Abstract
Numerous researchers and organizations have announced their opposition to proposed changes to the Patent Act that are under consideration in Congress. The changes would run counter to three Supreme Court decisions on intellectual property and permit gene patenting, opponents of the bill argue, creating impediments to diagnosis and research and increasing health care costs.
Proposed legislation to revamp U.S. patent law has drawn opposition from more than 150 health care, scientific, and patient organizations. If enacted, these critics say, the changes could re-open the door to gene patenting, deny patients necessary tests, raise health care costs, and impede research.
Three Supreme Court decisions in the past decade shook up patent law. The most famous case, Association for Medical Pathology v. Myriad Genetics, quashed Myriad Genetics' patents on BRCA1 and BRCA2 on the grounds that, as the Supreme Court's 2013 decision put it, “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” The Court's 2012 decision in Mayo Collaborative Services v. Prometheus Laboratories and its 2014 ruling in Alice Corporation v. CLS Bank also restricted what could be patented.
But in May, Senators Thom Tillis (R-NC) and Chris Coons (D-DE), along with three cosponsors in the U.S. House of Representatives, released a draft bill that, if passed, would amend the Patent Act to address these decisions. “We believe this draft framework represents a true balance that will restore integrity, predictability, and stability to our nation's patent system, while also preventing the issuance of overly broad patents,” says Tillis.
The provision in the draft bill that most worries critics would eliminate the “judicially created exceptions to subject matter eligibility” for patents. That language “explicitly overrules” the three Supreme Court decisions, notes Jacob Sherkow, JD, of New York Law School in New York, NY. As a result, genes and associations between genes and diseases would be patent eligible, according to the organizations and institutions that have announced their opposition to the potential revisions.
The Supreme Court's patent rulings were essential for incorporating technologies such as next-generation sequencing into diagnosis, says Roger Klein, MD, JD, of the Center for Law, Science, and Innovation at the Sandra Day O'Connor Law School at Arizona State University in Phoenix. He is a member of the Board of Directors of the Association for Medical Pathology, based in Rockville, MD, which opposes the proposed changes. “None of the large-scale sequencing at the center of the genetic or genomic revolution could have happened with these patents,” he says.
At a hearing about the draft language on June 4, Coons addressed worries about gene patenting, stating that “our proposal would not change the law to allow a company to patent a gene as it exists in the human body.” However, Klein says that statement does not allay his concerns because it does not rule out patenting of isolated genes, as occurred before the Myriad decision.
“The big issue is access,” says Donald Karcher, MD, of George Washington School of Medicine and Health Sciences in Washington, DC, a spokesman for the College of American Pathologists. He says that gene patents mean that patients must receive tests produced or licensed by the patent holder—even if they aren't as accurate or comprehensive as others—and prevent development of improved tests. If the proposed changes become law, medicine “will go back to the earlier situation when patients were denied access to confirmatory testing or arguably better testing.”
The proposed bill could also inhibit research and raise health care costs, notes E. Richard Gold, LLB, SJD, who teaches U.S. patent law at McGill University in Montreal, Canada. “It poses a significant threat to future development of treatments and the cost of those treatments.”
However, Sherkow says that because DNA technology has changed so much since Myriad Genetics' original gene patents were granted in the 1990s, he doesn't expect any changes to lead to an explosion in “mini-Myriads” that try to lock up exclusive rights to individual genes. Nonetheless, he says, the changes could “open the floodgates” for more patents in biomedicine, including for currently unpatentable diagnostic software. “It's right to be fearful,” he says.
The Senate Judiciary Subcommittee on Intellectual Property has held three hearings on the proposal. The sponsors of the draft bill plan to introduce a final bill incorporating recommendations from experts later this summer. –Mitch Leslie
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