In Association for Molecular Pathology v. Myriad Genetics, the court ruled that “a naturally occurring segment” of DNA — genetic material that has been isolated from human chromosomes — cannot be patented because it is simply a product of nature. For policy wonks, the case was a David-and-Goliath fight, one of the most important patent cases in a decade, with an outcome sure to affect the
$100 billion biotechnology industry, no matter how it was decided.
But while the Supreme Court’s ruling has been welcomed enthusiastically by many, the Myriad case has been only a modest victory for the advocates of genetic-data sharing. Indeed, none of the underlying tensions have truly been resolved: we still need to find a way for the biotech industry to keep a competitive advantage without endangering the welfare of patients and slowing medication innovation.
In reality, gene patents were only one part of the problem. A more vexing, and still pressing, issue is how companies withhold genetic data as a trade secret.
The company at the heart of the case, Myriad Genetics, was awarded two patents in the late 1990s for the human genes BRCA1 and BRCA2 and offered an exclusive test to detect inherited mutations in them; certain variations in a copy of either one can markedly increase a person’s risk of developing breast and ovarian cancers.
Since then, nearly one million patients have taken the Myriad test and have had their genetic data compiled in the company’s
proprietary database. That, in turn, has helped provide the company with an
extraordinary informational advantage when it comes to interpreting patients’ test results. While Myriad has published some research based on its findings and says it plans “to progressively release” more, for the most part it has designated its trove of patient data as confidential business information: a
trade secret.
Myriad was able to isolate the BRCA genes in the first place largely because it had access to government-financed public databases. But fairness aside, there are significant public health consequences when any one company gets to wall off such important human biological data from its competitors and, ultimately, from the public.
That information, stripped of any patient-identifying data, could be a boon to
cancerresearchers as they try to design optimal treatments for breast and
ovarian cancerpatients, based on the individual genetic “signatures” of their tumors. Such a trove could help scientists better understand the cancer process itself. It seems crazy to keep that potentially lifesaving knowledge away from the broad cancer research community.
Even before last week’s Supreme Court decision, the importance of gene-related trade secrets, compared with that of outright patents, was clear. Myriad had already announced that it would begin, this fall, to replace its BRCA test with one that examines multiple genes implicated in hereditary cancers — most of which were outside the scope of its gene patents before Thursday’s ruling. The new test, likewise, is expected to use complex proprietary algorithms, developed from its prodigious patient data, and therefore be largely protected from competition.
If anything, the court’s decision may prompt biotech companies to rely even more heavily on that strategy than they do now — an unintended consequence that could stall research in many critical areas. Those with established beachheads on a gene-related disease or condition will be able to deter competition, much as they did before last Thursday’s gene-patent ruling.
In the end, it will be patients and the public who pay.
We shouldn’t wait as long to fix this problem as the Supreme Court waited to remedy its
1980 decision that enabled the patenting of human genes until now.
As a first step, the United States Food and Drug Administration should immediately investigate the impact of trade-secret protection on innovation in personalized medical treatments. The F.D.A. could also mandate public disclosure as a condition of market approval for genetic testing. Insurers too have some leverage: they could refuse reimbursements unless clinical data is shared for interpretation. But perhaps an even more effective remedy would be for scientific researchers themselves to get genetic information out into the public domain before any one company can call it a secret.
Ad hoc efforts in this regard, including that by the
Personal Genome Project at Harvard Medical School, have already put an impressive amount of genetic and molecular information into open-access databases. But to make sure no company gets an exclusive hold on human genetic data, we need a data-disclosure effort that reaches critical mass.
On June 5, a consortium of 69 organizations in 13 countries made a great stride toward this end, agreeing to facilitate the sharing of DNA sequences and clinical information. But the effort still needs financing for researchers to work together on technical standards for sharing and interpreting genetic data. An annual public investment of just $1 million would be a start. Research funders like the National Institutes of Health could induce more institutions to join by asking grantees to abide by standards set by the consortium. This would help keep open-access efforts viable and help make sure no one company is able to keep an essential diagnostic test or treatment out of the public’s reach.
Eleonore Pauwels is a researcher with the Science and Technology Innovation Program at the Woodrow Wilson International Center for Scholars
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source: nytimes.com
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