In a 156 page opinion issued on March 29, 2010, Judge Robert W.
Sweet of the U.S. District Court for the Southern District of New
York declared that certain claims to isolated DNA sequences in
patents licensed to Myriad Genetics are invalid because they cover
unpatentable subject matter (Ass'n for Molecular Pathology
v. United States Patent and Trademark Office, No. 09-4515,
slip op. (S.D.N.Y. March 29, 2010). An appeal to the Federal
Circuit is expected.
The lawsuit was brought by the American Civil Liberties Union and
others, including the Public Patent Foundation, medical doctors,
researchers, and patients, against Myriad Genetics, the University
of Utah Research Foundation, and the United States Patent and
Trademark Office. The complaint attacked Myriad's patent claims
to methods of analyzing gene sequences as well as claims to the
gene sequences themselves, alleging that such claims violate
established legal principles that prohibit the patenting of laws of
nature, products of nature, or abstract ideas.
Myriad's patents relate to BRCA1 and BRCA2, two genes that were
discovered by researchers to be associated with breast and ovarian
cancer. The researchers apparently found that short segments of
those genes could be prepared and used to diagnose a woman's
risk of developing breast or ovarian cancer. The claims struck down
by the court are of essentially two types: composition claims
directed to isolated DNA sequences coding for BRCA polypeptides,
and method claims directed to analyzing or comparing BRCA gene
sequences in the diagnosis of a patient.
The court held that the method claims, which in general recite
simply comparing one DNA sequence to another, were invalid as
claiming an abstract idea, and thus failing to meet the machine or
transformation test under the Federal Circuit's holding in In
re Bilski, 545 F.3d 943 (Fed. Cir. 2008), a case which has been
appealed to the U.S. Supreme Court and in which an opinion is
expected soon. Of greater significance may be the district
court's potentially more far reaching holding regarding claims
directed to isolated DNA sequences. Adopting an express definition
from one of the patents, the court construed "isolated
DNA" to refer to: [A] segment of DNA nucleotides existing
separate from other cellular components normally associated with
native DNA, including proteins and other DNA sequences comprising
the remainder of the genome . . . includ[ing] both DNA originating
from a cell as well as DNA synthesized through chemical or
heterologous biological means. (Ass'n for Molecular
Pathology, slip op. at 92).
Under that construction, the court concluded that Myriad's
claims to "isolated DNA" fail to satisfy the requirements
for patentable subject matter because isolated DNA is not
"markedly different" from native DNA in a person's
body (Id. at 125). The court further expounded that the difference
between isolated DNA and corresponding native DNA "constitutes
a difference of purity that cannot serve to establish subject
matter patentability." (Id. at 131).
As is often the case with court decisions, the actual impact of
this decision likely will not be known for some time. As noted
above, an appeal to the Federal Circuit is expected, and the
Federal Circuit will decide the case without giving any deference
to the district court's opinion. An appeal to the Federal
Circuit typically requires about one year from filing before a
decision is rendered. It is also likely that, given the stakes,
whichever party loses in the Federal Circuit will ask the Supreme
Court to review the decision.
Further, like most court cases, patent cases often turn on the
specific facts, including in patent cases the particular language
of the claims at issue. As noted above, the method claims at issue
in the Myriad Genetics' case were simple comparison claims. It
may well be that a court would reach a different result for other
claims, including somewhat more complex methods. As always, patent
applicants are well-advised to consult their patent counsel about
the specific facts of their patents or applications and strategies
that may still result in meaningful patent protection.
Barnes & Thornburg LLP will continue to monitor the progress of
this important decision, and may issue subsequent alerts as
appropriate.
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.
