In its long-awaited landmark decision in the case of Association
for Molecular Pathology v. Myriad Genetics Inc., the U.S.
Supreme Court has unanimously held that naturally occurring DNA
sequences are products of nature and not patent eligible merely
because they have been isolated. However, the Court also found that
artificially created DNA sequences, such as cDNA, are eligible for
patent protection because they do not occur naturally.
The decision represents a compromise position that was proposed
during oral arguments in April 2013 by the Department of Justice
Solicitor General, Donald Verrilli, Jr. and effectively takes the
U.S. out of line with the current laws in relation to gene patents
that currently exist in Europe and Australia.
The Court ruled that five of Myriad's claims covering
isolated genomic DNA are invalid. In response to the ruling, Myriad
remained optimistic by issuing a statement indicating that it holds
more than "500 valid and enforceable claims in 24 different
patents conferring strong patent protection for its BRACAnalysis
test." Investors appeared to be convinced by Myriad's
statement as, following the decision, Myriad shares were up by
In the decision, the Court noted "Myriad's principal
contribution was uncovering the precise location and genetic
sequence of the BRCA1 and BRCA2 genes."
Although this was an important contribution, "Myriad did not
create or alter either the genetic information encoded in the BCRA1
and BCRA2 genes or the genetic structure of the DNA."
The Court also indicated that Myriad's claims were not
"saved by the fact that isolating DNA from the human genome
severs chemical bonds and thereby creates a non-naturally occurring
molecule." Interestingly, the Court suggested that the
relevant Myriad claims might have been deemed to be valid if they
claimed the DNA in terms of chemical structure rather than in terms
of the genetic sequence. This perhaps provides a hint as to how
valid gene claims may be drafted in the future.
Predictably, parties opposed to gene patents were pleased with
the decision. Breast Cancer Action, a non-profit advocacy group,
described the decision as a "tremendous win for women's
health — and for all our health!". Opinions such as
these simply fail to consider and understand the financial
investment that is required to bring life-saving diagnostic tests,
such as the BRCA tests, to the market and for which patent
protection plays a substantial role. This was clearly emphasized in
one of the findings of a recent report into the economics of
isolated human gene patents in Australia. Specifically, it was
found that patents play a key role in promoting innovation and the
public-private partnerships required to bring new gene-based
medicines and diagnostics to market. For further information, refer
to the article at the following link:
A potential ramification that was not considered in the Supreme
Court decision is that any product of nature in an isolated form
may no longer represent patentable subject matter in the U.S. This
would include isolated proteins that may be found in nature and
that have a commercial use, such as antibodies.
The Court did not rule on any method claims and a number of
commentators have indicated that methods of using genes would
likely still be held patentable. However, such "use
claims" would have to meet the patentability requirements set
down in the US Supreme Court decision in Mayo Collaborative
Services v. Prometheus Laboratories, Inc. (2012). In the
Prometheus decision, it was controversially held by the Supreme
Court that a "relationship" between the concentrations of
blood metabolites and response to a therapeutic drug, claimed in
patents owned by Prometheus Laboratories Inc., was not patentable
because it represented a "principle of nature". Such a
"relationship" most likely would also encompass an
invention involving the identification of a gene mutation(s) that
renders an individual susceptible to developing a disease. If so, a
claim directed to the use of a mutation in genomic DNA to determine
the susceptibility of developing a disease may not be
At this early stage, the Myriad decision may not be the
"game-changer" for the US biotechnology sector that it
could have been. However, it is clear that patents in the life
sciences area will need to be drafted very carefully to ensure they
meet the new US patentability threshold requirements.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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