Suchergebnisse

The Court of Appeals for the Federal Circuit, charged with adjudicating appeals in patent cases, has adopted an unusual approach that arrogates power over fact finding while it simultaneously invokes rule-formalism. Although the Federal Circuit's approach may be justified by the fact-finding and policy application deficiencies of the trial courts and the Patent and Trademark Office (PTO), it has had a negative impact on innovation policy and has resulted in a patent system that is sorely in need of reform. This Article argues that because of the interdependence of the various institutions within the patent system, reform of the system must be both multi-institutional and closely attentive to the institutional competence of the system's actors. Although Congress should clearly bolster the PTO's fact-finding abilities, giving plenary responsibility over factual questions to the PTO would not be cost effective. Accordingly, Congress should endow the system with improved fact-finding expertise through the institution of specialized trial courts. As for actual policy formulation, each of the available institutional options-the legislature, the PTO, and the courts-has substantial associated liabilities. On balance, however, the Federal Circuit is probably best positioned to formulate Patent Policy, so long as the fact-finding expertise of inferior institutions is bolstered and additional appellate mechanisms are instituted. By paying attention to institutional design and revising our institutions accordingly, we can achieve the patent system we should have had all along.

With the human genome mapped, and with the mapping of more
than one hundred animal genomes in progress, the amount of genetic
data available is increasing exponentially. This exponential
increase in data is having an immediate impact on the process of
drug development. By using techniques of information technology to
manipulate data regarding the genes, proteins, and biochemical
pathways associated with various diseases, scientists are beginning
to be able to design drugs in a systematic fashion. In the context
of any given disease, scientists look to see whether a gene, a protein
for which the gene codes, or another protein in the relevant biochemical
pathway could be the "target" biological molecule, the
"knocking out" of which would halt or slow the
disease's progression. Once a target molecule has been
identified and characterized structurally, drug therapies that
would be likely to knock out this target can be identified and
tested systematically. The merger of information technology
and genetic technology has changed the process of pharmaceutical
development so much that a new term—bioinformatics—has
been coined to describe this new approach to such development.