Essays on Science and SocietyGenome-Sequencing Anniversary

Gene Patents: The Shadow of Uncertainty

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Science  18 Feb 2011:
Vol. 331, Issue 6019, pp. 873-874
DOI: 10.1126/science.1203458

Twenty-two years ago, the Congressional Office of Technology Assessment released a report about policy options for federal support in scaling up genome research. It contained the misleading statement, “genome projects raise no new questions of patent or copyright law.” I wrote that sentence and have spent the past decade studying how wrong it was.

The general parameters of intellectual property law do indeed cover all technologies, not just genomics. Patent law applies to new technologies in distinctive ways, however, and using and interpreting it differs markedly among fields. Genomics has served up more than its share of controversy.

The year 2010 was tumultuous in the world of gene patents. In February, the Secretary's Advisory Committee on Genetics, Health, and Society approved a report that recommended exemptions from patent infringement liability for research and for diagnostic use. On 29 March, Judge Robert Sweet of the federal district court for southern New York turned gene patents on their heads by ruling that contested claims over BRCA1 and BRCA2 genes were invalid. Most of the ruling argued that DNA molecules cannot be patented because they are embodiments of information and products of nature, and another section argued that the methods claims did not pass muster. That ruling is being appealed, and the final resolution may not be for several more years. In December, the Court of Appeals for the Federal Circuit reaffirmed the patentability of a diagnostic method.

The stakes are high, because present uncertainty over the existence and extent of patent rights casts a shadow over those making decisions about clinical and other applications of gene patents. Promising new methods for full-genome analysis might or might not face patent infringement liability. Some assert that patent rights have hindered research, although evidence of such harm is not compelling, but the evidence that patent rights have fostered diagnostic innovation is even weaker. Many laboratories have gotten genetic tests to market without patent rights. Those with exclusive rights have rarely, if ever, been first to market. Companies that became sole U.S. providers did so by clearing the market of competitors. This is not unique to gene patents, but it creates intense controversy. Patent rights could, however, prove crucial to product development if payers demand evidence of clinical utility or if the U.S. Food and Drug Administration begins to regulate genetic tests, because developing such tests would suddenly become more costly and time-consuming, and a patent incentive could help induce private investment.

In 2011, we may finally begin to develop case law on how patent law will apply to DNA technologies beyond protein therapeutics. The debate over establishing a human genome project included disagreement over patent policy; that disagreement continues, but the effects of uncertainty are moving from equivocal and probably weak effects on research to actual impact on private investment decisions that will affect what genomic technologies get developed in the real world. Reducing the uncertainty surrounding diagnostic uses of gene patents is important.

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