SCOPE OF BIOTECHNOLOGY & INDUSTRIAL MICROBIOLOGY
NATURE OF BIOTECHNOLOGY AND
INDUSTRIAL MICROBIOLOGY:
There are many definitions of biotechnology. One of the broadest is the one given at United Nations Conference on Biological Diversity (also called the Earth Summit) at the
meeting held in Rio de Janeiro, Brazil in 1992. That conference defined biotechnology as
“any technological application that uses biological systems, living organisms, or
derivatives thereof, to make or modify products or processes for specific use.” Many
examples readily come to mind of living things being used to make or modify processes
for specific use. Some of these include the use of microorganisms to make the antibiotic,
penicillin or the dairy product, yoghurt; the use of microorganisms to produce amino
acids or enzymes are also examples of biotechnology.
Developments in molecular biology in the last two decades or so, have vastly
increased our understanding of the nucleic acids in the genetic processes. This has led to
applications of biological manipulation at the molecular level in such technologies as
genetic engineering. All aspects of biological manipulations now have molecular biology
dimensions and it appears convenient to divide biotechnology into traditional
biotechnology which does not directly involve nucleic acid or molecular manipulations
and nucleic acid biotechnology, which does.
Industrial microbiology may be defined as the study of the large-scale and profit motivated production of microorganisms or their products for direct use, or as inputs in
the manufacture of other goods. Thus yeasts may be produced for direct consumption as
food for humans or as animal feed, or for use in bread-making; their product, ethanol,
may also be consumed in the form of alcoholic beverages, or used in the manufacture of
perfumes, pharmaceuticals, etc. Industrial microbiology is clearly a branch of
biotechnology and includes the traditional and nucleic acid aspects.
CHARACTERISTICS OF INDUSTRIAL MICROBIOLOGY:
The discipline of microbiology is often divided into sub-disciplines such as medical
microbiology, environmental microbiology, food microbiology and industrial
microbiology. The boundaries between these sub-divisions are often blurred and are
made only for convenience.
Bearing this qualification in mind, the characteristics of industrial microbiology can
be highlighted by comparing its features with those of another sub-division of microbiology,medical
microbiology.
Industrial vs Medical Microbiology:
The sub-disciplines of industrial microbiology and medical microbiology differ in at least
three different ways.
First is the immediate motivation: in industrial microbiology the immediate motivation is profit and the generation of wealth. In medical microbiology, the immediate
concern of the microbiologist or laboratory worker is to offer expert opinion to the doctor
about, for example the spectrum of antibiotic susceptibility of the microorganisms
isolated from a diseased condition so as to restore the patient back to good health. The
generation of wealth is of course at the back of the mind of the medical microbiologist but
restoration of the patient to good health is the immediate concern.
The second difference is that the microorganisms per se used in routine medical
microbiology have little or no direct economic value, outside the contribution which they
make to ensuring the return to good health of the patient who may then pay for the
services. In industrial microbiology the microorganisms involved or their products are
very valuable and the raison d’etre for the existence of the industrial microbiology
establishment.
The third difference between the two sub-disciplines is the scale at which the
microorganisms are handled. In industrial microbiology, the scale is large and the
organisms may be cultivated in fermentors as large as 50,000 liters or larger. In routine
medical microbiology the scale at which the pathogen is handled is limited to a loopful or
a few milliliters. If a pathogen which normally would have no economic value were to be
handled on the large scale used in industrial microbiology, it would most probably be to
prepare a vaccine against the pathogen. Under that condition, the pathogen would then
acquire an economic value and a profit-making potential; the operation would properly be termed
industrial microbiology.
Multi-disciplinary or Team-work Nature of
Industrial Microbiology:
Unlike many other areas of the discipline of microbiology, the microbiologist in an
industrial establishment does not function by himself. He is usually only one of a number
of different functionaries with whom he has to interact constantly. In a modern industrial
microbiology organization these others may include chemical or production engineers,
biochemists, economists, lawyers, marketing experts, and other high-level functionaries.
They all cooperate to achieve the purpose of the firm, which is not philanthropy, (at least not immediately) but the generation of profit or wealth.
