What is patentable subject matter? The Supreme Court dismissed LabCorp v. Metabolite Laboratories, but the issue is not going away.

AuthorMota, Sue Ann

Introduction

Patent law seeks to strike a balance regarding patentable subject matter between overprotection, which can impede the free exchange of ideas, and underprotection, which can lessen the incentive to invent. (1) Thus, what actually constitutes patentable subject matter under the Patent Act (2) is an important question and a question that the U.S. Supreme Court avoided in June 2006 by dismissing Laboratory Corp. of America Holdings (LabCorp) v. Metabolite Laboratories, Inc. (3)

Section 101 of the Patent Act regarding patentable subject matter was not argued in the court below so the Court did not decide LabCorp on the patentable subject matter issue. (4) Future litigants, however, will not likely neglect to argue this so the Court will no doubt face this issue again. This article will examine the LabCorp case and the issue of patentable subject matter, concluding with recommendations for when the issue is raised by subsequent litigants. It seems probable that the Court will again address the subject of statutory subject matter on a case brought properly before it and will strike the balance that will encourage innovation but will not extend protection to processes or business methods that are merely ideas, phenomena of nature, or laws of nature.

  1. PATENTABLE SUBJECT MATTER

    "The Congress shall have Power ... [t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." (5) Pursuant to this power, Congress passed several patent acts, starting with the Patent Act of 1790, which allowed one who "invented or discovered any useful art, manufacture, engine, machine, or device, or any improvement" not known or used before to petition for a patent. (6) The Patent Act of 1793 allowed an inventor to obtain letters patent for "any new and useful art, machine, manufacture or composition of matter, or any new and useful improvement." (7) The Patent Act of 1836 again protected "any art, machine, manufacture, or composition of matter" and provided the foundation of the modern American system. (8) The Patent Act of 1870 again revised patent law. (9)

    Under the current patent law, as originally enacted through the Patent Act of 1952, an inventor may obtain a patent for "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement." (10) Congress replaced the term "art" from prior acts with "process." (11)

    The Court has interpreted patentable subject matter numerous times. An illustrative and nonexhaustive discussion of key cases follows.

    In 1854, the Supreme Court considered one of Samuel Morse's claims regarding his patent on the electromagnetic telegraph in O'Reilly v. Morse. (12) Morse's eighth claim on the patent for use of the motive power of electric current, or electromagnetism, designed for making or printing letters or characters at a distance, (13) was deemed overbroad by the Court. (14) Generally, the use of natural phenomena cannot be patented. (15)

    The Court in 1972 in Gottschalk v. Benson (16) held that a method of computer programming to convert binary-coded-decimal numbers into pure numbers, which was not limited to any particular art or technology, was not a patentable process. The Court cited Morse when reaching the conclusion that a mathematical formula, like a law of nature, may not be patented. (17) Ideas, phenomena of nature, and algorithms are not patentable, (18) as they are the basic tools of scientific and technical work. (19)

    The Court in Parker v. Flook (20) in 1978, citing both Morse and Gottschalk, held that a method for updating alarm limits during a catalytic conversion process was not patentable subject matter under 35 U.S.C. [section] 101. (21) The Court stated that this case turned on the proper construction of [section] 101. (22) The plain language of this section does not answer the question, and the line between a patentable process (23) and an unpatentable principle is not always clear. The Court concluded that the patent application contained no claim of a patentable invention, as the processes involved in catalytic conversion were well-known, and the application simply provided for new methods of calculating alarm limit values. (24)

    The Court again construed [section] 101 in 1980 in Diamond v. Chakrabarty (25) and held that a live, human-made, genetically engineered bacterium capable of breaking down crude oil was a patentable subject matter. (26) While Congress has the role of defining patentable subject matter in [section] 101, the courts must construe Congress's language. Finding no ambiguity in the statute, (27) the Court found that the language covered Chakrabarty's invention. (28) This does not mean, however, that [section] 101 has no limits or embraces every discovery. Citing Morse, Gottschalk, and Parker, the Court found that laws of nature, physical phenomena, and abstract ideas were not patentable. (29) Similarly, a new mineral discovered in the earth or a new plant discovered in the wild could not be patented, just as Einstein's equation and Newton's law of gravity could not be patented. (30)

    The Court interpreted patentable subject matter again in the 1981 case of Diamond v. Diehr, (31) holding that a physical and chemical process of curing synthetic rubber fell within the statutory subject matter requirements, even though a mathematical equation and computer program were used in several steps of the process. (32) While mathematical formulae and laws of nature are outside the statutory subject matter, (33) the subject matter for which a patent was sought in Diehr was defined as a process. (34) Citing Chakrabarty, which had been decided in the prior Term, the Court examined the statute and reached the conclusion that such industrial processes have historically been eligible for patent protection. (35)

    Against this backdrop of Supreme Court statutory jurisprudence, the dissent in the Supreme Court's dismissal of LabCorp (36) reached its conclusion.

  2. LABCORP

    In the 1980s, three university doctors conducted medical research on vitamin deficiencies and discovered a correlation between high blood levels of homocysteine and deficiencies of folate (folic acid) and cobalamin (vitamin [B.sub.12]). (37) The researchers developed more accurate homocysteine tests using a gas chromatography and mass spectrometry method; they then published their findings and applied for a patent. (38)

    Patent number 4,970,658 (the '658 Patent) was issued to the inventors in 1990 for a method for determining total homocysteine levels, including methods for detecting cobalamin and folic acid deficiencies using an assay for total homocysteine levels and methods for distinguishing cobalamin deficiency from folic acid deficiency using an assay for total homocysteine levels in conjunction with an assay for methylmalonic acid. (39) The claim at issue was claim number thirteen, which contained a method for detecting a cobalamin or folate deficiency using the steps of "assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate." (40)

    The inventors' universities assigned the '658 Patent to University Patents, Inc., which later became Competitive Technologies, Inc. (41) Competitive Technologies then granted a license of the '658 Patent to Metabolite Laboratories. (42) Metabolite sublicensed the patent to Roche Biomedical Laboratories, which is now LabCorp. (43) In 1998, LabCorp switched to a total homocysteine assay developed by Abbott Laboratories and stopped paying royalties to Metabolite Laboratories. (44)

    Competitive Technologies sued LabCorp for patent infringement, inducing infringement, and contributory infringement; Metabolite Laboratories sued LabCorp for breach of the license agreement. (45) The district court held a Markman hearing (46) to construe terms of the patent claims. The term...

To continue reading

Request your trial

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT