The US Supreme Court is deliberating on the legality of patenting human genes in a landmark case that that could have profound ramifications on US research in the fight against certain cancers, with billions of dollars at stake.
The US Supreme Court is hearing a case against a US biotech company that wants to defend its exclusive rights over two human gene sequences that could be used to identify people at greater risk of developing ovarian and breast cancer.
Myriad Genetics, based in Salt Lake City, Utah, developed a genetic diagnosis tool based on the BRCA1 and BRCA2 genes -- sequences that the company successfully patented -- in the late 1990s.
Since then, around one million women have taken Myriad’s BRAC Analysis tests, at a cost of 3,000 dollars each.
But Myriad’s monopoly over the two genes is contested. Researchers, doctors and patients argue that the company’s patents prevent wider testing and research into cancer.
“If these patents are upheld by the supreme court, all tests on these particular genetic sequences would have to be done at Myriad’s own laboratories,” Professor Sandrine de Montgolfier, head of “Biotechnologies” at the Paris Val de Marne University, told FRANCE 24.
“If someone were to invent a different diagnostic method based on these sequences, they would have to pay royalties to Myriad,” she added.
“There is also an ethical problem. All genetic material from such tests would have to be sent to Myriad’s laboratories, raising the question of what the US company would do with such an enormous collection of genetic material.”
Product of nature or human scientific research?
The US-based Association for Molecular Pathology (AMP) is one of several scientific bodies contesting Myriad’s patents at the Supreme Court, whose nine justices are expected to deliver their ruling in June.
The AMP argues that the genetic sequences for which Myriad holds the patents, awarded in 1997 and 1998, unfairly block further and more extensive research into cancer treatments.
On Monday, AMP lawyer Christopher Hansen argued to the court that a company could not have exclusive rights over DNA, it being a substance created by nature.
“The question presented by this case is what exactly did Myriad invent?” Hansen said. “And the answer is nothing.”
The groups opposing Myriad’s patents are supported by Nobel Prize-winning scientist James Watson, who discovered the double helix structure of DNA in 1953. He argued that the product of nature could not be monopolised by any entity.
"Knowledge per se cannot be patented. Myriad should not own breast cancer genes," Watson said outside the Supreme Court.
Myriad, meanwhile, wants to secure its rights on the genetic sequences and so safeguard the substantial investments it made in researching and developing its analysis tools.
The company’s lawyer Gregory Castanias argued that Myriad's genes could be patented because the DNA it isolated from the body had a “markedly different chemical structure” from DNA within the body.
“What was ‘merely snipped’ out of the body here is fundamentally different in kind from what was in the body,” Castanias said. “The most important reason it's different in kind is that it cannot be used in the body to detect the risk of breast and ovarian cancers.”
To illustrate his example, he compared the isolation and identification of the crucial DNA sequences to the manufacture of baseball bats: “A baseball bat doesn't exist until it is 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.”
The European dimension
Scientists and the medical profession in Europe are following the case closely.
In 2001 Myriad tried to file patents on the two DNA sequences, prompting a wave of protest and appeals to the European Patent Office (EPO).
“Myriad has lost a number of times in Europe and its patent applications were definitively revoked here in 2005,” explained Prof. de Montgolfier. “According to European law, you can’t have a patent on a gene because it is not a human invention and if it hasn’t been created by technical means. I don’t understand how Myriad could have obtained patents on these genes because there has been no transformation by them of the genetic sequence.”
De Montgolfier added that the US Supreme Court’s ruling would create waves on both sides of the Atlantic: “If the court rejects Myriad’s case, it will very strongly reinforce the European attitude to these kinds of patents.”
Date created : 2013-04-17