US federal appeals court hears arguments in Myriad gene patent case
This article was originally published in SRA
In a case involving the patentability of isolated DNA, lawyers arguing before the US Court of Appeals for the Federal Circuit on 4 April used hypothetical situations and analogies, for the most part, instead of relying on historical case law on which to base their arguments, with both sides referencing extractions involving everything from baseball bats from trees, to kidneys from the body, to minerals from rocks to get their points across1.
The top US lawyer, acting solicitor general Neal Katyal, used a different type of metaphor, asking the court to visualise a "magic microscope" that could see deep into the body or anything in nature. Anything within that realm, he argued, should be outside the scope of patent eligible subject matter.
The case, Association for Molecular Pathology v Myriad Genetics, involves patents held by Myriad Genetics on the BRCA1 and BRCA2 genes.
Salt Lake City-based Myriad argued that isolated DNA does not and would never exist in nature except for the human ingenuity and research that brought it to that state.
But siding with the plaintiffs in the case, Judge Robert Sweet of the US District Court for the Southern District of New York in Manhattan last year ruled that the US Patent and Trademark Office (USPTO) had improperly granted Myriad seven BRCA gene patents because they involved a law of nature, and that the broad method-of-use claims for analysing and comparing DNA sequences were abstract mental processes, and therefore, unpatentable2.
The lawsuit was brought by the American Civil Liberties Union (ACLU) and a coalition of patients, pathologists, genetic researchers and other scientists, who filed their complaint in May 2009.
Because of Myriad's patents, the firm is the only company in the US that can legally provide diagnostic testing on the BRCA1 and BRCA2 breast and ovarian cancer genes. The company charges about $3,300 per test.
The ACLU and the other plaintiffs insist that the BRCA patents stifle diagnostic testing and research leading to potential cures. They also contend that the patents limit women's options for medical care because of a lack of affordability for the expensive tests, although Myriad argues that it offers financial assistance for eligible low-income, uninsured patients.
What Myriad can "fairly and easily admit" is that a new mineral found in the ground or a plant in the wild is not eligible for patenting under section 101 of the US patent law, said Gregory Castanias, a partner at Jones Day, who represented the company.
But Judge Kimberly Moore, one of the three judges on the appeals court panel that heard the oral arguments on 4 April, asked: what if the mineral was embedded in rock, "and you have to perform extensive excavation, you have to apply some sort of acidic substance to peel it away, effectively breaking the bonds of the mineral and rock from each other. How is that different than isolating the DNA?"
Applying human interaction to separate the mineral from the rock makes it a composition of matter, and therefore, it is eligible for a patent, Mr Castanias said. The problem in that case, he said, is "that patent would fail unless you give me more facts," because otherwise, "all you have done is the work of an ordinary skilled artisan".
But Judge Moore drilled deeper, questioning whether what geneticists do is any different than being the skilled artisans in their field.
Mr Castanias noted there had been no findings on those grounds, or at least, not with what was known in 1995 when Myriad applied for its BRCA gene patent. He then turned the discussion back to the issue of Judge Sweet's ruling, in which the district judge had applied the "products of nature exception" to Myriad's patents. "This decision is going to have consequences for all sorts of other areas, including other areas of the biotechnology industry," Mr Castanias insisted.
He argued that Myriad's patents cover "new tools, things that molecular biologists use . . . not products of nature or god". Using another metaphor, Mr Castanias asked the court to consider that, while "only god can make a tree," inside that tree is a baseball bat, which he said is a composition of matter. In that light, the BRCA genes are "things that are pulled out of a human body, and there is a necessary transformation" that takes place, he said.
Using a different analogy, Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project, argued that isolating DNA was nothing different from when a surgeon "slices" out someone's kidney during a transplant procedure. "It is an isolated kidney, but it is still a kidney. It's not an invention," he contended. "All Myriad does here is isolate the gene. All Myriad does here is simply snip the gene out of the body."
Judge Alan Lourie, a former organic chemist, shot back at that, insisting that isolating DNA is "not so easy". "It's not just sitting there," he said.
Mr Hansen countered that the USPTO does not reward patents for the difficulty of the work involved, "and Myriad didn't invent the difficulty of the work. Myriad used methods well known in the science in order to do that".
While Myriad's "entire" legal argument turns on its assertion that isolated DNA is different than DNA, the firm's business was "built on the proposition that isolated DNA and DNA are identical," Mr Hansen asserted.
With all of the analogies flying around the room, Hans Sauer, deputy general counsel at the Biotechnology Industry Organization, whose organisation sided with Myriad in the case, said he was not sure the parties, including the judges, fully understood each other, with some "puzzled exchanges" occurring, especially about purified DNA molecules.
"I think there was a lot of puzzlement on the panel where the judges found their questions weren't quite understood, or when there were answers that the judges were not quite understanding the answer and not quite seeing the distinction," he told Regulatory Affairs Pharma sister publication Scrip Intelligence3.
At the end of the day, Mr Sauer said, "my assumption is this is one of those cases where the technical experts of the Court of Appeals will probably get a lot of questions" in assisting the judges. He noted that more than a third of the hour-long oral arguments was spent on the issue of whether the plaintiffs in the case had standing to bring the suit.
BIO filed a joint amicus brief with the Association of University Technology Managers; they have contended that, if upheld, the lower court's ruling rejecting the patentability of isolated DNA molecules would not only cast a cloud of uncertainty over thousands of similar patents, but also could compromise the ability of biotechs to pursue groundbreaking discoveries, while harming university research and innovation by impeding the transfer of technology from academia to industry.
References
1. US Court of Appeals for the Federal Circuit, 4 April 2011, www.cafc.uscourts.gov/argument/upcoming-oral-arguments.html
2. Patent claims for two human genes declared invalid by US court, Regulatory Affairs Pharma, 31 March 2010
3. Personal communication, BIO, 4 April 2011