On Friday, the Federal Circuit heard oral arguments once again in the case of Association for Molecular Pathology v. Myriad Genetics, Inc. (the “Myriad case”). Last April, the Federal Circuit held its first round of oral arguments and decided that “isolated” DNA molecules do not exist in nature, and are therefore patent-eligible subject matter under 35 USC 101, and that Myriad’s claims to a method for screening potential cancer therapeutics via changes in cell growth rates is not merely a scientific principal, and therefore are also patent-eligible under 35 USC 101. AMP appealed to the U.S. Supreme Court, who remanded the case back to the Federal Circuit to consider whether the recent U.S. Supreme Court decision of Mayo v. Prometheus (which dealt with the patent eligibility of diagnostic method claims) has any bearing on the Myriad case. After briefing on this point, each side had an opportunity to argue their respective positions.
Counsel for Myriad again relied largely on Diamond v. Chakrabarty, arguing that it established the law for subject matter patent eligibility under 35 USC 101, and that the decision in Prometheus does nothing to alter this established law. He maintained that the human judgment needed to determine where cuts in the genomic DNA must be made to excise a particular gene, which parts to keep and which parts to discard, and even what definition of a gene (for which there is much debate over) is being used to drive such decisions renders the creation of “isolated” DNA something of man-made ingenuity and not something as it occurs in nature. In support of this, he directed the Court again to the numerous differences between DNA as it occurs in nature and the isolated DNA of the claims.
Counsel for AMP continued his previous position that the breadth of the claims at issue preempt naturally occurring DNA, and should therefore not be patent eligible. This, however, involved a very broad reading of the term “isolated DNA” that seemed taken out of context from the remainder of the claims. He relied heavily on the preemption argument, stating that Prometheus applies even though it dealt with method claims and AMP is challenging composition of matter claims here, since the product of nature doctrine applies equally to both. The breadth and preemption arguments were maintained even when challenged by the Judges that the breadth of the claims is irrelevant – if broadly excluded or narrowly excluded, it would still be excluded.
The representative of the U.S. government focused its arguments on the isolation or extraction process, and whether the changes made to DNA in isolating it are enough to render the resulting DNA product patentable. They put forth that they could not find a line where the Myriad patent claims could stand as patent eligible and yet other products of nature would not be preempted. Insisting that the U.S. government is seeking general rules or laws for patent eligibility under 35 USC 101, and not on gene patents specifically, they seemed most concerned during this stage of argument with the process of extracting DNA, and possible policy concerns that would prohibit the public from having access to products of nature.
The Court expressed concern over the possibility of disrupting property law rights (which patents provide) and the expectations of biotech companies that have come to highly value, and almost require, patents on their technology. Specifically, the Court queried why gene patents haven’t been challenged before in the course of the 30 years they have been granted, if they are not eligible for patent protection. A great deal of the Court’s focus also revolved around whether isolating or extracting DNA in order to arrive at the “isolated” DNA claims is more similar to merely extracting DNA from its natural surroundings or something entirely different.
The Court has already heard many of these arguments before, and we know how the Judges have decided on these issues, which is a rare situation. However, it remains to be seen whether Judge Moore, who appears to be the swing vote, will side with patent eligibility as she did last time, or will change her mind and decide the other way now.
For those interested, the audio recording of the oral arguments can be found here