On the Road to the Supreme Court
The ACLU filed suit in the US District Court for the Southern District of New York (SDNY) in May 2009 asking the court
to invalidate Myriad's patents for failing to satisfy 35 U.S.C. § 101. The ACLU also challenged the diagnostic method claims
but these were not appealed to the Supreme Court (8). The ACLU also argued that the USPTO's policy of granting patents on
isolated human genes violated the First Amendment of the US Constitution.
Myriad sought to dismiss the suit, arguing that the patent claims were valid because the difference in the structural and
functional properties of isolated DNA rendered its claims patent-eligible. Additionally, the USPTO had been granting similar
patents on this technology for decades, and the biotechnology industry had relied on patents to support research and investment.
The ACLU prevailed (9). Judge Sweet of the SDNY held that Myriad's challenged patent claims were invalid. Judge Sweet opined
that DNA represents the physical embodiment of biological information and that Myriad's focus on the chemical nature of DNA
failed to acknowledge the unique characteristics of DNA that differentiate it from other chemical compounds. Judge Sweet concluded
that the preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that
the challenged composition of matter claims are directed to unpatentable products of nature (9).
Myriad appealed to the US Court of Appeals for the Federal Circuit, where the judges twice reversed Judge Sweet's ruling.
The first appeal was returned to the district court after the Supreme Court granted ACLU's petition for certiorari, vacated
the Federal Circuit's prior decision, and remanded the case to the Federal Circuit for further consideration in light of its
decision in Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. __, 132 S.Ct. 1289 (2012) (10).
A three-judge panel, led by Judge Lourie, held that all claims were valid but the opinions of the other judges on the panel
varied with the claims. Judge Lourie opined that all appealed claims were patentable and Judge Moore agreed, but on different
grounds. Judge Lourie reasoned that: "[t]he isolated DNA molecules before us are not found in nature. They are obtained in
the laboratory and man-made, the product of human ingenuity. While they are prepared from products of nature, so is every
other composition of matter. All new chemical or biological molecules, whether made by synthesis or decompositions, are made
from natural materials" (11). Judge Lourie also cautioned that Congress, not the courts have the appropriate mandate to categorically
exclude subject matter such as isolated genes from patenting. Congress, he noted, was aware of the controversial issue when
it recently enacted the comprehensive patent reform act, and it is ultimately for Congress to act if it wishes to overturn
case law and the long practice of the USPTO to determine that isolated DNA must be treated differently from other compositions
Judge Bryson opined that only the synthetic man-made "cDNA genes" were patent-eligible and agreed with Judge Sweet that claims
to isolated naturally occurring genes and fragments are invalid. The ACLU appealed to the Supreme Court.