by Deborah A.
Somerville and Joseph A. Coppola, Ph.D.
On April 15, the U.S. Supreme Court heard oral arguments
in Association for Molecular Pathology, et al. v. Myriad Genetics Inc., et
al., a case that addresses the question "Are human genes patentable?" At
stake are a group of patents owned by the biotechnology company Myriad Genetics
claiming isolated breast cancer genes. Myriad provides diagnostic tests given
primarily to women who seek to know if they harbor certain mutations in the
genes, which increase the likelihood of developing breast or ovarian cancer.
The patents are challenged by a group of doctors, researchers, and patients who
argue that Myriad's claims are directed to unpatentable products of nature. The
case has produced heated debate in the scientific and patent communities, leading
to the filing of numerous amicus briefs on both sides.
The Justices struggled with the problem of balancing
concerns relating to scientific freedom to experiment with natural products,
the need for economic incentives to stimulate investment, and the widespread
availability of medical care. In doing so, they often turned from the
complexities of molecular biology, with its talk of introns, exons, base pairs,
and information content, to simpler scenarios - a baseball bat carved from a
tree limb, chocolate chip cookies, or a plant plucked from the jungles of the
Amazon - seeking a way to understand by analogy the isolation of a particular
gene from the vast collection of DNA sequences that is the human genome.
The challengers to Myriad's patents viewed the chemical differences created
when the genes are isolated as being trivial, making the isolated genes
essentially the same as the natural versions. The challengers also stressed the
need for the scientific and medical communities to be free to use products of
nature, unhindered by patent worries, in order to make further discoveries and
inventions. Some Justices seemed inclined to agree, apparently taking the
position that companies like Myriad might rely on method of making or method of
use patents rather than patents directed to DNA itself. In this vein, Justice
Breyer drew out the Amazonian plant analogy, saying "Of course, if you get a
new satisfying process to extract the sap from the plant in the Amazon,
patented. Of course, if you get the sap out and you find that you can use it,
you manipulate it, you use it, you figure out a way to use it to treat cancer,
wonderful, patented. But what you can't patent is the sap itself."
Myriad contended that the chemical differences created
when the genes are isolated are enough to distinguish the claimed genes from
their natural counterparts. Myriad also argued that ingenuity was required to
merely recognize the breast cancer genes it patented and to bring them into a
form in which they are medically useful. According to Myriad, patent protection
for subject matter such as its claimed genes is necessary if companies are to
obtain a return on investments made in this area. Myriad's economic argument
seemed to resonate with some of the Justices, indicating that at least some on
the Court appreciate the role the patent system plays in furthering investment
in biotechnology. For example, at one point Justice Scalia asked the
challengers' counsel "Why would a company incur massive investment if it can't
patent?"Justice Kagan also voiced this concern. "Why shouldn't we worry that
Myriad or companies like it will just say, 'Well, you know, we're not going to
do this work anymore?'", she queried.
Also taking part in the oral argument was the Solicitor
General, presenting the views of the U.S. Government. The Government took a
middle position - isolated cDNA might be patentable, but isolated genomic DNA
is not. The Solicitor General argued that genomic DNA is not patentable because
it has essentially the same structure as DNA found in nature but cDNA is
patentable because it is artificially created and has significant structural
differences compared to the DNA found in nature, primarily a lack of introns.
One possibility for the Justices to resolve the delicate
balancing act that confronts them would be to rule, in line with the tack taken
by the U.S. Government, that cDNA is patentable but genomic DNA is not. Several
of the Justices made it clear that they are keeping this option in mind. For
example, Justice Kennedy asked Myriad's counsel whether that approach "would
give the industry sufficient protection for innovation and research." Other
possibilities discussed by the Justices included permitting claims to DNA
tagged for use as probes, in addition to novel therapeutic uses of the genes
and/or methods of isolation. Justice Roberts also questioned if the the
appropriate approach might be to rely upon the obviousness or other
requirements of patentability, rather than limiting the scope of eligible
subject matter as a threshold issue.
One can only wish the Justices well in their quest to
find a workable solution. Not just claims to DNA are at stake. Rather, many
other areas of biotechnology, and industries that touch on biotechnology, have
an interest in having the Justices get it right. Stem cell research and
development, natural products drug discovery, agricultural biotech,
personalized medicine, tissue engineering, and biofuels are just some of the
areas of scientific and commercial activity that involve natural products and
that thus could be affected by the Court's ruling. Also, as pointed out by
Myriad's counsel, the U.S. Patent and Trademark Office has issued patents with
claims to DNA for more than 30 years, creating significant reliance issues for
the biotechnology industry.
A decision in the case is expected sometime in June.
Kenyon & Kenyon LLP's team of experienced attorneys is prepared to assist
you in developing a strategic plan for your patent portfolio and your
patent-related business activities in light of the Court's ruling.
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