248 • Impacts of Applied Genetics— Micro-Organisms, Plants, and Animals 
within 120 days of the Chakrabarty decision on 
the ad\’isabilitv of shifting the examining func- 
tion to USDA.*® As of December 1980, this issue 
was still under study. These questions could be 
resolved by the courts, but they are probably 
more amenable to a statutory solution. 
Another effect of the decision could be on 
patent enforcement. The various uncertainties 
discussed above may have to be resolved 
through costly litigation. Moreover, in specific 
cases, the problems associated with describing a 
micro-organism in sufficient detail may increase 
the chances that a patent will be declared 
invalid. In any event, litigation costs would 
probably increase as more expert testimony is 
needed. 
The fact that organisms mutate might intro- 
duce still another complication into infringe- 
ment actions. A deposited micro-organism is the 
standard by which possible infringement would 
be judged. If it has mutated with respect to one 
of its significant characteristics, a patent holder 
who is seeking to prove infringement may have 
no case. While this problem does not appear to 
be amenable to a statutory solution, the risk of 
such a mutation is actually quite small.* 
Because a living invention reproduces itself, 
the statutory definition of infringement may 
have to be changed. Presently, infringement 
consists of making, using, or selling a patented 
invention without the permission of the patent 
holder. Theoretically, someone could take part 
of a publicly available micro-organism culture, 
reproduce it, and give it away. Arguably, this is 
not "making” the invention, and the patent 
holder would have the burdensome and expen- 
sive task of going after each user. The two plant 
protection statutes deal with this problem by 
specifically prohibiting unauthorized repro- 
duction of the protected plant. This approach 
may be necessary for other living inventions. 
How all of these uncertainties will affect the 
Patent Office’s processing of applications cannot 
be predicted. Currently, the average processing 
time for all applications is 22 months; separate 
‘^’S. Kept. No. 96-251, 96th Cong. 1st sess., 1979, p. 46. 
‘Most micro-organisms can be stored in a freeze-dried form, 
which entails virtuallv no risk of mutation. 
information on genetic engineering applications 
is not available.^® It may take examiners longer 
to process applications on micro-organisms than 
for those covering only microbiological proc- 
esses or products because of the interpretixe 
problems mentioned. Moreoxer, the Patent Of- 
fice will have to develop greater expei'tise in 
molecular genetics— a frontier scientific field 
that has only recently been the subject of patent 
applications. On the other hand, the Office 
generally faces this problem for any nexx- area 
of technology. 
In terms of increased numbers of applica- 
tions, the decision is not expected to hax e a sig- 
nificant effect on the Patent Office operations in 
the next few years. The Office receix es appi'ox- 
imately 100,000 applications a year, and it has 
about 900 examiners, each |)rocessing an ax ei'- 
age of about 100 applications per year. Kiguix's 
on the number of apjilications on genetically 
engineered organisms xary, depending on hoxx- 
the category is defined, and precise information 
has not been tabulated by the Patent Officiv 
Rough estimates indicate that in February 1980 
about 50 applications xvere pending, and by 
December 1980, that numhei' had increased to 
about 100. Applications are being fiU'd at the 
rate of about 5 per month. Also, just oxcm' 100 
are pending on microbes that hax e h(‘en isolated 
and purified from natui'al sources, hut hax(‘ not 
been genetically engineered. Four (vxaminers 
are xvorking on both catc'gories as xxcll as 
others. Thus, in x iexv of th(? total operations of 
the Office, these ai)plications re(|uire only a 
small part of its I’esources. Ox(M’ the next lexx 
years, the number is (h\pect(ul to increa.sc* be- 
cause of the decision and dex ('lo|)inents in the 
field but not to a point xx Ikm'c more than a fexx 
additional examiiK'rs xx ill he need('d.^' 
Impact of the Ccntrt’s iltu'ision on 
academic research 
Many academicians haxe xoiced concerns 
about the effects on res(’ai’ch t)f the Chakrahartv 
decision and th(^ commercialization ol molecu- 
lar biology in gtMKM'al. Fhey claim that the re- 
r(?gtnicv(M . |)('i-sr)n;il (-ommimK .limn l)i-i I '• I'tsn 
= 'll)i(t. l)('c 1,5. 1980. iind l.in 8 1981 
