In the on-going saga of the patentability of correlations between blood test results and patient health, Prometheus Laboratories submitted its brief to the U.S. Supreme Court.  The Court granted cert for the second time in Mayo Collaborative Services v. Prometheus Labs., Inc, Supreme Court No. 10-1150, to consider whether to set limits on when inventors can patent medical diagnostic tests.

An earlier judgment was vacated and the case remanded to the U.S. Court of Appeals for the Federal Circuit for further consideration in light of Bilski v. Kappos, 561. The Federal Circuit, reversing the district court, upheld Prometheus’s patent claims covering a means to measure the level of 6-thioguinine (6-TG) and 6-methylmercaptopurine (6-MMP), which indicates that an adjustment in drug dosage may be required at certain metabolite levels.

The district court decided as a matter of law that the asserted claims were drawn to non-statutory subject matter and as such, unpatentable.  However, the Federal Circuit held that methods of treatment claims fall within the realm of patentable subject matter. Prometheus Laboratories, Inc. v. Mayo Collaborative Services (08-1403).   The Supreme Court will review that ruling.

The question presented is:

Whether the Federal Circuit correctly held that concrete methods for improving the treatment of patients suffering from autoimmune diseases by using individualized metabolite measurements to inform the calibration of the patient’s dosages of synthetic thiopurines are patentable processes under 35 U.S.C. §101.

Brief Highlights:

“Mayo’s brief distorts the record and ignores the Federal Circuit’s unchallenged construction of the patents-in-suit. Prometheus’s claims are not drawn to scientific facts in the abstract, and they do not “preempt” broad principles like the laws of chemistry or the idea of measuring metabolites. No one can infringe these claims merely by thinking about correlations. The claims describe concrete and specific physical processes, employing synthetic drugs and machines, that are used only to improve the clinical treatment of seriously ill patients.

Mayo argues that the claims’ physical steps should be disregarded because they were old in the art, but that is precisely the discredited “point-of-novelty” approach to 35 U.S.C. §101 that this Court flatly rejected thirty years ago in Diamond v. Diehr, 450 U.S. 175 (1981), and again recently in Bilski v. Kappos, 130 S. Ct. 3218 (2010). This Court has made clear that a process must be evaluated for patent eligibility under §101 as a whole. Novelty and non-obviousness are distinct, fact-intensive questions that are not before this Court. And there certainly is no reason, at the dawn of the 21st century, for this Court to adopt special rules that would render personalized medicine inventions, or other processes designed to produce useful information, uniquely unpatentable under §101.”

The method claims in the patent at issue typically include two separately lettered steps: (a) administering a drug that provides 6-TG to a subject and (b) determining the levels of the drug’s metabolites, 6-TG and/or 6-MMP, in the subject. The measured metabolite levels are then compared to pre-determined metabolite levels, wherein the measured metabolite levels indicate a need to increase or decrease the level of drug to be administered so as to minimize toxicity and maximize efficacy of treatment.

Mayo, in its brief, continues to play up the harm to patients tactic saying:

Prometheus’s patents, which the district court invalidated but the Federal Circuit upheld, give Prometheus a sweeping monopoly on a biological correlation between drug administration and natural changes in blood chemistry. If these patents are sustained, health care providers, such as Mayo Clinic, cannot improve the numbers Prometheus has assigned to this correlation and provide more accurate drug monitoring services to patients at a lower cost, without permission from Prometheus.

In my mind, this argument is disingenuous.   The term “monopoly” is often misused in the context of patent law, but has a better-defined meaning in antitrust laws. A patent does provide the owner a limited monopoly to the claimed invention granted by the government for the term of the patent.

Patents are granted by governments in exchange for making a invention public. Once an invention is made public, others can improve upon it by making further inventions.  Thus, patents encourage research and development of ideas and concepts, which can improve our quality of life.

Saying that someone could provide a product or service for lower price but for a patent is just crying “WHAAAAAAA!” over the patent owner exercising legal patent rights.  To the extent that Prometheus is engaged in conduct permitted by patent laws, Prometheus cannot be construed as the bad guy.

The question here is whether the patent claims fail under 35 U.S.C. § 101 if it preempts all practical use of an abstract idea, natural phenomenon, or mathematical formula.  Mayo is arguing that the Prometheus patents claim a naturally occurring correlation between metabolites of a drug and the toxicity or efficacy of that drug, without specifying any concrete use of this correlation, which would preempt all practical use of the naturally occurring correlation.

Prometheus notes that “[a] patent system that recognizes thiopurine compounds themselves as potentially patentable subject matter, allowing preemption of all uses of these compounds, cannot be concerned that a process patent may preempt some of their uses. ”

Merits Briefs for the Petitioners

Amicus Briefs in Support of the Petitioners

Amicus Briefs in Support of Neither Party

Merits Briefs for the Respondent

Amicus Brief in Support of the Respondent

 

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