The environmental and public health impacts of U.S. patent law: making the case for incorporating a precautionary principle.

• Author: Kolitch, Shawn

1. INTRODUCTION II. THE IMPACTS OF PATENTED TECHNOLOGY: THREE CASE STUDIES A. Chlorofluorocarbons (CFCs) B. Dichlorodiphenyltrichloroethane (DDT) C. Asbestos and Public Health III. PATENTABLE SUBJECT MATTER IN THE UNITED STATES A. Historical Development of US Patent Law B. Modern US. Patent Law 1. Formal Requirements 2. The Substantive Scope of Patentable Subject Matter IV. THE PRECAUTIONARY PRINCIPLE A. History of the Principle B. Strengths of Precaution 1. Distinguishing Strong and Weak Principles 2. Hybrid Principles C. Scope of the Principle V. PRECAUTIONARY MEASURES IN FOREIGN PATENT LAWS A. Types of Patentability Exclusions B. The Public Health Exclusion C. The Environmental Harm Exclusion VI. INCORPORATING THE PRECAUTIONARY PRINCIPLE INTO U.S. PATENT LAW A. Proposed Method of Incorporating the Principle B. Practical Considerations: How to Draw the Precautionary Line 1. Internal USPTO Evaluation 2. Purely External Evaluation 3. Internal Evaluation with External Consulting. C. Policy Considerations: Where to Draw the Precautionary Line 1. Banned Substances and the "Ultraweak" precautionary Principle 2. Other Applications of the "Ultraweak" Principle 3. Scientific Uncertainty and True Precaution VII. CONCLUSION I. INTRODUCTION

   Scientific consensus regarding the environmental and public health impacts of a technological innovation often arrives years, or even decades, after the innovation itself. One well-documented example of this time delay between an innovation and a reliable scientific assessment of its potential impacts is the case of chlorofluorocarbons (CFCs). The United States Patent and Trademark Office (USPTO) granted the first patents on CFCs for use as refrigerants in the early 1930s, (1) and even as late as the 1950s, CFCs were still considered "miracle chemicals." (2) However, scientists later hypothesized that chlorine radicals from CFCs destroy atmospheric ozone, (3) which absorbs potentially damaging ultraviolet-B radiation (UV-B). Destruction of atmospheric ozone by CFCs leads to a wide range of harmful impacts, (4) including harm to the skin, eyes, and immune systems of humans and animals, (5) decreased photosynthesis and greater susceptibility to disease by terrestrial plants, (6) and a general reduction in productivity of phytoplankton. (7)

   Due to these and other effects, in 1990 the United States signed an international treaty banning CFCs from domestic production beginning in 2000, (8) with very limited exceptions for "essential uses." (9) Other notable examples of patented innovations later proven harmful to the environment and public health include dichlorodiphenyltrichloroethane (DDT), first patented in the United States as a highly promising insecticide in 194319 and eventually banned due to unacceptable risks of negative ecological and public health impacts in 1973, (11) and asbestos, first patented in 1828 as an insulating material in steam engines (12) and ultimately banned from most products in 1989. (13)

   In general, the state of scientific knowledge regarding the potential environmental and public health impacts of an invention 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, when CFCs were invented, the scientific community was ignorant of their harmful impacts and initially knew only of the beneficial uses of CFCs as refrigerants. (14) The era of scientific uncertainty began in 1974, when scientists first theorized that CFC emissions could significantly deplete atmospheric ozone. (15) Finally, scientific certainty dawned in the late 1980s, when scientists accepted as conclusive the link between CFC emissions and ozone depletion. (16)

   Perhaps surprisingly, USPTO grants patents without considering the state of scientific knowledge regarding an invention's possible harmful impacts; in fact, the agency is required by federal law to do so, (17) because federal law requires only a showing of patentable subject matter, utility, novelty, and nonobviousness. (18) As a result, USPTO routinely grants patents for inventions that are harmful to the environment and public health, as in the cases of CFCs, DDT, and asbestos. For example, USPTO has granted at least seventeen patents for inventions claiming aerosol uses of CFCs since the United States signed the Montreal Protocol in 1990. (19) In this manner, U.S. patent law arguably encourages--and certainly fails to discourage--the development of harmful technologies.

