242 • Impacts of Applied Genetics — Micro-Organisms, Plants, and Animals 
Even if section 101 were interpreted as cover- 
ing other genetically engineered organisms, 
they probably could not be patented for failure 
to meet another requirement of the patent 
laws— the enablement requirement. It is gener- 
ally impossible to describe a living organism in 
writing with enough detail so that it can be 
made on the basis of that description. Relaxing 
this requirement for plants was one reason 
behind the Plant Patent Act of 1930. For micro- 
organisms, the problem is solved by depositing a 
publicly available culture with a recognized na- 
tional repository and referring to the accession 
number in tbe patent.* While such an approach 
• This procedui e was accepted hv the Court of Customs and Pat- 
ent Appeals ICX'PA) in upholding a patent on a process using micro- 
organisms. Application of Argoudelis, 434 F.2d 1390 (CXiPA 1970). 
Phis procedure should also he acceptable for patents on micro- 
organisms themselves. 
Potential impacts of the 
related policy issues 
During the 8-year history of the Chakrabarty 
case and the surrounding public debate, nu- 
merous assertions were made about tbe poten- 
tial impacts of permitting patents on genetically 
engineered organisms. They ranged from more 
immediate effects on the biotechnology indus- 
try, the patent system, and academic research 
to the long-term impacts on genetic diversity 
and the food supply. In addition, two major pol- 
icy issues that have been raised are the morality 
of patenting living organisms; and the propriety 
of permitting private ownership of inventions 
from publicly funded research. 
Impacts on industry 
The basic question for industry is tbe extent 
to which permitting patents on genetically en- 
gineered organisms will stimulate both their de- 
velopment and the growth of the industries em- 
ploying them. To ascertain this requires first an 
examination of the theory and social policies 
underlying the patent system. 
may be theoretically possible for animals and in- 
sects, it may be logistically impractical. How- 
ever, if tissue culture techniques ad\ ance to tbe 
point where genetically engineered organisms 
can be made from single cells and stored indefi- 
nitely in that form, there appears to be no rea- 
son to treat them any differently than micro- 
organisms, in the absence of a specific statute 
prohibiting their patentability. 
decision and 
THE RELATIONSHIP BETWEEN l»A TEN I S 
AND INNOVATION 
The patent system is su[)posed to stimulate in- 
novation— tbe process by which an iiux'iition i.s 
brought into commercial use— hecausi* the* in- 
ventor does not receive financial ix'uaixls until 
the invention is used commercially. Ihe ( on- 
stitution itself presumes this, as do the statutes 
enacted pursuant to the |)atent clause in article 
I, section 8. Attempts ha\'e been mad(> to subject 
this presumption to empirical analysis; but in- 
novation is extraordinarily (X)mple\ and in- 
volves interacting factor's that ai'c difficult to 
separate. In addition, the existence ol patent> 
and trade secrets as altei iiatix c means for |)io- 
tection makes it almost impossible to study the 
effects of patents alonr' on iinx'iition and in- 
novation.* 
‘A major reason lor the lack ol em)iiric.il sUhIii-s h.e. Iiren Ihe 
lack ol a|i|)ro|iriale data I he inlorm.ilioo .i \ ail.ihli - on Ihr I’liinh' i 
ol palenis a|)|)lle(l tor and issued does not mdieale Ihe ini|“'i l.n*. , 
economic benidits, or economic I'osls ol imenlions Iwhelhi i I'.e 
ented or unpalenledi dial ma\ nol h.i\ e evisled ,il ,dl m m.n i 
been crealed more slou K il nol lor ibe paleni s\ siem ' le I’m 
