A congressional proposal that would overturn a landmark U.S. Supreme Court decision that barred the patenting of human genes and ease other restrictions on patenting software and biomedical inventions is drawing fierce criticism from some scientific societies and patient advocates. Yesterday, the American Civil Liberties Union (ACLU) in Washington, D.C., along with more than 100 other signatories from research institutes and advocacy groups, released a letter to lawmakers arguing the changes would stifle medical research and hinder patients’ access to diagnostic tests.
The draft bill “would result in a quagmire of patent claims and legal impediments to the normal scientific exchange,” said Harold Varmus, a cancer biologist at Weill Cornell Medicine in New York City and former director of the National Cancer Institute, in a press conference yesterday. “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.”
The ACLU letter comes as the Senate Committee on the Judiciary kicks off the first in a series of three hearings that will examine potential changes to U.S. patent law. Today’s hearing is expected to include discussion of the draft proposal, released last month by a bipartisan group of lawmakers, which would overturn current restrictions on patenting products and processes that occur in nature, including human genes.
The bill aims to address a complaint that has been brewing for years in the biotechnology and software industries: that recent Supreme Court decisions have created confusing and overly stringent patent eligibility rules. In particular, critics point to three recent rulings:
- The 2012 decision in Mayo Collaborative Services v. Prometheus Laboratories invalidated a patent on adjusting drug dosage based on levels of metabolites in a patient’s blood because it relied on a “law of nature.”
- The landmark 2013 ruling in Association for Molecular Pathology (AMP) v. Myriad Genetics Inc. said that human genes can’t be patented because they are a “product of nature.”
- In 2014, software patents took a blow from the Alice Corp. v. CLS Bank International decision, which found a financial trading program to be an unpatentable “abstract idea.”
The new bill “makes it clear in no uncertain terms that all the Supreme Court [decisions] are just gone,” says Arti Rai, a patent law expert at Duke University in Durham, North Carolina. It says decisions about patent eligibility should not rely on “judicially created exceptions … including ‘abstract ideas,’ ‘laws of nature,’ or ‘natural phenomena.’”
The bill’s sponsors in the Senate, Thom Tillis (R–NC) and Chris Coons (D–DE), have described it as a way to restore incentives for U.S. innovation by making the process for protecting new inventions more predictable. (Competition with China, where no comparable restrictions exist in the patent system, may have motivated the lawmakers, Rai says.)
But opponents say the bill would enable monopolies on discoveries that should be widely available for research and medical use. In the 2013 Myriad case, the diagnostic company Myriad Genetics of Salt Lake City claimed that its broad patents on two human genes gave it exclusive rights to clinical tests for cancer-associated mutations in those genes. In striking down the patents, the Supreme Court allowed other diagnostic companies to offer such tests without fear of infringement lawsuits. Signatories on the new letter—including plaintiffs who challenged the Myriad patents, and ACLU, which represented them—argue that if the proposed law is enacted, “We will again see high prices for tests with no competition in the market.”
But Rai notes that the scientific and business landscapes have changed since Myriad. “I don’t think anyone is really trying to get single gene patents anymore,” she says. Patents that have already been struck down can’t be resurrected, she notes, and thanks to extensive research on the human genome, many claims to individual genes would no longer be considered “novel,” as U.S. patent law requires. “If the information is already out there—and most of the information about the human genome at a single-gene level is already out there—you can’t patent it because it’s no longer new.”
Still, the proposed bill would also apply to patenting complex methods of estimating a person’s risk for disease based on a combination of many genes—so-called polygenic risk scores. Some of these approaches have already won patent protection, Rai says, though it’s not clear whether, under the current rules, the existing patents would hold up to a challenge in court.
Even if the draft language gets enacted, the current law’s requirement of novelty—and other requirements untouched by the proposed changes—would ensure that “people won’t be able to go totally crazy” in trying to patent discoveries based on nature, predicts Dan Burk, a law professor at the University of California, Irvine. But adoption of the change could cause a surge of patent applications for software, and potentially also for biotechnology and medical diagnostics, he says. And even if most human genome sequences remain off limits, previously unexplored genes from many other species—some potentially useful to medicine—would newly become eligible for a patent.
Burk, for one, doubts the exact language in the draft will be enacted, but he does expect changes to the law. “I am pretty confident,” he says, “that if we have a conversation in 6 months to a year, the patent statute will look different than it does today.”
*Update, 5 June, 11:30 a.m.: In the first of three patent reform hearings, Senators Coons and Tillis said they didn’t intend to upend all restrictions on patenting human genes or other basic research discoveries. “Our proposal would not change the law to allow a company to patent a gene as it exists in the human body,” Coons said in his opening statement. “We do not intend to overrule that holding of the 2013 Myriad decision.”
But the witnesses at the hearing had different interpretations of the bill’s text. The intent to preserve Myriad is “inconsistent with the legislative text that’s been put forward,” said patent policy researcher Charles Duan of the R Street Institute in Washington, D.C., in his testimony. The proposed language could make it possible to patent many kinds of “pure scientific research,” he said. “I don’t think that’s the intent, but … that’s what the language does.”
“I think your proposal does overturn the Myriad decision, and I hope it does,” Sherry Knowles, an attorney at Knowles Intellectual Property Strategies in Atlanta, told the Senators. The cancer drug adriamycin, which she credited with her own remission from breast cancer, is a compound first discovered in soil microbes, she noted, and it “would never have been developed … without the patent framework we had before Myriad.” Since that decision, she said, “There’s been a dead stop in research in the United States on isolated natural products.”
Tillis told Science that another section of the draft bill—which contains new stipulations about what makes an invention sufficiently “useful” to be patent-eligible—should ensure that naturally occurring genes and pure laws of nature remain off limits. Reviving human gene patents “was never the intent” of the bill, he said. “If we get sufficient input from legal scholars and others that we may not be clear on that, then we’ll draft language that makes it very clear.”