Supreme Court: US genes patent decision may depend on strands in Myriad argument

by jeeg 28. May 2013 21:43

It was obvious from the questions they asked and analogies that they dreamt up that the nine US Supreme Court justices hearing one of the most important and complex patent cases in a decade were not wholly comfortable with the subject at hand.


The question before them – whether human genes could be patented – seems straightforward on the surface. Yet as the arguments turned to talk of recombinant DNA and whether isolated DNA fragments were found in nature or were a product of man, the judges quickly turned to quizzing attorneys with more accessible analogies involving baseball bats and chocolate chip cookies.


In June the Supreme Court is set to release its decision on whether genes may be patented, in a ruling expected to have broad implications for a biotechnology industry that is valued at $83bn. Just how far-reaching the case will be for other patent holders is difficult to determine before the ruling is announced. Most experts agree that it will trouble the likes of biotechnology group DuPont, drugmaker GlaxoSmithKline, and Amgen, the bio pharmaceutical company.


The case before the court centres on the actions of a Utah company, Myriad Genetics. Myriad created a monopoly in the US when its co-founder, Mark Skolnick, became the first scientist to isolate, sequence and patent two gene mutations that have a high risk of breast and ovarian cancer, BRCA1 and BRCA2.


While Myriad insists that it never stopped any scientists from performing research on the genes, it has long held exclusive rights for all clinical use of the BRCA mutations, including genetic tests for patients who worry that they carry the mutations.


In its challenge to Myriad, the ACLU has argued that the longtime practice of patenting genes in humans defied a rule of patent law that says things found in nature, such as elements on the periodic table, could not be patented. While proponents of the patents argued that the isolated fragments of DNA in question could not – in and of themselves – be found in nature, the ACLU has relied on the arguments of scientists who have said such fragments do indeed occur through natural processes in the human body.


When they heard the case in April, the majority of the nine justices seemed sceptical about whether these kinds of genes should continue to be patented. But they were also wary of dealing too great of a blow to entrepreneurs and companies that have come to rely on the promise of patents to raise investor capital and pursue scientific research.


Most experts believe, based on the questions and comments heard in court, that the majority of justices may decide to invalidate patents on isolated DNA, including the main patents in question in the case of Myriad. But they are expected to maintain the patent protection for what is known as complementary DNA, or cDNA, which is essentially synthetic and used for many medical and agricultural purposes.


Scientific and legal experts are trying to gauge just how disruptive the case may be. Before it was heard, one patent expert predicted the results could be disastrous.

“Synthetic DNA sequences, designed by humans, may be excluded from this prohibition but the invalidation of patents claiming human genes will wipe out vast amounts of private investment, and be a body blow to the biotechnology industry,” says Andrew Torrance, professor at the University of Kansas law school. A Study published by Nature Biotechnology found that the extent to which certain patent claims would be affected by the ruling would be determined by how the justices define the “line of demarcation” between the “natural” and the “invented” DNA.


It is unclear whether the high court would draw distinctions between human and non-human genetic sequences.


The question of what patents are at risk is complex. The study, which was led by Gregory Graff of Colorado State University, used algorithms and other methods to sift through more than 70,000 patents. It determined that 15,359 of them contained claims that were similar in nature to those held by Myriad.

Of these, 39 per cent involved human sequences, seven involved other mammals, 12 per cent involved plants, 21 per cent involved microbial sequences and another 21 per cent were seen as using “synthetic” claims of DNA.


The study found that the companies with the most at stake were pharmaceutical or biomedical companies. But big agricultural technology firms, focused on plants and microbial genes, such as DuPont, the largest holder of US gene patents, also stand to lose.


Whatever the court decides, the authors noted, the future seems to lie not in the controversial patents that Myriad established in the late 1990s, but in the “non-natural” genetic constructs that most experts believe will be safe from the Supreme Court.


 Stephanie Kirchgaessner, Financial Times





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