The Supreme Court Identifies Categories of Patent-Eligible and Patent-Ineligible DNA Sequences

Supreme Court Myriad decision that naturally occurring DNA is a product of nature not patent eligible impacts biotech and genetic medicine.

August 09, 2013

Perhaps no other Supreme Court case involving patent law has attracted as much public attention as Association for Molecular Pathology v. Myriad Genetics Inc1. In a June 13, 2013, opinion authored by Justice Clarence Thomas, the Court unanimously held that

a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA2 is patent eligible because it is not naturally occurring.3


This seemingly straightforward bright-line rule establishes that, contrary to the past practices of the U.S. Patent and Trademark Office (‘‘USPTO’’), a gene is not a ‘‘chemical compound, albeit a complex one.’’4 Instead, DNA is identified primarily by its sequence, and after Myriad, those DNA sequences that occur in nature may not enjoy patent protection.

1. 133 S.Ct. 2107 (2013).
2. ‘‘cDNA’’ stands for complementary DNA, which the Court characterized as ‘‘synthetic DNA created from mRNA’’ containing only exon sequences of genes. Op. at 3; see id. at 2-3 (presenting an overview of genes, DNA transcription to create messenger RNA (‘‘mRNA’’), and mRNA’s translation to create proteins).
3. Slip Op. at 1.
4. Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1206 (Fed. Cir. 1991).


Reproduced with permission from Life Sciences Law & Industry Report, 7 LSLR 842, 08/09/2013. Copyright 2013 by The Bureau of National Affairs, Inc. (800-372-1033)

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Matthew McFarlane

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