On Monday, April 15, 2013, the United States Supreme Court heard oral argument in Association of Molecular Pathology vs. Myriad Genetics. As has been amply discussed, this case involves the patent eligibility under 35 U.S.C. 101 of certain isolated DNA molecules encoding a mutation that is associated with an increased risk of breast cancer in women.
The American Intellectual Property Law Association (AIPLA), in its amicus brief in support of neither party, provides an excellent framework that could, and should, be used by the Justices in deciding this case. As AIPLA points out, this case is not about patentability, but about patent eligibility:
“To be sure, ‘human genes’ as they exist in the body are not ‘patent eligible’ under 35 USC 101; they also are not patentable under other provisions of patent law. For instance, human genes are not ‘new’ and therefore a claim to a human gene would be anticipated by naturally occurring human genes in contravention of 35 U.S.C. 102. ‘Patentability,’ however, is not at issue in this case. ‘Patentability’ refers to compliance with all statutory provisions that govern whether a patent is valid and enforceable, including those directed to, inter alia, obviousness, anticipation, enablement, and written description. The focus of this appeal is solely on 35 U.S.C. 101, the gatekeeper provision that determines what subject matter is eligible for patent protection.” AIPLA Amicus Brief, p. 3.
Rather than following the Supreme Court’s own precedent in earlier cases that addressed the patentability of “products of nature” (such as Diamond v. Chakrabarty, 447 U.S. 303 (1980) and Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)), some of the Justices seem to focus on the difficulty of the invention. The Court’s own holding in Chakrabarty is that whether a composition of matter passes the eligibility threshold of 35 U.S.C. 101 depends on whether the claimed composition is “a product of human ingenuity ‘having a distinctive name, character, and use” from naturally occurring starting materials.” 447 U.S. at 309-10. However, some of the Justices seem to be focusing more on the level of human ingenuity involved than on the characteristics of the claimed composition. Not only so, but they appear to be turning the degree of difficulty on its head.
For example, some of Chief Justice Roberts’ questions to the attorney for Myriad Genetics focus on the difficulty of making a baseball bat from a tree branch as opposed to “simply” cutting the claimed DNA molecules out of a human gene.
“CHIEF JUSTICE ROBERTS: My understanding -my understanding is that here, what’s involved, obviously through scientific processes, but we’re not talking about process. Here, what’s involved is snipping. You’ve got the thing there and you snip -snip off the top and you snip off the bottom and there you’ve got it. The baseball bat is quite different. You don’t look at a tree and say, well, I’ve cut the branch here and cut it here and all of a sudden I’ve got a baseball bat. You have to invent it, if you will. You don’t have to invent the particular segment of the — of the strand; you just have to cut it off.”
According to Roberts’ remark, the former would be patent eligible but the latter is questionable.
In an even more absurd analogy, Justice Sonia Sotomayor compared the nucletotide sequence of isolated DNA to the natural ingredients in chocolate chip cookies such as eggs and flour.
“JUSTICE SOTOMAYOR: 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.”
With all due respect to Justice Roberts’ ability as a carpenter and Justice Sotomayor’s talents as a chef, these remarks signal the Court’s fundamental mis-characterization of the biological molecules involved in the case and the difficulty of obtaining them. The Supreme Court should uphold the Federal Circuit in finding the claimed isolated DNAs as patent eligible under 35 U.S.C. 101.
If these simplistic analogies were to win the day, might it not be possible (purely on the basis of 35 USC 101) to allow a patent for a new baseball bat and deny one for the Star Trek Warp Drive? Is there not something wrong with a jurisprudence that even entertains such questions? If the “person on the street” were asked “Which invention is more worthy of a patent: a new baseball bat or a warp drive?” can anyone credibly believe that the person would choose the former? Which advances the frontiers of science more?
The problem suggested by these simplistic analogies seems to be one of finding “laws of nature” (and thus ineligibility under 35 USC 101) the further that science goes towards the microscopic but not finding such “laws of nature” at the macroscopic level. Hence, such arguments as those above and in those presented earlier at the Federal Circuit (which Judge Lourie capably defeated).
One way of understanding the scientific and philosophical implications of this case is presented in my earlier article “Myriad Genetics: Laws of Nature and the Philosophy of Science” http://intellectualip.com/2012/10/12/myriad-genetic…phy-of-science/