breakthroughs, especially customizing treatments based on an individual’s genome,” said Hudgins. “This makes the need for FDA reform more urgent.”
AnneMarie Schieber ([email protected])is managing editor of Health Care News.
Coalition Letter Opposing Draft Legislation of Section 101 of Patent Act, June 3, 2019: https://heartland.org/publications-resources/publications/coalition-letter-opposing-draft-legislation-of-section-101-of-patent-act
Edward Hudgins, “A Modern System for Improving the Cures of the Future,” April 30, 2019: https://heartland.org/publications-resources/publications/a-modern-system-for-approving-the-cures-of-the-future
Draft Text to Reform Section 101 of the Patent Act, May 22, 2019:https://www.tillis.senate.gov/services/files/E8ED2188-DC15-4876-8F51-A03CF4A63E26