WASHINGTON, D.C. - (Mealey's) In a unanimous ruling June 13, the U.S. Supreme Court found that although complementary DNA, or "cDNA," is patent-eligible, isolated DNA is not (The Association for Molecular Pathology, et al. v. Myriad Genetics Inc., No. 12-398, U.S. Sup.). (lexis.com subscribers may access Supreme Court briefs and the opinion for this case).
The narrowly-tailored opinion authored by Justice Clarence Thomas partly reverses a July 2011 Federal Circuit U.S. Court of Appeals ruling in favor of respondent Myriad Genetics Inc., owner of several patents for diagnostic tests relating to mutations along the BRCA1 and BRCA2 genes.
"It is important to note what is not implicated by this decision," the court wrote.
"First, there are no method claims before this Court . . . . . Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. . . . We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material," the court added.
BRCA1 and BRCA2 are two genes responsible for most cases of hereditary *** and ovarian cancer. Myriad has sued to stop competitors from offering genetic testing for the two genes and has sent numerous cease-and-desist letters to laboratories, universities and others. In 2009, several medical organizations and individuals - including lead petitioner the Association for Molecular Pathology, along with six patients diagnosed with or at risk of hereditary *** or ovarian cancer - filed a complaint in the U.S. District Court for the Southern District of New York against the U.S. Patent and Trademark Office (PTO), Myriad and the directors of the University of Utah Research Foundation.The petitioners alleged that 15 claims from seven Myriad patents are invalid under Section 101 of the Patent Act because they cover products of nature, laws of nature and abstract ideas. They also alleged that the effect of the challenged patents is to preempt scientific inquiry and medical care to the detriment of patients' health and scientific advancement, in violation of both Article I, Section 8, clause 8, of the U.S. Constitution and the First Amendment. The petitioners and Myriad subsequently cross-moved for summary judgment, and the petitioners prevailed.In granting the plaintiffs summary judgment, the court construed the term "isolated DNA" as "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." Accordingly, the court characterized the genes at issue as "products of nature" and deemed the patents invalid pursuant to Gottschalk v. Benson (409 U.S. 63, 67 ) [an enhanced version of this opinion is available to lexis.com subscribers], Diamond v. Chakrabarty (447 U.S. at 309 ) [enhanced version] and other cases. Myriad appealed to the Federal Circuit U.S. Court of Appeals, which in a divided July 2011 opinion, reversed, finding that the isolated DNA molecules as claimed do not exist in nature and are thus subject to patent protection. The Federal Circuit further found that the composition claims for the patents at issue that are limited to "complementary DNA," or cDNA, are patent eligible because cDNA is a synthesized genetic material that does not occur in nature but rather is the product of considerable human creativity.
The plaintiffs filed a petition for writ of certiorari with the Supreme Court, which granted the petition for the limited purpose of vacating and remanding in light of its ruling in Mayo Collaborative Services v. Prometheus Laboratories Inc. (No. 10-1150, U.S. Sup.) [enhanced version]. In another divided ruling, the Federal Circuit in August 2012 again reversed the District Court's ruling, reaffirming its earlier ruling upholding the challenged composition claims and one of the method claims. The Federal Circuit also found that isolated DNA molecules "are not found in nature" and are instead "obtained in the laboratory and are man-made, the product of human ingenuity."The plaintiffs submitted a second petition for writ of certiorari to the high court, presenting three questions. On Nov. 30, the Supreme Court granted certiorari, limited to the first question presented: "Are human genes patentable?" Oral arguments were held April 15.
Siding with the petitioners with regard to isolated DNA, the Supreme Court noted that the "location and order of the nucleotides existed in nature before Myriad found them." Furthermore, the respondent did not "create or alter" the genetic structure of native DNA. Uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13 is insufficient to render the genes patentable as new compositions of matter, according to the Supreme Court. Distinguishing the instant dispute from Chakrabarty, the court wrote "Myriad did not create anything."
"To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry," it added.
The Supreme Court was similarly unmoved by Myriad's claim at oral argument that by isolating DNA from the human genome, chemical bonds are severed and a non-naturally occurring molecule results. The respondent's argument is "simply not expressed in terms of chemical composition," nor does Myriad "rely in any way on the chemical changes that result from the isolation of a particular section of DNA" according to the ruling.
"Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad's patent claims on entire genes . . .by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule 'invented' by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule," the Supreme Court concluded.
Myriad prevailed with regard to cDNA, however, with the Supreme Court affirming the Federal Circuit's finding that creation of a cDNA sequence from messenger RNA results in an exons-only molecule that is not naturally occurring. To that end, the Supreme Court rejected the petitioners' contention that the nucleotide sequence of cDNA is dictated by nature, and not a lab technician. "That may be so," the court wrote, "but the lab technician unquestionably creates something new when cDNA is made."
"cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a 'product of nature' and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA," the Supreme Court added.
The petitioners are represented by Christopher A. Hansen, Steven R. Shapiro, Sandra S. Park, Aden J. Fine and Lenora M. Lapidus of American Civil Liberties Union Foundation in New York and Daniel B. Ravicher and Sabrina Y. Hassan of Public Patent Foundation, Benjamin N. Cardozo School of Law in New York.The respondents are represented by Gregory A. Castanias and Jennifer L. Swize of Jones Day in Washington; Brian M. Poissant and Laura A. Coruzzi of Jones Day in New York; Israel Sasha Mayergoyz and Dennis Murashko of Jones Day in Chicago; and Richard M. Marsh, Benjamin G. Jackson and Matthew S. Gordon of Myriad in Salt Lake City.The United States is represented by Solicitor General Donald Verilli Jr. and Stuart F. Delery, Malcolm L. Stewart, Beth S. Brinkmann, Ginger D. Anders, Scott R. McIntosh, Mark R. Freeman and Melissa N. Patterson of the Department of Justice in Washington.
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