Those might not be the usual topics of conversation in the nation’s highest court, but on Monday, April 15, the Supreme Court Justices turned to simpler analogies to debate the complexities of DNA patents. In the Association for Molecular Pathology et al v. Myriad Genetics, the ACLU argued that patents on the isolated DNA sequences and cDNA of two hereditary breast and ovarian cancer genes are invalid. (cDNA is DNA synthesized using messenger RNA; it is often easier to manipulate in a lab setting.) With more than 20% of the human genome currently patented, Monday’s arguments and the much-anticipated Court’s decision in late June have the potential to dramatically alter the biotechnology industry.
The original complaint was filed on behalf of patients, physicians and researchers who argued that the patents, which claimed isolated breast cancer genes, cover a product of nature and are therefore invalid.
The plaintiffs believe that while Myriad might have identified these two hereditary cancer genes, they did not invent the DNA sequence itself. Drawing on the product of nature doctrine, plaintiffs argued that DNA exists in nature and cannot be patented. In response, Myriad’s lawyers pointed to baseball bats saying that similar to DNA, they are isolated from the wood of a tree and are patentable. Justices were quick to push back by pointing out that you can’t “snip” a bat out of a tree by cutting a few branches the way you can “snip” a sequence of DNA out of a chromosome. Justice Sotomayor preferred a sweeter comparison explaining that while she could patent a chocolate chip cookie, she can’t envision patenting the sugar, salt, and other ingredients used to bake that cookie. But the analogy that captured the most attention focused on removing the sap from a tree in the Amazon that has curative properties. While one can change the concentration of the sap and patent its use, one cannot patent the tree or the sap itself since it is a product of nature.
Analogies aside, the decision will focus on two types of DNA—isolated DNA and cDNA. In their briefs, geneticists stated that the latter does exist in the body, but acknowledged that this type of genetic material can also be synthesized in the laboratory. The Solicitor General argued that while isolated DNA is not patent-eligible, patents on cDNA are valid. This position also put forth at the appellate level is a reversal of the US Patent and Trade Office position of granting patents on isolated DNA sequences. Lawyers believe that reversing the patents on isolated DNA will be enough to enable other clinical laboratories to test these hereditary cancer genes, and for researchers to study the sequences even if the patents on cDNA are upheld.
Demonstrating the importance of this case, many Nobel Laureates and famous geneticists traveled to witness the arguments in person including Dr. James Watson, co-discoverer of the structure of DNA, who filed a brief in support of the plaintiffs. Patient advocates also rallied on the steps of the Supreme Court calling for the end of gene patents. Many of them shared their personal struggle with obtaining genetic tests for these cancer genes, and the inability to get a second opinion or confirmatory test from another lab before having radical surgeries and treatments to prevent cancer.