The proper scope of patentability in international law.

• Author: Kolitch, Shawn J.

INTRODUCTION I. THE ENVIRONMENTAL AND PUBLIC HEALTH CONSEQUENCES OF PATENTED TECHNOLOGY II. THE SCOPE OF PATENTABILITY A. A Brief Examination of Patentable Subject Matter in the United States 1. Formal Requirements 2. The Substantive Scope of Patentable Subject Matter B. Patentable Subject Matter in Foreign Laws and International Treaties 1. Exclusions for Harmful Inventions 2. Exclusions for Beneficial Inventions 3. Exclusions in International Treaties III. A PROPOSED INTERNATIONAL STANDARD FOR THE SCOPE OF PATENTABILITY A. Harmful Inventions: What to Exclude 1. Banned Substances 2. Other Inherently Reasonable Exclusions 3. Scientific Uncertainty and True Precaution B. Beneficial Inventions and Selective Exclusion CONCLUSION INTRODUCTION

The primary goal of patent law is to promote technological progress. (1) To this end, a patent generally provides an inventor with the incentive of a temporary monopoly on the right to make, use, and sell a patented invention, (2) in return for full public disclosure of the invention. (3) However, both the incentive to invent and the reward for inventing may have unintended and undesirable consequences because the harm caused by some inventions, or in some cases simply by the grant of the monopoly, may outweigh the benefits of the disclosure. On one hand, society may not wish to provide an incentive to invent in areas where the potentially harmful effects of an invention outweigh its putative benefits. On the other hand, even for an entirely beneficial invention, providing a patent may limit public access to the invention by allowing monopolistic pricing during the term of the patent. In such cases, the patent incentive is arguably misplaced.

Rather than ignoring the unintended--but nonetheless, harmful--effects of granting a patent, and focusing solely on maximizing the economic benefit to the inventor, patent law should counteract those effects by selectively limiting both the incentive to invent and the reward for inventing. This Article examines the undesirable consequences that may result from the patent incentive currently provided under U.S. and international law, and proposes a method by which those impacts can be limited by selectively narrowing the legal scope of patentability.

In this country, the United States Patent and Trademark Office (USPTO) is required by federal law to grant patents without considering either an invention's possible harmful impacts or the effects on public health of monopoly pricing resulting from a patent. (4) Instead, U.S. law requires only a showing of utility, novelty, and nonobviousness, (5) with patentable subject matter broadly defined to include "anything under the sun that is made by man." (6) This policy has two important consequences. First, the USPTO routinely grants patents for inventions that are harmful to the environment and public health. (7) Second, by indiscriminately granting patents on beneficial inventions, U.S. law allows monopoly pricing of many such inventions without regard to the impact of such pricing. This may, for example, contribute to the high costs of pharmaceuticals and of health care generally in this country. (8) Although such costs may be appropriate in the United States--and in other highly industrialized and relatively wealthy Nations (9)--monopoly power can severely limit access to pharmaceutical drugs and other beneficial inventions in developing nations. The problem is exacerbated by the fact that many developing nations lack the effective antitrust regulations of the United States.

Denying a patent based on the potentially harmful impacts of an invention is complicated by the fact that scientific consensus regarding the environmental and public health impacts of a new technology often arrives years, or even decades, after the technology itself. In the interim, the state of knowledge regarding the potential impacts of an invention generally progresses from scientific ignorance, when any harmful impacts of the invention are completely unknown and unsuspected, to scientific uncertainty, when harmful impacts are suggested by some scientific evidence, but the scientific community has not yet reached consensus, and finally to scientific certainty, when harmful impacts, if any, are well accepted by the scientific community. For example, the USPTO granted the first patents on chlorofluorocarbons (CFCs) for use as refrigerants in the early 1930s, (10) and CFCs were still considered "miracle chemicals" as late as the 1950s. (11) However, scientists later hypothesized that chlorine radicals from CFCs destroy atmospheric ozone, (12) resulting in a wide range of harmful impacts. (13) In the late 1980s, scientists accepted as conclusive the link between CFC emissions and ozone depletion, (14) and in 1990, the United States signed an international treaty banning CFCs from production starting in 2000. (15) There are many other notable examples of patented innovations that have later proven harmful, two of which--dichlorodiphenyltrichloroethane (DDT) and asbestos--will be discussed in more detail below. (16)