Despite the necessity for team work emphasized above, the microbiologist has a
central and key role in his organization. Some of his functions include:
a. the selection of the organism to be used in the processes;
b. the choice of the medium of growth of the organism;
c. the determination of the environmental conditions for the organism’s optimum
productivity i.e., pH, temperature, aeration, etc.
d. during the actual production the microbiologist must monitor the process for the
absence of contaminants, and participate in quality control to ensure uniformity of
quality in the products;
e. the proper custody of the organisms usually in a culture collection, so that their
desirable properties are retained;
f. the improvement of the performance of the microorganisms by genetic
manipulation or by medium reconstitution.
Obsolescence in Industrial Microbiology:
As profit is the motivating factor in the pursuit of industrial microbiology, less efficient
methods are discarded as better ones are discovered. Indeed a microbiological method
may be discarded entirely in favor of a cheaper chemical method. This was the case with
ethanol for example which up till about 1930 was produced by fermentation. When
cheaper chemical methods using petroleum as the substrate became available in about
1930, fermentation ethanol was virtually abandoned. From the mid-1970s the price of
petroleum has climbed steeply. It has once again become profitable to produce ethanol by
fermentation. Several countries notably Brazil, India and the United States have officially
announced the production of ethanol by fermentation for blending into gasoline as gashol
Free Communication of Procedures in
Industrial Microbiology:
Many procedures employed in industrial microbiology do not become public property for
a long time because the companies which discover them either keep them secret, or else
patent them. The undisclosed methods are usually blandly described as ‘know-how’.
The reason for the secrecy is obvious and is designed to keep the owner of the secret one
step ahead of his/her competitors. For this reason, industrial microbiology textbooks
often lag behind in describing methods employed in industry. Patents, especially as they
relate to industrial microbiology, will be discussed below.
PATENTS AND INTELLECTUAL PROPERTY RIGHTS IN
INDUSTRIAL MICROBIOLOGY AND BIOTECHNOLOGY:
All over the world, governments set up patent or intellectual property laws, which have
two aims. First, they are intended to induce an inventor to disclose something of his/her
invention. Second, patents ensure that an invention is not exploited without some
reward to the inventor for his/her innovation; anyone wishing to use a patented
invention would have to pay the patentee for its use.
The prerequisite for the patentability of inventions all over the world are that the
claimed invention must be new, useful and unobvious from what is already known
in ‘the prior art’or in the ‘state of the art’. For most patent laws an invention is
patentable:
a. if it is new, results from inventive activity and is capable of industrial application,
or
b. if it constitutes an improvement upon a patented invention, and is capable of
industrial application.
For the purposes of the above:
a. an invention is new if it does not form part of the state of the art (i.e., it is not part of
the existing body of knowledge);
b. an invention results from inventive activity if it does not obviously follow from the
state of the art, either as to the method, the application, the combination of methods,
or the product which is concerns, or as to the industrial result it produces, and
c. an invention is capable of industrial application if it can be manufactured or used
in any kind of industry, including agriculture.
In the above, ‘the art’means the art or field of knowledge to which an invention relates
and ‘the state of the art’means everything concerning that art or field of knowledge
which has been made available to the public anywhere and at any time, by means of a
written or oral description, or in any other way, before the date of the filing of the patent
application.
Patents cannot be validly obtained in respect of:
a. plant or animal varieties, or essentially biological processes for the production of
plants or animals (other than microbiological processes and their products), or
b. inventions, the publication or exploitation of which would be contrary to public
order or morality (it being understood for the purposes of this paragraph that the
exploitation of an invention is not contrary to public order or morality merely
because its exploitation is prohibited by law).
Principles and discoveries of a scientific nature are not necessarily inventions for the
purposes of patent laws.
It is however not always as easy as it may seem to show that an invention is ‘new’,
‘useful’, and ‘unobvious’. In some cases it has been necessary to go to the law courts to
decide whether or not an invention is patentable. It is therefore advisable to obtain the
services of an attorney specializing in patent law before undertaking to seek a patent. The
laws are often so complicated that the layman, including the bench-bound microbiologist
may, without proper guidance, leave out essential details which may invalidate his claim
to his invention.
