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Are academic researchers exempt from the patent laws?
There are very few exemptions from the patent law. One of those is the research exemption, which protects scientists who are engaging in "philosophical" research. The overriding goal of providing an inventor exclusive rights is to provide the public with new and useful inventions and the associated knowledge; issuing a patent gives the inventor an incentive to fully disclose his invention and related information. However, the patentee's rights must yield when the benefit to the public outweighs the harm to the patentee.
The judicially created research-use doctrine is a recognized limitation on the patentee's right to exclude others from making, using or selling the invention in the United States during the patent term. This doctrine holds that it is not an act of infringement to make and use a patented invention if the use is limited to research or experimentation and the user (or institution) does not profit or gain any advantage in its business from the research.
The courts have interpreted this doctrine narrowly. Courts have held that the research exemption does not apply if the scientist conducts experiments to adapt the patented invention to further any commercial or "business" interests. However, academic researchers may be outside the scope of the exemption if their activities further the interests of their institutions, such as in attracting researchers or securing research grants. In practice, the effective standard is pragmatic. With rare exception, a patent owner will not go to the trouble and expense of infringement litigation if the research activities in question do not implicate its commercial interests.
Some proponents of broadening the exemption do not want the test to be based on whether the use of the patented invention was "for profit" and, therefore, infringing. Rather, they believe that the exemption should allow the patented invention to be used by any party to develop an improved product or another product.
Research-Exemption Legislation
Congress has enacted laws for two specific research-use exceptions to liability for infringing intellectual property rights, one involving the patent statute, and the other, the Plant Variety Protection Act ("PVPA)
The first permits basic research on a pharmaceutical invention during the life of a patent if the research is to develop and submit information to the FDA. It appears in the patent statute at 35 U.S.C. section 271(e)and was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman" Act). This statute provides for a limited research-use exemption for the use of a patented invention "solely for uses reasonably related to the development and submission of information" for FDA approval. While a patented drug cannot be placed on the market (and profit derived therefrom) by another during the life of the patent without infringing, basic research and clinical validation can be performed to develop and submit information to the FDA during the life of the patent. Section 271(e)(1) protects both studies involving a drug that would not infringe the patent and studies to support a generic version of the patented drug for approval when the patent expires.
The other statutory research exception broadly permits the use and reproduction of a protected plant variety for plant breeding or other bona fide research. It is found in the PVPA (7 U.S.C. section 2321 et seq.). Section 2544 provides that "[t]he use and reproduction of a protected variety for plant breeding or other bona fide research shall not constitute an infringement of the protection provided under this Act" (i.e., it immunizes the user from liability under the PVPA) The PVPA was enacted to encourage the development of novel varieties of sexually reproduced plants and to make them available to the public, thus providing protection to those who breed, develop or discover them, and thereby promoting progress in agriculture in the public interest.
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