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With the U.S. Court of Appeals for the Federal Circuit set to consider a landmark case over the validity of human gene patents, attorneys for the plaintiffs in the suit are asking the court’s chief judge to recuse himself from the matter—before the panel that will hear it has even been selected. In a motion filed quietly in late June, Christopher Hansen of the American Civil Liberties Union and Daniel Ravicher claim that remarks made by Federal Circuit Chief Judge Randall Rader at a biotechnology industry event show he may have a biased view of the case in question, Association of Molecular Pathology et. al. v. U.S. Patent and Trademark Office et. al, and should not be one of the three judges to decide the appeal. Questioning Rader’s objectivity is an unusual move that underscores just how high the stakes are in the case at issue, in which several doctors’ groups have joined the ACLU and PubPat in seeking to invalidate patents on two genes related to breast cancer that are owned by Utah-based Myriad Genetics–and, more broadly, to challenge the legality of the thousands of genetic patents already in existence. In March, New York federal district court judge Robert Sweet ruled in favor of the plaintiffs on summary judgment, saying Myriad’s patents on the BRCA1 and BRCA2 genes cover parts of the natural world and therefore don’t conform to the nation’s patent laws. Myriad has appealed Sweet’s ruling. The parties are to file appellate briefs by the end of the month, with amicus briefs to follow. In a further sign of the case’s importance, the Federal Circuit Bar Association jumped into the fray this week, filing a brief in which it argued that judges should be free to discuss the issues of the day at educational conferences, without fear they will have to recuse themselves repeatedly. Rader’s participation in such a discussion at a Biotechnology Industry Organization (BIO) event in May—and his comments about Sweet’s ruling—is what prompted the recusal request, according to the ACLU-PubPat motion. According to a report in the BNA Patent Copyright and Trademark Journal, Hansen and Ravicher write, Rader commented at one point during a session on gene patents that “a troublesome question for me is the lack of legal standard for making this decision….Using Section 101 to say that the subject matter is unpatentable is so blunt a too that there is no neutral step to allow me to say that there is aline here that must be crossed and that this particular patent claim crosses it or not….This approach is subjective and to be frank, it’s politics. It’s what you believe in your soul, but it isn’t the law.” Hansen and Ravicher say in their motion that Rader’s comments show that he is prejudiced in the matter. “Without reading the briefs submitted by the parties or hearing argument,” they write, “Chief Judge Rader expressed his view of the district court’s decision.” How this particular skirmish will play out is unclear. A notation on the case docket (PACER login required) indicates that the Federal Circuit has refused to rule on the motion until the three-judge panel that will consider the appeal is formed. The notation, dated July 29, reads: “The panel in this case has not yet been chosen. In the event that Judge Rader is assigned, we will transmit your motion to him.” The notation, signed only “clerk,” indicates that Hansen was informed of this by letter. The Federal Circuit’s three-judge panels are chosen at random, and Rader, despite his status as chief judge, has no special authority creating them. There are currently nine active judges and three vacancies on the 12-member court, making it unlikely that Rader will be among those tapped to hear the appal. PubPat’s Ravicher, who worked as an intern for Rader after graduating from University of Virginia Law School, declined to comment on the motion seeking the judge’s recusal. A separate section of the motion cites an exchange between Rader and Ravicher in April during a panel discussion at a Fordham University conference on “patent eligible subject matter.” At that session, the motion notes, Ravicher began his remarks by pointing to a bottle of purified water, and asking if in addition to allowing patents on a method of purification, it was a good idea to allow patents on purified water itself: “This is not water that exists in nature… The question we have to ask ourselves is, Was that sufficient intervention betwen what God gave us… and what man created, to merit a patent?” According to a transcript, Rader, who was in the audience, interjected: “How many people have died of water pollution over the course of human events?” “That’s an interesting question,” said Ravicher. “Probably billions,” Rader said, before Ravicher continued his talk. The motion describes Rader’s comments as “troubling” and says they “raise further questions about the appearance of his impartiality.” While asking a judge to step aside in a patent appeal is rare, the ACLU-PubPat move—asking a judge to recuse himself before a panel has even been formed—is even more unusual, if not unprecedented. It may also be part of a long-range strategy. The Federal Circuit, which is in charge of all patent appeals in U.S. courts, has been ruling on questions related to gene patents almost since its creation in 1982. In fact, the Federal Circuit has largely created the body of law that makes genetic patents enforceable. For that reason, many observers believe it’s unlikely that a panel of federal circuit judges will affirm the most dramatic aspects of Judge Sweet’s most ruling, which would effectively ban all patents covering human genes. Which is why Ravicher and Hansen may be pinning their hopes on the U.S. Supreme Court, which has over the past few years shown a decidedly more skeptical view of the patent system. If the Supreme Court is their ultimate goal, creating a record that suggests they didn’t believe they could get a fair shake at the Federal Circuit could help their case. The patent bar, meanwhile, appears to be taken aback by the request for Rader to recuse himself. Jennifer Gordon, the Baker Botts attorney who hosted the BIO panel cited in the motion and wrote BIO’s amicus brief in the Myriad case, says she finds the ACLU-PubPat motion “sort of surprising,” and disagrees that Rader’s comments were an indication that he had already made up his mind about the gene patent suit. “At conferences, people are talking about ideas, and not saying anything about cases they would decide once they have briefs in front of them,” Gordon says, adding that if motions like this proliferate, judges could become reluctant to attend panels and discuss legal issues. “It’s so wonderful to be able to hear from judges,” she says. “My main reaction to that brief is that I hope it doesn’t deter the judiciary from coming to conferences and sharing their thoughts.” The motion mentions that Gordon began the panel discussion by asking attendees to vote on whether they agreed with Sweet’s ruling. Gordon says only one hand went up in support of Sweet’s opinion. Other attorneys who specialize in biotech patents confirm that there is near-universal opposition within the industry—and among the lawyers who represent it—to a ban on genetic patents. “If you can’t cover the gene—if all you’re going to do is cover a particular test with steps that are easily designed around—that may not be sufficient coverage for a company to move forward [and market a genetic test],” says Michael Samardjiza, an IP attorney at Bracewell Giuliani in Houston. Samardjiza’s reception to the recusal request is just as skeptical. “I understand why the plaintiff-appellees want him off, but at the same time, I don’t think they have a case,” he says. “For them to actually raise this—they’re trying to find excuses.” Patent attorney Matt Osenga, who blogs at Inventive Step, was more strident, writing that the motion “seems to be a desperate act by parties that realize they have no chance of winning this appeal at the Federal Circuit… The ACLU is seeking publicity and to inflame the public with misleading rhetoric on gene patents.” And, as the Federal Circuit Bar Association’s brief makes clear, the move for Rader to recuse himself is widely opposed within the patent bar. Signed by FCBA Vice President Terence Stewart and attorneys from Gibson, Dunn & Crutcher and Weil Gotshal, the brief emphasizes that the federal Judicial Code of Conduct specifically allows for judges to discuss the issues of the day at educational conferences. Such interactions should be allowed even when “those general issues happen to have relevance to… pending cases,” the brief states. And if “generally stated views regarding the law” are enough to disqualify judges from cases, the brief notes, judges are likely be discouraged from teaching at law schools. Previous coverage of Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al.

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