Association for Molecular Pathology v. Myriad Genetics made its way to the Supreme Court this week as the court heard oral arguments. This is an important and closely watched case involving the patentability of human genes. Notably, the genes are not within the human body. Rather, the genes which have been patented by numerous biotechnical companies and research institutions are isolated human genes. In isolation, these genes do not possess the extraneous DNA within them as found in the human body.
More specifically, in this case, the University of Utah and Myriad Genetics own several patents covering methods of using a gene that correlates with early-onset breast cancer to test for that disease. The specific genes are known as BRCA1 and BRCA2.
It is already well established patent law that information classified as natural phenomena, such as discovering the process of photosynthesis cannot be patented. However, as discussed above, these genes have been isolated and changed from their natural location (within cells) and their natural state (with extraneous DNA). Thus, the crux of the issue is that even with isolation and extraction of these genes, the core of the patent claims involve natural phenomena – DNA sequences found naturally. Thus, a consortium of groups opposed to the patenting of genes chose to challenge these patents.
First, in the United States Supreme Court oral arguments, the justices focused on whether the isolated DNA sequences have a different function than the genes as they exist in nature. Justice Alito stated that “isolated DNA has a very different function from DNA as it exists in nature.” However, attorneys for the petitioners, Chris Hansen, proffered an analogy that “[i]f I find a new way of taking gold and making earrings out of it, that doesn't entitle me to a patent on gold.”
Next, the court turned the focus to how Myriad and other biotechnology companies should be rewarded for the time and money spent developing these inventions. As Justice Scalia questioned “[w]hy would a company incur massive investment if it –if it cannot patent?”
We expect that the Supreme Court will hand down its decision within the next couple of months. Although it is somewhat difficult to determine whether the Supreme Court will decide that isolated gene sequences are patentable. We believe that, in reading the oral arguments, available here http://www.supremecourt.gov/oral_arguments/argument_transcripts/12-398-amc7.pdf, the Court appears to be leaning in favor of making the distinction between isolated genes and genes as they exist in nature. More importantly, the Court appears reluctant to remove the financial incentive of biotechnology companies to conduct expensive and time consuming research to identify and isolate gene sequences. On the other hand, should the court decide against the patentability of isolated genes, we expect that methods of using such isolated genes will not be impacted by the Court's decision. However, depending on the breadth of the Court's decision, it may affect companies outside of the biotechnology arena who are researching and developing other products derived from natural sources. Thus, in our opinion, claims directed to both the isolated product derived from a natural source and methods of using the product are essential in any well drafted patent application.