Are Human Genes Patentable?
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Are Human Genes Patentable? Dan L. Burk
Published online: 20 September 2013 Ó Max Planck Institute for Intellectual Property and Competition Law, Munich 2013
On June 13, 2013 the United States Supreme Court delivered its long-anticipated opinion in Association for Molecular Pathology v. Myriad,1 a decision addressing the question posed by the Court to the parties, ‘‘Are human genes patentable?’’2 As has already been widely reported in the popular press, in a relatively short and essentially unanimous opinion authored by Justice Thomas, the Court held DNA sequences extracted from human cells to constitute products of nature, outside patentable subject matter. But what has been less widely reported is the simultaneous holding that other human gene sequences, entailing equivalent information, remain within patentable subject matter. The reasoning behind this distinction is puzzling and contradictory, and leaves the law in this area far more confused and uncertain than before the Court undertook its answer to the gene patenting question. Two types of claimed nucleotide sequences were at issue in the case: genomic or gDNA that was extracted and isolated from human cells, and complementary or cDNA that is produced in a laboratory procedure called reverse transcription, using messenger RNA as a template. A three-judge panel of the intermediate Federal Circuit court of appeal had unanimously found the cDNA to be the patent eligible product of human intervention, but the Federal Circuit judges split over the patentability of the isolated gDNA molecules.3 The principal opinion, written by Judge Lourie, found the gDNA molecules to be patentable subject matter due to their chemical separation from the chromosome in which they were naturally 1
569 U.S. ___ (2013).
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133 S.Ct. 694 (2012) (granting certiorari).
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Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 689 F.3d 1303, 1329 (Fed. Cir. 2012). D. L. Burk (&) Professor of Law University of California, Irvine, 401 East Peltason Dr., Law 4800-N, Irvine, CA 92697-8000, USA e-mail: [email protected]
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situated. A concurring opinion by Judge Moore argued that they constituted patentable subject matter due to the technical uses to which an isolated molecule could be put. A dissenting opinion by Judge Bryson rejected the gDNA as patentable subject matter, arguing that the molecules were not significantly different from the sequences found in nature. These three rationales effectively constitute the familiar patentability criteria of novelty, utility, and non-obviousness. Judge Lourie believed the genomic DNA sequences to be patentable because they were new structures not previously described in the prior art; Judge Moore believed them to be patentable because they facilitated a new use; Judge Bryson believed them to unpatentable because they were not sufficiently inventive. As I have pointed out elsewhere,4 it is hardly surprising that these experienced judges resorted to filling the vacuum that is the products of nature doctrine with conte
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