On April 15, 2013, tackling an issue of significant importance
to the biotechnology and health care industries, the U.S. Supreme
Court heard oral arguments over whether human genes are patentable
and more specifically, whether isolated DNA is patentable.
The debate in the case, Association for Molecular Pathology v.
Myriad Genetics, Inc., U.S., No. 12-398, centered around
whether isolated DNA encoding BRCA1 polypeptides are unpatentable
as products of nature. The patent at issue covers the
isolated DNA molecules used for testing breast and ovarian cancer
risk, which the Association for Molecular Pathology argued are not
eligible for patents under 35 U.S.C. §101 because they are DNA
found in nature. Myriad defended the patent as claiming
isolated and extracted molecules created by the inventors as
products of "manipulation."
The Justices actively engaged in questioning around the issue of
patentability of isolated DNA, complementary DNA (cDNA), and
processes for extracting and isolating natural products. In
response to Justice Ginsberg questioning why isolated DNA should be
considered differently from other isolated natural products, the
Association argued that manipulation of a product of nature
requires alteration to a product that is no longer what it was in
nature. The Association emphasized that the isolated DNA are
naturally-occurring sequences.
Justice Sotomayor and Chief Justice Roberts characterized the
invention as merely "snipping" pieces from naturally
occurring material (genetic sequence). Justice Sotomayor
questioned how one can patent a sequential numbering series (of DNA
sequences) occurring in nature. Myriad explained that the
isolated DNA was not merely "snipping" a sequence out of
a gene. Rather, it involves a transformation to a new
molecule.
The Department of Justice presented a position that isolated DNA
should not be eligible for patenting, but the cDNA would be
patentable subject matter. Justice Alito noted that this new
position from the government is contrary to the U.S. Patent and
Trademark Office's long-standing practice of granting patents
to isolated DNA.
While questioning appropriate limits for the expansive view of
patentable subject matter, Justice Ginsburg and Chief Justice
Roberts noted that patentability is further assessed by review for
obviousness. Chief Justice Roberts wondered whether
patentability of DNA should be addressed under the rubric for
obviousness rather than patent-eligible subject matter.
A few justices noted the incentives of patents for innovation, and
the negative impact if patentability is restricted at the broadest
level under § 101. Justices Kagan, Scalia, Kennedy,
Alito and Sotomayer each questioned the result of limiting patent
protection for products isolated from nature, but they offered that
"process" patents (process of extracting a product of
nature) and "use" patents (new use for the isolated
product) would be alternatives.
The Court of Appeals for the Federal Circuit twice ruled that the
claims in Myriad's patent are eligible for patent
protection. By a 2-1 decision, claims to isolated DNA were
found to be patentable subject matter, and the panel unanimously
held that claims to cDNA and a method of using genes to screen for
potential cancer therapeutics are patentable. The Supreme
Court appeared to agree that cDNA claims satisfy § 101 for
patentability as sequences that do not occur in nature (conceded by
the Solicitor General). Patent eligibility for the extraction
and isolation process was undisputed. Overall review of this
case and the debate at the hearing hints that the Court may have a
different opinion of eligibility for the isolated DNA.
This case follows a few recent high-profile decisions in which the
Court struck down patents as claiming ineligible laws of nature or
abstract ideas. Decisions in Mayo Collaborative Services
v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), and
Bilski v. Kappos, 130 S. Ct. 3218 (2010), are indications
of the Court's willingness to limit the broad view of
patentable subject matter. Further clarification of
ineligible "products of nature" is expected in this
case.
With the validity of thousands of patents previously issued to
genes and isolated DNA molecules potentially at risk, many others
join the biotechnology industry to await the Court's
decision. We expect an opinion in June.
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