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Intellectual property: Trademarks, Copyrights, Trade Secrets, and Patents Patent type: Utility Subject matter Statutory requirements: useful, novel, non-obvious Reproduction and use Inventorship |
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Reprinted with permission of John R. Wetherell, Ph.D., Patent Attorney © All rights reserved 1995 In recent years, society has witnessed the explosive growth of biotechnology research. Much of this research has had a profound effect on our perception of the fundamental fabric of life itself. However, because of the complex nature of these discoveries, commercialization is often a long and expensive process. As a result of the need to achieve a proprietary position over this technology and the investment entailed in its commercialization, the field has seen phenomenal growth in the number of biotechnology patent applications which have been filed. BIOTECHNOLOGY PATENT CONCEPTS Intellectual property is a term used to describe property that is not tangible, but which instead originates through the creative effort of the inventor. Such property can be further characterized as a trademark, a copyright, a trade secret, or a patent. These divergent areas have in common a highly abstract concept of property. Trademarks include words, names, slogans, logos, and symbols which are used to indicate the source of a product or service. A trademark owner has the right to stop the commercialization of competitive goods having trademarks which are confusingly similar to those of the trademark owner. A copyright is the right to the exclusive publication, reproduction, adaptation, display, and performance of an original work which is fixed in a tangible medium of expression. A copyright protects the expression of an idea, but not the idea itself. A trade secret can be patentable and, unlike patents, is potentially indefinite in duration. However, the value of a trade secret is lost once it is disclosed. Also, the holder of a trade secret has no cause of action against those who independently discover the trade secret. From a societal standpoint, probably the greatest disadvantage of a trade secret is that, by its very nature, the trade secret may die with the owner. For example, the methods of treating wood employed by the famous violin maker, Stradivarius, have been lost forever. It was partly in response to the drawbacks of trade secret protection, as embodied by the Guild System of Medieval Europe, that the patent system was established. The public policy behind the patent system is to encourage inventors to share their discoveries with the general public and thereby advance the general status of technology. The advancement is accomplished by encouraging innovation through giving the inventor the right of exclusive commercial use, and by encouraging competitors to design around the invention. Thus, the knowledge of the inventor is preserved for the benefit of society and future generations. In the U.S., patents can be further categorized as design, plant, and utility patents. The most important type of patent, from a scientific and commercial standpoint, is the utility patent. From the standpoint of the inventor, the purpose in trying to obtain a utility patent is to secure the exclusive right to make, use and sell the patented invention. Those exclusive rights exist for the term of the patent. Patent terms were recently changed: (1) for applications filed after June 8, 1995, the term of any patent that issues will be 20 years from the first effective United States filing date of the application; (2) for applications on file on or before June 8, 1995, and for patents in force on June 8, 1995, the term of the patent is the longer of 20 years from the date of filing or 17 years from issuance of the patent. The first thing which should be considered in determining whether a utility application should be filed is whether the subject matter of the invention is proper under the patent laws. One can address this issue by first considering what types of subject matter are not patentable. Non-patent subject matter includes:
In biotechnology, some of the most valuable types of patents fall into the composition of matter category. The term "composition of matter" includes mixtures of chemicals, pure chemical compounds, polymers (such as plastics), and purified products not pure in nature. Examples of this latter category are antibiotics, enzymes, and lymphokines. More specifically, patents can be obtained for:
Assuming an invention is patentable in terms of subject matter, there then remain three statutory requirements which the invention must meet: the invention must be useful, novel, and non-obvious. "Useful" means the invention must be of some (even if small) benefit. Thus, the statute precludes obtaining a patent on an invention which is merely a curiosity, or which is illegal or immoral. For example, a machine useful solely for producing counterfeit money is unpatentable. The requirement that the invention be useful does not mean it must rise to the level of being commercially useful. Many inexperienced applicants believe they must delay filing a patent application until they have developed the invention to the point where it is a commercial product. For example, where a new anti-cancer drug has been discovered, inventors sometime believe, wrongly, that human data meeting the requirements of the FDA must be obtained in order to file a patent application, whereas it is usually sufficient to have in vitro data showing inhibition of a cancer cell line. In fact, delaying filing a patent application in order to generate elaborate experimental results carries with it the very real risk that another inventor will file ahead of you. Another statutory requirement of the patent law is that the invention be novel. The events which can prevent an invention from being considered novel are events which occur (1) before the date of invention, and (2) more than 12 months before the filing date of the patent application. Thus, a patent cannot be obtained if, before the date of invention, the invention was: (1) publicly known or used by others in this country, or (2) patented or described in a printed publication anywhere in the world. Further, a patent cannot be obtained if, more than 12 months before the filing of the patent application, the invention was: (1) patented or described in a printed publication anywhere in the world, or (2) in public use or on sale in this country. It is important to keep in mind that the 12-month publication grace period is unique to U.S. law; most foreign countries have a different rule, known as absolute novelty. Absolute novelty means patent protection is lost by sale or publication of the invention prior to the filing of the patent application. Non-obviousness of an invention, like novelty, involves a comparison of the invention with the prior art. But, unlike novelty, which only considers prior art which is the same as the invention, obviousness considers the prior art with respect to what the next obvious step would have been. In evaluating obviousness, it is necessary to evaluate the so-called subjective and objective indicia of obviousness. The subjective factors relating to obviousness have been defined by the U.S. Supreme Court: (1) the scope and content of the prior art; (2) the differences between the invention and the prior art; and (3) the level of ordinary skill in the art. The objective obviousness factors, developed by the courts over several decades, are: (1) commercial success; (2) long-felt need; (3) failure of others; (4) unexpected results; (5) skepticism by others; and (6) teaching away in the literature. A patent application also must teach one of the ordinary skill in the field how to make and use the invention. This is known as the enablement requirement. If the patent application is so inexact as to require substantial experimentation for success, the invention may be unpatentable. The patent statute also requires that the inventor disclose the best mode for making and using the invention. Thus, where an inventor has developed two different processes for synthesizing a compound, but one of the processes is less expensive or simpler, then the patent application must teach that preferred process. In biotechnology, the enablement and best mode requirements have resulted in what has become known as the deposit requirement. When life forms are an essential part of a patent application, special problems arise with respect to satisfying the enablement requirement. Sometimes these types of inventions cannot be reproduced by following a written description. For example, new antibiotics made by microorganisms not generally available to the public raise the issue of whether merely describing the microorganisms, and where and how they were found, satisfies the enablement requirement. It was on this basis that the Patent Office established the policy of requiring inventors to place these rare organisms in depositories accessible to the public. Another issue which must be addressed when filing a patent application is that of inventorship. In the U.S., unlike many foreign countries, the patent application must be filed in the name of the true inventor or inventors. Joint inventorship requires that each inventor contribute to the conception of the invention. Conception is the mental formulation of an idea complete enough so as to enable one of ordinary skill in the field to reduce the concept to practice without undue experimentation. Contribution to the actual reduction to practice is irrelevant for purposes of determining inventorship. Although it is not necessary for joint inventors to physically work together, there must be some degree of collaboration among them. Further, an individual who merely follows the instructions of another is not a joint inventor. For example, a lab technician who carries out experiments under someone else's instructions and records the results is not an inventor. Finally, an individual does not become a joint inventor by suggesting a desirable end or result without suggesting the means of accomplishing the result. |