Since the decoding of the human genome, biotechnology companies have claimed that by matching a person’s genetic make-up with specialised treatments, they can tailor drugs to maximise benefits and minimise side effects. Alas, researchers have discovered that the link between a given person’s genetic make-up and specific diseases is much more complex than they had hoped. The tantalising vision remains out of reach.
A rare exception has been the success that Myriad Genetics, an American firm, has had with two genes called BRCA1 and BRCA2. Certain versions of these genes, it has been shown, are associated with a high risk of breast and ovarian cancer. The University of Utah has patented the genes and licenses them to Myriad. The firm uses that exclusivity to create expensive genetic tests for cancer risk which only it offers for sale (the patents and licensing conditions are different outside the United States).
The BRCA patents have long frustrated medical researchers, cancer lobbyists and legal activists. They claim that the firm’s grip on the two genes unlawfully stifles both innovation and basic science. Given the history of patent rulings in America, that has been a fringe argument—until now.
On March 29th the New York District Court made a ruling that, taken at face value, turns America’s approach to the patent protection of genes on its head. A coalition led by the American Civil Liberties Union (ACLU) had challenged the very basis of Myriad’s patents. The nub of the case was this question: “Are isolated human genes and the comparison of their sequences patentable things?”
Until now, the answer had been “Yes”. But Robert Sweet, the presiding judge, disagreed, at least as far as the BRCA genes are concerned. After weighing up Myriad’s arguments, he ruled: “It is concluded that DNA’s existence in an ‘isolated’ form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issues directed to ‘isolated DNA’ containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter.” Mr Sweet reasoned that DNA represents the physical embodiment of biological information, and that such biological information is a natural phenomenon.
The ACLU’s and PUBPAT’s lawsuit against Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes, as well the U.S. Patent and Trademark Office (USPTO), charged that the challenged patents are illegal and restrict both scientific research and patients’ access to medical care, and that patents on human genes violate the First Amendment and patent law because genes are “products of nature.”
The specific patents that the ACLU had challenged are on the BRCA1 and BRCA2 genes. Mutations along the BRCA1 and 2 genes are responsible for most cases of hereditary breast and ovarian cancers. The patents granted to Myriad give the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes.
William L. Warren, partner at Sutherland Asbill & Brennan, believes this is a “poor decision that may have negative short-term implications for financing in the biotechnology sector, and hence the development of new diagnostics and therapeutics, until it is overturned by the U.S. Court of Appeals for the Federal Circuit in the next one to two years. Certainly, the sequencing of genes and disease-associated mutations for use in developing diagnostic probes and assays provides useful nonnaturally occurring subject matter that should qualify for patentability under the statute.
“While native genes in the body are originally products of nature, isolating portions of the DNA in order to perform a diagnosis transforms the DNA structurally and functionally into patentable subject matter,” he continues. “The isolated DNA has been markedly changed to become a useful product, even though it carries some of the same information as the native gene.
“Whether through the progress of scientific knowledge and techniques the isolation of such DNA fragments becomes routine or obvious is a separate question, which was not at issue in this case.”
Megan Carpentier at The Washington Independent
Ronald Bailey at Reason:
GenomeWeb quotes ACLU attorney Chris Hansen as saying:
“Today’s ruling is a victory for the free flow of ideas in scientific research. The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas.”
Hansen is making the argument that gene patents have created an anti-commons that is impeding important research. But is that so? I looked into the issue three years ago and could find little empirical support for the …
… concern that the over-proliferation of patents, instead of encouraging innovation, is stifling it. This argument achieved prominence in an influential 1998 article published in Science by two University of Michigan law professors, Michael A. Heller and Rebecca S. Eisenberg. Heller and Eisenberg worried that the privatization of biomedical research “promises to spur private investment but risks creating a tragedy of the anticommons through a proliferation of fragmented and overlapping intellectual property rights.”
By “anticommons,” they meant a situation in which the existence of a large number of intellectual property rights applicable to a single good or service unduly retards or even prevents its provision. The blockage to innovation would occur because of high transaction costs, the conflicting goals of various intellectual property owners, and cognitive biases in which owners overvalue their own patents, undervalue others’ patents, and reject reasonable offers.
