An overview of patentable subject matter and the effect of Mayo Collaborative Services v. Prometheus Laboratories, Inc.

CONTENTS INTRODUCTION I. PATENT ELIGIBILITY: THE MERGER OF STATUTORY GUIDANCE UNDER 35 U.S.C. [section] 101 AND PATENT LAW PRECEDENT II. OPPOSITE SIDES OF A BRIGHT-LINE RULE: THE CONFLICTING CONCLUSIONS OF THE FEDERAL CIRCUIT AND THE SUPREME COURT A. Mayo's Inescapable Ties to the Parallel Bilski v. Kappos Proceedings B. A Unanimous Decision: Analyzing Application Rather than Transformation III. THE IMPACT OF MAYO ON FUTURE PATENT EXAMINATION AND LITIGATION A. New 35 U.S.C. [section] 101 Patent Examination Procedures in the Wake of the Mayo Ruling B. Will the Federal Circuit Acquiesce to the Mayo Holding? CONCLUSION INTRODUCTION

This Comment provides a summary of the Supreme Court's most recent decision analyzing the bounds of patent eligibility: Mayo Collaborative Services v. Prometheus Laboratories, Inc. (1) In this March 2012 decision, the Court significantly departed from the Federal Circuit's (2) prevalent use of the "machine-or-transformation test" for determining the limits of patentable subject matter. (3) The Court unanimously reversed the Federal Circuit's decision in favor of Prometheus and found that the correlation between thiopurine drug dosage and a patient's subsequent metabolic response amounted to an unpatentable law of nature. (4)

The synopsis herein is intended as a general overview of subject matter that is patentable under 35 U.S.C. [section] 101, as well as the impact of the Mayo decision on patent examination and patent eligibility. (5) Thus, this Comment is predominantly intended for nonspecialists, as it does not scrutinize the scientific principles of Prometheus's patents or the decision's overall impact on the field of medical technology. (6) Part I of this Comment provides a brief introduction to the statutory bounds of patentable subject matter under 35 U.S.C. [section] 101. Part II summarizes the patents at issue in Mayo and the complex history of Prometheus's dispute. That section goes on to clarify the meaning and impact of the Court's landmark interpretation regarding the patent eligibility of natural laws. Finally, Part III discusses the effect of the Mayo ruling on patent examination procedures at the United States Patent and Trademark Office and the holding's potential impact on pending Federal Circuit cases.

1. PATENT ELIGIBILITY: THE MERGER OF STATUTORY GUIDANCE UNDER 35 U.S.C. [section] 101 AND PATENT LAW PRECEDENT

   Under 35 U.S.C. [section] 101, a patent is conferred upon "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof," subject to the additional requirements of the Patent Act. (7) In a broad sense, [section] 101 acts as a threshold to patentability by distinguishing between the discovery of an existing principle versus the creation of an original invention. Of course, the subsequent questions of whether an invention is novel, (8) nonobvious, (9) and adequately filed (10) are critical inquiries that encompass the bulk of patent examination and litigation. (11) But in order to warrant further examination, an inventor must first overcome the subject matter eligibility threshold of [section] 101. (12)

   The underlying premise of patent law is to incentivize progress and innovation by rewarding an inventor with the right to exclude others from capitalizing upon his advancements for a particular period of time. (13) To grant an inventor a monopoly over a general scientific rule would directly counteract patent law's purpose of promoting innovation. (14) Thus, even celebrated breakthroughs such as Newton's law of gravity and Einstein's revelation that E=[mc.sup.2] would not constitute patentable subject matter. (15) Although such discoveries were previously unknown and groundbreaking scientific advancements, the concepts as a whole describe existing natural laws and do not satisfy the patentability requirements of [section] 101. (16)

   Thus, the policy rationale behind subject matter inquiries--and patent law as a whole--is to balance an individual's right to capitalize upon his invention against the risk of hindering innovation by imposing an effective monopoly through patenting. (17) The Mayo Court described the balance between rewarding innovation and protecting the public domain:

