If the U.S. Supreme Court reached any consensus on the patenting of human genes, it was not evident from yesterday’s oral arguments, in which the justices posed questions using analogies of plants from the Amazon and chocolate chip cookies, while plaintiff Myriad Genetics invoked its own metaphor of a baseball bat.
Myriad is trying to protect its seven patents for BRCA 1 and 2 from a four-year-old legal challenge raised by 20 medical associations and individual doctors led by the Association for Molecular Pathology (AMP) and assisted by the American Civil Liberties Union (ACLU) and Public Patent Foundation (PUBPAT). They sued Myriad and the U.S. Patent and Trademark Office in 2009 over the patents, as well as Myriad’s method for analyzing sequences of those genes for mutations associated with breast cancer.
Before the high court, AMP and its co-litigants repeated their arguments that the patents on BRCA 1 and 2 are unconstitutional and invalid, contending that human genes are unpatentable “products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought” under Section 101 of Title 35 of the U.S. Code.
“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,” Christopher A. Hansen, Esq., an ACLU lawyer, told the justices.
Justice Samuel Alito asked Hansen whether a hypothetical process of extracting a molecule in the leaves of an Amazonian plant could be patented.
“You might be able to get a method patent on it, you might be able to get a use patent on it, but you can't get a composition patent,” Hansen replied. Unless, he added, the molecule were “substantially more concentrated than it was in nature” and thus given a new function compared to its natural state.
“When you concede that, then I'm not sure how you distinguish the isolated DNA here, because it has a different function,” Alito replied, to Hansen’s disagreement.
Myriad has countered that patent protection was needed for companies to develop diagnostics like its BRACAnalysis® test. That argument appeared to resonate with Justice Elena Kagan, who with Justice Antonin Scalia asked Hansen: “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?”
Hansen replied that other labs promised not to patent the BRCA genes if they discovered them, and that neither ACLU nor co-litigants sought to prevent recombinant DNA from being patented: “If the patents are upheld, recombinant DNA is frustrated (because) people can't use pieces of the BRCA gene to recombine them and find new treatments and find new diagnoses and find new things that will advance medicine and science as a result of these patents.”
Countered Justice Anthony Kennedy: “I just don't think we can decide the case on the ground, ‘oh, don't worry about investment, it'll come.’”
Justice Sonia Sotomayor asked Myriad’s lawyer, Gregory A. Castanias, why gene sequences were not unpatentable by using a baking analogy: Why a patent on a chocolate chip cookie was possible for creating a new use or product from its ingredients, but not for the salt, flour, and eggs themselves?
Castanias replied that human invention was applied in where to begin the gene and where to end it.
“You haven't created a type of gene that does not exist in the body naturally,” Scalia shot back.
Sotomayor said human invention was at work in complementary DNA but not a mere DNA fragment, whose patentability Breyer later questioned since it was a portion of the body’s genetic sequence. The Obama administration took a similar tack in a brief filed with the court.
Castanias answered with another analogy: “A baseball bat doesn't exist until it's isolated from a tree. But that's still the product of human invention to decide where to begin the bat and where to end the bat.”
Michael Samardzija, Ph.D., a partner in the IP group of law firm Bracewell & Giuliani in Houston and an attendee at Monday’s oral arguments, told GEN he expects justices will avoid a sweeping decision: “What they’re going to say is that this is too broad of a claim because it seeks to pre-empt too much, and they’re going to force people who want to file a patent on an isolated DNA sequence to be able to do so in a much more narrow way."