A unanimous US Supreme Court on Thursday prohibited patents on naturally occurring human genes but allowed legal protections on synthetically produced genetic material in a compromise ruling hailed as a partial victory for patients and the biotechnology industry.
The ruling by the nine justices, the first of its kind for the top US court, buttressed important patent protections relied upon by biotechnology companies while making it clear that genes extracted from the human body cannot be patented.
Researchers and advocates for patients said it could make it easier for people to get cheaper genetic tests for disease risk.
The court’s ruling came in a challenge launched by medical researchers and others to seven patents owned by or licensed to Salt Lake City, Utah-based biotechnology company Myriad Genetics Inc on two genes linked to breast and ovarian cancer.
The decision “sets a fair and level playing field for open and responsible use of genetic information,” said Dr Robert Darnell, president and scientific director of the New York Genome Centre, an alliance of medical centres and research universities. “At the same time, it does not preclude the opportunity for innovation in the genetic world.”
Myriad's work on cancer screening gained worldwide attention this year when actress Angelina Jolie announced she had a double mastectomy after undergoing a test and finding she had an extremely high risk of developing breast cancer.
The biotech industry saw some good in the ruling, noting that the justices left intact patent protections on forms of DNA produced by scientists in laboratories and the processes used to carry out tests such as cancer screenings. The industry had said an expansive ruling against Myriad could have threatened billions of dollars of investment.
The contentious, uniquely 21st century question before the court was whether any human genes can ever be patented - meaning the holders have exclusive rights to their intellectual property for a defined period. The issue has gained increasing importance as scientists make progress in identifying specific genes, or mutations, linked to a variety of diseases.
The court, in an opinion written by Justice Clarence Thomas, ruled that forms of DNA that have been manipulated in the lab in a way that alters their natural state can be patented.
Called cDNA - the “c” stands for “complementary” - it is essentially an edited form of a gene, with extraneous stretches excised. This DNA is patent eligible, the court said, because it is not naturally occurring, unlike isolated DNA simply extracted from a human body.
In the opinion, Thomas wrote that because cDNA is not naturally occurring, it can be patented under federal law. A laboratory technician, he added, “unquestionably creates something new when cDNA is made.” Thomas noted that so-called method patents, which concern technical procedures for carrying out a certain process, are not affected by the ruling.
The compromise outcome, which had been recommended to the justices by the Obama administration, will have less impact on Myriad than if the court had barred patents for all types of human genetic material. The Myriad patents in dispute will all expire by 2015, though the company said it holds other patents that will protect its tests through 2018 and potentially beyond.
