The Proper Scope of Patentability in International Law

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. …