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As public and private sector initiatives raced to complete the sequence of the human genome, patent issues played a prominent role in speculations about the significance of this achievement. How much of the genome would be subject to the control of patent holders, and what would this mean for future research and the development of products for the improvement of human health in a patent system developed to establish rights in mechanical inventions of an earlier era up to the task of resolving competing claim, to the genome on behalf or the many sequential innovators who elucidate its sequence and function, with due regard to the interests of the scientific community and the broader public?

Given that applicants have been seeking and obtaining patent claims on DNA sequences for 20 years, one might expect that the U.S. Patent and Trademark Office (PTO) and the courts would have resolved many of the legal issues surrounding this practice. The patent system has had many opportunities to apply traditional patent law principles to a broad range of issues involving genetic discoveries as the industry has pursued and litigated patent claims covering biotechnology products. One might therefore expect that biotechnology patent law would now be entering a relatively mature phase in which fundamental questions have been resolved and the issues that remain to be addressed are incremental and interstitial. Instead, the patent system is struggling to clarify the ground rules for patenting DNA sequences, while years' worth of patent applications accumulate in the PTO. What accounts for this persistent lack of clarity about how patent law applies to these discoveries?

A significant part of the problem is that new technologies are rapidly changing how discoveries are made in genetics and genomics research. The patent system, which inevitably requires years to resolve even routine matters, has so far focused primarily on the discoveries of the 1980s. DNA sequences that were the subject of patent claims in that era typically consisted of cloned genes that enabled the production of proteins through recombinant DNA technology. Patents on the genes encoding these proteins promised exclusivity in the market for the protein itself, equivalent to the protection that a pharmaceutical firm obtains by patenting a new chemical compound that can be used as a drug. From this perspective, patents on DNA sequences seemed analogous to patents on new chemical entities. The Court of Appeals for the Federal Circuit (Federal Circuit) accordingly turned to prior cases considering patents on chemicals in resolving disputed issues about how patent law should apply to DNA sequences. Whatever the limitations of this analogy, it provided a relatively clear point of departure for analyzing patent law issues presented by the first generation of biotechnology products - therapeutic proteins produced through recombinant DNA technology.

As DNA sequence discovery has moved beyond targeted efforts to clone particular genes to large-scale, high-throughput sequencing of entire genomes, new questions have come into view. The DNA sequences identified by high-throughput sequencing look less like new chemical entities than they do like new scientific information. From the perspective of patent claimants, the chemical analogy is of little value as a strategic guide to exploiting this information as intellectual property. From the perspective of the PTO and the courts, claims to these discoveries raise unresolved questions that strain the chemical analogy. The result is profound uncertainty concerning how to apply the doctrinal tools of patent law for determining what may be patented and for drawing boundaries between the rights of inventors and the rights of the public.


Reprinted from The Commodification of Information, 2002, 415-31, with permission of Kluwer Law International.