As evidence for a biomedical anticommons, analysts regularly cite the high profile case of “probably the most hated diagnostics company,” Myriad Genetics.
As evidence against the existence of a research anti-commons, I cited a number of studies by the National Academy of Sciences and I further noted that …
… in 2006, Nature Biotechnology published a review (free registration required) of the academic literature on the existence of a research anticommons. The review concluded that “among academic biomedical researchers in the United States, only one percent report having had to delay a project and none having abandoned a project as a result of others’ patents, suggesting that neither anticommons nor restrictions on access were seriously limiting academic research.” Worryingly, the review noted there was evidence that secrecy was growing among academic researchers. However, patent issues do not seem to be fueling this secrecy. One study suggested that increased academic research secrecy arises chiefly from concerns about securing scientific priority (scientific competition) and the high cost and effort involved in sharing scientific materials and data.
In 2007, the American Association for the Advancement of Science (AAAS) released a report, International Intellectual Property Experiences: A Report of Four Countries, which surveyed thousands of scientists in the U.S., Germany, the U.K. and Japan to assess their experiences in acquiring, using, or creating intellectual property. The AAAS study found “very little evidence of an ‘anticommons problem.'” As Stephen Hansen, the director of the AAAS study, noted in a press release, “All four studies suggest that intellectual property rights had little negative impact on the practice of science.”
Perhaps there is newer and better evidence for a research anti-commons. I will look into it again and report back.
Daniel McCarthy at The American Conservative:
Biotech businesses and their scientists say the decision will stifle research, destroy incentives for product development, and grow government by leaving federally supported universities as the only institutions willing to undertake further genetic studies. None of this rings true. No doubt holding legal monopoly over a part of a human being is more lucrative for any firm than having to compete with other companies in developing biotechnology, but it is not necessarily best for patients. Other industries do just fine in terms of innovation, and much better in terms of cost control, without being able to patent their consumers.
I think this paragraph from the New York Times‘ story gets at the nub of the matter:
[The company] sells a test costing more than $3,000 that looks for mutations in the two genes to determine if a woman is at a high risk of getting breast cancer and ovarian cancer. Plaintiffs in the case had said Myriad’s monopoly on the test, conferred by the gene patents, kept prices high and prevented women from getting a confirmatory test from another laboratory.
Considering the amounts of money at stake in the principle, we’ll be hearing much more about this in months to come.
Josh Rosenau at Science Blogs:
This does not invalidate patents on organisms with modified genes or genomes, nor does it invalidate the act of modifying a gene in order to insert it into an organism. This does not, by my reading, set up Monsanto’s genetically modified Roundup Ready crops to lose patent protection, though it may free up competitors to develop similar genes, and may give farmers an easier way to protect themselves against a claim when Monsanto asserts patent violations because of crosspollination.
The court was asked to consider the chilling effect on research produced by patents for naturally occurring genes. Fortunately, the decision seems to have avoided that line of argument, as it opens a massive can of worms. In general, I’m inclined to oppose patents and copyright laws that restrict research, artistic development, medical care, or other humanitarian services. On the other hand, I don’t think that’s a call judges ought to be making. I’d rather see the laws themselves fixed when such chilling effects are seen. This judge’s ruling fired a shot across the bow of lawmakers about the abuses of genetic patents, and one hopes lawmakers will listen.
Given the sweeping victory on a summary judgment motion, the ACLU is understandably elated. “We are extremely gratified by this groundbreaking decision,” said Sandra Park, staff attorney with the ACLU Women’s Rights Project. “This is the beginning of the end to patents that restrict women’s access to their own genetic information and interfere with their medical care.” We can hope so. The appeals are inevitable, and are headed toward a notably pro-corporate and anti-woman Supreme Court, so there’s no guarantee that this ruling will hold up, but it’s a good first step.
As John Ball, executive vice president of the American Society for Clinical Pathology put it: “It’s good for patients and patient care, it’s good for science and scientists. It really opens up things.”
Katherine Harmon at Scientific American
Ashby Jones at WSJ Law Blog:
Peter Meldrum, Myriad’s chief executive, said the company will appeal. “I don’t believe that the final outcome of this litigation will have a material impact on Myriad’s operations,” he said. “We have 23 patents relating to BRCA genes, and this litigation only involves seven of those 23 patents.