Toward a Clear Standard of Obviousness for Biotechnology Patents
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TOWARD A CLEAR STANDARD OF OBVIOUSNESS FOR
BIOTECHNOLOGY PATENTS
The term biotechnology refers to scientific activity that manipu-
lates living systems and yields useful biological products or processes.
Since the discovery of the double-helical structure of DNA in 1959,
biotechnology has experienced exponential growth. This unprece-
dented expansion of knowledge has generated large financial re-
search costs.1 Accompanying these costs, conflict has arisen over
ownership and use of the newly discovered information. During the
1980s, patents have emerged as an important and controversial tool
for protecting this knowledge.2 Rapid scientific advances underscore
the need to clarify the legal standards for determining the ownership
and use of valuable scientific information. By explicitly acknowledg-
ing that patent analysis properly embraces the methods, and not final
products, of scientific research, the Federal Circuit can establish a
clear standard that will aid the biotechnology industry.
Through a series of four recent cases,3 the Federal Circuit has
attempted to apply the broad statutory language of patent law to the
unique needs of biotechnology.4 The most contentious issue relates
1 In 1992, the average cost of discovering and bringing a single drug to market ex-
ceeded $230 million. This amount has increased as 1990 United States' biotechnology
sales reached $2.9 billion. Biotechnology Plant Protection Act, H.R. REP. No. 260, 102d
Cong., 2d Sess. 5-6 (1992).
2 See generally Nicholas H. Carey & Peter E. Crawley, Commercial Exploitation of the
Human Genome: What are the Problems?, in HuMAN GENETIC INFORMATION: SCIENCE, LAW AND
Emics 133-47 (Ciba Foundation Symposium 149) (1990) (assessing the industry's need for
patents in commercial fields where the high cost and long time frames of research require
exclusive ownership rights to achieve an acceptable investment return); Reid G. Adler,
Genome Research: Fulfillng the Public's Expectations for Knowledge and Commercialization, 257
SciENcE 908 (1992) (summarizing academic and industry positions on patent law and argu-
ing that careful development of policies is needed to successfully encourage commercial
product development). [D]ue consideration must be given to protecting the market ex-
clusivity necessary for the private sector to risk enormous sums of money in product devel-
opment efforts. Id. at 908.
3 Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367 (Fed. Cir. 1986), cert.
denied, 480 U.S. 947 (1987) (assay using monoclonal antibodies is non-obvious); In re
O'Farrell, 853 F.2d 894 (Fed. Cir. 1988) (expression of fused foreign protein in bacteria is
obvious); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir.), cert. denied,
112 S. Ct. 169 (1991) (DNA sequence for the erythropoietin protein is a non-obvious in-
vention); In reVaeck, 947 F.2d 488 (Fed. Cir. 1991) (expression of an insecticide protein in
cyanobacteria is non-obvious). For discussion and explanation of these cases see infra sec-
tion III.
4 The Federal Circuit is the Federal Court of Appeals for all cases involving patent
disputes. Generally, patent disputes arise from either infringement action initiated at the
district court level or an appeal from a decision of the Patent and Trademark Office deny-
ing a patent application. The Court of Appeals for the Federal Circuit was created in 1982
by the Federal Courts Improvement Act, Pub. L. No. 97-164, 96 Stat. 25 (1982), and
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Toward a Clear Standard of Obviousness for Biotechnology Patents
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