PATENT PROTECTION FOR NATURALLY OCCURRING SUBSTANCES
The extent to which patent protection is available for naturally occurring substances may tend to affect significantly the amount of research and testing that takes place with such substances.
During the conference on natural substances, no consensus could be reached on the definition of the term "natural". Had a definition been agreed upon, however, that definition almost certainly would have been different from the manner in which the term "natural" is interpreted in the patent law. A brief examination of some basic principles of patent law will demonstrate the problems that exist in this area.
Under the patent statute, 35 U.S.C. Sec. 101, anyone who "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 for the invention, provided it is not obvious. In addition to the general patent statute, there are two laws that specifically address the patentability of plants. In the Plant Patent Act of 1930 Congress allowed certain plants that reproduce asexually to be patented, and in the Plant Variety Protection Act of 1970 Congress permitted certain sexually reproduced varieties to be patented. The purpose of these statutes was to reward the inventiveness of plant breeders who created new living organisms.
In 1980, the Supreme Court addressed the issue of whether a living organism, other than a plant, could be patented. Diamond v. Chakrabarty, 447 U.S. 303 (1950). Chakrabarty involved a patent for a human-made, genetically engineered bacterium which was capable of breaking down multiple components of crude oil. The Supreme Court held that the bacterium could be patented because it did not naturally occur in nature. In so doing, the Court stated that Congress intended the patent laws to "include anything under the sun that is made by man." 447 U.S. at 309. The Court further recognized that "the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions". 447 U.S. at 313. The patent laws do not, however, embrace the "laws of nature, physical phenomena, and abstract ideas". 447 U.S. at 309.
In the area of "natural" substances, therefore, it is possible to patent a plant if the plant is the product of man's ingenuity. A new process for extracting a pharmacologically active constituent of a plant could also be patented, even if the plant could not. Genetic engineering techniques which enable scientists to create analogues of naturally occurring products are also patentable even if the organism cannot be patented.
The patent laws provide considerable protection for novel products produced by man and, therefore, should provide some economic incentive for researchers who wish to conduct studies with natural substances. [color=red]The patent laws, however, provide limited economic protection for research with a naturally occurring substance, even if research shows that the substance is effective in the treatment of a particular disease.[color=red][/color]
In the absence of patent protection marketing exclusivity may be obtained only if the researcher obtains approval of a new drug application (NDA) from the Food and Drug Administration. An NDA is a license that authorizes the manufacture and distribution of a particular drug for a designated purpose. It is individual to the person who holds it. No one else can lawfully market that product without first obtaining approval of his own NDA. In any event, the NDA process is very costly.
In conclusion, patent protection is available on a limited basis for those who develop innovative processes and uses for natural substances and for those who create new substances. Natural substances that occur in nature, however, may not be patented.
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