17 April 2013
The US Supreme Court heard oral arguments on Monday on the question of whether human genes can be patented.
Although the question has been brought to court several times (see previous news for background to the case), the Supreme Court itself has never ruled on the issue, but has instead referred the matter to lower courts, which have always ruled the patents valid.
The nature of the Court’s questioning on Monday suggested they are unlikely to consider unmodified DNA isolated from human cells to meet the criteria for patent protection, but that they may be disposed to regard complementary DNA (cDNA) that has been synthesised in the laboratory to be eligible.
This case was specifically brought against the patents held by Myriad Genetics on the breast and ovarian susceptibility genes BRCA1 and BRCA2. The Court’s ruling however would apply to any similar gene patents, and could potentially have enormous implications for genetic research and industry; in particular the business model and value of hundreds of small companies.
The Justices of the Court directed many of their questions towards determining what impact invalidating the Myriad patents would have on the biotechnology industry, and whether maintaining the patent eligibility of cDNA and other forms of synthesised DNA would allow sufficient protection for the intellectual property of most companies.
Summarising the proceedings on the Supreme Court blog, Tom Goldstein said “I would be very surprised if the Supreme Court says isolated gene sequences would be patent-eligible subject matter after today’s argument”. By contrast, the Australian Supreme Court recently ruled that unaltered DNA isolated from human cells qualified as patentable material on a number of grounds (see previous news). The US Court is expected to deliver its decision later this Summer.