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OCR for page 73
Patents
As industry moved from genetic engineering research to product de-
velopment, they encountered uncertainty about patent protection for
their inventions. Clearly, the processes used in creating a specific re-
combinant microorganism were patentable. But what about the genet-
ically engineered microorganisms themselves, such as those designed
to degrade of] spills or combat soil-borne diseases? Could these novel
life forms be patented?
For many years, Section 101 of the Patent Law has provided protection
for any process, machine, manufacture, or composition of matter that
meets certain criteria. Yet as Rene D. Tegtmeyer, assistant commissioner
for patents of the U.S. Patent and Trademark Office, explained, it had
been widely thought that the section did not apply to plants and other
living things. In 1930 the Plant Patent Act was passed to allow patent
protection for certain asexually propagated plants. The distinction was
made between asexually and sexually propagated plants, because at that
time it was not thought possible to produce a stable, uniform line through
sexual reproduction. Those ideas were rf~vi~H Once
-rim , ~ in 1970 Congress
passed the Plant Variety Protection Act, which allowed protection of
some sexually reproduced plants. The act specifically excluded bacteria,
fungi, tuber-propagated plants, uncultivated plants, and first-generation
hybrids.
In some situations, a genetic engineering company might prefer to
rely on trade secret protection rather than apply for a patent. The ad-
vantage is that the trade secret need not be revealed and that such
protection lasts indefinitely. The drawback is that if the secret is made
public, either through legal or illegal means, then protection is lost. For
these reasons, trade secret protection might prove inadequate or inap-
propriate for genetic engineering. Many of the products could be "re-
73
OCR for page 74
74
GENETIC ENGINEERING OF PLANTS
verse engineered" that is, a competitor could use the product to de-
duce the original process. In addition, academic researchers might balk
at trade secret protection, as they wouIcl not be able to publish their
results.
Patents, too, have their drawbacks. Under patent law the applicant
must have an invention that is new, useful, and unobvious and must
describe the invention in sufficient detail to allow a person skilled in
the field to use or operate it without undue experimentation. The dis-
closure requirement was a balance struck by Congress to encourage
invention both by protecting the rights of the inventor and by making
new technical information publicly available so that others can learn
from it. Patents provide the holder with exclusive rights to an invention
for 17 years. During this time, if the patent is infringed, the holder has
legal recourse.
In most cases, patents would seem to be the preferred method of
nrot~rtin~ s'~n~tir ~n~n~rin~ technolo~v Te~tmever said. "Inventions
rat O 0~ On = ~ Oil --On ,
In this field have a goon prospect tor relatively long commercial fire or
usefulness though requirements for pre-marketing approval may be a
factor in some areas. Competition will be heated; new entrants to the
field will be many; market potentials are huge; and research and de-
velopment is expensive. Genetic engineering is a suit tailor-made for
the patent system." But first, the uncertainties had to be resolved.
The Test Case
The test case was a patent application filed in 1972 by Ananda Chak-
rabarty, a General Electric scientist. By transferring plasmids from sev-
eral bacteria into one bacterium, he had endowed this bacterium with
the ability to degrade oil. His patent application included claims for the
process used to engineer the new bacterial strain, for the carrier material
to be used with the modified bacteria, and the genetically engineered
bacterium itself.
The U.S. Patent and Trademark Office granted a patent on the process
and the carrier but denied a patent on the bacterium on the grounds
that living organisms are not patentable subject matter under Section
101. The Court of Custom and Patent Appeal then ruled that a patent
could not be denied solely because the invention was a living organism.
In its 1980 Diamond v. Chakrabarty ruling, the Supreme Court upheld the
decision, affirming that genetically engineered microorganisms are pat-
entable. The court ruled that "the relevant ctistinction was not between
living and inanimate things but between products of nature, whether
OCR for page 75
PATENTS
75
living or not, and human-made inventions." In other words, human
intervention determines whether an organism is patentable subject mat-
ter.
Questions seem certain to arise concerning how much human inter-
vention is necessary before an organism qualifies as subject matter that
can be protected by patent. The Patent and Trademark Office has said
that it will clecide which genetically engineered organisms are patentable
on a case-by-case basis.
Other issues may complicate the patenting of biotechnology products.
For one, the applicant must demonstrate that the invention is novel and
not obvious to someone having ordinary skills in the field. Yet "the very
scope and complexity of the field and its rapid growth creates difficulty
in determining what ordinary skill is at any time and what is obvious
or novel," Tegtmeyer said. Similarly, the requirements for full disclosure
of the "best mode" for using or creating the invention may also prove
difficult. It may not be possible to adequately describe a microorganism
or plasmid, or the genetic engineering processes. In those cases, a sam-
ple must be available to the public.
~ ~ ~ 1 {A
Patent Activity
Difficulties aside, the Chakrabarty decision has greatly increased pat-
ent activity in the field of genetic engineering. A number of patent
applications were suspended pending resolution of the case; those and
new applications have since been processed. Now some 500 applications
related to genetic engineering are pending. More are expected: patent
Top Assignees in Genetic Engineering (Class 435/172), 1979-1982
Assignees
Percent
Upjohn Co.
Ortho Pharmaceutical Corp.
Ajinomoto Co., Inc.
President and Fellows of Harvard College
Regents of University of California
Research Corp.
Cetus Corp.
Genentech, Inc.
Noda Institute for Scientific Research
Agroferm Ag
All Other Organizations (44)
9.7
7.1
5.3
4.4
4.4
3.6
2.7
2.7
2.7
1.8
47.0
SOURCE: U.S. Patent and Trademark Office.
OCR for page 76
76
GENETIC ENGINEERING OF PLANTS
32
70
in
~ 60
UJ
<` 50
O 40
us 30
m
be
20
10
o
~ Go/ ~ ~ Organizations
I=
u)
28 0
24 ~
N
_
20 ~
O:
16 0
LL
12 o
to
llJ
Q m
in
4
—O
1973 1974 1975 1976 1977 1978 1979 1980 198 1 1982
YEARS
U.S. patenting activity on genetic engineering (Class 435/172~: 1973-1982. Courtesy of
U.S. Patent and Trademark Office.
60
in
uJ 40
cat
30
20
10
Cl All Technologies
(all Classes)
Genetic Engineering
_ ~
Growth Between 1980
and 1982 as Compared
to the 1 973-1982 Total
Comparative trends in U.S.
Foreign Origin,
1980-1982
patenting: Percent growth and
foreign origin. Courtesy of
U.S. Patent and Trademark
Office.
activity in genetic engineering is increasing at roughly twice the rate of
other technologies.
A sizeable portion of U.S. patents are issued for inventions developed
in other countries. From 1980 to 1982, the percentage of foreign patents
issued for genetic engineering was lower than that for other technolo-
gies. "This seems to indicate a concentration of genetic engineering
inventiveness in the United States at this time," Tegtmeyer said.
Representative terms from entire chapter:
trade secret