The exact wording may vary, but the general ideas regarding patentability are the
same around the world. The current Patent Law in the United States is the United States
Code Title 35 –Patents (Revised 3 August, 2005), and is administered by the Patents and
Trademarks Office while the equivalent UK Patent Law is the Patent Act 1977.
An examination of the patent laws of a number of countries will show that they often
differ only in minor details. For example patents are valid in the UK and some other
countries for a period of 20 years whereas they are valid in the United States for 17 years.
International laws have helped to bridge some of the differences among the patent
practices of various countries. The Paris Convention for the protection of Industrial
Property has been signed by several countries. This convention provides that each
country guarantees to the citizens of other countries the same rights in patent matters as
their own citizens. The treaty also provides for the right of priority in case of dispute.
Following from this, once an applicant has filed a patent in one of the member countries
on a particular invention, he may within a certain time period apply for protection in all
the other member countries. The latter application will then be regarded as having been
filed on the same day as in the country of the first application. Another international
treaty signed in Washington, DC came into effect on 1 June, 1968. This latter treaty, the
Patent Cooperation Treaty, facilitates the filing of patent applications in different
countries by providing standard formats among other things.
A wide range of microbiological inventions are generally recognized as patentable.
Such items include vaccines, bacterial insecticides, and mycoherbicides. As will be seen
below however, micro-organisms per se are not patentable, except when they are used as
part of a ‘useful’ process.
On 16 June, 1980 a case of immense importance to the course of industrial
microbiology was decided in the United States Court of Customs and Patent Appeals. In
brief, the court ruled that “a live human-made micro-organism is patentable”.
Dr. Ananda Chakrabarty then an employee of General Electric Company had introduced
into a bacterium of the genus Pseudomonas two plasmids (using techniques of genetic
engineering discussed in Chapter 7) which enabled the new bacterium to degrade
multiple components of crude oil. This single bacterium rather than a mixture of several
would then be used for cleaning up oil spills. Claims to the invention were on three
grounds.
a. Process claims for the method of producing the bacteria
b. Claims for an inoculum comprising an inert carrier and the bacterium
c. Claims to the bacteria themselves.
The first two were easily accepted by the lower court but the third was not accepted on
the grounds that (i) the organisms are products of nature and (ii) that as living things they
are not patentable. As had been said earlier the Appeals Court reversed the earlier
judgment of the lower court and established the patentability of organisms imbued with
new properties through genetic engineering.
A study of the transcript of the decision of the Appeals Court and other patents
highlights a number of points about the patentability of microorganisms.
First, microorganisms by themselves are not patentable, being ‘products of nature’and
‘living things’. However they are patentable as part of a useful ‘process’i.e. when they
are included along with a chemical or an inert material with which jointly they fulfill a
useful purpose. In other words it is the organism-inert material complex which is
patented, not the organism itself. An example is a US patent dealing with a bacterium
which kills mosquito larva granted to Dr L J Goldberg in 1979, and which reads thus in
part:
What is claimed is:
A bacterial larvicide active against mosquito-like larvae comprising(this author’s
italics):
a. an effective larva-killing concentration of spores of the pure biological strain of
Bacillus thuringiensis var. WHO/CCBC 1897 as an active agent; and
b. a carrier….
It is the combination of the bacterial larvicide and the carrier which produced a unique
patentable material, not the larvicide by itself. In this regard, when for example, a new
antibiotic is patented, the organism producing it forms part of the useful process by
which the antibiotic is produced.
