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74 J. Pat. & Trademark Off. Soc'y 903 (1992)
Can Product-By-Process Patents Provide the Protection Needed for Proteins Made by Recombinant DNA Technology

handle is hein.journals/jpatos74 and id is 929 raw text is: Can Product-by-Process Patents Provide the Protection Needed for Proteins Made by Recombinant DNA Technology? Donald R. Holland I. INTRODUcTION R ecombinant DNA1 technology2 has evolved over nearly two dec- ades from a scientific breakthrough3 into a major U.S. industry. Hundreds of biotechnology companies formed during the period of from 1980 to 1984 and, currently, issues from 46 companies trade publicly on the various securities exchanges.4 This new technology promises to revolutionize medicine, agriculture, and a number of other areas that impact on our daily lives.5 In the area of new drugs, the Food and Drug Administration has approved 15 biotechnology- based drugs whereas about 100 more remain in the approval pipeline.6 Along with the growth and development of the biotechnology industry, many problems have emerged to challenge the ability of 1 DNA (Deoxyribonucleic acid) polymers consist of monomeric nucleotides composed of a deoxyribose sugar moiety and either a pyrimidine base (thymine or cytosine) or a purine base (adenine or guanine). See Bent, Patent Protection for DNA Molecules, 64 J. Pat. Off. Soc'y 60, 63-4 (1982). 2 Recombinant DNA technology along with monoclonal antibody technology constitute bio- technology. The United Kingdom legally defines gene manipulation which is the basis of bio- technology as the formation of new combinations of heritable material by the insertion of nucleic acid molecules, produced by whatever means outside the cell, into any virus, bacterial plasmid or other vector system so as to allow their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation. R. Old & S. Primrose, Principles of Gene Manipulation 3 (3d. ed. 1985). 3 Cohen and Boyer first reported their experiments on gene isolation and insertion into a host cell in 1973. Cohen & Boyer, Construction of Biologically Functional Bacterial Plasmids in Vitro, 70 Proc. Nat'lAcad. Sci. 3240 (1971). The first biotechnology patent issued to Cohen & Boyer in 1980. U.S. Pat. 4,237,224 (1980). 4 Abelson, Biotechnology in a Global Economy, 255 Science 381, 381 (1992) (citing Off. Tech. Assessment, Biotechnology in a Global Economy (1991)). 5 Jones, Patentability of the Products and Processes of Biotechnology, 73 J. Pat. & Trademark Off. Soc'y 372, 372 (1991). 6 Abelson, supra note 4, at 381.

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