Supreme Court Limits Patentability of Human Gene Sequences
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![PattonBoggs.com Intellectual Property Client Alert 1
JUNE 13, 2013
This Alert provides only general
information and should not be
relied upon as legal advice. This
Alert may be considered attorney
advertising under court and bar
rules in certain jurisdictions.
For more information, contact your
Patton Boggs LLP attorney or the
authors listed below.
SCOTT CHAMBERS, PH.D.
schambers@pattonboggs.com
KEVIN BELL
kbell@pattonboggs.com
RICHARD OPARIL
roparil@pattonboggs.com
MATTHEW LASKOSKI
mlaskoski@pattonboggs.com
ABU DHABI
ANCHORAGE
DALLAS
DENVER
DOHA
DUBAI
NEW JERSEY
NEW YORK
RIYADH
WASHINGTON DC
INTELLECTUAL PROPERTY CLIENT ALERT
SUPREME COURT LIMITS PATENTABILITY OF
HUMAN GENE SEQUENCES
The Supreme Court today issued a decision in Association for Molecular Pathology v.
Myriad Genetics, which reduced the ability to patent human gene sequences.
In a departure from established Federal Circuit law, the Supreme Court determined
that isolated gene sequences found in nature are natural phenomena and not patent
eligible. Myriad’s patents covered gene sequences removed from a cell, referenced by
Myriad as isolated DNA. The gene sequences are identical to those found in the body
except that they are isolated from the remainder of the strand of DNA. The Supreme
Court found that these isolated gene sequences are a “product of nature and not
patent eligible merely because it has been isolated.” The Court found that “Myriad
did not create or alter either the genetic information encoded in the [isolated] genes or
the genetic structure of the DNA.” In particular, Justice Thomas, writing for the
Court stated “[t]he claims are not expressed in terms of chemical composition, nor do
they rely on the chemical changes resulting from the isolation of a particular DNA
section. Instead, they focus on the genetic information encoded in the [isolated]
genes.”
The Supreme Court did, however, specifically hold that complementary DNA
(“cDNA”) was patentable because it is not found in nature and something new is
created when portions of the DNA are removed to make the end product.
The Court was explicit in noting that this decision did not cover “method claims,
patents on new applications of knowledge about the [isolated] genes, or the
patentability of DNA in which the order of the naturally occurring nucleotides has
been altered.”
Patent owners with issued patents related to gene sequences and patent applications
with currently pending or unfiled applications should carefully review their portfolios
to determine how this decision will affect the value and enforceability of their
applications, and determine if there are strategies to create value around this decision.
A copy of the decision may be found here.](https://image.slidesharecdn.com/ipclientalertsupremecourtlimitspatentabilityofhumangenesequences061313-130619134423-phpapp02/85/Supreme-Court-Limits-Patentability-of-Human-Gene-Sequences-1-320.jpg)
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Supreme Court Limits Patentability of Human Gene Sequences
- 1. PattonBoggs.com Intellectual Property Client Alert 1 JUNE 13, 2013 This Alert provides only general information and should not be relied upon as legal advice. This Alert may be considered attorney advertising under court and bar rules in certain jurisdictions. For more information, contact your Patton Boggs LLP attorney or the authors listed below. SCOTT CHAMBERS, PH.D. schambers@pattonboggs.com KEVIN BELL kbell@pattonboggs.com RICHARD OPARIL roparil@pattonboggs.com MATTHEW LASKOSKI mlaskoski@pattonboggs.com ABU DHABI ANCHORAGE DALLAS DENVER DOHA DUBAI NEW JERSEY NEW YORK RIYADH WASHINGTON DC INTELLECTUAL PROPERTY CLIENT ALERT SUPREME COURT LIMITS PATENTABILITY OF HUMAN GENE SEQUENCES The Supreme Court today issued a decision in Association for Molecular Pathology v. Myriad Genetics, which reduced the ability to patent human gene sequences. In a departure from established Federal Circuit law, the Supreme Court determined that isolated gene sequences found in nature are natural phenomena and not patent eligible. Myriad’s patents covered gene sequences removed from a cell, referenced by Myriad as isolated DNA. The gene sequences are identical to those found in the body except that they are isolated from the remainder of the strand of DNA. The Supreme Court found that these isolated gene sequences are a “product of nature and not patent eligible merely because it has been isolated.” The Court found that “Myriad did not create or alter either the genetic information encoded in the [isolated] genes or the genetic structure of the DNA.” In particular, Justice Thomas, writing for the Court stated “[t]he claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Instead, they focus on the genetic information encoded in the [isolated] genes.” The Supreme Court did, however, specifically hold that complementary DNA (“cDNA”) was patentable because it is not found in nature and something new is created when portions of the DNA are removed to make the end product. The Court was explicit in noting that this decision did not cover “method claims, patents on new applications of knowledge about the [isolated] genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.” Patent owners with issued patents related to gene sequences and patent applications with currently pending or unfiled applications should carefully review their portfolios to determine how this decision will affect the value and enforceability of their applications, and determine if there are strategies to create value around this decision. A copy of the decision may be found here.