The winning plaintiffs in the “Myriad Genetics” case, in which the U.S. District Court for the Southern District of New York ruled that isolated DNA sequences (genes) are not patentable subject matter under 35 U.S.C. §101, have asked Chief Judge Randall R. Rader of the Federal Circuit to recuse himself from the pending appeal of that decision, arguing that comments by the Chief Judge at two recent conferences suggest that he has already made up his mind that the district court’s decision is wrong. Acknowledging that Chief Judge Rader has not yet been assigned to the panel that will hear the appeal and may not be, the plaintiffs explain that they are moving for recusal now to give the Chief Judge time to consider the issue, rather than having to confront it for the first time, if he is assigned to the panel, on the day of argument. Association for Molecular Pathology v. United States Patent and Trademark Office, Appeal No. 2010-1406 (Fed. Cir.).

Background

In a widely reported decision earlier this year, Judge Robert W. Sweet of the Southern District of New York invalidated several patent claims directed to the isolated BRAC1 and BRAC2 genes – licensed exclusively by Myriad Genetics and used by Myriad in breast cancer screening – on the ground that isolated genes are unpatentable products of nature. The decision caused an uproar in the biotechnology industry, which has been obtaining patents on isolated genes for over 30 years and relies heavily on such patents to protect the fruits of its research. For an in-depth discussion of Judge Sweet’s decision, see IP Insight, July 2010, pp. 11-14.

As expected, Myriad and the other defendants appealed to the Federal Circuit. The appeal has not yet been calendared for argument and, under Federal Circuit procedures, the identity of the judges assigned to hear the appeal will not be known to the parties and the public until the day of argument. Even though the identity of the panel is not known, however, the parties who successfully challenged the validity of Myriad’s patents in the district court have filed a preemptive motion for the recusal of Chief Judge Rader. They argue that comments by the Chief Judge at two recent conferences suggest that he has already formed an opinion on the merits of the case, and that this requires recusal under 28 U.S.C. §455(a), which provides that a judge “shall disqualify himself in any proceeding in which his impartiality might reasonably be questioned.”

Statements at BIO and Fordham Conferences

The first statement cited in the recusal motion occurred on May 4, 2010, at the Biotechnology Industry Organization (BIO) conference in Chicago. BIO had submitted an amicus brief in support of the patentability of isolated genes in the district court. At the conference, Chief Judge Rader was a panelist in a session titled “Patenting Genes: In Search of Calmer Waters.” The motion states that “Chief Judge Rader listened to his fellow panelists discuss the facts of the case and the details of the patents as well as the wisdom and propriety of the decision.” The motion then quotes a report from BNA’s Patent, Trademark & Copyright Journal (May 14, 2010 at 47) allegedly showing that the Chief Judge “participated directly in this discussion”:

Rader, who had been mostly quiet in the discussion up to this point, said, ‘A troublesome question for me is the lack of legal standard for making this decision. In an obviousness analysis, there are some neutral steps that I can apply. But using Section 101 to say that the subject matter is unpatentable is so blunt a tool that there is no neutral step to allow me to say that there is a line here that must be crossed and that this particular patent claim crosses it or does not.’ [Chief Judge] Rader continued, ‘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.’

The motion then argues: “In other words, without reading the briefs submitted by the parties or hearing argument, Chief Judge Rader expressed his view of the district court’s decision.” The motion asserts that the Chief Judge’s comments are especially problematic because he “not only expressed his views on this specific case, but did so in front of an audience that was heavily biased in favor of one party.”

The other statement by Chief Judge Rader cited in the recusal motion occurred in April 2010 at the Fordham University School of Law Eighteenth Annual Conference on International Intellectual Property Law & Policy. There, one of the counsel for plaintiffs in the district court had begun speaking about “patent eligible subject matter” without mentioning the Myriad case. He pointed at a bottle of purified water and asked: “Was that [purification] sufficient intervention between what God gave us. . . and what man created to merit a patent?” In response, Chief Judge Rader asked: “How many people have died of water pollution over the course of human events?. . . Probably billions.” According to the recusal motion, this rhetorical question by the Chief Judge “hint[ed] at disagreement” with plaintiffs’ view of the law.

Myriad’s Response

Myriad’s opposition to the recusal motion cites case law and an advisory opinion from the U.S. Judicial Conference stating that a judge’s participation in a conference, even one “emphasiz[ing] a particular viewpoint or school of thought,” is not improper. Thus, according to Myriad, plaintiffs’ complaint that the audience at the BIO conference “was heavily biased in favor of one party” is not a valid basis for recusal. Myriad also disputed the plaintiffs’ assertion that the BIO panel in which the Chief Judge participated was one-sided, pointing out that the panel included a geneticist who had submitted a declaration in support of plaintiffs in the district court. With respect to plaintiffs’ assertion that “Chief Judge Rader expressed his view of the district court’s decision at the BIO conference” and “hint[ed] at disagreement” with plaintiffs’ position at the Fordham conference, Myriad argues that “each of these allegations depends on a subjective and unreasonable gloss placed on the reported remarks by [plaintiffs] and their counsel. . . .”

