The Nonobviousness Requirement for Biotechnological Inventions-Resolving Uncertainty in Favor of Innovation (2005)

I. INTRODUCTION The biotechnology industry is primarily concerned with the commercial development of therapeutic, biochemical, and pharmaceutical products and processes, many of which are derived from manipulation of DNA molecules and their encoded proteins. Over the last thirty years, patents have emerged as an important, and sometimes controversial, tool for protecting these biotechnological products and processes. However, with the rapid scientific advances in this field, a degree of uncertainty regarding the nonobviousness requirement involving certain biotechnological inventions has been encountered. (1) Accordingly, there is a need to clarify the legal standards for determining the nonobviousness requirement--also referred to as the ultimate condition of patentability. While this determination is ultimately a question of public policy, based on underlying factual inquiries, (2) the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) has attempted to articulate legal standards of nonobviousness applied specifically in certain biotechnological inventions. Through the analysis of five major cases decided by the Federal Circuit dealing with biotechnological inventions from 1988 to 1995, (3) this paper will explore the legal standard for obviousness in this field and the related public policy considerations. Generally, there exist two major themes surrounding the nonobviousness standard: (1) in the three decisions before the decision in In re Bell (4) in 1993, the Court of Appeals for the Federal Circuit focused its analysis on the scientific methods involved in the invention and primarily gave weight to two factors: (i) whether the prior art would have suggested to those of ordinary skill in the art that they should make the claimed composition or device, or carry out the claimed process; and (ii) whether the prior art would also have revealed that in so making or carrying out, those of ordinary skill would have a reasonable expectation of success; (5) and (2) through the Bell decision in 1993 and the decision in In re Deuel (6) in 1995, an emphasis on the analytical framework has been shifted from the scientific methods to the obviousness of the claimed composition (e.g., a particular purified, isolated and sequenced DNA or cDNA molecule encoding a protein). (7) The reasoning underlying the two themes might seem to be related to the fact that the claimed inventions in the earliest three decisions were essentially directed to a method or process while the subject matters sought to be patented in the most recent two cases involved a product or composition. Despite the particular facts that may largely dictate the particular analytical framework in each of the five cases to be discussed, this paper will also argue that the Federal Circuit should be conscientious about a general responsibility to make an ultimate judgment as to which inventions should be patented and which should not, by taking into account the broad public policy implications and ramifications in order to realize the goal of promoting the progress of useful arts mandated by the United States Constitution. (8) One example regarding the practical effects of the two decisions in Bell and Deuel was that companies specializing in genomic research have filed many DNA sequence applications. This new trend of patent filings within the biotechnology field is problematic because genomic research companies are stockpiling DNA sequence patents directed merely to partial DNA sequences that have no known function. (9) An apparent public policy implication of this trend is that innovation in the biotechnology field may be impeded, rather than promoted, if scientists will have to negotiate and obtain a license from, and pay a royalty to, the multiple patent holders for making or using patented DNA sequences in their scientific research. Part II of this paper will analyze the five cases decided by the Federal Circuit dealing with biotechnological inventions (including processes and products). …