Justices Consider Whether Patents on Genes Are Valid

The Supreme Court is poised to take up the highly charged question of whether human genes can be patented.

The Supreme Court is poised to take up the highly charged question of whether human genes can be patented.

The Supreme Court is poised to take up the highly charged question of whether human genes can be patented.

But another question could trump it: Has the field of genetics moved so far so fast that whatever the court decides, it has come too late to the issue?

The patents give Myriad a monopoly on testing for these mutations, a highly lucrative business.

The patents give Myriad a monopoly on testing for these mutations, a highly lucrative business.

Myriad and its allies in the biotechnology industry counter that a ruling that invalidates gene patents would upend three decades of patenting practice and undermine billions of dollars of investments to develop not only genetic tests but also biotech drugs, DNA-based vaccines and genetically modified crops.

Myriad and its allies in the biotechnology industry counter that a ruling that invalidates gene patents would upend three decades of patenting practice and undermine billions of dollars of investments to develop not only genetic tests but also biotech drugs, DNA-based vaccines and genetically modified crops.

Myriad and its allies in the biotechnology industry counter that a ruling that invalidates gene patents would upend three decades of patenting practice and undermine billions of dollars of investments to develop not only genetic tests but also biotech drugs, DNA-based vaccines and genetically modified crops.

Myriad and its allies in the biotechnology industry counter that a ruling that invalidates gene patents would upend three decades of patenting practice and undermine billions of dollars of investments to develop not only genetic tests but also biotech drugs, DNA-based vaccines and genetically modified crops.

He said the impact of the Supreme Court’s decision “will be much more ideological than it will be practical.”

And experts say a relatively small number of other diagnostic tests or drugs are protected by patents on single genes.

“I don’t think this affects many patents that really matter to companies,” said Robert Cook-Deegan, a professor at Duke University’s Institute for Genome Sciences and Policy.

But in a study, Christopher Holman, a professor of law at the University of Missouri, Kansas City, found that many of those patents merely mentioned genes but would not block genetic testing, and many patents had been allowed to lapse.

And whole genome sequencing might not infringe patents on isolated genes.

The question before the court is whether isolated human genes are products of nature, and therefore ineligible for patents, or are sufficiently different from the genes found inside the body’s cells.

The plaintiffs won the first round when Judge Robert W. Sweet of Federal District Court in Manhattan said that isolated DNA was the same as DNA in the body in what really mattered — the genetic information it carries.

The plaintiffs won the first round when Judge Robert W. Sweet of Federal District Court in Manhattan said that isolated DNA was the same as DNA in the body in what really mattered — the genetic information it carries.

But Myriad prevailed at the United States Court of Appeals for the Federal Circuit, twice, by 2-to-1 decisions.

But Myriad prevailed at the United States Court of Appeals for the Federal Circuit, twice, by 2-to-1 decisions.

One of the majority opinions said that DNA was a chemical, not an information medium, and that disconnecting DNA from the chromosome changed it enough structurally to qualify for patenting.

“Under this rationale, a kidney ‘isolated’ from the body would be patentable, gold ‘isolated’ from a stream would be patentable and leaves ‘isolated’ from trees would be patentable,” they say in their brief.

Myriad and allies argue that patents can and have been granted on products derived from nature — like the immune-suppressing drug rapamycin, which comes from a bacterium — as long as sufficient inventiveness is involved.

Briefs in support of the plaintiffs were submitted by the American Medical Association, AARP, and various consumer and patient advocacy groups.

He said 18,000 researchers had published 10,000 papers on those genes, a sign that research was not being hindered.

One concern going forward is that a thicket of patents on individual genes will impede development of newer tests that look at multiple genes or of whole genome sequencing.

InVitae, a start-up developing a single test for all rare inherited diseases, filed a brief arguing against gene patents for this reason.

Dr. Cook-Deegan of Duke, along with Timothy Caulfield of the University of Alberta and some other researchers, argued in a recent essay that the Myriad case “stands as an example of the power of an anecdote or outlier case rather than definitive proof of systemic problems” with gene patents.

Dr. Cook-Deegan of Duke, along with Timothy Caulfield of the University of Alberta and some other researchers, argued in a recent essay that the Myriad case “stands as an example of the power of an anecdote or outlier case rather than definitive proof of systemic problems” with gene patents.