Can human genes be patented as intellectual property or are they products of nature that cannot be patented under current law?
That is the fundamental question in the case, Association for Molecular Pathology et al. v. Myriad Genetics Inc. et al.
, on which the U.S. Supreme Court heard oral arguments for slightly more than an hour on April 15, with a decision expected in June when the court’s current term ends.
Questions and hypothetical examples raised by the justices signaled a wariness on patents for isolated genomic DNA, but not necessarily on synthesized cDNA, noted Stephanie Murg, managing director at G2 Intelligence, who attended the hearing and spoke afterward during a webinar sponsored by Bloomberg, G2 Intelligence’s parent company, and SCOTUSblog.
The patents under challenge are held by Myriad Genetics (Salt Lake City) on BRCA1 and BRCA2 genes and their mutations that are associated with hereditary predisposition to breast and ovarian cancer. Myriad has the exclusive right to perform diagnostic testing on these genes, license the testing to others, and threaten litigation against any unlicensed use.
Seeking to invalidate these patents are a host of plaintiffs spearheaded by the American Civil Liberties Union (ACLU) and the Public Patent Foundation on behalf of researchers, genetic counselors, patients, breast cancer and women’s health groups, and medical professional associations representing 150,000 geneticists, pathologists, and laboratory professionals. They argue that the patents give Myriad a monopoly over the terms and costs of testing and researching these genes and bar patients who get the potential lifesaving test from obtaining a second opinion from another provider.
The plaintiffs contend that Myriad did not invent 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 made by nature, not by Myriad,” Christopher Hansen of the ACLU said in his opening argument.
Myriad’s attorney, Gregory Castanias of Jones Day, countered that a federal appeals court has twice declared the patents valid under Section 101 of the U.S. Patent Act, ruling that they involve DNA isolates “markedly different” in molecular composition from the DNA that naturally exists in chromosomes in the body.
Several justices, including Sonia Sotomayor and Ruth Bader Ginsberg, indicated they did not think that the process of isolating and removing human genes should be patented, while others such as Elena Kagan and Samuel Alito raised concerns about the impact a broad ruling could have on companies that invest in such research.
Emphasizing the need to tread carefully, Justice Stephen Breyer noted that patent law often involves “uneasy compromises.” The U.S. Patent and Trademark Office has granted patents on at least 4,000 human genes to companies, universities, and others that have discovered and decoded them.
As Murg pointed out, the justices appeared to lean toward a more amenable option presented by Solicitor General Donald B. Verrilli Jr., who presented the Obama administration as an amicus but did not support either side. He made a distinction between genomic DNA and cDNA, which is synthesized from an mRNA template and thus is not a product of nature. “While isolated genomic DNA falls on the ineligible side, we do think cDNA is patent-eligible.”
If the court were to adopt that approach, which neither the plaintiffs nor Myriad accept, Murg noted, some of Myriad’s patents, concerning synthetic molecules called cDNA, could survive, although the parties disagree on that point as well.
In subsequent questioning, during which Stephen Breyer reiterated the court’s “nervous[ness] about tying up laws of nature,” the justices seemed inclined to agree with Verrilli and later queried Hansen on the value of striking down patents on genomic DNA yet upholding patents on cDNA.
“That’s among the key questions facing the clinical lab and diagnostics industries, as they ponder the implications of a world in which the more sweeping, first-generation gene patents of Myriad and other companies are declared invalid while those constructed narrowly, such as those covering cDNA, are upheld,” Murg concluded. “Given the relative rarity of the former type of patents and their rapidly approaching expiration dates (the first of Myriad’s BRCA patents expires in 2014, BRCA2 in 2015), the significant outcome may be in the area of diagnostic genome sequencing. While this technology has rapidly entered the clinical laboratory, the incorporation of genome, exome, and transcriptome sequencing into medical practice has been slowed by the specter of patent infringement.”