The Problem of Process in Biotechnology

Abstract:     
Patent law routinely relies on distinctions between products and processes, but the courts appear to have a great deal of trouble distinguishing the two when it comes to biotechnology cases. Over the past two decades, this has led to a series of cases grappling with a process-related problems that are characteristic of biotechnology patents. These cases include those dealing with obviousness of macromolecules, those addressing the so-called "Durden" problem of patenting old processes that use novel substrates or create novel products, and several recent importation cases considering sections 271(f) and 271(g) of the U.S. patent statute. It is no accident that biotechnology patent cases repeatedly coalesce around such process-related issues; rather, in biotechnology patenting a discontinuity at the center of patent law has finally come to light. This anomaly is due to the character of molecules as channels for informational transfer processes, and the inability of current patent doctrine to encompass information transfer. Consequently, conflicts regarding process and product will be endemic not only to the patenting of biotechnology products, but also other informational products, particularly software.

Keywords: biotechnology, patent, process patent, Shannon, entropy, information theory, 35 USC 271(f), 35 USC 271(g)

JEL Classifications: O31, O32, O33, O34, L65, L86

Accepted Paper Series