Biotechnology Patent Protection Act of 1993 : report (to accompany S. 298).

  • United States Senate Committee on the Judiciary
Date:
[1993]
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Licence: Public Domain Mark

Credit: Biotechnology Patent Protection Act of 1993 : report (to accompany S. 298). Source: Wellcome Collection.

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    continues to grow because of the enormous need for biotechnology products.® Commerical successes in 1990 garnered the U.S. biotechnological industry sales of $2.9 billion, doubling the sales of 1989 and quad- rupling the amount for 1988.6 However, the biotechnology industry faces formidable challenges in continuing this groundbreaking re- search. Japan has targeted pharmaceutical development as an in- dustry of vital economic importance.’ Europe invests heavily in biotech research and actually leads in the production of monoclonal antibodies.2 Therefore, it is vitally important that the United States maintain its edge in this competitive and fast paced indus- try by continuing its investment in biotechnical breakthroughs. B. Biotechnology patenting Biotechnology, an intensely competitive industry, requires effec- tive, enforceable intellectual property laws to deter piracy of its in- ventions. Currently, however, patent protection for biotech products is difficult to obtain under current U.S. law and is unavailable in many foreign countries. Without such protection, venture capital- ists fearful of an inability to recover their investment may refuse to provide R&D costs which, in turn, jeopardizes future biotechnological advancements.9 Biotech products are often the recombinant versions of a natu- rally occurring substance usually found in an animal or plant. When the scientific literature or other available information re- veals that the naturally occurring version of the protein has been purified to some extent, even if it has not been definitively charac- terized, a patent for the recombinant version may be denied for lack of novelty. In patent law terms, the product has already been discovered.!° This may occur even when the amount of the natural product that has been isolated is insufficient for any practical use and the method employed cannot provide practical quantities of the material. Inventors of some recombinant versions of naturally oc- curring products have found it difficult to obtain adequate patent protection because of the mere existence of literature disclosing in- complete information about the natural protein.!! A second hurdle inventors must overcome is that a patent appli- cation for a recombinant product may be denied because it is deemed obvious, and thus unpatentable, despite its novelty. In many cases, although the protein has never before been isolated in 5U.S. Congress, Office of Technology Assessment, “New Developments in Biotechnology: U.S. Investment in Biotechnology—Special Report,” OTA—-BA-401. (Washington, DC: U.S. Govern- ment Printing Office, July 1988.) §“Biotechnology Patent Protection Act of 1991,” penrng on S. 654 before the Judiciary Sub- committee on Patents, Copyrights and Trademarks, 102d Cong., 1st sess. (1991), [hereinafter hearings], (statement of Henri Termeer, president and CEO of Genzyme Corporation, on behalf of Industrial Biotechnology Association). 7The President’s Council on Competitiveness, “Report on National Biotechnology Policy,” at 5, nen DC (February 1991). ®U.S. Congress, Office of Rar pea Assessment, “New Developments in Biotechnology: Pat- enting Life—Special Report,” OTA—-BA-370 at 101 (Washington, DC: U.S. Government Printing Office, April 1989), [hereinafter OTA report]. 10 See generally, Murashige, “Section 102/103 Issues in Biotechnology Patent Prosecution,” 16 A.I.P.L.A., Q.J. 294, 303-04 (1988-89); Andrews, “Unaddressed Question in the Amgen Case,” .Y. Times, Mar. 9, 1991, at A30. 11A natural protein is a tery encoded by DNA that occurs in nature. A recombinant protein is a protein encoded by DNA that has been produced by combining genetic material from at least two different sources.