|Trends & Perspectives|
In the ongoing legal saga that could significantly affect the development of molecular diagnostics, the Federal Circuit Court of Appeals in Washington, DC partially reversed a lower district court’s earlier ruling in a case challenging patents on two human genes associated with breast and ovarian cancer. The appeals court ruled that companies can obtain patents on the genes but cannot patent methods to compare those gene sequences.
“The ruling is a blow to the idea that patent law cannot impede the free flow of ideas in scientific research,” said Chris Hansen, JD, a staff attorney with the Speech, Privacy, and Technology Project at the American Civil Liberties Union (ACLU; New York City). “Human DNA is not a manufactured invention, but a natural entity like air or water. To claim ownership of genetic information is to unnecessarily block the free exchange of ideas.”
In 2009, ACLU and the Public Patent Foundation filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer not only stifle research that could lead to cures but also limit women’s options regarding their medical care. ACLU sued the U.S. Patent and Trademark Office as well as Myriad Genetics (Salt Lake City) and the University of Utah Research Foundation (Salt Lake City), which hold the patents on the BRCA1 and BRCA2 genes.
Under the patents, Myriad has the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes, and prevent any researcher from even looking at the genes without first getting the company’s permission. Myriad also has the right to enforce its patents against other entities and the rights to future mutations discovered on the BRCA2 gene. One of ACLU’s arguments was that Myriad’s patents are illegal and invalid under patent law because genes are products of nature.
In 2010, the Federal District Court for the Southern District of New York ruled that certain claims covering isolated DNA sequences in seven patents on the BRCA genes owned or exclusively licensed to Myriad Genetics were invalid.
In its appeal, Myriad argued that its patent claims on BRCA genes, which are used in its BRACAnalysis test for predicting breast and ovarian cancer risk, do comply with patent law. The company also argued that isolated DNA is a chemical composition, which is not found in the human body and has important diagnostic and therapeutic uses that cannot be accomplished with a human’s natural or native DNA as found in the body.
In its ruling, the appeals court said that it considered several issues that were presented in oral arguments and briefs, concerning whether isolated DNA was similar to naturally occurring elements or was rather something in part engineered by human development. The court also considered whether or not the plaintiffs in the suit had demonstrated that Myriad’s patents have caused any harm or hindered research on these gene variants. After reviewing the arguments, the appeals court stated that its decision that isolated DNA molecules are patentable comports with longstanding practices of the patent office.
However, one of the judges on the appeals court panel dissented in part with the decision, writing that patents on genes should be invalid. “Extracting a gene is akin to snapping a leaf from a tree,” Judge William C. Bryson wrote in his opinion. “Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention.”
“Upon contemplating the various opinions, I was not surprised by the result reached by the two judges who overturned the lower court’s ruling,” said Janet S. Hendrickson, PhD, a patent attorney at Senniger Powers (St. Louis). “The focus of their analyses was the differences between the DNA molecules claimed and the form that the DNA takes as part of a whole gene in the human body. When considering these differences, there are chemical differences at the cleavage points, which were emphasized particularly by the judge who wrote the majority opinion. In contrast, the dissenting judge focused on the similarities of the claimed DNA sequences compared to the DNA sequences in the genes in the human body and found for that reason that the DNA fragments were not patent eligible. I think these opinions reflect the range of possible frameworks that can be applied to the analysis of patent eligibility for DNA molecules.
“In terms of how this decision affects patent law and the IVD industry, I believe it was generally expected that the appeals court would decide the case as they did by returning to the status quo of isolated DNA molecules being patent eligible. This has been the stance of the patent office, and there are many granted patents that would become invalid if the opposite ruling was reached. With respect to the method claims that were held patent ineligible, the decision that the claims requiring only comparing or analyzing DNA sequences was not surprising since those steps could be performed solely by mental steps and were not transformative steps.”