|July 25, 2012|
Previously published on July 22, 2012
On Friday, July 20, 2012, the Federal Circuit heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), which is on remand in view of the Supreme Court decision in Mayo v. Prometheus. The courtroom was crowded again, but the mood seemed a bit lighter than the first oral arguments in April 2011. Reading the tea leaves from the judges’ questions and comments, I think the panel decision will depend on whether Judge Moore again concurs with Judge Lourie on the patent-eligibility of isolated DNA, or whether she feels compelled by Mayo to join Judge Bryson, who would invalidate the claims. A decision is likely a few months away, and the case is expected to make its way to the Supreme Court again.
The Question on Remand
After the Supreme Court remanded the case, the Federal Circuit asked for briefing on the following issue:
What is the applicability of the Supreme Court’s decision in Mayo to Myriad’s isolated DNA claims and to method claim 20 of the ’282 patent?
Did the Court Get Any Answers?
Each party started its argument by answering the remand question, but each turned quickly to arguments as to whether isolated DNA or cDNA is excluded from patent-eligibility as a product of nature and whether method claim 20 is excluded from patent-eligibility as being fundamentally a natural phenomenon.
For Myriad, Greg Castanias argued that Chakrabarty, not Mayo, is the Supreme Court case that governs this case. He emphasized the “human ingenuity” and “human judgment” required to arrive at the claimed DNA constructs, particularly with regard to deciding the starting and ending points of the genes (“where to cut” the isolated DNA from the genomic DNA sequence). He analogized this process with Judge Bryson’s baseball bat analogy, emphasizing that both involve human decision in which parts of the natural product to keep and which to discard. Judge Bryson countered with a tree trunk analogy, asking whether deciding where to cut a tree makes a tree trunk eligible for patenting.
Judge Bryson also asked if using a special laser to cut a tree would make the resulting tree trunk patent-eligible if the laser chemically altered the tree molecules where it made a cut. Although Mr. Castanias said “no,” I am not sure that I agree. Am I holding on too tightly to the machine-or-transformation test? At one point, Judge Moore went so far as to say, ”transformation is somewhat irrelevant at this point,” apparently referring to the Supreme Court’s decision in Mayo v. Prometheus.
With regard to claim 20, Mr. Castanias emphasized that the method is patent-eligible because it starts with a new “manufacture” (the transformed host cell), even though that new starting material is manipulated by known method steps. During his rebuttal time, he reminded the judges that Justice Breyer’s opinion in Mayo confirmed the principle that the new use of a known drug is patent-eligible, and analogized claim 20 to such a method.
The ACLU’s Arguments
For the ACLU, Chris Hansen argued that Mayo does govern this case, and that Myriad’s claims should be invalidated under Mayo. Mr. Hansen emphasized the breadth of the claims, and their preemptive effect on the ability of anyone to work with the naturally occurring breast cancer genes. Judge Moore was dissatisfied with the “breadth” arguments, stating that under Mayo breadth seems to be irrelevant, because laws of nature—no matter how narrow—cannot be patented.
With regard to claim 20, Mr. Hansen argued that it falls squarely under Mayo, and recites only putting the elements together and seeing what happens. Judge Lourie asked whether claim 20 was “significantly more” than a natural phenomenon, and Judge Moore asked whether claim 20 wasn’t more like Chakrabarty and less like Mayo. When Mr. Hansen got caught up in a line of questioning that had him saying that a method of using penicillin as an antibiotic would not be patent-eligible, Judge Bryson steered him back on track by “rephrasing” his point.
The United States’ Arguments
For the United States (but not for the USPTO in particular), Melissa Patterson argued that Mayo provides useful guidance for analyzing Myriad’s isolated DNA claims. Judge Lourie asked if the United States had abandoned its “magic microscope” test, and Ms. Patterson responded that although they still find it to be a useful metaphor, they understand that it was not particularly “helpful” to the court.
Ms. Patterson argued that the only differences between isolated DNA and naturally occurring genomic DNA are incidental to extraction, and so do not support patent-eligibility. She stated that even the asserted “new” utilities depend on properties that are inherent to naturally occurring DNA, such as its hybridization properties. She distinguished Chakrabarty by arguing that the human intervention at issue here did not confer any new utilities, but rather the utilities still stem from properties inherent to naturally occurring DNA.
During the United States’ arguments Judge Moore herself brought up her concerns about disturbing the settled expectations of the biotech industry after 30 years of granting patents to isolated DNA. Ms. Patterson responded that, under Mayo, policy concerns do not impact the application of § 101.
Reading the Tea Leaves
As Judge Lourie noted during the oral arguments, we are in the relatively unique position of knowing the judges’ views on the issues, since they already decided this case once. I did not see or hear anything in the judges’ questions and comments to suggest that either Judge Lourie or Judge Bryson have any different views after Mayo. Because Judge Moore’s concurrence seemed to rely at least in part on policy concerns, I think the main question that will impact the decision on remand is whether she reads Mayo as precluding consideration of the settled expectations of an entire industry and, if, so, whether she sides with Judge Lourie or Judge Bryson on the chemical divide that led to their original decisions.