By now word has spread of the Supreme Court’s ruling last week declaring “naturally occurring” DNA to be a “product of nature and not patent eligible.” The mainstream news has focused mainly on the implications this ruling has for the specific breast cancer test marketed by the defendant Myriad and how that test may now be less expensive. But what of the larger implications of the case for patents in general? Will this holding, that bars patents for naturally occurring human genetic material but allows them on synthetically created DNA, have a major effect on the U.S. patent landscape?
A recent paper published in Nature Biotechnology attempts to answer that very question. By compiling a list of all U.S. patents that claim nucleotide sequences somewhere in their text the authors generate a list of patents currently in force that make a claim on DNA. By analyzing the specific patents they are able to further break this list down into patents which claim human DNA versus synthetic DNA or the DNA of other species. With the individual patents broken out into these categories, they are able to show that of over 70,000 patents dealing with DNA material, only about 8,000 deal with genetic material in a way that suggests they could be invalidated by the Court’s ruling. However, as the author’s note, this 8,000 includes genes from both humans and other species. From the article:
“We find that, of these 8,073 patents with composition-of-matter claims to simple nucleic acid molecules with natural sequences, 3,535 (41%) involve human genetic sequences whereas the other 4,538 (59%) involve sequences from other taxa, including animals, plants and microbes. Based upon the legal logic of the “product of nature” principle as well as the biological logic of the conservation of genetic sequences across species, we reason that the only workable product-of-nature exception would necessarily be broader in scope than just human genes. Therefore, an overturn by the Supreme Court will affect claims of patents not only on human genetic diagnostics and therapeutics but also on a wide range of other genetic technologies in other industries, particularly in agriculture . . .”
So if the Court’s ruling is strictly interpreted to apply only the human genes, the number of current patents that will be affected is around 3,500. Given the wording of their decision, however, it seems more likely that the ruling will apply to both human and non-human genes.
Perhaps more interesting, though, is the implications the case will have for future research. The authors touch on that as well, noting that:
“In the longer run, a judicial exception to the patentability of isolated nucleic acid molecules with naturally occurring sequences would likely only accelerate trends that are already very much evident in the data. More than a decade ago, applicants began to move away from drafting claims to simple isolated DNA molecules and from those with explicitly human sequences.”
As the graph shows, patent claims have increasingly dealt with the synthetic DNA similar to the cDNA that the Court explicitly notes can be patented. Given this split decision, in which the court forbid “product of nature” patents but gave the green-light to patenting of synthetic DNA, it seems the author’s final conclusion that the case ultimately will cause little change in the direction of future patents is accurate.
Indeed, it appears that access to naturally occurring genes — biodiversity in some sense — will remain uninhibited while “the patenting of engineered, ‘non-natural’ genetic constructs . . . is likely to continue to surge ahead.”
Image Credit: National Geographic