Download Supreme Court Invalidates Patents on DNA

Supreme Court Invalidates Patents
on DNA Markers, Beneficial to
Cattle Producers
By Gene Summerlin, Michael Annis and David Newman1
Summerlin
G
Annis
enetic testing continues to play an
increasingly important role in the
selection of animals for beef cattle
production. Recently, the United States
Supreme Court determined that the discovery
of the location of a gene on a chromosome is
not eligible for patent protection. This ruling
will significantly alter the playing field for
cattle genomics companies that seek to
patent genes in relation to tests for traits like
marbling, tenderness, or milk production.
In Association for Molecular Pathology v.
Myriad Genetics, Inc.,2 the Supreme Court
held that the location of genes and the order of
nucleotides in a gene are “products of nature”
that do not meet the Patent Act’s invention
requirement. At issue in Myriad were patents
directed to two DNA markBy holding that individuals ers that identified the
BRCA1 and BRCA2 genes
or companies cannot patent as well as the normal
sequence of nucleotides
naturally occurring genes
within those genes.
the Court insured that comWomen with certain
mutations
in these genes
petition for genetic testing
have an extraordinarily
will remain robust.
high risk of developing
breast or ovarian cancer.
Myriad’s patent claimed the exclusive right to
isolate an individual’s BRCA1 and BRCA2
genes and the sequence of the nucleotides
within those genes. As a result, no other laboratories could perform tests for mutations of
these genes because isolating the genes and
their DNA sequence in any individual would
infringe Myriad’s patent.
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Newman
The Court struck down the patent because
“Myriad did not create or alter any of the
genetic information encoded in the BRCA1
and BRCA2 genes. The location and order of
the nucleotides existed in nature before Myriad found them. Nor did Myriad create or
alter the genetic structure of DNA. Instead,
Myriad’s principal contribution was uncovering the precise location and genetic sequence
of the BRCA1 and BRCA2 genes. . . . To be
sure, [Myriad] found an important and useful
gene, but separating that gene from its surrounding genetic material is not an act of
invention. Groundbreaking, innovative, or
even brilliant discovery does not by itself
satisfy the [patent eligibility] inquiry.”
Why does this matter to beef producers?
Genomic companies in the beef industry
follow a similar strategy — finding DNA
markers that identify genes related to a
specific trait and then offering genetic tests
to determine whether an animal possesses
those genes. Whether the trait is positive
(like tenderness or marbling) or negative
(like curly calf or dwarfism), the technology
is premised on identifying the location of the
relevant gene and offering a test to determine
whether the gene is present or absent in a
given animal.
By holding that individuals or companies
cannot patent naturally occurring genes
(or their nucleotide sequence), the Court
insured that competition for genetic testing
will remain robust. While genomics companies may still protect their discoveries as
trade secrets, those companies can no longer
prohibit competitors from engaging in research to locate
the same genes and offering competing tests under the
Patent Act. As genetic technology becomes more sophisticated and a more accurate predictor of phenotypic
results, the absence of monopoly power among genomics
companies may serve to keep testing costs lower by
encouraging price competition among these providers.
On the downside, the absence of the Patent Act’s
monopoly protection may cause private companies
to think twice before devoting substantial sums to
research and development of new gene markers and
tests. Though, as with many products and services, the
ability to be the first in the market place to offer new or
particularly valuable tests may well offer sufficient financial rewards to keep the private capital flowing. Yet, even
if there is some limitation on private research, land grant
institutions and federally funded institutions like the
National Beef Cattle Evaluation Consortium and the
US Meat Animal Research Center are likely to continue
investing significant time, energy and funds into identifying DNA markers for commercially relevant traits.
Finally, and probably more importantly, the Myriad
ruling will allow genomics companies to discover and
offer tests for multiple gene pairs relevant to a given trait
without fear of incurring patent liability. Especially for
those traits that we know are governed by multiple genes
like marbling and tenderness, the impact of the Myriad
holding will be significant. Assume, for example, that
a thousand gene pairs have a statistically significant
effect on marbling. If ten genomics companies each hold
patents on one-hundred of the one-thousand relevant
genes, each company could only offer tests that represent
ten-percent of the relevant genome. Absent a producer’s
willingness to pay for ten separate tests, we would never
get a true picture of an animal’s genetic merit for marbling. For now, Myriad insures that we won’t have to
face this scenario.
While no one can predict the exact effect that the
Myriad decision will have on the beef industry, the
Supreme Court’s determination that the location of a
gene is not patentable is a positive step for producers
who seek to profit through science. ◆
1Gene Summerlin and Michael Annis are partners in Husch Blackwell
LLP’s Food and Agribusiness practice. Mr. Summerlin represents livestock producers, breed associations and related entities. Mr. Annis
represents a wide variety of food, agriculture and biotechnology companies
in intellectual property matters. Mr. Newman is an associate in the
firm’s Nebraska office.
2Ass’n. for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398,
2013 WL 2631062 (U.S. June 13, 2013)
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