|Illustration by Chris Madden|
On Monday, a New York District Court became the first to rule on human gene patents. Judge Robert Sweet's landmark ruling [PDF] holds that human genes cannot be patented because they are products of nature. Judge Sweet made his decision in the form of a seldom-granted "summary judgment" - which means that he considered the case brought by the American Civil Liberties Union and the Public Patent Foundation against Myriad Genetics and the University of Utah Research Foundation to be so strong that a full trial was unnecessary. The ruling will be appealed, and could well reach the Supreme Court.
The plaintiffs argued that Myriad Genetics' patent claims on genes
associated with breast and ovarian cancer are illegitimate and
harmful. In particular, they asserted, the claims establish a monopoly on genetic tests for these genes, thus restricting patients' access. The Center for Genetics and Society (CGS) and many other organizations, including women's health,
public interest and scientific groups, have filed briefs [PDF] supporting this
position. CGS and allies stressed that:
- Human genes and their relationships with phenotypic characteristics are not patentable because they are products and laws of nature, respectively.
- Such patents harm people by hindering health access and medical research (in this case, on breast and ovarian cancer).
- The human genome is the common heritage of humanity, and thus part of the public domain.
ACLU staff attorney Sandra Park called the decision "the beginning of the end to patents that restrict women's access to their own genetic information and interfere with their medical care." CGS said it was "a victory for patients, consumers and responsible research."
Others disagree, sometimes vehemently. One intellectual property lawyer termed it "an inane ruling" and speculated about whether the judge had been "duped by the ACLU."
The reactions seemed mostly to fall into three camps. Science bloggers and public interest groups generally hailed the decision, patent attorneys assaulted it, and many interested observers seemed too stunned to have a clear opinion. (A fourth response was a shocked "who knew?" -- many
people's reaction to learning that 20% of the human genome is already
claimed by patents.)
With the benefit of a day or so to think, the Los Angeles Times editorial board called the ruling "a welcome rebuke to an expansive reading of patent law." Genomics Law Report headlined a generally sober and comprehensive summary "Pigs Fly: Federal Court Invalidates Myriad's Patent Claims." Science Progress emphasized that "the decision presents DNA as pure information" but took a wait-and-see approach, anticipating (as do others) a Supreme Court ruling on this and, sooner, on the controversial Bilski case on which this judge in part relied.
The business press noted that Myriad's stock price fell, and some suggested that the judge "appears to have thrown the biotech industry into a tailspin," while the WSJ law blog and BioWorld hedged their bets, and Genetic Future called the ruling "jaw-dropping." Looking further afield, Singularity Hub considered whether the ruling would "cover human genes that have undergone engineering" thus affecting gene therapy, and raising the "terrifying prospect" that a natural mutation could lead to copyright infringement.
Cory Doctorow at BoingBoing noted that "many of us have a strong intuition that when someone else claims to own something from our genome, they're being ridiculous, or evil, or both." And finally, Jim Dwyer's column at The New York Times had perhaps the best headline:
In Patent Fight, Nature, 1; Company, 0
See also: "The Battle to Patent Your Genes: The Meaning of the Myriad Case" by Marcy Darnovsky and Jesse Reynolds (The American Interest, September/October 2009)
Previously on Biopolitical Times:
Posted in Biotech & Pharma, Media Coverage, Patents & Other IP, Personal genomics, Pete Shanks's Blog Posts, Sequencing & Genomics, US Federal
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