   Patent protection is, after all, a two-edged sword. On the one hand, the promise of exclusive rights provides monetary incentives that lead to creation, invention, and discovery. On the other hand, that very exclusivity can impede the flow of information that might permit, indeed spur, invention, by, for example, raising the price of using the patented ideas once created, requiring potential users to conduct costly and time-consuming searches of existing patents and pending patent applications, and requiring the negotiation of complex licensing arrangements. (18) Both courts and commentators frequently cite the notion that an inventor may patent "anything under the sun that is made by man." (19) In practice, though, such a broad statement is ambiguous and somewhat misleading. Defining the precise bounds of what constitutes a patentable "process, machine, manufacture, or composition of matter" under [section] 101 has been a source of considerable debate, given the vague language of the statute and the fast pace of scientific advancements. Although not explicit in the language of [section] 101, courts are bound by the fundamental precedent that "laws of nature, physical phenomena, and abstract ideas" are not patentable subject matter. (20) The purpose of these exceptions is to bar an inventor from monopolizing discoveries that are "manifestations of ... nature, [that must remain] free to all men and reserved exclusively to none." (21)

   Although laws of nature, physical phenomena, and abstract ideas are never patentable, the boundaries that these exceptions encompass are frequently less straightforward than the aforementioned examples of attempting to patent gravity or the law of relativity. In Diamond v. Diehr, the Supreme Court noted that "'a process is not unpatentable simply because it contains a law of nature or a mathematical algorithm,'" because, in fact, "an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection." (22) In Diehr, the Court analyzed whether a mathematical formula, the Arrhenius equation, was a patentable matter within a process for curing synthetic rubber. (23) The Court held that although the "Arrhenius equation is not patentable in isolation," the inventors merely incorporated the equation to calculate optimal cure time, and the patent as a whole provided an innovative, new approach to the entire precision molding process. (24) Thus, the Court held that the "process [was] at the very least not barred at the threshold by [section] 101." (25)

   The boundary that separates prohibited recitations of natural laws from permissible applications of the same natural laws is unclear and thus a prime target for litigation. Mayo was the most recent effort by the Court to clarify where, precisely, this boundary exists. (26)

2. OPPOSITE SIDES OF A BRIGHT-LINE RULE:

   THE CONFLICTING CONCLUSIONS OF THE FEDERAL CIRCUIT AND THE SUPREME COURT

   Prometheus was the exclusive licensee of U.S. Patent No. 6,355,623 (27) and U.S. Patent No. 6,680,302. (28) In essence, the process protected by the patents instructed medical personnel to first administer a thiopurine drug to a patient and thereafter to measure the metabolites in a sample of the patient's blood. (29) The medical researchers behind the invention calculated the optimal ratios of the drug dosage to the patient's blood sample in order to maximize the dosage's efficiency while minimizing the risk of overdose. (30) Thus, the final aspect of the patented process indicated that a doctor should adjust the amount of thiopurine subsequently administered to the patient based on these precise ratios. (31)

   Thiopurine drugs are typically administered to treat gastrointestinal disorders such as ulcerative colitis and Crohn's disease. (32) Prior to the patents' claimed discoveries, researchers in the field understood the general relationship between the dosage of thiopurine relative to the amount of metabolites in a patient's blood; however, medical researchers had not established any sort of precise test to evaluate the correlation or determine the likely effectiveness of the medicine. (33)

   Prometheus developed the patented research into tangible diagnostic tests for medicinal use. (34) As the exclusive licensee of the technology, Prometheus sold the diagnostic tests to Mayo Medical Laboratories and Mayo Collaborative Services. (35) In June 2004, Mayo announced the company's intention to begin marketing its own diagnostic test with similar--though not precisely the same--thiopurine dosage parameters, and thus Mayo effectively terminated its relationship with Prometheus. (36) Immediately following Mayo's announcement, Prometheus Laboratories sued for patent infringement on June 15, 2004. (37)

   1. Mayo's Inescapable Ties to the Parallel Bilski v. Kappos Proceedings

      Prometheus's lengthy, and ultimately unsuccessful, effort to uphold their patents' validity was riddled with unusual procedural twists. Initially, the United States District Court for the Southern District of California found the Prometheus patents to be invalid and granted summary judgment in favor of Mayo. (38) The court concluded that the patents simply claimed correlations between thiopurine levels and the drug's therapeutic effects, and thus the patents were no...