Scores of organizations, including the American Civil Liberties Union (ACLU), scientific organizations, and patient advocacy organizations, are mobilizing to stop proposed legislation that would dramatically broaden patent law to include genes themselves along with other "natural phenomena" and even "laws of nature."
The Supreme Court ruled in 2012 in Association for Molecular Pathology v. Myriad Genetics that the latter couldn't patent the BRCA1 and BRCA2 genes for isolation to assess a patient's cancer risk.
"The Patent Act permits patents to be issued to '[w]hoever invents or discovers any new and useful ... composition of matter,' but 'laws of nature, natural phenomena, and abstract ideas' are 'basic tools of scientific and technological work' that lie beyond the domain of patent protection," wrote Justice Clarence Thomas in the unanimous .
On May 23, to change several sections of the Patent Act was released by Senators Thom Tillis (R-N.C.) and Chris Coons (D-Del.) and Representatives Doug Collins (R-Ga.), Hank Johnson (D-Ga.), and Steve Stivers (R-Ohio). Most are on committees that would have jurisdiction over the bill, language of which isn't restricted to gene patents, although facilitating them appears to be the motivation.
Specifically, the to Section 101 of the Patent Act includes the following: "No implicit or other judicially created exceptions to subject matter eligibility, including 'abstract ideas,' 'laws of nature,' or 'natural phenomena,' shall be used to determine patent eligibility under section 101 , and all cases establishing or interpreting those exceptions to eligibility are hereby abrogated."
A opposing the draft legislation was sent June 3 by the ACLU and 150 others, including patient groups and an array of professional societies around genetics, rare diseases, cancer, and genetic counseling, along with major academic institutions such as the Broad Institute of MIT and Harvard and Baylor College of Medicine. Even some biotech companies in the genomics field signed onto the letter.
"The overall effect will be to shift the structure of the statute to eliminate the principle that it is in the public interest that certain building blocks of human innovation should not be reserved to anyone's exclusive use," Kate Ruane, ACLU senior legislative counsel, said in a press briefing by several of the original plaintiffs in the Myriad case. "History teaches that gene patents impede innovation, raise prices, and harm patients."
Tara Burke, PhD, senior director of public policy and advocacy at the Association for Molecular Pathology, noted in the briefing that the Myriad ruling "was celebrated across the greater scientific community."
"The ruling eliminated infringement for large scale genome sequencing and was essential to our ability to perform exome, genome, and next-generation sequencing panels," she said. "The many robust and rapid developments in molecular diagnostics since 2013 only justify the belief that eliminating patents on genes would encourage, not dampen innovation in the field."
"However, this issue goes beyond access to testing the genes," Burke added. "It's about sharing the data itself. Patents on genes mean researchers and laboratories can't share genetic data that is both important for understanding disease but also making accurate interpretation of test results."
Harold Varmus, MD, the Nobel Prize-winning cancer researcher and former head of the NIH and National Cancer Institute now at Weill Cornell Medicine in New York City, agreed.
"Based on these various roles and multiple studies of intellectual property protection and on my own experience in making a variety of decisions both in academia and the federal government about whether to apply for patents on various kinds of scientific advances, I am convinced first that it's in the interest of virtually everyone to keep ideas and basic discoveries about the laws and products of nature in the public domain," he said at the briefing.
Patents on inventions and methods are crucial for industry "but the obstacles that are created by patents that extend to sharing of information and materials in basic research of laws and products of nature and even ideas can severely retard the collaborations and new discoveries that have proven to be vital to both the public and industries that depend on the growth of knowledge," Varmus said.
The proposed legislation would almost certainly lead to thickets of patents, a quagmire of lawsuits, and impaired vitality of basic research, he said.
Senate Judiciary Subcommittee on Intellectual Property hearings are planned for June 4, 5, and 11 on patent eligibility.
Ruane cautioned: "While a lot of the witnesses may disagree on the merits of Section 101 reform, there are no patient advocates or representatives of the broader scientific community on the witness list" for those hearings. "Their voices are necessary to ensure that any reforms will not result in unintended consequences."