Date: 1994-09-20
Speaker: HAM FISH (republican)
Chamber: H

for their help in scheduling this legislation for the floor and the subcommittee chairman. the gentleman from New Jersey . for his hard work and leadership in this complex area. I also would like to thank the gentleman from Virginia. RICK BOUCHER for all of his effort and support of this important legislation. From an economic point of view. the U.S. biotech industry has gone from zero revenues and zero jobs 15 years ago to $6 billion and 70.000 jobs today. The White House Council on Competitiveness. projects a $30 to $50 billion market for biotech products by the year 2000. and many in the industry believe this estimate to be conservative. Companies that depend heavily on research and development are especially vulnerable to foreign competitors who copy and sell their products without permission. The reason that high technology- companies are so vulnerable is that for them the cost of innovation. rather than the cost of production. is the key cost incurred in bringing a product to market. In addition to the ability to obtain and enforce a patent. small companies in particular must be concerned about obtaining a patent in a timely fashion. In l992 the pendency of a biotech patient application was 27 months with the backlog in applications increasing from 17.000 in 1990 to almost 20.000 in 1992. The Patent Office has taken steps to improve the situation by reorganizing its biotechnology examination group and increasing the number of new examiners. The PTO has also implemented special pay rates for their biotechnology examiners. As a result. biotech patent application pendency has been reduced from 27 months to 21 months and the backlog in applications have been reduced from 20.000 in 1992 to 17.000 in 1994. Although this is slow progress it is a substantial improvement. However. we must continue to reduce these delays because this industry is so dependent on patents in order to raise capital for reinvestment in manufacturing plants and In new product development. and even. more so. for an industry targeted by Japan for major and concerted competition. The House Judiciary Committee took the first step in 1988 when the Congress enacted two bills which. I introduced relating to process patents and reform of the International Trade Commission. However. our work will not be complete until we enact H.R. 4307. This bill modifies the test for obtaining a process patent. It overrules In Re Durden (1985). a case frequently criticized that has been cited by the Patent Office as grounds for denial of biotech patents. as well as chemical and other process patent cases. Because so many of the biotech inventions are protected by patents. the future of that industry depends greatly on what Congress does to protect U.S. patents from unfair foreign competition. Americas foreign competitors. most of whom have invested comparatively little in biotechnology research. have targeted the biotech industry for major and concerted action. According to the Biotechnology Association. in Japan the Ministry of International Trade and Industry [MITI] and the Japanese biotechnology industry have. joined forces and established a central plan to turn Japanese biotechnology into a 127 billion yen per year industry by the year 2000. If we fail to enact this legislation. the Congress may contribute to fulfillment of that projection. In conclusion. Mr. Speaker. this is important legislation. The biotech industry. is an immensely important industry started in the United States with many labs housed in California. In the decade ahead. biotechnology research will improve the lives and health of virtually every American family. It will put people to work and it will save peoples lives. I urge its adoption. Mr. Speaker. I yield back the balance of my time.