Second, a new organism produced by genetic engineering constitutes a ‘manufacture’
or ‘composition of matter’. The Appeals Court made it quite clear that such an organism
was different from a newly discovered mineral, and from Einstein’s law, or Newton’s law
which are not patentable since they already existed in nature. Today most countries
including those of the European Economic Community accept that the following are
patentable: the creation of new plasmid vectors, isolation of new DNA restriction
enzymes, isolation of new DNA-joining enzymes or ligases, creation of new recombinant
DNA, creation of new genetically modified cells, means of introducing recombinant
DNA into a host cell, creation of new transformed host cells containing recombinant
DNA, a process for preparing new or known useful products with the aid of transformed
cells, and novel cloning processes. Patents resulting from the above were in general
regarded as process, not substance, patents. (The above terms all relate to genetic
engineering and are discussed in Chapter 7.) The current US law specifically defines
biotechnological inventions and their patentability as follows:
“For purposes of (this) paragraph …. the term ‘biotechnological process’means:
(A) a process of genetically altering or otherwise inducing a single- or multi-celled
organism to-(i) express an exogenous nucleotide sequence,
(ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide
sequence, or
(iii) express a specific physiological characteristic not naturally associated with
said organism;
(B) cell fusion procedures yielding a cell line that expresses a specific protein, such as
a monoclonal antibody; and
(C) a method of using a product produced by a process defined by subparagraph (A) or
(B), or a combination of subparagraphs (A) and (B).”
Third, the patenting of a microbiological process places on the patentee the obligation
of depositing the culture in a recognized culture collection. The larvicidal bacterium,
Bacillus thuringiensis, just mentioned, is deposited at the World Health Organization
(WHO) International Culture depository at the Ohio State University Columbus Ohio,
USA. The rationale for the deposition of culture in a recognized culture collection is to
provide permanence of the culture and ready availability to users of the patent. The
cultures must be pure and are usually deposited in lyophilized vials.
The deposition of culture solves the problems of satisfying patent laws created by the
nature of microbiology. In chemical patents the chemicals have to be described fully and
no need exists to provide the actual chemical. In microbiological patents, it is not very
helpful to describe on paper how to isolate an organism even assuming that the isolate
can be readily obtained, or indeed how the organism looks. More importantly, it is
difficult to readily and accurately recognize a particular organism based on patent
descriptions alone. Finally, since the organism is a part of the input of microbiological
processes it must be available to a user of the patent information.
Culture collections where patent-related cultures have been deposited include the
American Type Culture Collection, (ATCC), Maryland, USA, National Collection of
Industrial Bacteria (NCIB), Aberdeen, Scotland, UK, Agricultural Research Service
Culture Collection, Northern Regional Research Laboratory (NRRL), Peoria, Illinois,
USA. A fuller list is available in the World Directory of Cultures of Micro-organisms. Culture
collections and methods for preserving microorganisms are discussed in Chapter 8 of
this book.
Fourth, where a microbiologist-inventor is an employee, the patent is usually assigned
to the employer, unless some agreement is reached between them to the contrary. The
patent for the oil-consuming Pseudomonas discussed earlier went to General Electric
Company, not to its employee.
Fifth, in certain circumstances it may be prudent not to patent the invention at all, but
to maintain the discovery as a trade secret. In cases where the patent can be circumvented
by a minor change in the process without an obvious violation of the patent law it would
not be wise to patent, but to maintain the procedure as a trade secret. Even if the nature of
the compound produced by the microorganisms were not disclosed, it may be possible to
discover its composition during the processes of certification which it must undergo in
the hands of government analysts. The decision whether to patent or not must therefore
be considered seriously, consulting legal opinion as necessary. It is for this reason that
some patents sometimes leave out minor but vital details. As much further detail as the
patentee is willing to give must therefore be obtained when a patent is being considered
seriously for use.
In conclusion when all necessary considerations have been taken into account and it
is decided to patent an invention, the decision must be pursued with vigor and with
adequate degree of secrecy because as one patent law states:
…. The right to patent in respect of an invention is vested in the statutory inventor,
that is to say that person who whether or not he is the true inventor, is the first to
file…(the) patent application.
Cited By Kamal Singh Khadka
Msc Microbiology
Assistant Professor in PU,RE-COST, PNC, LA, NA.
Pokhara, Nepal.
REFERENCES:
INDUSTRIAL MICROBIOLOGY:
There are many definitions of biotechnology. One of the broadest is the one given at United Nations Conference on Biological Diversity (also called the Earth Summit) at the
meeting held in Rio de Janeiro, Brazil in 1992. That conference defined biotechnology as
“any technological application that uses biological systems, living organisms, or
derivatives thereof, to make or modify products or processes for specific use.” Many
examples readily come to mind of living things being used to make or modify processes
for specific use. Some of these include the use of microorganisms to make the antibiotic,
penicillin or the dairy product, yoghurt; the use of microorganisms to produce amino
acids or enzymes are also examples of biotechnology.
