Is an isolated gene a product of human ingenuity or a natural
occurrence? That distinction will decide whether Myriad
Genetics' patents on isolated breast cancer genes are upheld or
bounced as ineligible when the Federal Circuit Court of Appeals reconsiders the IP next month, in light of the U.S. Supreme
Court's ruling in Mayo v. Prometheus Laboratories.
In March, the Supreme Court vacated the Federal Circuit's
endorsement of Myriad's patents and instructed the same
three-judge appellate panel that first considered the case to
hear it again, this time with the direction the Supreme Court
offered in Mayo, in which it raised the bar for patent eligibility for naturally occurring phenomena. On Friday Myriad
and the parties challenging its IP, the American Civil Liberties
Union and the Public Patent Foundation, filed new briefs at the
Federal Court, outlining how they believe Mayo should alter the
panel's analysis of the breast cancer genes. A raft of amici,
led by the Justice Department, also registered their positions
on the question, which will have a potentially enormous impact
on the pharmaceutical and biotech industries.
For Myriad and its lawyers at Jones Day, there's an easy
answer: Hold the Mayo. (Sorry, couldn't resist.) Myriad's supplemental brief asserts that the Supreme Court ruling
addressed a method patent -- specifically, a patent on a
diagnostic test based on a metabolic process. Myriad's IP is, by
contrast, compositional. It protects a physical thing, an
isolated strand of DNA, not a process. According to Myriad's
brief, that's a crucial distinction, since the tests of
eligibility for the two kinds of patents are not the same.
Compositional patents, in Myriad's view, must have a name,
character and use that's distinct from anything found in nature.
They must also be the product of human invention. Myriad argued
that the Federal Circuit has already weighed whether its breast
cancer patents meet those criteria and has found that they do.
"Mayo sheds no new light on the patent eligibility of the
isolated DNA claims, and thus should not alter the court's prior
judgment that those claims are the patent-eligible work of human
inventors," the brief said. To drive home the potency of
composition patents to the Federal Circuit, Myriad noted that no
product patent has been ruled ineligible by an appeals court
"This is not a patent on organic genes," said Gregory
Castanias of Jones Day, who will argue for Myriad at the Federal
Circuit on July 20. "We're talking about an entirely different
molecule." Myriad isolated a gene that would otherwise not be
found on its own in nature and brought new diagnostic utility to
its invention, Castanias said. "The panel has already ruled that
isolated DNA molecule claims are the product of human invention"
and thus eligible for patents, he told me.
You will not be surprised to hear that Christopher Hansen of
the ACLU disagrees. "I don't think anyone can seriously argue
that Mayo didn't strengthen our position," he said. In their
brief, the ACLU and PubPat outlined three Mayo-based arguments
against the patent eligibility of isolated human genes. First,
patents on genes pre-empt the use of unpatentable products of
nature. According to the ACLU's interpretation, Mayo holds that
a patented invention may not preclude more future invention than
it reasonably justifies, and "it is clear that patents on
'isolated' DNA ... impermissibly foreclose future scientific
work and innovation."
The brief also asserts that, under Mayo, Myriad's isolated
human gene is not sufficiently different from naturally
occurring DNA to be patent-eligible and that the Federal Circuit
should not defer to the policies of the U.S. Patent and
Trademark Office, which has been granting patents on genes for
many years. "Isolation of DNA was a well-known technique at the
time these patents were sought, and continues to be a routine,
conventional preparatory step for using human genes in research
and clinical practice," the ACLU brief said. "Isolating DNA
merely makes visible a person's inherited genetic makeup." (For
good measure, the brief mentions that isolated breast cancer
genes are actually found in the human body during the process of
Hansen pointed out that the Federal Circuit panel that
reinstated Myriad's patents after they were ruled invalid by a
U.S. district judge in Manhattan was sharply divided. One
appellate judge said the patents were invalid, and the two who
sided with Myriad offered different explanations. To prevail in
the reconsideration, the ACLU and PubPat only have to change the
mind of one of them.
More than a dozen amicus briefs have already been logged,
but both sides told me they haven't done a final survey of who's
supporting whom. Of particular note is the Justice Department's brief, which purports to be in support of neither side but
actually agrees with the ACLU and PubPat that isolated genes
should not be patentable.
"Patent protection is not available to those who simply
discover existing aspects of nature, even if the discovery
requires arduous work, represents keen scientific insight, and
is of great value to society," the brief said. "Mayo underscores
this fundamental limitation on patent protection." As in the
earlier round at the Federal Circuit, both sides asked for the
Justice Department's support, and the DOJ sided with Myriad's
foes. Once again, the PTO did not sign the brief.
(Reporting by Alison Frankel)
Follow us on Twitter @AlisonFrankel, @ReutersLegal | Like us on Facebook