Ariosa v. Sequenom -- Ariosa's Responsive Brief

By Kevin E. Noonan --

The Federal Circuit heard oral argument in the Ariosa v. Sequenom case last Friday, and a discussion of that argument will be posted in due course.  Having posted on Sequenom's opening brief and the amicus brief filed by BIO, completeness requires a post on Ariosa's responsive brief and the amicus brief by Invitae, one of the defendants in the consolidated Myriad cases pending before the District Court for the District of Utah.

If Sequenom's brief focused on the lack of undue preclusive effect of their claims to a method for detecting paternal cell-free fetal-derived DNA (cffDNA) in maternal blood, Ariosa directs its arguments to the purported lack of "inventive concept" in Sequenom's claims.  This makes sense, because inventive concept is a patent feature even more standardless than undue preemption.  As a reminder, claim 1 of U.S. Patent No. 6,258,540 recites:

A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises
    amplifying a paternally inherited nucleic acid from the serum or plasma sample and
    detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

The argument Ariosa asserts is as follows.  First, the "discovery" of cffDNA is a natural phenomenon that is not itself patent eligible.  Ignoring the inconvenient fact that Isis, Sequenom's licensor, did not claim the isolated cffDNA per se, it may not even be the case that amplified cffDNA itself is not patent eligible, depending inter alia on whether the DNA is modified during amplification (see Section III of the Myriad opinion, where Justice Thomas specifically allows for that eventuality).  These considerations are important, because Ariosa then argues that Supreme Court authority (the Court's Mayo decision) "requires" method claims that "focus on the use of a natural phenomenon" to also set forth an inventive concept "apart from the natural phenomenon" in order to be patent eligible.  This argument follows the District Court's decision to treat all the judicial exceptions as equivalents, so that the Supreme Court's teachings regarding what is required to convert a natural law into a method reciting an inventive concept is equally applicable to natural phenomenon.  The propriety of treating the judicial exceptions as equivalents is not discussed but rather is accepted as a given, but it is not difficult to apprehend that method claims relying on the existence of a natural phenomenon may not be the same as such claims relying on a natural law; in any event this provides an unaddressed question at the heart of Ariosa's argument.

Next, Ariosa asserts that this inventive concept requirement cannot be satisfied by combining the natural phenomenon (sic) by combining it with "well-understood, routine and conventional activity."  The brief then sets forth the evidence that all the steps in the claim (the fractionating step, the amplifying step and the detecting step) were "well-understood, routine and conventional.  Thus, according to Ariosa, the '540 patent claims are invalid for failing to recite an inventive concept because the claims combine the natural phenomenon of cffDNA with such "well-understood, routine and conventional" method steps.  This portion of the brief addresses the key question posed by the Ariosa case:  should the law assess what is "routine, well-understood and conventional" per se, that is, outside the context of the claims as a whole, or is the proper question whether what is "well-understood, routine and conventional" is the claim as a whole, i.e., detecting cffDNA in maternal blood (consistent with the claims the Court analyzed in Mayo).  (This question is considered at greater length in "The Indefiniteness of What is 'Routine, Well-understood and Conventional' in Assessing Patent Eligibility of Diagnostic Method Claims.")

The brief also sets forth an argument that the Supreme Court's decision in Myriad is consistent with the District Court's decision that the '540 patent claims should not be patent eligible.  This argument reiterates Ariosa's earlier claims that cffDNA is a natural phenomenon.  Specifically, Ariosa argues that Myriad renders isolation of "newly discovered genetic material through conventional means" as not patent eligible; again, isolation is not the subject of these patent claims.  Ariosa then argues that Myriad can be distinguished from this case because here, the claims do not require creation of novel, man-made DNA, and that the '540 patent claims cannot be analogized to claim 21 of Myriad's U.S. Patent 5,753,441 because this claim has not been considered by any court (being among the overwhelming number of Myriad's claims not challenged by the ACLU and their plaintiffs in the Myriad case).

Ariosa addresses Sequenom's preemption argument by stating it conflicts with Supreme Court and Federal Circuit precedent, specifically with regard to the inventive concept question.  Finally, at the end of the brief, Ariosa deals with the three references asserted by Sequenom to show lack of undue preemption.  In this argument, Ariosa agrees with the District Court that the references are not relevant because they post-date the time the patent application that granted as the '540 patent was filed, and also asserts that the references failed to disclose a "substantial practical application" of alternatives to the claimed method, directing this portion of its argument on purported failures of the references to be able to detect cffDNA in maternal blood.  Tellingly, Ariosa does not address the District Court's standard that the only patent-eligible method claim would be one where there was a commercially practicable, non-infringing method available at the time a patent application claiming such a method was filed.

Invitae's amicus brief, filed to "rebut" BIO's brief, is itself rather short and consists of but a few propositions.  The first is that "following" what Ariosa and Invitae argue is "controlling precedent" from Mayo will not harm innovation in the genetic diagnostics industry because it has not happened yet, and there are those (mostly academics) who believe that patents are not necessary for the development of this industry.  Invitae further argues that preventing patents for genetic diagnostic methods will not result in data suppression, again based on unsupported predictions on how the industry will develop.  This amicus also argues that patents will prevent the development of the industry by "broadly preempting [the] application of natural laws" and that affirming the District Court will not constitute a "ban" on diagnostic patents.  Support for these assertions include the falling costs of genetic sequencing, which Invitae alleges will reduce costs and make genetic diagnostic testing available without needing patent exclusivity.  This argument misplaces the focus on the costs of the testing (which is only partly tied to sequencing costs) and ignores the costs associated with bringing such a test to market.  Failing to find any examples of diagnostic testing to support their "patents are not necessary" argument, the brief cites "the open source software movement for an illustration of a vibrant culture of innovation persisting in the absence of patent protection";  even here, the brief relies on an assessment of the "vibrant culture" from 2003.  And the brief raises the specter of a "patent thicket" that does not now and is unlikely to ever exist; indeed such fears have been raised since the days of the Human Genome Project as part of the "tragedy of the anticommons," another mythical beast never shown to exist.

The case is now in the hands of the Federal Circuit panel, with a decision expected in the next few months.

Comments

[GrzeszDeL]

"This makes sense, because inventive concept is a patent feature even more standardless than undue preemption."

Well said!

"The case is now in the hands of the Federal Circuit panel, with a decision expected in the next few months."

Based on the tone and tenor of the oral argument, may God help us.

[TVALOIR]

Ariosa is correct, in that it repeats the Supreme Court's analysis correctly. But of course, the Supremes have muddled the law, conflated 101 with 102/103 issues, and chops claims up for analysis, rather than considering the claim as a whole.

As to the Invitae argument that getting rid of gene and diagnostic patents will not result in data suppression, it ALREADY has since Myriad began keeping their variants of unknown significance as a trade secret for several years now. Without patent protection, other companies will be forced to do the same thing, though of course academics will continue to publish.

Even if the Federal Circuit sorts this mess out, the chances are good that the Supremes will just take the case and overrule them again.

Some 80 countries already prohibit patents on drugs, medical treatments and diagnostics, and in spite of the US position on the Trans Pacific Partnership (see QQE.1(3) at https://wikileaks.org/tpp), we are heading that way by judicial intervention.

[Kevin E. Noonan]

Well, TVALOIR, I'm not so sure Ariosa gets it right. If you click on the link to my earlier post you will see a fuller explication of my thoughts, but I do think there is a way to distinguish this case from Ariosa.

Thanks for the comment