The High Court’s decision against patents on isolated genes raised questions about how non-expert judges can rule on science.By Wendy Zukerman.
The BRCA1 gene and science in the courtroom
Many were agog when the full bench of the Federal Court ruled that companies in Australia could patent genes. In 2014, Myriad Genetics persuaded five judges that when the BRCA1 gene – related to breast cancer – was isolated from the human body it transformed into a chemical so different from its original form that it could be owned. At the time, Dr Luigi Palombi, a patent lawyer and professor in the school of law at Murdoch University, said, “The decision ignores the scientific facts.” Today he’s more critical, dubbing the full Federal Court judgement “gobbledygook”.
When the High Court overturned the decision last month, in a case brought by former breast cancer patient Yvonne D’Arcy, the ruling that an isolated gene was not a patentable invention was approved by many scholars. Bruce Arnold, an assistant professor of law at the University of Canberra, hailed the judgement “a victory for common sense”, which showed “that the High Court does understand the genome”.
More than a win for common sense, the case highlights some of the key issues at play when science, which includes highly specialised and complex fields, enters the adversarial courtroom. Myriad’s lawyers have been criticised for making the science in their case appear more complicated than it needed to be, and thus dragging out the time, and cost, of the trial. Meanwhile, it recently emerged that for decades flawed forensic scientific evidence provided during criminal trials had been swallowed by scientifically naive judges and juries. And the consequences for the misuse of science in the courtroom cannot be understated.
Earlier this year, the FBI announced that testimony using bungled scientific evidence to link defendants’ hair samples to crimes may have led to the wrongful execution of nine people. In an editorial on the issue, Niamh Nic Daéid, a professor of forensic science at the University of Dundee, Scotland, wrote that behind these problems “lurks an astonishing judicial compliance” for accepting shoddy science in courtrooms.
And while the repercussions of allowing genes to be patented is less clear cut, recent history is instructive. Since the 1980s, applications to patent isolated genes have been granted by the patent offices of the United States and Australia. By the early 2000s, surveys from across the pond suggested the enforcement of these patents was hampering research and the provision of genetic tests to patients. In one survey, 46 per cent of geneticists said they felt their work was delayed or limited by gene patents. Another report found that 25 per cent of laboratory directors surveyed stopped performing a clinical genetic test because of a patent or licence, and more than half decided not to develop new gene tests because of this.
Part of the problem with interpreting science in the courtroom is that many judges are not scientifically trained. “There are many cases where science is poorly understood in courts – from the psychology of human behaviour, to the biology of novel diseases or syndromes,” says Dr Alastair Iles, an environmental lawyer from Melbourne turned academic at the University of California, Berkeley.
While one of the judges in the 2014 Federal Court Myriad decision has a PhD in biochemistry, and the chief justice of the High Court has a bachelor of science in physics, Dianne Nicol, a professor of law at the University of Tasmania, says this is unusual. Despite this, “many legal decisions that judges have to make are in areas of high technology and science”. And the courtroom is not designed to educate judges, but to persuade them.
Experts are called to explain the science, and while legal requirements obligate these witnesses to be impartial, Peter Cashman, professor of law and social justice at the University of Sydney and junior counsel in the case against Myriad, says that, in practice, experts are only selected “if they support the adversarial position of the side retaining and paying them”.
“Scientists invariably argue over the methods, evidence and criteria they use to decide whether a claim is legitimate,” says Iles. “So, we shouldn’t be surprised that lawyers try to exploit these differing views.” More than this, however, Iles argues that it’s “common practice” for lawyers to attempt “to confuse juries or judges with their own invocations of science. They may make the science seem very complex so as to intimidate judges and juries into accepting their defence.” Alternatively, he says, they may attempt “to oversimplify science, to show that there is a strong scientific consensus in favour of their position, which doesn’t actually exist”.
The scientific process being put under the microscope during the Myriad trial begins when cells are removed from a woman’s breast tissue. The cells’ membranes are then burst, spewing out their contents, and most critically, releasing their DNA. A cocktail of chemicals and salts isolate the genetic material, which is then spun in a centrifuge until a solid clump of purified DNA is left behind. Its sequence is compared with a known string of genetic letters that spell an increased likelihood of having breast or ovarian cancer. Judges, in Australia and the US, were tasked with pondering this process: how did removing genetic material from inside the body change it? And did it even matter?
It was always understood that DNA inside the cells of the human body could not be patented. Up for grabs, however, was a gene sequence that had been removed from the body. “They are not the same,” the Federal Court ruled. “They have different beginnings and different ends.” More specifically, the isolated gene was found to be “chemically, structurally and functionally different to what occurs in nature”.
Cashman, and his colleagues, argued that wasn’t the point. And the High Court agreed, with Justice Michelle Gordon noting that any such arguments were “misplaced”. Isolated or not, a gene was not patentable.
“One byproduct of the way in which Myriad conducted the case was to overly complicate the scientific issues and to drag the trial court and the appeal courts into considering complex scientific issues which we contended, and which the High Court ultimately agreed, were irrelevant,” says Cashman. Consequently the cost of the trial blew out, and the case ran for more than five years. Myriad declined to comment to The Saturday Paper.
And while Cashman has “little doubt” that all judges involved in the Australian litigation understood the scientific evidence, the same cannot be said of Myriad’s trial in the US. Justice Antonin Scalia of the US Supreme Court – who agreed that isolated genes could not be patented – admitted in his judgement that he didn’t understand the science. He wrote that when it came to the “fine details of molecular biology, I am unable to affirm those details on my own knowledge or even my own belief”.
Major concerns with another area of courtroom science emerged in 2009, when the US National Academy of Sciences published a damning report of forensic scientific evidence. It cited a “notable dearth of peer-reviewed, published studies” to support many claims forensic scientists had provided in courts. As part of the fallout, the FBI has been scrutinising evidence from past cases involving bunk science. In April, they announced that errors were found in 96 per cent of the re-analysed cases where testimony had been given using “highly unreliable” microscopic hair analysis to connect defendants to crimes. In 33 of these cases defendants received the death penalty. Nine had already been executed. Five died from other causes while on death row.
A scientifically untrained judiciary is not the only problem here. When it comes to the “current crisis” of forensic science, Professor Nic Daéid says, “Much of the challenge is levelled at us as scientists.” She calls for her colleagues to take more responsibility for the evidence presented in the courtroom. In an editorial published this year, she wrote: “We must be both bold and brave about exposing and recognising baseless ‘junk’ science and cowboy practitioners.”
To help judges and juries understand science presented to them there are moves to change some standard court procedures. In 2013, Justice Steven Rares of the Federal Court wrote a glowing review of “hot tubbing”, a process where expert witnesses give evidence concurrently. He noted this sped up court proceedings, and allowed witnesses to “immediately” expose “inappropriate” answers from their colleagues. Iles believes courts could also call independent experts more often to help judges accurately assess the science provided in their courtrooms.
Judges “can learn to appraise scientific evidence very carefully and critically”, says Iles, but they need appropriate training and guidance: “Without this, we can expect more court confusion with, perhaps, unintended consequences.”
This article was first published in the print edition of The Saturday Paper on November 14, 2015 as "Laws of science".
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