Supreme Court Strikes Down Gene Patents

The Supreme Court’s decision in June that genes can’t be patented has far-reaching consequences for research and medicine — and for every one of us

The patent Myriad Genetics filed in 1994, laying claim to the DNA sequence of the gene BRCA1, wasn’t remarkable. It was one in a long line of some 40,000 patents on DNA molecules awarded in the past three decades, covering more than 20 percent of human genes.

But that patent took on a new importance last summer, when the Supreme Court ruled [PDF] that it and untold numbers of other DNA patents are invalid because naturally occurring DNA sequences cannot be patented. The decision has had immediate benefits for researchers and doctors, but creates new worries for the biotech and pharmaceutical industries. 

Before the ruling, Utah-based Myriad had a legal monopoly in the U.S. on tests for mutations in the genes BRCA1 and BRCA2 that contribute to aggressive forms of breast and ovarian cancer. The tests cost nearly $4,000, and patients couldn’t seek second opinions from other test providers. 

Women who participated in clinical research on the genes reportedly couldn’t even be told if they carried the mutation. Medical professionals argued that the patents threatened patient health by restricting access to the test. And researchers generally shied away from clinical research on any patented genes — a 2003 survey found that 53 percent of genetics labs decided not to develop a new genetic test because of a patent or license.

The June 13 ruling was a victory for some: By the end of the day, two competitors were offering lower-priced tests for the breast cancer genes. Future genetic tests are expected to come down in price. And labs are now freed to perform clinical testing on previously patented genes without fear of litigation. 

Wayne Grody, director of the Molecular Diagnostics Laboratories at the University of California, Los Angeles Medical Center, says his lab plans to offer tests for 15 to 20 previously patented genes, including those for congenital deafness and neurological diseases.

But the decision wasn't a slam dunk for gene-patent opponents. The judges agreed that isolating a stretch of DNA from surrounding genetic material is not a patentable innovation. 

However, cDNA — a widely used lab-made molecule that mirrors a natural gene but is edited to remove non-functional DNA — is eligible, as are patents covering testing methods. For this reason, Myriad contends that hundreds of its patents are still valid, and has sued competitor test-providers Ambry Genetics and Gene by Gene for patent infringement. 

The overall implications for the biotechnology industry are unclear. Companies and academic labs that offer genetic testing can now incorporate previously patented genes into their products. But if lower courts interpret the decision broadly, that could invalidate patents on other biological molecules, says Leslie Meyer-Leon, a registered patent and intellectual property lawyer. 

Anything “discovered” rather than “invented” might no longer be eligible for patent, including newly discovered and purified antibiotics, vitamins, proteins and antibodies — a huge share of pharmaceutical companies’ wares.

Meanwhile, technology limits the impact of the Supreme Court ruling: The falling price of whole-genome sequencing, which sidesteps patents altogether because it doesn’t require isolating a gene, makes it a reasonable alternative to a patented BRCA-style test. 

Eventually, time itself will clear up the remaining confusion: Gene patents are issued for 20 years, and many will soon expire.

New Signs of Long-Gone Life on Mars

A spectacular nail-biter of a landing was just the beginning. This was the year Mars’ rover Curiosity proved its worth by giving researchers unprecedented access to the Red Planet.



Curiosity looks back at the walls of Gale Crater in this colorized view.

In 1976, the Viking spacecraft gave us the first clear picture of the Martian surface — and sparked hopes that the barren, toxic planet once hosted life. In 2013, the rover Curiosity found the most convincing evidence yet that the planet was once habitable, as well as clues about why life there might have died out.

The $2.5 billion rover, roughly the size of a Mini Cooper automobile, discovered an ancient streambed soon after landing — evidence that water once flowed there. Next, Curiosity used its considerable payload of geologic tools to dig up further proof. 

Its robotic arm drilled a 2.5-inch borehole in mudstone bedrock. The robot fed the resulting rock powder into its Sample Analysis at Mars (SAM) instrument, which heated the sample, vaporizing it into gases that the tool could analyze.

Meanwhile, the Chemistry and Mineralogy (CheMin) tool beamed X-rays at the powder. The scattering of the rays reveals crystal structures, making it possible to identify Martian minerals.

The findings: carbon, hydrogen, oxygen, nitrogen, sulfur and phosphorous — key ingredients for life — plus chemicals such as sulfur dioxide and hydrogen sulfide that could provide energy for microorganisms. All were found in a locale that was once wet, and neither too salty nor too acidic.

“To tie that all up in one ball of twine: We found a habitable environment,” says John Grotzinger, Mars Science Laboratory project scientist at the California Institute of Technology.

Nonetheless, the rover found no sign of methane in the atmosphere, dashing hopes that methane-producing microbes might still dwell there now. By sampling other atmospheric gases, Curiosity also found one reason why life-friendly conditions vanished. 

Compared to the raw materials found elsewhere in the solar system (a record preserved in the sun and the gaseous planets Jupiter, Saturn, Uranus and Neptune) the Martian atmosphere has more heavy isotopes — heavier versions of basic elements such as carbon and oxygen. The skewed ratio suggests that the planet’s lighter isotopes escaped as part of a gaseous atmosphere and left a disproportionate amount of the heavy ones behind. 

The rover’s journey also collected evidence that a manned mission to Mars would require better shielding to safeguard the crew. The spacecraft carrying Curiosity found that with today’s propulsion and shielding technology, Mars-bound astronauts would be exposed every five or six days to as much radiation as a whole-body CT scan, a total of about 662 millisieverts by the end of the yearlong round-trip journey. This figure is beyond safety guidelines and enough to raise lifetime cancer risk by as much as 3 percent.

NASA is testing out new lightweight, durable shielding materials such as one made with hydrogen-filled nanotubes. Unlike larger atoms, when hydrogen is hit by cosmic rays it does not break down into showers of secondary particles that bombard astronauts with additional radiation.

Curiosity is now trekking toward the 3.4-mile-high Mount Sharp, where exposed rock layers that have preserved billions of years of geologic history may reveal more secrets about the Red Planet’s past. The rover should cover the five rugged miles in about a year. “Right now, it’s pedal to the metal,” says Grotzinger.