12 Intellectual Property & Technology Law Journal Volume 17 Number 10 October 2005

A
person who eats cornflakes at breakfast, puts on
a cotton shirt, or takes a vitamin C supplement
to ward off a cold almost certainly benefits from the
US Supreme Courts 1980 decision in Diamond v.
Chakrabarty.
1
It has been 25 years since this landmark
decision, in which the Supreme Court held that a live,
man-made microorganism is patentable subject matter
under Section 101 of the US Patent Act.
2

Chakrabarty is not well known outside the intellec-
tual property community--the average person probably
has never even heard the name. Yet Chakrabarty has
affected the lives of virtually everyone in the United
States, having contributed to a revolution in biotech-
nology that has resulted in the issuance of thousands of
patents, the formation of hundreds of new companies,
and the development of thousands of bioengineered
plants and food products.
In Chakrabarty, the US Patent and Trademark Office
(PTO) rejected claims to a genetically engineered bac-
terium on the ground that living organisms are not
patentable. The Supreme Court disagreed, deciding by
a five-to-four majority that a patent may be obtained
on anything under the sun that is made by man.
3
The
Supreme Court decision opened the floodgates for pro-
tection of biotechnology-related inventions and helped
spark the growth of an industry that no one, regardless
of his or her moral or philosophical views, can deny is
capable of modern-day miracles.
The Proceedings before the PTO and
the Lower Court
Chakrabarty began with a patent application filed
in 1972 by microbiologist Ananda Chakrabarty on an
invention for treating oil spills. Scientists in the petro-
chemical industry had long been aware of the potential
of certain strains of bacteria to metabolize and degrade
hydrocarbon compounds into simpler, harmless sub-
stances that could serve as a food source for aquatic
life. Because no single strain of bacteria was capable of
metabolizing all the different hydrocarbon compounds
present in crude oil, however, prior methods had to
rely on a mixture of bacterial strains, each of which
acted on a different set of hydrocarbon components.
Unfortunately, not all the bacterial strains in the mix-
ture could thrive in the various environmental condi-
tions existing in the area of an oil spill, so that when a
mixture of bacterial strains was used, only some of the
bacteria survived long enough to attack the spill.
The key discovery in Chakrabartys research was
that plasmids control the oil degradation abilities of
certain bacteria. Plasmids are transmittable, non-nuclear
segments of DNA. Chakrabarty developed a process by
which multiple plasmids capable of degrading different
hydrocarbon components could be incorporated within
a particularly hardy single bacterium. This genetically
engineered bacterium was capable of breaking down
oil spills at a much faster rate than naturally occurring
bacteria. As importantly, it was not affected by varying
environmental conditions.
Chakrabartys 1972 patent application contained
three groups of claims directed to
1. The method of producing the bacterium
2. An inoculum composed of a carrier material and the
bacterium
3. The genetically engineered bacterium itself
The patent examiner allowed the first two groups
but rejected the claims directed to the bacterium as
unpatentable under 35 U.S.C. 101. On appeal at the
PTO, the Board of Patent Appeals and Interferences af-
firmed the examiners rejection. The Court of Customs
and Patent Appeals reversed the Boards decision, how-
ever, ruling that living organisms are patentable subject
matter.
4
The PTO then filed a petition for writ of cer-
tiorari to the Supreme Court.
The Supreme Court Decision
The Supreme Court heard the Chakrabarty case
in March 1980. Deputy Solicitor General Lawrence
Wallace argued on behalf of the PTO. Edward McKie,
William Schuyler, and Dale Hoscheit of Schuyler,
Diamond v. Chakrabarty: A Retrospective on
25 Years of Biotech Patents
By Douglas Robinson and Nina Medlock
Douglas Robinson and Nina Medlock are shareholders in the
Washington, DC, office of Banner & Witcoff, Ltd., and can be reached
at [email protected] and nmedlock@bannerwitcoff.
com, respectively. The views expressed in this article are the
authors own. Special thanks go to Joslyn Barritt for her assistance in
preparing this article.
Volume 17 Number 10 October 2005 Intellectual Property & Technology Law Journal 13
Birch, McKie & Beckett represented Chakrabarty.
5

The question before the Court was whether the
claimed microorganism constituted a manufacture or
composition of matter within the meaning of the US
Patent Act. Reviewing the broad congressional man-
date regarding patentable subject matter, the Supreme
Court concluded that it did and asserted the principle
for which Chakrabarty is best known: that anything
under the sun that is made by man is eligible for pat-
enting.
The Immediate Aftermath
The Chakrabarty patent was not the first US patent
to issue on a living organism. The PTO had granted
patents on single-cell organisms on several occasions
dating back to 1873, when Louis Pasteur obtained a
patent (US Patent No. 141,072) on a purified yeast
cell. It was only after Chakrabarty, however, that the
PTO clarified what had been an inconsistent approach
to patenting living organisms. This clarification came
in Ex Parte Allen,
6
when the Board of Patent Appeals
and Interferences reversed the examiners rejection of
claims for genetically engineered oysters as unpatent-
able because it found no evidence that the claimed
polyploid oysters occur naturally without the interven-
tion of man.
7