Turning first to the BIO conference, Myriad explains that the Chief Judge’s comments came in response to a statement by George Washington University Law School Associate Dean John Whealan regarding the lack of guidance from the Supreme Court concerning the standard for patentability under §101. Whealan is reported to have said that “part of the problem” is that the Supreme Court has laid out exceptions to patentability “without a lot of detail about what they were.” It was in response to this comment that Chief Judge Rader made the statement cited in plaintiffs’ recusal motion: “[The] troublesome question for me is the lack of legal standard for making this decision. In an obviousness analysis, there are some neutral steps that I can apply. But using Section 101 to say that the subject matter is unpatentable is so blunt a tool that there is no neutral step to allow me to say that there is a line here that must be crossed and that this particular patent claim crosses it or does not.” Considered in this context, Myriad argues, the statement provides no ground for recusal:

This statement could not reasonably be read as prejudging the case now before the Court. Indeed, it does not even suggest how Chief Judge Rader might vote, were he a member of the panel assigned to decide this case. To the contrary, this statement expressed precisely the sort of “views on general legal matters,” “expressions of opinion on legal issues,” and “[a] judge’s views on legal issues” that Plaintiffs-Appellees conceded “may not serve as the basis for motions to disqualify.”. . . Judge Rader’s comment was aimed at the difficulties he encounters in identifying a neutral principle for applying Section 101 because of the state of the law; his references to “the troublesome question for me,” “neutral steps that I can apply,” and “no neutral step to allow me to say that there is a line here” make that crystal clear.

Indeed, it is telling that the comments attributed to Judge Rader do not, on their own, make Plaintiffs-Appellees’ case for them; rather, they draw their own subjective- and unjustified-conclusion about what those words mean: “In other words, without reading the briefs submitted by the parties or hearing argument, Chief Judge Rader expressed his view of the district court’s decision.”. . . There is nothing in that press account that ties Judge Rader’s generalized comments about the state of the law to “the district court’s decision” in this case.

Plaintiff’s allegations with respect to the Fordham conference, according to Myriad, “are even more far afield.” As noted, the allegedly offending “hint” at disagreement with plaintiffs’ view of the law came after a speaker – one of plaintiffs’ counsel in the district court – pointed to a bottle of purified water and questioned whether the act of purification was “sufficient intervention between what God gave us. . . and what man created to merit a patent?” The Chief Judge asked in response: “How many people have died of water pollution over the course of human events? . . . Probably billions.” Myriad disputed plaintiffs’ assertion that this comment revealed bias against plaintiffs in this case:

This case, of course, does not involve purification of water, and so it is difficult to see how the brief exchange – which did not in any way involve the facts or decision in this case – could cause a reasonable and wellinformed observer to conclude that Judge Rader had pre-judged this case, which involves not bottled water, but the patenteligibility of isolated DNA and associated methods. Again, this comment was, at most, directed to the complex policy issues surrounding patents generally and Section 101 in particular; no reasonable, informed observer would take that as a comment on the merits of this particular case.

Federal Circuit Bar Association Amicus Brief

The Federal Circuit Bar Association has filed an amicus brief in support of neither party which stresses the importance of allowing judges to speak freely about general legal topics at conferences, in teaching classes at law schools, and in scholarly articles. The FCBA suggests the following standard of assessing whether recusal is required based on a judge’s allegedly case-related comments at a conference:

If the judge’s comments can reasonably be understood as general expressions regarding the law, recusal is not warranted, even if the views expressed are also relevant to a particular pending or impending case. Correspondingly, recusal should be considered, based on such comments, only if the objectively reasonable interpretation is that those comments constituted the expression of the judge’s specific views regarding the proper disposition of a particular identifiable pending or impending case, and reflect bias or predisposition (i.e., an unwillingness to consider the case with an open mind).

No Action For Now

The Federal Circuit has stated that it will not forward the motion papers to Chief Judge Rader unless and until he is assigned to the panel or the case is heard en banc. It is likely, however, that Chief Judge Rader will eventually have to rule on the motion. Even if the appeal is assigned to a three-judge panel that does not include the Chief Judge, the losing party at the Federal Circuit level can be expected to petition for rehearing en banc. Regardless of whether the en banc court elects to take the case, Chief Judge Rader would have to rule on the recusal motion before voting on the petition. If the appeal progresses along the usual schedule, with no significant extensions of time, it will likely be argued in early 2011.