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36 Judges J. 46 (1997)
Intellectual Property Law and the New Biology

handle is hein.journals/judgej36 and id is 149 raw text is: Intellectua Property Law and the New Biology By Pmine Newman A dvances in molecular bi- ology, genetics, and bio- technology offer scien- tific, medicinal, and societal opportunities un- matched in our time. These opportuni- ties are implemented in part by indus- trial activity, whereby the products and processes of scientific research are made broadly available to the public. The potential benefits are too important for society to rest with less than an op- timal legal framework to support this industrial activity. Of the many areas of law that are implicated, one of the most pivotal is intellectual property law. I shall outline some of the legal issues that have arisen as the law is adapted to the new biology. Although its roots are in the com- mon law of property and natural rights, today the primary role of intellectual property law is to support creativity and technology-based industry. The field broadly encompasses patent, copyright, and trademark laws, laws of proprietary information and trade se- crets, and patent-like laws such as those directed to new plant varieties, orphan drugs, and semiconductor chips. The unifying legal threads de- rive from the principles of good faith, fairness, and order that underlie sys- tems of property rights, interwoven with the practical economics of com- merce and trade. Thus the legal principle that persons should have the right to control the fruits of their labors, including intellec- tual labors, is combined with the eco- nomic principle that commercial incen- tive depends on profit opportunity. Although these principles are of ancient provenance, their application to the subject matter of the new biology re- flects a balance of many interests- scholarly, industrial, and competitive. Patents are the form of intellectual property most directly concerned with scientific and technological advance and its relation to commercial activity. Many factors affect industrial innova- tion; the patent aspect is only one of them. But industrial innovation is an economic enterprise, and laws that af- fect the return on investment in re- search-based products and processes affect not only commercial activity but also the predicate research and devel- opment. These concepts underlie the patent law and the definition of patentable subject matter. PATENTABLE SUBJECT MATTER Throughout history, new areas of technology have been accommodated by patent principles. The basic issues of patentability of biotechnologic in- ventions have been resolved, although questions of the social and ethical im- plications of this technology are often raised as the legal framework is con- sidered in the legislature and the courts. Life Forms. The patentability of living products of biological and chemical processes was considered by the U.S. Supreme Court in Diamond v. Chakrabarty.1 That litigation arose when the Patent Office refused to grant a patent on a new bacterium that had been made, by genetic modifica- tion, for the purpose of treating oil spills. Dr. Chakrabarty's bacterium contained four different plasmids, each capable of generating an enzyme spe- cific to degrading a different compo- nent of crude oil. The Patent Office had denied a patent on the ground that bacteria are living things, whether made by nature or modified in the lab- oratory, and therefore not within the scope of the patent statute. The Court of Customs and Patent Appeals re- versed the ruling of the Patent Office, and the Supreme Court affirmed that court's decision. The Court stated that the terms manufacture and compo- sition of matter in Section 101 of the patent statute2 do not exclude living things, and that the statute is intended to include anything under the sun that is made by man.3 This decision is credited with enabling the rapid growth of the biotechnology industry in the United States. Issues of the hazards and social consequences of genetic engineering were raised in Chakrabarty, leading the Court to explain that such issues are separate from the question of patentability. The Court suggested that legislative or judicial fiat as to patentability will not deter the scien- tific mind from probing into the un- known any more than Canute could command the tides.4 Nonetheless, controversy again arose upon issuance in 1988 of a patent on the Harvard mouse, a mouse that was genetically designed for use in certain cancer re- search. The mouse was produced by the recombinant modification of cells of the embryo to contain the desired cancer-producing sequence. This patent thrust the patent system into the public debate about genetic research and the propriety of tampering with the natural order, leading to congres- sional hearings and a four-year mora- torium on patents on new life forms. The moratorium was lifted in 1992 with the grant of several patents that included a mouse that produced human interferon, another that devel- oped benign prostatic hypertrophy, and a third without an immune system for use in studying cancer and AIDS. Patents on other animal life forms have since been granted, usually de-

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