Mayo Collaborative Services v. Prometheus Labs., Inc. (Supreme Court 2011)
The briefing continues in this patentable subject matter case pending before the US Supreme Court. (Read Professor Golden's discussion of the first round of merits briefs). In its newly filed merits brief, Prometheus attempts to refocus attention on the "concreteness" of its patented method of personalizing the dosage of a particular drug treatment. The refocus begins with the statement of the question presented. Download 2011-10-31_Prometheus Merits Brief.
Mayo, the petitioner challenging the patent, opened briefing with a question of whether a patent that "covers observed correlations between blood test results and patient health, so that the patent effectively preempts use of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve "transformations" of body chemistry." This language of Mayo's question is directly suggestive of the decisions of Benson and Flook — both of which held claimed methods to be unpatentable.
In its brief, Prometheus restates the question in a way that instead highlights the concrete and practical application language found in Diehr and Brenner v. Manson. Prometheus asks: "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."
Prometheus describes its challenged invention as follows:
First, most of the claims begin with the administration of a thiopurine compound to a patient with an autoimmune disorder. As noted, the thiopurine converts within the body into metabolites that do not otherwise exist in nature.
Second, the patient's metabolite levels are determined. Because "metabolite levels are not detectable in raw human tissue," all methods for measuring their concentration require "significant chemical and physical alteration of blood or human tissue" and sophisticated laboratory equipment and machines. Some of the dependant claims, for example, specify the use of high pressure liquid chromatography (HPLC), which entails an intricate series of operations on the blood (including heating, centrifuging, separating, and adding various reagents), running the resulting solution through a computer-controlled chromatography instrument, calculating the peak height or peak area, and feeding those figures into an equation, which finally outputs the metabolite levels.
Third, the metabolite measurements are compared to the patents' reference levels, "warning" the physician about the potential efficacy or toxicity of the patient's dosage.
Several important points are hidden by the patentee's statement of its invention: First, although most of the patented claims do require administration of thiopurine some claims do not include that particular step. Second, although current technological methods of measuring metabolite levels apparently require the extraction of human tissue and the use of "sophisticated laboratory equipment," the broadest claims only require "determining" of the metabolite levels. Finally, it is likely important to recognize that the claimed method is about tweaking the dosage of thiopurine and at the time of the invention most of the individual elements of the claim were already well known: It was well known that thiopurine could be used to treat IBD; it was well known that that the body converted thiopurine to the claimed metabolite; it was known that individuals had varying responses to thiopurine; and it was known that dosage should be adjusted so that it would be both effective and nontoxic.
Summary of the Prometheus argument:
First, to be patent-eligible, a process must really be a process—a series of steps that involve physical action in the real world, as opposed to merely an idea or principle stated in the abstract. Second, that process must be described at a narrow and specific enough level of generality that it does not preempt abstract ideas or basic building blocks of science that go far beyond what the patentee actually invented: A process for using a telegraph is patentable; the basic idea that information might be transmitted at a distance by exploiting laws of electromagnetism is not.
A. Prometheus's patented methods describe concrete methods for improving treatment of seriously ill patients with specific synthetic drugs. These patents do not claim the "correlations" they employ in the abstract, but as part of specific physical processes employing drugs and machines. . . . As the Federal Circuit recognized, the patents-in-suit pass [the machine-or-transformation] test with flying colors and easily satisfy the requirements of §101. Mayo attempts to avoid that conclusion in three ways, none of which has merit. First, Mayo invites this Court to discard the two initial steps (administering the thiopurines and determining the resulting metabolite levels) because they were "well known" in the art. But this Court rejected that "point-of-novelty" approach over 30 years ago in Diehr and again recently in Bilski. Second, Mayo argues that those same two initial steps should be disregarded because, according to Mayo, they are not "central" to the patents' purpose. Mayo does this only by ignoring the Federal Circuit's settled construction that the claims are limited to patient treatment (a question not presented here) and that those two steps are essential to that purpose. Third, Mayo invites this Court to invent, out of whole cloth, a categorical rule that processes ending with the provision of useful information cannot be patentable—even if preceding steps involve machines and physical transformations. That argument also is inconsistent with Bilski, and it would impose an arbitrary and (in the information age) absurd limitation on patentability.
B. The patents-in-suit do not preempt natural phenomena in any relevant sense. Their "correlations" concern certain properties attending certain uses of non-natural thiopurine compounds, which would not exist but for the handiwork of man. 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. . . .
C. Prometheus agrees with the United States that the Patent Act's express statutory criteria for patentability—under 35 U.S.C. §§102, 103, and 112—make expansive judicial lawmaking under §101, of the sort invited by Mayo's arguments, unnecessary. But the application of those provisions is not before the Court in this case, and presents difficult and fact-bound questions that the lower courts should address in the first instance on remand.
II. Mayo proposes to transform §101 into an invitation for ad hoc, case-by-case evaluation of whether granting a particular patent will promote or retard the progress of the useful arts. That would create an unadministrable morass for courts and patent examiners, doom any hope for consistent administration of the patent laws, and usurp Congress's authority to determine the appropriate scope of the patent laws.
III. Any change in the Court's §101 jurisprudence that permitted a ruling in Mayo's favor, on whatever grounds, would have drastic and unfortunate consequences. It would upend settled expectations by invalidating thousands of diagnostic and personalized treatment patents. And it would stifle investment and innovation in the nascent field of personalized medicine. Contrary to Mayo's understanding, government funding does not translate pure academic research into practical products that benefit patients, and doctors themselves cannot bring to bear the resources necessary to fuel innovation and commercialize inventions on a large scale. Mayo's contention that patents like these hinder medical care is also unpersuasive. The United States is the world leader in biotechnology and personalized medicine, in part because investors have committed billions of dollars in capital in reliance on the prospect of patents like these. Thousands have been issued, including many to Mayo itself. Mayo's short-sighted view would exchange long-term innovation (including cost reductions) for ephemeral savings. In any event, Congress already considered Mayo's invitation to broadly restrict patent protection for medical diagnostic and treatment methods—and chose to adopt a limited personal immunity for doctors instead.
