NEW YORK – A bill recently introduced in the US Senate seeks to expand patent eligibility for genetic material and overturn previous US Supreme Court decisions with potentially worrying implications for labs developing tests and public health officials' ability to respond to disease outbreaks.
Earlier this month, Sen. Thom Tillis, R-N.C., introduced the Patent Eligibility Restoration Act of 2022. The bill seeks to make changes to the statutes covering patent eligibility dubbed "Section 101," which Tillis previously sought in 2019 in bipartisan draft legislation with Sen. Chris Coons, D-Del.
The new bill, so far sponsored solely by Tillis, proposes major changes that would sweep away the last decade of case law established by Supreme Court decisions in the Association for Molecular Pathology et al. v. Myriad Genetics (Myriad) and the Mayo Collaborative Services v. Prometheus Laboratories (Mayo) cases.
"I have long said that clear, strong, and predictable patent rights are imperative to enable investments in the broad array of innovative technologies that are critical to the economic and global competitiveness of the United States and to its national security," Tillis said in a statement. "Unfortunately, our current Supreme Court’s patent eligibility jurisprudence is undermining American innovation and allowing foreign adversaries like China to overtake us in key technology innovations."
The bill offers a "huge expansion" of what's eligible to be patented, especially with respect to molecular diagnostics, said Arti Rai, a legal scholar at Duke University and an expert in intellectual property law.
The text of the bill says that "any gene isolated or purified by human activity shall be eligible," she noted. "Myriad is overruled. Mayo is largely overruled. For [patent] eligibility it takes us to a pre-Myriad state," she said. Just about any DNA sequence is patentable, "as long as what you’re claiming doesn’t exist per se in the human body," she said.
The bill has drawn criticism and praise from various corners of the molecular diagnostics industry.
"I actually think it’s worse than [returning the law to a pre-Myriad state]," said Sandra Park, a senior staff attorney at the American Civil Liberties Union (ACLU). "Before Myriad, there was at least some question about other types of natural material, whether the patent office actually considered them to be an invention. This makes absolutely clear that any material isolated or otherwise altered is a patent eligible invention." ACLU, which sued Myriad on behalf of a coalition of plaintiffs in the case that struck down gene patents, has issued a statement condemning the bill.
In the statement, Park called the bill "a gift to patent lawyers and predatory companies while risking the creation of a disturbing market for exclusive rights over material found in nature and abstract ideas."
The Biotechnology Innovation Organization (BIO), a trade association representing the biotech industry, including major pharma and life science tools firms, was supportive of the bill. "This important legislation will bring much needed and overdue clarity to Section 101 of the Patent Act," BIO Chief Advocacy Officer Nick Shipley wrote in an open letter addressed to Tillis. "The existing uncertainty in the law has been a major impediment to the cutting-edge work of our innovators."
The bill "would also afford US innovators the same protections now enjoyed by their foreign competitors," he added, without specifying which geographical areas he meant. BIO did not immediately respond to a request for comment and clarification.
Some critics worried that the bill would allow for patents that could hinder the biomedical community's response to future infectious disease outbreaks.
"The legislation would explicitly allow for genetic sequences from infectious organisms such as SARS-CoV-2 and monkeypox virus, as an example, to be patent eligible," Mary Steele Williams, executive director of the Association for Molecular Pathology (AMP), said in an email. "This would prevent widespread access to diagnostic testing during outbreaks, restrict vaccine development, and more." She added that the legislation could have "a dramatic and negative impact on laboratory medicine and patient care."
Tillis' bill builds on a draft bill floated in 2019. At that time, Tillis and Coons, as members of the Senate Judiciary Subcommittee on Intellectual Property, held multiple days of hearings on the topic of patent eligibility, including several witnesses in the diagnostics industry.
At the close of the hearings, Tillis said the bill needed refinements.
"One major change they needed to address was whether human genes as they exist in the human body were eligible," Rai said. "It was clear that the opposition to the draft bill was arguing that, at least as they read the bill, there was the question of whether one could, simply by existing, infringe a patent."
There was also concern that mental processes could be patent eligible; however, those are "clearly excepted in this bill," Rai said. This is relevant to biomedical work, she said, because an assertive patent holder could allege that someone infringed their IP "simply by thinking about a correlation between a biomarker and disease."
If made law, the bill could lead to more patents awarded to smaller firms — and more patent lawsuits filed by them, Rai said. "Certain universities will be back to their patenting business," she added.
Steele Williams suggested that the bill would be harmful to molecular diagnostics on the whole.
"This bill will also make it very difficult for companies to rapidly innovate," Steele Williams said. "If this bill is made law, companies with new technologies and new treatments — such as vaccines — and medical professionals who provide laboratory-developed testing procedures (LDPs) would have to file objections to every application individually under a different section of the [Patent] Act, such as Section 105. This could potentially include EVERY biomarker and EVERY mutation of EVERY biomarker and would result in enormous harm, the scale of which is almost unfathomable. AMP v. Myriad opened the door to amazing progress with next-generation sequencing and put patients first. This new bill threatens to erect potentially deadly blockades between patients and the essential testing and treatments they need."
The current state of the law "has had an extremely positive impact on the state of innovation, research, and the US economy," she said, and "has allowed molecular professionals to be adaptable."
Park said she was "concerned" that the legislation would "incentivize companies that are focused on monopolizing the natural law, versus providing the best testing or most innovative testing."
As the world continues to grapple with COVID-19 and deals with the accelerating monkeypox epidemic, limits on patenting genetic sequences are important, Steele Williams said.
"If this bill had been enacted before the pandemic, patents on the SARS-CoV-2 genetic sequence would have been allowed and would have greatly hampered the United States' response efforts."
A rush to patent that virus' genome is not a hypothetical. "During the 2003 [SARS] outbreak, biotechnology and pharmaceutical companies raced to patent everything from the genetic sequences within the virus’ genome to the virus itself," she wrote in a September 2021 letter to the USPTO as part of a request for public input into a Patent Eligibility Jurisprudence Study. "In competition with these companies was the [Centers for Disease Control and Prevention], which sought to defensively patent the virus and its entire genetic content 'to make sure access to the virus remains available to anyone,' as stated by then CDC Director Julie Gerberding."
With midterm elections around the corner and the current session of Congress set to end in January, Tillis will likely have to resubmit the bill in the next Congress. Rai suggested that Tillis is "putting it out to see how people will react."
If he does continue to pursue this legislation, he'll be sure to face resistance. "AMP is confident our ongoing advocacy efforts will help to ensure that this legislation does not pass, at least in its current form," Steele Williams said.