Late last year, the nation’s highest court said it would consider a legal challenge to patents that biotechnology company Myriad Genetics holds on genes linked to risk of breast cancer. Now, Eric Lander -- a leader in the human genome project, a scientific adviser to President Obama, and the head of the Broad Institute in Cambridge -- has weighed in, filing an amicus brief.
The document, carefully described as Lander’s personal view, argues that Utah-based Myriad has patented products of nature, which are ineligible for such protection. The patents, Lander argues, are an “insurmountable barrier” to studying the DNA, with serious repercussions for medical progress.
Although the brief is filed “in support of neither party,” it is a strong critique of the reasoning that has been used to protect the gene patents that Myriad holds on BRCA1 and BRCA2, breast cancer risk genes for which it sells a diagnostic test. In his brief, Lander proposes a thought experiment, asking the court to consider what would have occurred if such restrictive patents had been taken on HIV.
“The patent holder would have been legally entitled to use his patent to block anyone from observing, characterizing or analyzing the virus by any means whatsoever. Scientists would not have been able to rapidly learn the secrets of this insidious virus; drug developers would not have been able to develop life-saving drugs; technologists would not have been able to develop effective diagnostics; and patients would not have been able to know their HIV status,” Lander wrote. “To their credit, the discoverers of HIV obtained appropriately narrow patents that do not exclude others from observing, characterizing and analyzing naturally occurring HIV.”
To build his argument, Lander gets back to basic biology. The federal Circuit Court, which ruled in favor of Myriad’s patents, had reasoned that the isolated DNA fragments of the human genome patented by Myriad were not products of nature because they required human intervention to be cleaved out of the chromosome.
Lander, however, notes that for three decades, scientists have known that isolated DNA fragments occur naturally. Every time a cell dies, chromosomal DNA is broken into fragments. DNA fragments are found in cells, urine, spit, and stool. They are found in the blood of people with cancer, viral infections, stroke, or trauma -- and even in samples taken from people who exercise excessively. Analyzing such fragments in a pregnant woman’s blood is already used as a prenatal test to flag chromosomal disorders in fetuses. Fragments that contain the exact breast cancer genes on which Myriad holds patents were found in two studies, Lander notes.
He goes on to argue that understanding the genome, such as the risks conferred by a gene, is not an invention, “but rather is more akin to discovery of a law of Nature.”
The Myriad case is due to be heard before the Supreme Court in April. The biotechnology industry argues that if the patents aren’t upheld, such a decision could erode much of the foundation for a wide array of businesses that range from pharmaceutical companies to agricultural companies. Scientific organizations and patient groups have argued that the patents impede research, and even patients’ ability to know their own risks.
Lander suggests that the court could rule carefully on the Myriad case without endangering the broader industry. The court could rule as invalid patents on fragments of the human genome, while allowing patents on DNA obtained through a process that involves reverse- engineering a DNA blueprint from other genetic material that produces proteins.
“Science is the systematic and cumulative study of the natural world,” Lander wrote. “For scientific progress to proceed, scientists must have the ability to study the handiwork of Nature.”