Federal Circuit Oral Arguments in BRCA Gene Patent Case (Round 2)

On Friday, July 20, 2012, the Court of Appeals for the Federal Circuit again heard the case Association for Molecular Pathology v. United States Patent and Trademark Office. The plaintiffs in the case are represented by the ACLU and PubPat, while the primary defendant in the case is Myriad Genetics.

Case History

The case was first decided in 2010 when District Court Judge Robert Sweet ruled for the plaintiffs in the case, invalidating Myriad’s claims. Myriad then appealed to the Court of Appeals for the Federal Circuit where by a 2-1 decision last year, the court reversed the lower court and upheld the majority of Myriad Genetics’ patent claims over the BRCA1 and BRCA2 genes. The decision, though, was a fractured one with each judge writing his or her own opinion and analyzing past precedent differently. Details and analysis of that decision are available here.

The plaintiffs in the case then appealed to the Supreme Court of the United States. Soon after the Supreme Court unanimously invalidated certain method patent claims involving a diagnostic method in the case Mayo v. Prometheus, the Supreme Court granted the petition for writ of certiorari, vacated the decision and remanded back to the Federal Circuit (known as a GVR case). The Supreme Court essentially directed the Federal Circuit to rehear the case in light of the Mayo v. Prometheus ruling. Oral arguments largely focused on the single method claim upheld by the Federal Circuit last year, but counsel for both parties also spent some time on the composition claims as well.

The three-judge panel re-hearing the case is the same panel as last year. Last year, Judge Lourie (appointed by George H.W. Bush) authored the majority opinion finding that the structural differences between isolated DNA and that found in nature was markedly different and therefore the claims were patent eligible. Judge Moore (appointed by George W. Bush) concurred, but determined that the isolated DNA was found to also have a difference in utility than that found in nature. Judge Bryson (appointed by Bill Clinton) dissented, arguing that the structural and utilitarian differences between the isolated DNA and that found in nature were insufficient to render the claims patent eligible.

July 20, 2012 Oral Arguments

Friday’s oral arguments began with Gregory Castanias of Jones Day, representing Myriad Genetics, asserting that nothing in the Mayo v. Prometheus decision changes the assessment of the case and that the preemption considerations mentioned several times in the recent Supreme Court opinion does not create a separate or additional test that must be satisfied to determine whether a claim is patent eligible.

Counsel for Myriad turned again to the baseball bat analogy used during oral arguments last year, where he argues that while no one can patent a tree, one could make a baseball bat from the tree and patent the bat. Judge Bryson did not find this argument favorable noting that if one were to cut or clip a tree, he would still be left with an unpatentable tree. Castanias tried to rescue this argument by arguing that Myriad Genetics must determine where to start and end the isolated DNA strands, and that this determination is what lends the patentability to the isolated DNA. Judge Lourie, in obvious disagreement with Judge Bryson asked Castanias whether the Myriad claim was the product of human ingeniuty whereas the cutting of a tree would not be.

Judge Lourie then began questioning counsel for Myriad on claim 20, the one method claim upheld by the Federal Circuit regarding Myriad’s method claim over screening potential cancer therapeutics by tracking changes in cell growth rates. Castanias immediately argued that claim 20 was not at issue because, in a footnote in the petition for writ of certiorari, the plaintiffs noted that claim 20 was not being litigated and the issue was therefore not preserved. Judge Bryson immediately noted that GVR cases are “do-over” cases, as if the Federal Circuit had never decided the case. Judge Bryson said that it did not matter what the plaintiffs put in their petition for writ of certiorari because in GVR cases, the court would hear the case as if it were hearing it in the first instance. Castanias admitted that he could not point to any authority stating otherwise. Chris Hansen of the ACLU, arguing for the plaintiffs, later cited to recent authority that supported Judge Bryson’s point and rejected Castanias’ arguments.

The plaintiffs’ time was split between Chris Hansen, counsel for the ACLU and Melissa Patterson, counsel for the US Department of Justice.

Chris Hansen began by noting the “stunning breadth” of Myriad Genetics’ patent claims and turned to a preemption analysis which had been cited several times in the Supreme Court’s Mayo v. Prometheus decision. He noted that the breadth of the composition claims would include all possible forms of DNA–genomic, synthetic, metholated, cDNA, rNA. Judge Lourie interrupted and asked whether the holding in Mayo, which involved method claims, was irrelevant in the present instance with respect to the composition claims. Judge Moore agreed, suggesting the preemption does not apply and all that matters is whether the claim-at-issue is a law of nature.

Hansen then turned to claim 20 where he argued that this claim was exactly like that in Mayo. He asserted that all that is done in claim 20 is putting something into a eukaryotic cell and watching what happens (checking the growth). When Judge Moore noted that eukaryotic cells are not found in nature, Hansen responded that Myriad genetics did not make the eukaryotic cell and that he was not arguing over the patentability of the eukaryotic cell, but rather the method of use. Using analogies of aspirin and penicillin, he argued that because Myriad’s method claim merely involved administration and looking to see what then happens, it would not be patentable. Although penicillin itself may be patentable, the administration would not. According to Hansen, taking penicillin and placing it next to a cell and watching what happens and comparing it to what happens when putting the cell next to water would not create a patentable method claim.

Patterson of the DOJ then took the US’ turn for oral arguments. The US noted that the Supreme Court’s repeated discussion of products of nature and preemption was relevant and applicable. When questioned as to the position of the USPTO, Patterson noted that she is here representing the position of the United States, as authorized by the Solicitor General, but is not at liberty to discuss the interagency discussions nor was she able to speak for other agencies.

Patterson argued that the position of the DOJ Is that this was not a close case and the only change to the isolated DNA is incidental to its extraction. She noted that there would always be a strong preemption concern because there is no other way for researchers to use the gene.

Judge Moore noted her concern regarding the USPTO practice of patenting genes for the past 30 years and that industry has been built upon these patents. Patterson countered that the Supreme Court’s ruling in Bilski invalidated hundreds of patents, but that was not a reason to change the analysis of whether something is patentable. She noted that extraction of coal from the ground may give the coal utility, but that the miner extracting the coal did not impart that new ability to the coal. She focused on the difference between deriving utility simply by extraction versus an inventor bestowing the properties onto the item.

During Myriad’s rebuttal time, Castanias suggested that Mayo was distinguishable from the present case. He also repeated that determining the start and stop points in defining the molecules required “inventive judgment.” At this point, Judge Moore raised questions on whether it did require inventive judgment and noted that such judgment would also be required in separating coal from rock. Castanias argued that while coal would not be patentable, the current case required more complexity and it was therefore distinguishable. Following upon Moore’s point, Judge Bryson questioned whether a kidney would be patentable. Castanias suggested that the start and stop point decision was more complex with respect to isolating genes. Judge Moore, in what appeared to be a moment of frustration with respect to Castanias’ line of reasoning, noted that Myriad’s entire case rested on this proposition.

Ultimately, Judge Moore’s decision will likely be the determinative one in the case as it seems fairly clear where Judge Lourie and Judge Bryson stand. Although she did question whether “inventive judgment” had been used in isolating the gene, she also seems to have strong reservations in invalidating patents on DNA due to the long practice of USPTO issuing such patents. Her concerns with respect to the biotechnology industry building off DNA patents could play a significant role in her final decision.

Regardless of whether the Federal Circuit issues the same opinion or not, the case will almost certainly be appealed once more.