Chapter 2 PATENTABLE SUBJECT MATTER The best ideas are common property. —Lucius Annaeus Seneca Epistles 12, 11 A. INTRODUCTION TO THE PATENT ACT This chapter deals with an issue generally known as “patentable subject matter” or “patent eligibility”: that is, the issue of which types of inventions are eligible for patent protection. Our inquiry in the chapter will focus on general classes of inventions. We shall consider, for example, whether patents can ever cover such things as living organisms, mathematical algorithms, laws of nature and business methods. Doctrines governing whether any particular organism, algorithm or method deserves a patent—what are known as “patentability” requirements—are reserved for Chapters 3 through 7 (which cover the utility, disclosure, novelty and nonobviousness requirements). Though patentable subject matter is conventionally treated (and will be treated here) as a distinct issue, it has significant connections to the history, thought and policies underlying the more specific patentability requirements mentioned above. Thus, this chapter will introduce policy considerations that will also be relevant in later chapters covering specific patentability doctrines. The statutory provisions relevant to patentable subject matter are quite brief; they are contained in only two sections of the statute. Section 101 of the statute provides: § 101. Inventions Patentable Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. This provision has been part of U.S. law for over two centuries; it descends directly from language enacted into law in 1793. See Patent Act of 1793, § 1, 1 Stat. 318, 319 (authorizing patents for “any new and useful art, machine, manufacture, or composition of matter, or any new and useful improvement on any art, machine, manufacture, or composition of matter”). In addition to § 101, the first two subsections of § 100 provides important definitions necessary for understanding the reach of § 101: § 100. Definitions When used in [the Patent Act] unless the context otherwise indicates — (a) The term “invention” means invention or discovery. (b) The term “process” means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material. At first glance, applying these statutory provisions might seem quite straightforward: simply ask whether an “invention” fits one of the listed categories in § 101—“process, machine, manufacture, or composition of matter”; if it does, the invention is eligible for a patent. Furthermore, the definitions in § 100(a) & (b) might seem to point toward a broad interpretation of the crucial words “invention” (which covers even a “discovery”) and “process” (which covers the older term “art” and extends even a “new use” of existing technologies). The approach taken by the courts, however, has not always been so simple. To take one example, a researcher who “discovers … [a] new and useful … composition of matter” — a pine needle with medicinal properties, for example — may be denied a patent on the grounds that the pine needle is merely a product of nature, not a human invention or discovery. In this and many other examples, the broadly worded provisions of the Patent Act must be read in light of the many cases over 200 years interpreting the statute. Thus, even though the law is ultimately based on statute, it has acquired a distinctly common law feel. In reading this chapter, you should be aware that patentable subject matter or patent eligibility doctrines are distinctly different in at least three ways from the patentability issues that will be covered in Chapters 3 through 7. First, as compared to the doctrines of patentability, patent subject matter is controlled much more by judge-made common law than by statutory law. While the patentability doctrines discussed in later chapters also have extensive case law that helps define the requirements of the law, each patentability doctrine can be tied back to fairly specific statutory text. That’s not true for patentable subject matter. The law of patentable subject matter is pretty much entirely judge- made, and indeed the Supreme Court has only occasionally attempted to reconcile its patentable subject matter case law with the text and structure of the Patent Act. Patentable subject matter thus raises an important question of power and institutional competence — specifically, whether Congress or the courts should have the predominant role in fashioning law of patents. Second, patentable subject matter law has a much broader focus than the individual patentability doctrines introduced in later chapters. While patentability doctrines tend to ask rather specific questions (e.g., Is the claimed invention new? Is it useful? Is it disclosed sufficiently well?), patentable subject matter tends to ask the much more basic and holistic question of whether the invention is the sort of thing that should be subject to exclusive rights. That more general focus of patentable subject matter could be seen as both a weakness and a strength of the doctrine. It’s a weakness because the generality of the inquiry can make the law in the area seem standardless and indefinite. But it also could be seen as a strength in that patentable subject matter allows courts to consider the complete aggregation of problems with a particular patent and to determine whether, on balance, permitting patentable eligibility advances or retards the goals of the statute. Third, at least in current practice, issues of patentable subject matter are treated as threshold issues to be decided by the PTO at the beginning of the administrative process to obtain a patent and by courts very early in infringement litigation (sometimes even as early as a motion New Chapter 2 – 2 to dismiss). By contrast, the patentability issues tend to be decided—at least under current lower court doctrine—towards the end of proceedings. It is questionable whether there should be such a dramatic procedural difference between patent eligibility and other patent validity doctrines, but the difference is a real one especially in current lower court practice. Given that difference, defendants in patent infringement litigation have strong incentives to raise patentable subject matter issues because success on them can invalidate the patent at the very beginning of litigation, saving months or years of litigation costs. Thus, patentable subject matter issues have been raised with dramatically increasing frequency in recent years. One of the most interesting and debated questions in current patent law—a question you should consider constantly as you proceed through this book—is to what extent issues of patent law and policy should be addressed through generalized, judge-made doctrines applied at the threshold of administrative or judicial proceedings, or alternatively, through more specific, statutory inquires to be addressed after administrative or judicial proceedings have developed a more detailed factual record. The following two opinions — one from 1980 and the other from 2010 — provide an excellent introduction to patentable subject matter doctrine. Though the decisions reach different outcomes in terms of whether the relevant subject matter is patentable, the two are more similar than they might at first seem. The opinions are presented below, with case notes after the two. DIAMOND v. CHAKRABARTY 447 U.S. 303 (1980) MR. CHIEF JUSTICE BURGER delivered the opinion of the Court. We granted certiorari to determine whether a live, human-made micro-organism is patentable subject matter under 35 U.S.C. § 101. I In 1972, respondent Chakrabarty, a microbiologist, filed a patent application, assigned to the General Electric Co. The application asserted 36 claims related to Chakrabarty’s invention of “a bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.”1 This human-made, genetically engineered bacterium is capable of breaking down multiple components of crude oil. Because of this property, which is possessed by no naturally occurring bacteria, Chakrabarty’s invention is believed to have significant value for the treatment of oil spills. 1 Plasmids are hereditary units physically separate from the chromosomes of the cell. In prior research, Chakrabarty and an associate discovered that plasmids control the oil degradation abilities of certain bacteria. In particular, the two researchers discovered plasmids capable of degrading camphor and octane, two components of crude oil. In the work represented by the patent application at issue here, Chakrabarty discovered a process by which four different plasmids, capable of degrading four different oil components, could be transferred to and maintained stably in a single Pseudomonas bacterium, which itself has no capacity for degrading oil. New Chapter 2 – 3 Chakrabarty’s patent claims were of three types: first, process claims for the method of producing the bacteria; second, claims for an inoculum comprised of a carrier material floating on water, such as straw, and the new bacteria; and third, claims to the bacteria themselves. The patent examiner allowed the claims falling into the first two categories, but rejected claims for the bacteria. His decision rested on two grounds: (1) that