The US Supreme Court ruled today that naturally-occurring human genes may not be patented, but a gene that is manipulated to create something that does not exist in nature may be patented, because it is an invention.
Writing for a unanimous court, Justice Clarence Thomas explained that a naturally-occurring DNA segment is a product of nature, it is not a human invention, and is thus not eligible for patent just because scientists isolated it.
However, if a gene is manipulated in a way that it becomes something unnatural, something we cannot find in nature, then it is an invention and is eligible for patent protection.
Scientists who make a new and useful scientific discovery, one that nobody knew about or thought about, cannot get a patent on it if it was already there – they did not create it. That is the difference between an invention and a discovery.
With an invention, it was not there before, but a discovery has always been there. However, somebody who comes up with an invention that makes use of that discovery is much more likely to get patent protection for that invention.
The main question for the Supreme Court justices in this case “Association for Molecular Pathology v. Myriad Genetics No. 12-398” was whether the genes the company isolated are human-made inventions or products of nature. A product of nature is not eligible for patent protection, while a human-made invention is.
Scientists and health care professionals had challenged the patents, saying that their ability to help patients as well as conducting research had been undermined.
Experts say that this Supreme Court ruling will set the course of medical testing and scientific R&D. However, it may also discourage companies from investing in the highly costly pursuit of understanding genetic material.
In a communiqué today, Myriad Genetics Inc. wrote that the ruling has given it 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRAC Analysis test.
Several of the company’s unchallenged claims are method claims applying knowledge regarding the BRCA 1 and BRCA 2 genes, which were not at issue in this case. However, the Court highlighted Judge Bryson’s opinion that “[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications to that knowledge.”
Peter D. Meldrum, Myriad’s president and CEO, said:
“We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward. More than 250,000 patients rely upon our BRAC Analysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall healthcare costs.”
Written by Christian Nordqvist