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their practical economic implementation. In a number of the areas, the analysis is international and comparative; the conclusions are intended to be international as well.


The three paradigm technologies were chosen as those recent technologies that probably represent the most severe tests for the intellectual property system. Each requires new forms of expertise; for none can traditional legal principles be applied without substantial modification. Also, intellectual property protection is crucial for each of the three; for all, front-end costs are very large, copying of a marketed product is much easier than initial development, and product cycles are long enough that copying is a serious consideration.2


Biotechnology is defined here as genetic engineering and particularly recombinant DNA manipulation. Although it is different from more traditional areas such as pharmaceutical technology in that living organisms are involved and can often reproduce themselves, what has most troubled the early evolution of the law is the fact that many of the products and processes being patented derive directly from natural products and processes.

Special Issues

The early generation of biotechnology products consists of proteins found in nature in very small quantities, but available in volume through cloning. Typically, the researcher started with the protein and then identified the sequences of its amino acids and of the corresponding nucleic acids in the gene that codes for the protein's production. The question, then, is whether such a protein or sequence can be patented; in common language, it has been discovered rather than invented. This question is usually answered in the United States on the basis that a purified natural product can be patented (because it is not found in purified form in nature),3 but the


Thus, this chapter does not face the question of the irrelevance of intellectual property to many industries, such as those in which the product cycle is much shorter than the time required to obtain a patent.


In re Bergy, 563 F.2d 1031 (C.C.P.A. 1977), vacated sub. nom. Parker v. Bergy, 438 U.S. 902 (1978), on remand, In re Bergy, 596 F.2d 952 (C.C.P.A.), cert. granted sub nom. Parker v. Bergy, 444 U.S. 924 (1979), vacated and remanded with instructions to dismiss as moot sub nom. Diamond v. Chakrabarty, 444 U.S. 1028 (1980).

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