Human gene patent case could impact ag, trade group says
By MATEUSZ PERKOWSKI
A U.S. Supreme Court case over the patenting of human genes could have significant repercussions for agriculture, according to a plant science trade group.
The nation's highest court heard oral arguments April 15 over the patent eligibility of genes that have been isolated from the rest of human DNA.
If isolated human genes are not eligible for patents, the same logic would apply to isolated plant and microbial genes used for agricultural innovation, according to CropLife International.
CropLife argues that the importance of such "biological isolates" extends "far beyond human genes useful for cancer diagnosis," such as isolated genes from bacteria, fungi and viruses that exhibit novel traits in plants.
"The potential to secure patent protection for these new developments is a chief means for recouping those investments and ensuring that innovations are brought to the public," according to CropLife's brief.
The lawsuit was initiated by researchers who challenged a patent held by a company, Myriad Genetics, on two isolated human genes. Mutations in these genes are correlated with an increased risk of breast and ovarian cancers.
Plaintiffs claim that the patents give Myriad a monopoly on the testing for such mutations and allow the company to "block avenues of scientific inquiry."
Genes isolated by Myriad are no more eligible for patenting than a kidney separated from the human body, the plaintiffs say.
"One way to address the question presented by this case is what exactly did Myriad invent? And the answer is nothing," said Christopher Hansen, the plaintiffs' attorney, during oral arguments.
The function of the two genes "are all decisions that were made by nature, not by Myriad," Hansen said.
Myriad countered that isolated genes are eligible for patenting similarly to other products extracted from natural materials, like the molecule that conveys a unique flavor to strawberries.
The company's scientists needed ingenuity to precisely carve out the two genes in question, according to Myriad.
"A baseball bat doesn't exist until it's isolated from a tree. But that's still the product of human invention to decide where to begin the bat and where to end the bat," said Gregory Castanias, attorney for the company.
During the oral arguments, the Supreme Court justices questioned both parties' arguments about role of isolation under patent law.
Chief Justice John Roberts disagreed with the analogy of carving a baseball bat from a tree, saying it's "quite different" than removing an already-existing strand of genetic material.
"You don't look at a tree and say, well, I've cut it here and all of a sudden I've got a baseball bat," he said. "You have to invent it, if you will."
Associate Justice Sonia Sotomayor told the attorney for Myriad that she faces an "analytical problem" in the case.
"I always thought to have a patent you had to take something and add to what nature does. So how do you add to nature when all you are doing is copying its sequence?" she said.
On the other hand, Associate Justice Samuel Alito asked why isolated genes were distinguishable from a medicine extracted from an exotic plant, which would be eligible for a patent.
"Isolated DNA has a very different function from the DNA as it exists in nature. And although the chemical composition may not be different, it certainly is in a different form. So what is the distinction?" Alito said.
Associate Justice Elena Kagan asked about the potentially disruptive effects of a ruling that held isolated genes are not eligible for patents.
"Why shouldn't we worry that Myriad or companies like it will just say, well, you know, we're not going to do this work anymore?" she said.