Janice Mueller’s New Article: Patent -Ineligible Methods of Treatment

Patent-Ineligible Methods of Treatment

Janice M. Mueller 

Chisum Patent Academy
October 3, 2015
Janice M. Mueller, Patent-Ineligible Methods of Treatment, in MUELLER ON PATENT LAW, VOL. I (PATENTABILITY AND VALIDITY) (Wolters Kluwer Law & Business 2012), last revised October 2015


The Supreme Court’s sweeping 2012 decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc. was soon to impact the medical diagnostics research community beyond the parties to Mayo. In the view of this author, the Mayo framework created the potential for (presumably) unintended negative consequences that may chill future medical diagnostic research (an issue raised by Prometheus and various amici in Mayo). The Federal Circuit’s June 2015 decision in in Ariosa Diagnostics, Inc. v. Sequenom, Inc., aptly illustrates the concern. Compelled by the Supreme Court’s broad language defining the second step of the Mayo framework, the Federal Circuit in Ariosa affirmed the invalidation under §101 of a groundbreaking patent on prenatal testing.

Mueller Patent Ineligible Methods of Treatment

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One Response to Janice Mueller’s New Article: Patent -Ineligible Methods of Treatment

  1. Paul Cole says:

    It has been a pleasant afternoon here in the UK, and wearing my law professor’s hat, I would award award my colleague Professor Mueller a 60% grade – good solid pass but falling short of distinction level.

    The discussion of Prometheus v Mayo summarizes and paraphrases the opinion of the Supreme Court in that case but in my view what is needed is correct briefing of the case in the sense demanded of law students to determine (a) the essential factual background, (b) the holding, (c) the underlying rules of law and (d) the legal reasoning that led to the conclusion. What was the essential core reason why the Court made the finding that it did? In truth Prometheus is an extremely difficult decision to brief, and it is wholly unclear what rule of law flows from it that does not have consequences that were unintended (e.g. for the patentability of new uses for old drugs) that the Court went out of its way to say that it did not intend.

    The strange language “method of optimizing” in the exemplified claim at first sight invites ridicule and appears to have been given no weight in the opinion of the Court. Professor Mueller repeats the conclusion of the Supreme Court that the claimed method did not require a physician to make any adjustment in a patient’s drug dosage. However, those troubling to read the patent in issue will find a definition of the term:

    “As used herein, the phrase “optimizing therapeutic efficacy of 6-MP drug treatment” refers to adjusting the therapeutic dosage of a 6-MP drug such as 6-MP or azathioprine so that the concentration of a 6-MP metabolite that is correlated with effective treatment is maintained.”

    If Justice Breyer and his law clerks had read the patent with the appropriate attention to detail, they would have figured out that the claim when correctly interpreted does not end with the factual statements in the wherein clauses but instead positively requires the further human activity of the the physician adjusting the dosage so as to maintain it in the therapeutically effective but non-hazardous range, the word “maintenance” implicitly requiring repetitive testing and adjustment. There is nothing to suggest that prior to the patent physicians were making or able to make informed adjustments so as to administer the drug safely and effectively.

    The suggestion that the process in Prometheus “embodied the equivalent of natural laws” is based on an interpretation of the claim which is manifestly incomplete as would be apparent to any skilled reader of the patent. The precedental value of an opinion based on fundamental error in underlying fact, however prestigious the court, is an interesting topic for discussion.

    As explained in repeated postings of mine, the finding that the amplified PCR material in Ariosa is a naturally occurring product so that the process ends with a natural phenomenon is firstly incorrect because that material is synthesized from individual monomers using enzyme-catalysed chemical reactions and is clearly the result of the hand of man and secondly in quantifiable terms is in error by a factor of 1000 to 1,000,000 as is clearly and unequivocally apparent on the face of the opinion itself.

    The legal interpretation of Myriad to render short nucleotide sequences ineligible is crass – Justice Thomas said nothing of the sort, merely that such sequences were not automatically eligible on the basis of the ruling for cDNA if they did not cross an intron-exon boundary. Hopefully if Ariosa is taken en band the Federal Circuit will take the opportunity to do a proper job.

    Professor Mueller’s analysis in my view correctly identifies failure to consider the claimed process as a whole, and rightly cites Diamond v Diehr for the proposition that “a new combination of steps in a process may be patentable even though all the constituents of the combination were well-known and in common use before the combination was made”.

    In relation to preemption, has anybody thought that the patent only covers paternal cffDNA in serum or plasma? It remains open to any researcher to design around the patent by finding another body tissue or fluid in which the cffDNA is also present.

    Much more could be said, and some of the further points are to be found in my amicus brief.

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