22 • Impacts of Applied Genetics— Micro-Organisms, Plants, and Animals 
Patenting living organisms 
On June 16, 1980, in a 5-to-4 decision, the Su- 
preme Court ruled that a human-made micro- 
organism was patentable under Federal patent 
statutes. The decision while hailed by some as 
assuring this country’s technological future was 
at the same time denounced by others as creat- 
ing Aldous Huxley’s Brave New World. It will do 
neither. 
FINDINGS 
1. Meaning and Scope of the Decision.— The 
decision held that a patent could not be denied 
on a genetically engineered micro-organism that 
otherwise met the legal requirements for pat- 
entability solely because it was alive. It was 
based on the Court’s interpretation of a provi- 
sion of the patent law which states that a patent 
may be granted on “. . . any new and useful . . . 
manufacture, or composition of matter. ...” (35 
U.S.C. §101) 
It is uncertain whether the case will serve as 
a legal precedent for patenting more complex 
organisms. Such organisms, however, will prob- 
ably not meet other legal prerequisites to paten- 
tability that were not at issue here. In any event, 
fears that the case would be legal precedent 
sometime in the distant future for patenting hu- 
man beings are unfounded because the 13th 
amendment to the Constitution absolutely pro- 
hibits ownership of humans. 
2. Impact on the Biotechnology Industry.— The 
decision is not crucial to the development of the 
industry. It will stimulate innovation by encour- 
aging the dissemination of technical informa- 
tion that otherwise would have been main- 
tained as trade secrets because patents are pub- 
lic documents that fully describe the inventions. 
In addition, the ability to patent genetically engi- 
neered micro-organisms will reduce the risks 
and uncertainties facing individual companies 
in the commercial development of those orga- 
nisms and their products, but only to a limited 
degree because reasonably effective alterna- 
tives exist. These are: 1) maintaining the orga- 
nisms as trade secrets; 2) patenting microbio- 
logical processes and their products; and 3) pat- 
enting inanimate components of micro-orga- 
nisms, such as genetically engineered plasmids. 
3. Impact on the Patent Law and the Patent and 
Trademark Office.— Because of the complexity, 
reproducibility, and mutability of living orga- 
nisms, the decision may cause some problems 
for a body of law designed more for inanimate 
objects than for living organisms. It raises ques- 
tions about the proper interpretation and appli- 
cation of the patent law requirements of no\ el- 
ty, nonobviousness, and enablement. In addi- 
tion, it raises questions about how broad the 
scope of patent coverage on important micro- 
organisms should be, and about the continuing 
need for two statutes, the Plant Patent Act of 
1930 and the Plant V'arietv Protection Act of 
1970. These uncertainties could result in in- 
creased litigation, making it more difficult and 
costly for owners of patents on li\ ing oi'ganisms 
to enforce their rights. 
The impact on the Patent and Trademark Of- 
fice is not expected to he significant in the luvxt 
few years. Although the number of patent ap- 
plications on micro-organisms ha\e almost 
doubled during 1980, the approximately 200 
pending applications represent less than 0.2 
percent of those processed each year by th(' Of- 
fice. While the number of such applications is 
expected to increase in the next few yeai’s 
because of of the decision and de\ elopm(Mits in 
the field, the Office should he ahU? to a(’- 
commodate the increase. A few additional ex- 
aminers may he needed. 
4. Impact on Academic Research.— Because th(' 
decision may encourage academic scientists to 
commercialize the results of their ix'search, it 
may inhibit the free exchange of information, 
but only if scientists rely on track' secrecy 
rather than patents to protect thc'ir iincntions 
from competitors in the marketplace*. In this re- 
spect, it is not clear how molecular biology dif- 
fers from other research fields w ith commercial 
potential. 
