The US Patent and Trademark Office is about to see a hell of a lot more test tubes in their mailbox.
The United States Court of Appeals for the Federal Circuit ruled on Friday that human genes can indeed be patented. The Public Patent Foundation and American Civil Liberties Union had made claims that putting a patent on human genes was a violation of the First Amendment and patent laws, but the federal appeals court says they believe otherwise.
Plaintiffs representing researchers, patients, cancer survivors and various scientific associations filed suit back in 2009 that Myriad Genetics and other institutes could not lawfully hold patents on gene, specifically two that Myriad claimed ownership of: BRCA1 and BRCA2. In their argument, the plaintiffs argued that genes are a “products of nature” and therefore cannot be patented to any given entity. In the court’s ruling, however, judges noted that the process of isolating genes from DNA changed the chemical structure of the strands.
“When cleaved,” writes Judge Alan D. Lourie, “an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.”
A New York District Court had earlier ruled that isolated human DNA molecules could not be patented.
The two gene sequences patented by medical testing company Myriad Genetics have been linked to breast cancer. The original ruling by the District Court in New York said that the patent issued by the patent headquarters was “improperly granted,” but Myriad fired back, saying that the method of isolating the gene was the subject of the patent — not the gene itself. Now the federal court is siding with Myriad and says that patents can indeed by assigned to isolated genes.
“The ability to visualize a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable,” reads the official wording out of the US Court of Appeals.
The ACLU had claimed that Myriad had a “monopoly” on two BRCA genes, and that women could not have access to alternate diagnostic tests to analyze BRCA1 and BRCA2 genes in their bodies. The presence of an inherited mutation of either of those genes has shown an immense likelihood in developing ovarian and breast cancer.
ACLU lawyer Sandra Park tells AFP that having exclusive rights to isolating that gene means that Myriad can charge whatever they please to let women know if they stand a larger chance of being diagnosed with those cancers. While the gene inside the body cannot actually be patented, the identification, removal and isolation — which is done by Myriad — can be.
The Court of Appeals says the “distinctive nature” of individual genes “as isolated compositions of matter” allows for them to be patentable. The Court ruled that the splitting and isolation of a gene in the process Myriad uses creates “a distinct chemical entity,” which, not found in nature, could thus be patented.
“Uses of chemical substances may be relevant to the non-obviousness of these substances or to method claims embodying those uses, but the patent eligibility of an isolated DNA is not negated because it has similar informational properties to a different, more complex natural material that embodies it,” reads the ruling.
“The claimed isolated DNA molecules are distinct from their natural existence as portions of larger entities, and their informational content is irrelevant to that fact. We recognize that biologists may think of molecules in terms of their uses, but genes are in fact materials having a chemical nature and, as such, are best described in patents by their structures rather than their functions,” the judges add.
Lawyers are expecting the appeals ruling to be challenged by opponents.
Upwards of 5,000 genes have already been patented by the US Patent and Trademark Office.