Shortly after Ex Parte Allen was decided, the PTO
issued a statement on April 7, 1988, announcing that
[t]he Patent and Trademark Office now consid-
ers non-naturally occurring non-human multicellular
living organisms, including animals, to be patentable
subject matter within the scope of 35 U.S.C. 101.
8

Almost exactly one year later, on April 12, 1988, the
PTO issued the first patent for a transgenic animal,
commonly known as the Harvard Mouse (US Patent
No. 4,736,866).
The Post-Chakrabarty World
At the time Chakrabarty was decided, biotechnol-
ogy was a newly developing field. No one could have
foreseen in 1980 the phenomenal pace at which new
biotechnology advances would develop. Neither could
anyone have predicted the exponential growth in the
number of patent applications and issued patents on
biotechnology-related inventions that would occur
over the next 25 years.
By virtually every measurable factor, the biotechnol-
ogy industry has literally exploded in the 25 years since
Chakrabarty. According to data compiled by Ernst &
Young:
9
As of December 31, 2003, there were 1,473 biotech-
nology companies in the United States; the US bio-
technology industry employed 198,300 people; and
the US revenues for the biotechnology industry had
increased from $8 billion in 1992 to $39.2 billion.
In 2003 alone, the US biotechnology industry spent
$17.9 billion on research and development.
As of mid-March 2004, the total value, or market
capitalization, of the 314 publicly held biotechnology
companies had risen to $311 billion as compared to
$45 billion in 1994.
The number of patent applications and issued
patents on biotechnology-related inventions also has
risen dramatically since Chakrabarty. Data complied
by the Biotechnology Industry Organization, based in
Washington, DC, shows that the number of biotech-
nology patents granted by the PTO rose from 2,160 in
1989 to 7,763 in 2002. Since 1998, that total has aver-
aged over 7,000 patents each year.
10
The biotechnology patents issued over the last 25
years have covered a wide range of technologies and
products from medicine and diagnostics for treating
diseases to agriculture and environmental products for
feeding the worlds growing population and safeguard-
ing the environment. Some of the significant biotech-
nology patents to issue since the Chakrabarty decision
are discussed below.
The Harvard Mouse
Among the most fascinating developments in the
post-Chakrabarty world is the Harvard Mouse, de-
veloped by Harvard University researchers Phillip
Leder and Timothy Stewart. US Patent No. 4,736,866
received a great deal of attention when it was issued
in April 1988, because it was the first US patent to
issue for a transgenic animal (i.e., an animal created by
injecting genes from another species into a fertilized
animal egg and then surgically implanting the egg into
the mother). The injected genes were oncogenes that
triggered cancer growth, making the oncomouse a
particularly valuable tool for testing the effects of can-
cer-fighting drugs and suspected carcinogens.
11

Since the Harvard Mouse patent was issued in 1988,
hundreds of other patents pertaining to transgenic
animals have been issued in the United States, includ-
ing patents to chickens (US Patent No. 5,656,479),
cows (US Patent No. 5,750,176), dogs (US Patent No.
6,498,791), mice (US Patent No. 6,552,246), mon-
keys (US Patent No. 5,489,524), pigs (US Patent No.
6,498,285), rabbits (US Patent No. 5,675,063), rats
(US Patent No. 5,489,742), and sheep (US Patent No.
5,763,739).
14 Intellectual Property & Technology Law Journal Volume 17 Number 10 October 2005
The Harvard Mouse is also patented in Europe and
Japan. However, not all countries have been willing to
join the United States in allowing patents on higher life
forms. Canada, for example, has refused to patent trans-
genic animals. The Supreme Court of Canada ruled in
December 2002 that the Harvard Mouse is not patent-
able subject matter within the scope of the Canadian
Patent Act.
12
The Polymerase Chain Reaction
The polymerase chain reaction (PCR)--the subject
of US Patent Nos. 4,683,195, 4,683,202, and 4,965,188,
issued in 1987 and 1990--has been hailed as one of the
most important scientific technologies to be developed
in the last hundred years. Euphemistically referred to
as a copying machine for DNA, PCR is a technique
for amplifying, detecting, and cloning DNA sequences.
Using this process, scientists can take a tiny fragment of
DNA and generate an unlimited number of copies in
just a few hours.
In the short time since its invention, PCR has
revolutionized drug research and medical diagnos-
tics, aiding scientists in detecting hereditary diseases,
identifying viruses, and mapping the human genome.
The process has become critical in the forensic sci-
ence of genetic fingerprinting, where initial samples
often are too small to test. PCR has even been used
successfully to analyze ancient DNA from sources
ranging from Egyptian mummies to a 40,000-year-
old mammoth.
Genetically Engineered Crops
US Patent Nos. 4,940,835 and 5,188,642 are two
key patents in the area of genetically engineered crops.
Issued to Dilip Shah of the Monsanto Company on July
10, 1990, and February 23, 1993, these patents are di-
rected to a technique for genetically altering plant seeds
so that the plants are resistant to glyphosate-containing
herbicides. These herbicides can then be safely applied
in crop fields to selectively kill and control weeds with-
out also killing the crops.
Other gene-altering techniques also are in use today
to increase the nutritional content of some foods and
the resistance of crops to particular insects
.13

