In advance of three scheduled hearings this week and next in front of the intellectual property subcommittee of the Senate Judiciary Committee, an American Civil Liberties Union (ACLU) coalition of more than 100 organizations from medical, scientific, patient advocacy, and women’s health groups today sent a letter to Capitol Hill opposing proposed legislation to amend Section 101 of the Patent Act, which would effectively allow for the patenting of human genes.
Senators Chris Coons (D-Del.) and Thom Tillis (R-N.C.) the ranking member and chair of the Senate Judiciary Committee’s intellectual property subcommittee, along with Rep. Doug Collins (R-GA), the ranking member of the House Judiciary Committee, Sen. Hank Johnson (D-GA), and Sen. Steve Stivers (R-OH) on May 22 released a draft bill after releasing in April a draft outline for section 101 reform.
In a joint May 22 press release, Johnson said “Section 101 of the Patent Act is foundational to the patent system, but recent court cases have upset what should be solid ground. That’s why I’ve been pleased to work with my colleagues—Senators Tillis and Coons; Representatives Collins and Stivers—on this effort to restore predictability and stability to the patent eligible subject matter inquiry that will ensure that the patent system is available to incentivize innovation in key areas of our economy.”
But according to the ACLU, the proposed change to Section 101 “would authorize patenting products and laws of nature, abstract ideas, and other general fields of knowledge,” issues the Supreme has unanimously ruled—in three separate instances—are not allowed under patent law. The most notable of these cases was the 2013 ruling in Association for Molecular Pathology v. Myriad Genetics, Inc. that overturned the U.S. Patent Office’s decision to award the Myriad patents for the BRCA1 and BRCA2 genes.
According to Kate Ruane, ACLU senior legislative counsel, the effect of the legislation, if passed, would be to allow for genes isolated from the human genome to once again be patent eligible. In addition, the bill would also narrow the scope of patent statute’s Section 112 specification requirement and would directly nearly all questions of what could be patented to other provisions in the statute. This approach that has been dismissed by the U.S. Supreme Court, Ruane added.
“Because Section 101 prohibited patents on natural phenomena, the Court’s decision in Myriad created precedent invalidating all patents on isolated DNA. If Section 101 had not contained these exceptions, patents on isolated DNA could only be challenged on a case-by-case basis examining the specific circumstance of the identification of the genes at issue,” Ruane said in a phone briefing. “This bill will actually harm innovation and progress. History teaches that gene patents impede innovation raise prices and harm patients. The draft legislation would bring us back to the time of chilled scientific inquiry, increased healthcare and diagnostic costs and lack of competition.”
This view is shared by the Association for Molecular Pathology, the industry group named as plaintiff in the 2013 action against Myriad.
“AMP maintains its position that the authorization of patents for human genes and naturally occurring associations between genes and diseases would impede the scientific community from working together to discover novel diagnostics and treatments for rare and common diseases including cancer, muscular dystrophy, Alzheimer’s disease, and heart disease. It would also create barriers to patients’ access to potentially life-saving genomic tests and eliminate access to confirmatory testing. Further, these patents would create monopolies that would stifle competition and dramatically increase costs for payers, patients and the healthcare system overall,” the association noted in a press release.