   Of course, USPTO cannot deny a patent on the basis of an invention's harmful impacts during an era of scientific ignorance of those impacts. In some cases, laws requiring testing and approval of potentially harmful substances may suffice to delay or prevent production and widespread use of the substances until they are proven safe. (20) In other cases of scientific ignorance, where the subject matter of an invention falls beyond the scope of required testing, measuring the invention's environmental and public health impacts may only be possible after the invention is patented and comes into widespread use. (21)

   USPTO, however, also issues patents even during eras of both scientific uncertainty and certainty regarding harmful impacts of the proposed invention. This occurs, for example, when a patent application describes an improvement to a previously patented invention, (22) the impacts of which have come under suspicion as harmful in the time since the original patent was issued, or when an invention's harmful impacts are a priori apparent (such as a known pollutant or carcinogen put to a novel use). During times of either scientific uncertainty or certainty with respect to an invention's potentially harmful impacts, one can reasonably ask whether granting a patent without regard to those impacts is sound public policy, or whether USPTO should apply a heightened patentability standard.

   USPTO encourages research, development, and production of an invention by offering the possibility of a patent for that invention, because a patent essentially provides a temporary monopoly to the inventor, with a term that begins when the patent issues and expires twenty years from the date of application for the patent. (23) More precisely, a patent provides a right to exclude others from manufacturing, selling, offering for sale, or importing products that contain all the elements of the patented invention. (24) Thus, an inventor or a patent holder is partially motivated to develop patentable technologies by the possibility of a federally granted temporary right to exclude.

   In providing such an incentive for the development and production of inventions without regard to their possible harmful impacts, Congress is tacitly relying on the market and on other areas of law, particularly environmental and public health law, to mitigate or prevent any potential resulting harm. However, due to the general insistence of the United States on a showing of actual harm before regulating an allegedly harmful activity, (25) these forces have been ineffective in many cases. This is particularly true during times of scientific uncertainty, when scientists suspect harmful impacts of an invention based only on limited evidence. However, delays in regulatory action often allow production and use of an invention even after scientists reach a state of certainty regarding its harmful effects. During such times of scientific uncertainty and certainty, providing a patent incentive to further develop and produce the invention seems questionable as a matter of public policy.

   The precautionary principle's evolution in environmental law is partially a result of the typical lag time between the development of a technological innovation and scientific certainty regarding the consequences of the innovation's production and use. Although the precautionary principle is still evolving and has no universally agreed-upon definition, (26) this principle may be viewed essentially as one of preventing environmental harm in cases where the scientific community has an incomplete understanding of the consequences of a putative environmental threat.

   In its "weak" form, the precautionary principle merely permits mitigating actions in the absence of scientific certainty about the environmentally harmful effects of an activity. For example, the Rio Declaration on Environment and Development (27) states that "[w]here there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation." (28) On the other hand, the "strong" precautionary principle requires such measures. For example, the Third International Conference for Protection of the North Sea (29) formulated a commonly cited example of the strong precautionary principle which requires "participants ... to take action to avoid potentially damaging impacts of substances that are persistent, toxic and liable to bioaccumulate even when there is no scientific evidence to prove a causal link between emissions and effects." (30)

   Despite differences in strength, essentially all versions of the precautionary principle share an important feature--although the principle will not necessarily stop an activity that may have environmentally harmful impacts, it provides that scientific uncertainty should not be used to postpone measures to prevent, mitigate, or reduce the adverse environmental impacts of the activity. In other words, although the potentially harmful activity typically will move forward, the principle provides that certain actions may--or, in the case of strong versions of the principle, must--be...