Thanks to biotechnology, the future has literally
come to the dinner table. By some estimates, more
than 70 percent of processed foods sold in the United
States today contain some biotechnology products. In
2004, the US Department of Agriculture reported that
genetically altered soybeans accounted for 85 percent
of the soybeans grown in this country and that geneti-
cally altered corn accounted for 45 percent of the US
corn crop.
Primate Embryonic Stem Cells
US Patent No. 6,200,806 was issued on March 13,
2001, to University of Wisconsins James Thomson for
his method of isolating and sustaining embryonic stem
cells in culture so that the cell lines continue to prolif-
erate in an undifferentiated state. Embryonic stem cells,
unlike other cell types, are pluripotent, meaning that
they can develop into any organ or tissue type.
Thomsons invention electrified developmental bi-
ologists, who saw the potential for directing cell differ-
entiation to generate any organ or tissue type desired.
It also created considerable controversy, as debates raged
regarding the harvesting of stem cells from aborted
embryos. Swayed by the tremendous promise that stem
cell research holds for the treatment of such tragic
diseases as Parkinsons and Alzheimers, the US House
of Representatives passed HR 810 on May 24, 2005,
expanding federal funding for embryonic stem cell re-
search. The Bush Administration is opposed to the bill,
but lawmakers are confident that there will be sufficient
votes to overcome any Presidential veto.
Conclusion
It is impossible to know whether biotechnology
research and development would have been stunted
had the Supreme Court ruled against the inventor in
Chakrabarty. Yet, the decision in Chakrabarty surely
provided companies in the nascent biotechnology in-
dustry with the needed incentives to invest in the pro-
duction of new medical treatments and drug therapies,
new and better diagnostic tools, and stronger and more
disease-resistant crops. It also emboldened the industry
to seek patent protection on an ever-broadening range
of technological advances. As biotechnology has pro-
gressed from the genetic manipulation of microorgan-
isms to transgenic animals and human gene sequences,
some religious and public interest groups who oppose
the patenting of animal life forms on moral and ethical
grounds have raised objections. Yet, these issues have less
to do with patent law than with defining the appropri-
ate ethical limits on scientific development. As stated by
Chakrabartys counsel, Dale Hoscheit:
The issue decided in Chakrabarty was a narrow one,
but it led to the removal of barriers to patents for a
wide variety of biotechnological innovations. The pat-
ents for these innovations are limited only by the skill
of the individuals drafting the claims. Although there
are moral and ethical issues involved in the manufacture
of living things, patents themselves are not designed to
address such issues. The role of the Patent Office is to
determine novelty and nonobviousness; issues of moral-
ity and ethics are best left to other organizations specifi-
cally tasked to deal with those issues.
Volume 17 Number 10 October 2005 Intellectual Property & Technology Law Journal 15
Notes
1. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
2. 35 U.S.C. 101.
3. Chakrabarty, supra n.1, at 309.
4. Application of Chakrabarty, 571 F.2d 40 (CCPA 1978), aff d
on rehg, 596 F.2d 952 (CCPA 1979).
5. Schuyler, Birch, McKie & Beckett is a predecessor firm to
the authors firm.
6. Ex Parte Allen, 2 U.S.P.Q.2d 1425, 1427 (Fed. Cir. 1987).
7. Id.
8. US Patent and Trademark Office Notice, Animals--
Patentability, 1077 O.G. 24 (Apr. 21, 1987) (emphasis
added).
9. Ernst & Young, LLP, Annual Biotechnology Industry Reports
19932004.
10. Biotechnology Industry Facts. June 9, 2005, available at
www.bio.org/ speeches/pubs/er/statistics.asp.
11. The patent is commonly referred to as the oncomouse pat-
ent, but the patent claims cover any transgenic nonhuman
mammal whose germ and somatic cells contain a recombi-
nant activated oncogene sequence introduced into the mam-
mal, or an ancestor of the mammal, at an embryonic stage.
12. President & Fellows of Harvard College v. Canada
(Commissioner of Patents) [2002] SCC 76.
13. Glenda D. Webber, Insect-Resistant Crops through Genetic
Engineering, University of Missouri-Columbia, June 9,
2005, available at www.muextension.missouri.edu/explore/reg-
pubs/ncr553.