Analyzing the effects of patentability on the pricing of beneficial inventions is also complicated, but by economic rather than scientific considerations. Although granting a patent for an invention results in less competition and higher prices in the marketplace, removing the patent incentive entirely gives rise to the possibility that a product will never reach the market at all. For some of the most beneficial products, such as pharmaceuticals, research and development involves large sunk costs, lengthy development times, and great financial risk. As a result, the lure of monopoly pricing may be the deciding factor that induces a company to develop the product in the first place. Therefore, any proposal to limit patent rights must maintain a financial incentive sufficient to justify the risk and expense of developing beneficial new products. In other words, the law should strike a balance between providing inventors with a sufficient incentive to invent, and maximizing the number of people who can afford to purchase the resulting products. A key to striking this balance may lie in the large disparity in wealth among various nations. For example, in 2004, per capita gross domestic product (GDP) ranged from a low of $400 in East Timor to a high of $69,900 in Bermuda, (17) a difference of more than two orders of magnitude. As this huge discrepancy indicates, regardless of the presence or absence of a patent incentive, the citizens of different nations are not equally able either to develop high-cost inventions or to pay monopoly prices for those inventions.

This Article examines the environmental and public health consequences of patent laws around the world and argues that the patent incentive should be selectively removed to mitigate the harmful effects of granting patents without regard to the invention-specific impacts of doing so. After examining the scope of patentable subject matter provided by the domestic laws of the United States, the laws of other nations, and several international treaties, I conclude that patentable subject matter should be universally limited to exclude from patentability inventions that are known or strongly suspected to cause certain sufficiently harmful impacts, and it should be selectively limited to exclude from patentability certain classes of beneficial inventions in developing nations.

Part I examines the phenomenon of the undesirable patent, exploring, in particular, several past instances in which the widespread use of a patent has led to significant environmental and public health consequences. In the context of such cases, I will explore the extent to which patent laws not only permitted, but facilitated, the development of harmful technologies. Part II examines various national laws and international treaties that address the scope of patentability. This includes a brief examination of the evolution of U.S. patent law toward an increasingly broader scope of patentable subject matter without adequate evaluation of the public welfare impacts of patents. I then focus, in particular, on the attempts by other nations to institute precautionary measures to mitigate harms caused by unlimited patent incentives. Part III offers an assessment of the current inadequacies of existing patent laws, ultimately concluding that placing selective limits on the scope of patentable subject matter, which will exclude protection for some inventions, is warranted as a necessary means to counteract the possible undesirable effects of unrestrained patent incentives. Part III also presents some specific suggestions regarding the proper scope of patentability, including an examination of what should be excluded in accordance with necessary public policy considerations.

1. THE ENVIRONMENTAL AND PUBLIC HEALTH CONSEQUENCES OF PATENTED TECHNOLOGY

   As technology evolves, opportunities for improvement are identified and instituted, but the passage of time may also bring with it new information and insight into the unintended consequences of that technology. Our understanding of the implications of various patented technologies for the environment and public health progresses through eras of scientific ignorance, uncertainty, and then finally to some degree of certainty regarding the potential consequences. Throughout this time, successive generations of improvements and modifications typically result in the issuance of an increasing array of patents.

   An examination of past practice of the USPTO in granting patents for inventions at various times during the evolution of scientific knowledge concerning the impacts of the underlying technology is instructive in better understanding this phenomenon. In three notable cases involving CFCs, DDT, and asbestos, patents were issued for substances that the scientific community ultimately--and universally--later came to recognize and accept caused...