Jun 5, 2019 6:21 PM

Congress Is Debating—Again—Whether Genes Can Be Patented

Critics worry that a new bill would overturn existing protections of DNA sequences and carve up the world's genetic resources into commercial fiefdoms.

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In 2013, the Supreme Court unanimously struck down patents on two human genes—BRCA1 and BRCA2—associated with breast and ovarian cancers. Justice Clarence Thomas wrote for the court at the time that isolated DNA “is a product of nature and not patent eligible.” The historic decision invalidated patents held by Myriad Genetics, the defendant in a 2009 lawsuit brought by dozens of patients and researchers represented by the American Civil Liberties Union, breaking the company’s virtual monopoly on predictive cancer testing and unleashing a torrent of competition. Today, more than a dozen companies, including mail-order spit-kit operations like 23andMe and Color, can tell you what your BRCA genes say about your risk of getting cancer.

Now lawmakers in Washington, DC, are weighing a new proposal that would upend that landmark decision and other recent rulings that created judicial exceptions to federal patent law. Under debate are the notions that natural phenomena, observations of laws of nature, and abstract ideas are unpatentable. That legal precedent includes a major victory for the software industry against a plague of patent trolls. If successful, some worry this bill could carve up the world’s genetic resources into commercial fiefdoms, forcing scientists to perform basic research under constant threat of legal action.

The bipartisan draft bill, released last month by Senators Thom Tillis (R-North Carolina) and Chris Coons (D-Delaware), makes changes to several sections of the statutes covering patent law and adds a provision that would nullify the Supreme Court’s exceptions to it. Critics of those decisions say they’ve left the US with incoherent and overly stringent patent eligibility rules that are hurting innovation, at a time when technological rivals, in particular China, are speeding ahead. Proponents of the current legal doctrine fear reform will send the US back to a time when you could slap intellectual property rights on almost anything—from a DNA sequence to the act of scanning and sending a file with a single click.

The proposed patent bill now pits the pro-reformers, which include the biomedical and pharmaceutical industries, against the internet giants of Silicon Valley. That clash is on display in a series of three public hearings that began this week in the Judiciary Subcommittee on Intellectual Property, which Tillis chairs and of which Coons is ranking member.

The goal, Tillis said in his opening remarks on Tuesday, was to hear concerns from both sides and move toward compromise in the form of a final bill they could introduce in the Senate later this summer. “If I was a CEO of a company in [the tech and software] industries, I would want to maintain the status quo because it provides certainty,” said Tillis. “Unfortunately it does so for only a portion of our current innovation economy. I’m concerned about the US economy as a whole.”

Forty-five witnesses are expected to testify, among them law professors, retired judges, former heads of the US Patent and Trademark Office, pharmaceutical and medical diagnostic testing executives, and trade associations representing Big Tech, including Amazon, Facebook, Google, and Microsoft. Joining the bill’s opponents is the ACLU, which is testifying this afternoon. On Monday, the organization sent a letter to lawmakers signed by 169 scientific societies, research institutes, and patient advocacy groups arguing that the proposed changes would suffocate potentially life-saving biomedical research and impede patients from accessing affordable diagnostic testing.

But the lawmakers say that their bill doesn’t in fact revive companies’ power to patent human genes or other basic research discoveries. “I want to be clear on one thing,” Coons said Tuesday. “Our proposal would not change the law to allow a company to patent a gene as it exists in the human body.”

The confusion is understandable though. Even witnesses at Tuesday’s hearings had differing interpretations of the bill’s language. Charles Duan, a patent policy researcher at the R Street Institute in Washington, DC, said he was encouraged by Coons’ words but that his assertion is inconsistent with the proposed text. “The result of the legislation as it’s been drafted right now could make it possible to obtain patents on pure scientific research,” he said. “I don’t think that’s the intent, but I think that’s what the language does.”

Sherry Knowles, an intellectual property attorney in Atlanta, celebrated the proposed bill precisely because she believes it would overturn Supreme Court decisions like the Myriad case. Since that decision, she said during her testimony Tuesday, “there’s been a dead stop in research in the United States on isolated natural products.” She cited as an example the drug adriamycin, which was first discovered in bacteria and which helped her survive a bout with breast cancer. If the Myriad case had happened earlier, she argued, she wouldn’t have had access to the drug.

The differing interpretations spawn from a single provision. It states that “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.”

As with many legal fights, meaning can turn on the interpretation of a single word. In this case, that word is abrogation. By most legal dictionary definitions, it means the formal nullification of a law through an act of Congress—as in, Congress overruling the outcomes of the Supreme Court. Its more common usage, though, basically says that whatever legal approach the courts used in the past isn’t going to be used anymore, says David O. Taylor, a legal scholar who specializes in patent eligibility at Southern Methodist University.

“They’re not saying, ‘OK, now you can patent natural phenomena,’" Taylor says. "They’re saying it can be hard to figure out what is an abstract idea, what is a law of nature, what do we mean when we say ‘natural phenomena’?” This bill creates a clarified legal test for how patent evaluators should determine those things in place of Supreme Court precedence.

The new legal test includes an updated definition of the term “useful.” To be eligible for a patent, a discovery or invention would now have to have an identifiable benefit made possible only through human intervention. And it would have to be in a “field of technology,” which Taylor believes is meant to create a safe zone for pure scientific research. He agrees with the senators that these new stipulations should keep human genes and other laws of nature off-limits to patent-seekers.

Arti Rai, a patent law scholar at Duke University, finds more comfort in the parts of the statute the new bill leaves unchanged, namely the novelty requirement. If the draft bill passed, she believes it could still allow patents on versions of genes “isolated” by human scientists, the defense Myriad used in its case. “But the novelty requirement would make patenting individual human genes no longer a possibility,” she wrote in an email to WIRED, because those genes are no longer new. Two decades of research into how human DNA at the single-gene level codes for traits and diseases has already put most of that information in the public domain. But the proposed law could affect situations where multiple genes are being assessed for their role in certain conditions. This would encompass the emerging field of polygenic risk scores. People are already seeking patents for some of the methods for calculating them, says Rai.

All these conflicts and more are on display today and next Tuesday, when the third hearing takes place. No one expects to resolve the issues in a week. But, as Coons said in his opening statement, the point of the hearings is to expose any weaknesses in their solution, to test whether it’s workable, and determine if such changes are even necessary at all.