Plaintiffs Begin Appellate Fight Over Gene Patents

As expected, Myriad has appealed the ruling by Judge Sweet that its patents on isolated genes and associated methods were invalid as not directed to patentable subject matter.  IPLaw360 (subscription service) is now reporting that the plaintiffs (the ACLU and others) have filed a motion at the Federal Circuit requesting that new Chief Judge Randall Rader recuse himself from the appeal saying that he has “pre-judged” the case prior to hearing the appeal.

Judge Sweet ruled in March that, because isolated DNA claimed in the patents was not “markedly different” from naturally-0ccuring DNA, the claims to isolated DNA were not patentable.  He made the ruling despite numerous precedent to the contrary by cobbling together some random statements from the Supreme Court’s decisions on patentable subject matter from the late 1970s and early 1980s.  The “markedly different” test for patentability had never been used before and seemed to be pulled out of thin air.

Judge Sweet went on to use the Federal Circuit’s machine-or-transformation test from In re Bilski to invalidate the method claims.  Given that the Supreme Court recently ruled that this is not the only test for patentability of method claims, the ruling on the gene patent method claims is also immediately suspect.

The plaintiffs point to several recent public statements made by Chief Judge Rader to argue that he has pre-judged the case without actually hearing the appeal.  According to the plaintiffs, in remarks at the May 4 Biotechnology Industry Organization annual conference, Judge Rader made these statements.

A troubling point 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;

[T]o be frank, it’s politics. It’s what you believe in your soul, but it isn’t on the law.

The plaintiffs also allege that Judge Rader made comments at another conference that he has applied his own patentable subject matter standard to the facts of the case and reached a conclusion.  This has been done without reading the parties’ briefs or hearing arguments in the case.


Filing a motion to have a judge recuse himself in a case is a drastic measure.  Recusals are generally at the discretion of a particular judge.  Appellate courts (in this case, the Supreme Court) only get involved if there is an extreme case of prejudice or bias.  It is difficult to know how Chief Judge Rader is reacting to the motion, but needless to say, he can’t be pleased.

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 Chief Judge is one of the more pro-patent members of the court, so the plaintiffs definitely do not want him on the panel that will hear the appeal.  They would also like to make sure that he isn’t involved in any potential en banc hearing should the case make it that far (given the 3 vacancies on the court, that would mean that only 8 judges would hear an en banc appeal).

This case has only been about one thing since the beginning and it’s not to get these particular patents invalidated.  The ACLU is seeking publicity and to inflame the public with misleading rhetoric on gene patents.  Filing a motion like this is simply another way of gaining such publicity.

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One Response to “Plaintiffs Begin Appellate Fight Over Gene Patents”

  1. Jocuri Barbie Says:

    Good blog!, I’m going to bookmark it on Twitter to get more clicks for you

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