Biotechnology's Uncertainty Principle

Abstract

In theory, we have a unified patent system that provides technology-neutral protection to all kinds of technologies. However, we have recently noticed an increasing divergence between the rules actually applied to different industries. Biotechnology provides one of the best examples. In biotechnology cases, the Federal Circuit has repeatedly held that uncertainty in predicting the structural features of biotechnological inventions renders them nonobvious, even if the prior demonstrates a clear plan for producing the invention. At the same time, the court claims that the uncertain nature of the technology requires imposition of stringent patent enablement and written description requirements that are not applied to patents in other disciplines. Thus, as a practical matter it appears that although patent law is technology-neutral in theory, it is technology-specific in application. Much of the variance in patent standards is attributable to the use of a legal construct, the person having ordinary skill in the art (PHOSITA), to determine obviousness and enablement. We do not challenge the idea that the standards in each industry should vary with the level of skill in that industry. We think the use of the PHOSITA provides needed flexibility for patent law, permitting it to adapt to new technologies without losing its essential character. We fear, however, that the Federal Circuit has not applied that standard properly in biotechnology. The court has a static perception of the field that was set in its initial analyses of biotechnology inventions, but which does not reflect the realities of the industry. In the final part of the paper, we offer a very preliminary policy assessment of these industry-specific patent cases. We suggest that the special rules the Federal Circuit has constructed for biotech cases are rather poorly matched to the specific needs of the industry. Indeed, in some ways the Federal Circuit cases have it exactly backwards. We offer a few suggestions as to what a consciously designed biotechnology patent policy may look like.