A decision is expected later this month from the U.S. Supreme
Court in the case of Association for Molecular Pathology v.
Myriad Genetics Inc., which is considering the patentability
of isolated human genes claimed in patents held by Myriad Genetics,
Commentators present at the oral arguments, which were heard in
April 2013, have indicated that a number of the Justices expressed
scepticism that isolated genomic DNA represents patentable subject
matter. Thus, it seems unlikely that the Supreme Court will deliver
a decision favourable to Myriad that is consistent with existing US
law. However, there was some indication that the Justices were
leaning towards a compromise position proposed by the Department of
Justice Solicitor General, Donald Verrilli, Jr., which would permit
the patenting of artificially created nucleic acid molecules, such
One potential issue with the proposed "compromise
position", is that by excluding isolated genomic DNA from
patent protection it will conceivably render protection of
inventions directed to genetic diagnostic tests very difficult in
view of the earlier 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 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 would not be
The decision that is finally reached by the U.S. Supreme Court
will potentially have serious ramifications in relation to the
development of life-saving, gene-related diagnostic tests and their
availability to the public. Specifically, the U.S. Biotechnology
Industry Organization (BIO) has indicated that an exclusion of
genetic material from patentability would potentially invalidate
thousands of granted U.S. patents and disturb long-standing,
investment-backed expectations of innovative businesses -
businesses that have relied on such patents to pursue real-world
solutions for life-threatening diseases.
All eyes will be on the U.S. Supreme Court this month to see
whether their decision will be a "game changer" for the
U.S. biotechnology sector and take the U.S. out of line with the
current laws in relation to gene patents that currently exist in
Europe and Australia.
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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