Patent law has a general set of legal rules to govern the validity andinfringement of patents in a wide variety of technologies. With a very fewexceptions, the statute does not distinguish between different technologiesin setting and applying legal standards. In theory, then, we have a unifiedpatent system that provides technology-neutral protection to all kinds oftechnologies.Of late, however, we have noticed an increasing divergence between therules themselves and the application of the rules to different industries.The best examples are biotechnology and computer software. In biotechnologycases, the Federal Circuit has bent over backwards to find biotechnologicalinventions nonobvious, even if the prior art demonstrates a clear plan forproducing the invention. On the other hand, the court has imposed stringentenablement and written description requirements on biotechnology patentsthat do not show up in other disciplines. In computer software cases, thesituation is reversed. The Federal Circuit has essentially excused softwareinventions from compliance with the enablement and best mode requirements,but has done so in a way that raises serious questions about howstringently it will read the nonobviousness requirements. As a practicalmatter, it appears that while patent law is technology-neutral in theory,it is technology-specific in application.The paper explains how the application of the same general legal standardscan lead to such different results in diverse industries. Much of thevariance in patent standards is attributable to the use of a legalconstruct, the "person having ordinary skill in the art" (PHOSITA), todetermine obviousness and enablement. The more skill those in the art have,the less information an applicant has to disclose in order to meet theenablement requirement - but the harder it is to meet the nonobviousnessrequirement. The level of skill in the art affects not just patentvalidity, but also patent scope.We do not challenge the idea that the standards in each industry shouldvary with the level of skill in that industry. We think the use of thePHOSITA provides needed flexibility for patent law, permitting it to adaptto new technologies without losing its essential character. We fear,however, that the Federal Circuit has not applied that standard properly ineither the biotechnology or computer software fields. The court has aperception of both fields that was set in earlier cases but which does notreflect the modern realities of either industry. The changes in an industryover time present significant structural problems for patent law, bothbecause law is necessarily backward-looking and precedent-bound and becauseapplying different standards to similar inventions raises concerns abouthorizontal equity. Nonetheless, we believe the courts must take more carethan they currently do to ensure that their assessments of patent validityare rooted in understandings of the technology that were accurate at thetime the invention was made.
Copyrightability of Recombinant DNA Sequences