Ch.12 — Patenting Living Organisms • 245 
\vhene\er the micro-organism was used for 
commercial purposes. Whether this would he a 
significant ad\antage in practice is uncertain. 
Usually, onl\’ one pi'oduct is optimally produced 
hy a gi\ en mici'o-organism and only one micro- 
organism is best for a gi\en process. Pre- 
sumably, the micro-organism’s inxentor would 
also ha\e disco\ered and patented its best use 
and product. 
.-\nother alternative to patenting a man-made 
micro-organism, besides trade secrecy, is to pat- 
ent its manmade components. Examples of 
these include a plasmid containing the cloned 
gene, a sequence of D\A, or a synthetic gene 
made by the reverse transcriptase process. 
These components, which are nothing more 
than strings of inanimate chemicals, would not 
be unpatentable products of nature if they were 
made in the laboratory and were not identical to 
the natural material. Patenting them would not 
be ecjuivalent to patenting the entire organism, 
since their function would be affected in vary- 
ing degrees by the internal environment of their 
host. Nevertheless, the inventor of a partic- 
ularly useful component, such as an efficient 
and stable plasmid, might want to patent it re- 
gardless of w hether or not the organism could 
be patented, since it could be used in an in- 
definite number of different micro-organisms. 
Thus, if Congress were to prohibit patenting 
of micro-organisms because they are alive, in- 
dustry could compensate to a large degree by 
patenting inanimate components. On the other 
hand, if Congress allows the Supreme Court’s 
decision to stand, certain components will un- 
doubtedly still be patented. In fact, such patents 
may become more important than patents for 
micro-organisms, since the components are the 
critical elements of genetic engineering. 
PATENT \ . TR ADE SECRET PROTECTION 
Even with the advantages provided by pat- 
enting a micro-organism, a company could still 
decide to rely on trade secrecy. In choosing be- 
tween these two options, it would evaluate the 
following factors:*^ 
'®R. Saliwanchik. '.Microbiological ln\'entions: Protect by Patent- 
ing or Maintain as a Trade Secret?" Developments in Industrial 
Microbiology, \ ol. 19, 1978. pp. 273, 277. 
• whether the organism itself or the sub- 
stance that it makes will be the commercial 
product, 
• w hether there is any significant doubt of 
its meeting the legal requirements for 
patenting, 
• whether there is the likelihood of others 
discovering it independently, 
• whether it is a pioneer invention, 
• what its projected commercial life is and 
how readily others could improve on it if it 
were disclosed in a patent, 
• whether there are any plans for scientific 
publication, and 
• what the costs of patenting are versus re- 
liance on trade secrecy. 
The first two factors make the decision easy. 
Obviously, an organism like Chakrabarty’s can 
best be protected by a patent. In most instances, 
the substance made by the organism is the com- 
mercial product. In that case, if there are sig- 
nificant doubts that the organism can meet all 
the legal requirements for patentability, the 
company would probably decide to rely on 
trade secrecy. 
The next three factors require difficult de- 
cisions to be made on the basis of the charac- 
teristics of the new organism, its product, and 
the competitive env ironment. If research to de- 
velop a particular product is widespread and in- 
tense (as is the case with interferon), the risk of 
a competitor dev^eloping the invention inde- 
pendently provides a significant incentive for 
patenting. On the other hand, reverse engineer- 
ing (examination of a product by experts to dis- 
cover the process by which it was made) by 
competitors is virtually impossible for products 
of micro-organisms because of the variability 
and biochemical complexity of microbiological 
processes. 
Thus, greater protection may often lie in 
keeping a process secret, even if the microbe 
and the process could be patented. This is es- 
pecially true for a process that is only a minor 
improvement in the state of the art or that pro- 
duces an unpatentable product already made by 
many competitors. The commercial life of the 
process might be limited if it were patented be- 
cause infringement would be difficult to detect 
