In the Association for Molecular Pathology v. Myriad Genetics decision, the U.S. Supreme Court unanimously held that naturally occurring DNA sequences are “products of nature” and therefore cannot be patented.
“The Supreme Court’s holding represents a significant shift from the status quo,” said Kevin Emerson Collins, JD, patent law expert and professor of law at Washington University in St. Louis. “It reverses both the lower court and 20 years of precedent at the U.S. Patent and Trademark Office.”
Collins discusses the decision, including its potential economic impact:
The economic impact of the Supreme Court’s opinion in Myriad Genetics will consist of both benefits and costs. On the one hand, genetic material will be more available to researchers, making the path to future innovations that employ genetic material as part of the research process a bit smoother.
On the other hand, the reduction in the scope of patentable subject matter may decrease investment in the biotech industry, as investors are less certain how companies will earn a profit. The size of the reduction in investment in the biotech industry will depend upon the breadth the opinion is given in subsequent cases.
If the opinion is interpreted narrowly so that it applies only to DNA, then its economic impact may not be very large.
Not many biotech companies still have business models that are dependent on patents covering naturally occurring DNA sequences. However, there is nothing in the opinion that suggests that it will be limited to DNA. It is likely to apply to all naturally occurring molecules, and the number of biotech companies that rely on patent protection for isolated and purified naturally occurring molecules in general is likely much higher.
One question that remains to be answered in future cases is how much of a change to a naturally occurring substance is required to transform a product of nature into a patentable, man-made invention.
By invalidating Myriad’s claims to naturally occurring sequences isolated from human chromosomes, the Supreme Court held that the simple act of “snipping” a particular sequence out of a longer DNA molecule was not enough of a change to give rise to a patentable invention.
However, the Supreme Court also provided a limit to the exclusion of products of nature from the patent regime. It held that cDNA claims — claims to human genes with naturally occurring “junk” DNA sequences (introns) removed — describe patentable inventions rather than products of nature.