WASHINGTON, D.C. - (Mealey's) The U.S. Supreme Court on April 15 appeared skeptical of claims that native DNA is patentable during oral arguments in a case closely watched by the medical community and biotech industry (The Association for Molecular Pathology, et al. v. Myriad Genetics Inc., No. 12-398, U.S. Sup.) [lexis.com subscribers may access the briefs in this case].
(Transcript available. Document #16-130506-001T.)
In what she deemed an "analytical problem," Justice Sonia Sotomayor mused, "I find it very, very difficult to conceive how you can patent a sequential numbering system by nature, in the same way that I have a problem in thinking that someone could get a patent on the computer binary code merely because they throw a certain number of things on a piece of paper in a certain order."
"I always thought that to have a patent you had to take something and add to what nature does. So how do you add to nature when all you are doing is copying its sequence?" she asked.
Products Of Nature
Respondent Myriad Genetics Inc. received several patents for diagnostic tests for mutations along BRCA1 and BRCA2, two genes responsible for most cases of hereditary breast and ovarian cancer. It 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 breast 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) and patent holders 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 ) [enhanced version 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.
2nd Petition Filed
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?"
Arguing for the petitioners, attorney Christopher A. Hansen said that while Myriad "deserves credit" for having "unlocked" the secrets of BRCA1 and BRCA2, "the genes themselves . . . where they start and stop, what they do, what they are made of, and what happens when they go wrong are all decisions that were made by nature, not by Myriad." Although conceding that a process for extracting naturally occurring things can sometimes be patentable, Hansen drew a distinction where the new product is "something different" and has "taken on a new function."
Justice Elena Kagan expressed concern, however, about the potential for decreased incentive among biotechnology firms should the Supreme Court overrule the Federal Circuit a second time. "If you assume that it takes a lot of work and takes a lot of investment to identify this gene, but the gene is not changed in composition, and . . . discovering uses for that gene would not be patentable even if those uses are new, what does Myriad get out of this deal?" she asked.
"Why shouldn't we worry that Myriad or companies like it will just say, well, you know, we're not going to do this work anymore," she added.
In response, Hansen argued that Myriad's virtual monopoly on the BRCA1 and BRCA2 tests has already had a detrimental effect. "The whole point of the product of nature doctrine is that when you lock up a product of nature, it prevents industry from innovating and making new discoveries," he said.
"That's the reason we have the product of nature doctrine, is because there may be a million things you can do with the BRCA gene, but nobody but Myriad is allowed to look at it and that is impeding science rather than advancing it," he added.
Attorney Gregory A. Castanias, arguing for Myriad, opened his remarks by citing Section 103A of the Patent Act, which counsels that "patentability shall not be negated by the manner in which the invention was created." He next indicated his disagreement with Justice Sotomayor's assessment that there is "nothing additive" about Myriad's patents, telling the Supreme Court that "what Myriad inventors created in this circumstance was a new molecule that had never before been known to the world." Justice Sotomayor continued to express skepticism, however.
"I can bake a chocolate chip cookie using natural ingredients - salt, flour, eggs, butter - and I create my chocolate chip cookie. And if I combust those in some new way, I can get a patent on that. But I can't imagine getting a patent simply on the basic items of salt, flour and eggs, simply because I've created a new use or a new product from those ingredients. Explain to me why gene sequences, whether in the actual numbers, why gene sequences are not those basic products that you can't patent," she said.
'Not Given By Nature'
In response, Castanias argued that isolated DNA "is actually a different structure" than native DNA. The chemical composition of the isolated DNA has 5,914 nucleotides, according to Castanias, while the genome itself has more than 3 billion nucleotides.
"It's arranged in the way set forth - as set forth in the SEQ IDs [sequence identifications] number 1 and 2. Number 2 is the so-called genomic DNA, SEQ ID number 1 is the . . . cDNA molecule. When you look at those particular sequences, there was invention in the decision of where to begin the gene and where to end the gene. That was not given by nature," Castanias added.
Solicitor General Donald B. Verilli, Jr. arguing on behalf of the U.S. government, noted the "necessary balance" between "encouraging individual inventors and keeping the basic building blocks of innovation free for all to use." However, "isolated DNA falls on the ineligible side of that divide because it is simply native DNA extracted from the body," Verilli told the Supreme Court.
"The claim that isolated DNA is a human invention rests entirely on the fact that it is no longer connected at the molecular level to what surrounded it in the body. But allowing a patent on that basis would effectively preempt anyone else from using the gene itself for any medical or scientific purpose. That is not true about a patent on cDNA. A patent on cDNA leaves the isolated DNA available for other scientists and other - and others in the medical profession to try to generate new uses," he added.
The petitioners are represented by 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 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 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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