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It is now possible to evaluate the performance of the system in developing the doctrines needed to resolve new intellectual property issues. Effective resolution requires that the new doctrines be economically effective in encouraging innovation. Legislators can take these economic aspects into account directly; courts must weave the economic factors into a preexisting network of doctrinal principles. In general, in the areas analyzed, doctrinal development has been left to the courts; there has been relatively little statutory activity.43 Given this pattern (in the United States) one would anticipate a spurt of judicial activity as unresolved issues are explored on an incremental basis, followed by a settling down as stable doctrines are developed.

Case Law Processes

On the biotechnology side, however, there have been relatively few cases. A count of two volumes of the United States Patents Quarterly Second reveals 183 patent cases, of which only 4 involve biotechnology issues.44 This probably suggests that the statutes need relatively little modification to respond to biotechnology. It should be noted, however, that certain of the court decisions, such as the new Amgen v. Chugai case, 927 F.2d 1200 (CAFC, 1991), have caused enormous confusion by leaving the principles unclear; the courts have almost certainly not done as well here as one would like.

The EC and WIPO activities in the biotechnology area have, however, been much more effective in locating the difficult issues early on; they suggest that a committee process can be more effective than case law in identifying new doctrinal issues. Although the EC proposals have not yet become law, the European discussions have produced quite thoughtful analyses of most of the hard issues and effectively illuminated the policy arguments on each side of these issues. Their result may be a sui generis EC law or modification of the existing patent law. Even in the absence of such a law, the analysis is one that is likely to be very helpful to courts (and it would be tragic if U.S. courts ignored these efforts).

On the software and network sides, case law efforts have been far less successful. Basically, it has proved impossible to modify the copyright concept to deal with software; the extensions needed to go beyond protection against literal copying have confused the doctrine and, in some cases,


The arguable exceptions are the Orphan Drug Act and the copyright amendments of 1980.


The count is based on volumes 15 and 16.

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