Perspectives in Biology and Medicine

PATENTING AND HUMAN GENES PATRICIA BAIRD* What Are Patents ? Without major investment of money, time, and skills in research and innovation over the last several centuries, many technologies and products that enhance our safety, comfort, and quality oflife would not exist. Patents were developed to find a way of encouraging the sizeable investment of resources into research and development that is needed if society is to be able to have such benefits. A patent is a monopoly right, granted for a specific time period to an inventor, in return for the publication to the world at large of the details of the invention. The monopoly is the exclusive right to use the invention, and the patent holder can prevent anyone else from making, using, or selling the patented invention without his permission. As well, he has the right to license others to use it, usually in return for money (a royalty). A patent holder therefore receives some expectation of profit in return for describing and disclosing the invention so that other people could duplicate it. The period of market monopoly means inventors and companies are likely to develop useful products if they are well protected by patents. On expiration of the patent, it becomes part of the public storehouse of knowledge, and thus society benefits as well. In essence, the basic principles of patent law achieve a compromise between the broader social desirability of increasing useful technology developments, and the social undesirability of ongoing market monopolies for critical processes or products [I]. The compromise is a way ofsecuring future benefits for the common good. The patent monopoly is "property" that is state-created for public purposes, and absent these, there is nojustification for a patent system. A very exten- *University of British Columbia, #222-6174 University Blvd., Vancouver BC V6T IZ3, Canada. The author wishes to thank members of the Population Health Program of the Canadian Institute for Advanced Research and members of her department for helpful comments on this paper.© 1998 by The University of Chicago. All rights reserved. 0031-5982/97/4101-1038$01 .00 Perspectives in Biology and Medicine, 41, 3 ¦ Spring 1998 | 391 sive body of law has grown up around patenting—in Europe over the last five centuries, in North America over the last two. With regard to the field of genetics, research into identification of particular DNA sequences and elucidation of their function involves the application of much expertise and work, and this costs large amounts of money. Some researchers and some of the funders of the research want to protect the fruits of their labor—in fact, they would not undertake it unless they judged that they would make a profit from the development and sale ofprocesses or products resulting from the research. There is enormous potential commercial application for knowledge gained about human genes. For example , the marketfor DNA diagnostics alone is conservatively anticipated to exceed $1 billion by 1998 [2] . Private funding from industry provides a large proportion offunding for research and development in this field. General Background on Patent Law In general there are several criteria to be met for patentability. These are that the subject of the patent must be novel, useful, and non-obvious, and not be simply the discovery of a preexisting naturally occurring phenomenon . These criteria were designed at a time when some of the issues raised by modern technology were unknown and did not have to be taken into consideration. The above criteria, laid out originally in patent law, were relatively easy to interpret in the context of the development of new chemical compounds and pharmaceuticals, and an extensive body of case law already existed when the recombinant DNA era arrived. Some inventions are excluded from patent protection for reasons related to public policy or to moral concerns. For example, innovative medical treatment performed on the human body cannot be patented in many countries. There are public policy reasons for this, which include a need for unimpeded access to medical procedures and surgeries, the avoidance of conflict of interest for physicians, and impartial evaluation of the safety and effectiveness of the treatments. On the other hand, innovative diagnostic tests and medical devices used in medical...