Developments in molecular biology in the last two decades or so, have vastly
increased our understanding of the nucleic acids in the genetic processes. This has led to
applications of biological manipulation at the molecular level in such technologies as
genetic engineering. All aspects of biological manipulations now have molecular biology
dimensions and it appears convenient to divide biotechnology into traditional
biotechnology which does not directly involve nucleic acid or molecular manipulations
and nucleic acid biotechnology, which does.
Industrial microbiology may be defined as the study of the large-scale and profit motivated production of microorganisms or their products for direct use, or as inputs in
the manufacture of other goods. Thus yeasts may be produced for direct consumption as
food for humans or as animal feed, or for use in bread-making; their product, ethanol,
may also be consumed in the form of alcoholic beverages, or used in the manufacture of
perfumes, pharmaceuticals, etc. Industrial microbiology is clearly a branch of
biotechnology and includes the traditional and nucleic acid aspects.
CHARACTERISTICS OF INDUSTRIAL MICROBIOLOGY:
The discipline of microbiology is often divided into sub-disciplines such as medical
microbiology, environmental microbiology, food microbiology and industrial
microbiology. The boundaries between these sub-divisions are often blurred and are
made only for convenience.
Bearing this qualification in mind, the characteristics of industrial microbiology can
be highlighted by comparing its features with those of another sub-division of microbiology,medical
microbiology.
Industrial vs Medical Microbiology:
The sub-disciplines of industrial microbiology and medical microbiology differ in at least
three different ways.
First is the immediate motivation: in industrial microbiology the immediate motivation is profit and the generation of wealth. In medical microbiology, the immediate
concern of the microbiologist or laboratory worker is to offer expert opinion to the doctor
about, for example the spectrum of antibiotic susceptibility of the microorganisms
isolated from a diseased condition so as to restore the patient back to good health. The
generation of wealth is of course at the back of the mind of the medical microbiologist but
restoration of the patient to good health is the immediate concern.
The second difference is that the microorganisms per se used in routine medical
microbiology have little or no direct economic value, outside the contribution which they
make to ensuring the return to good health of the patient who may then pay for the
services. In industrial microbiology the microorganisms involved or their products are
very valuable and the raison d’etre for the existence of the industrial microbiology
establishment.
The third difference between the two sub-disciplines is the scale at which the
microorganisms are handled. In industrial microbiology, the scale is large and the
organisms may be cultivated in fermentors as large as 50,000 liters or larger. In routine
medical microbiology the scale at which the pathogen is handled is limited to a loopful or
a few milliliters. If a pathogen which normally would have no economic value were to be
handled on the large scale used in industrial microbiology, it would most probably be to
prepare a vaccine against the pathogen. Under that condition, the pathogen would then
acquire an economic value and a profit-making potential; the operation would properly be termed
industrial microbiology.
Multi-disciplinary or Team-work Nature of
Industrial Microbiology:
Unlike many other areas of the discipline of microbiology, the microbiologist in an
industrial establishment does not function by himself. He is usually only one of a number
of different functionaries with whom he has to interact constantly. In a modern industrial
microbiology organization these others may include chemical or production engineers,
biochemists, economists, lawyers, marketing experts, and other high-level functionaries.
They all cooperate to achieve the purpose of the firm, which is not philanthropy, (at least not immediately) but the generation of profit or wealth.
Despite the necessity for team work emphasized above, the microbiologist has a
central and key role in his organization. Some of his functions include:
a. the selection of the organism to be used in the processes;
b. the choice of the medium of growth of the organism;
c. the determination of the environmental conditions for the organism’s optimum
productivity i.e., pH, temperature, aeration, etc.
d. during the actual production the microbiologist must monitor the process for the
absence of contaminants, and participate in quality control to ensure uniformity of
quality in the products;
e. the proper custody of the organisms usually in a culture collection, so that their
desirable properties are retained;
f. the improvement of the performance of the microorganisms by genetic
manipulation or by medium reconstitution.
Obsolescence in Industrial Microbiology:
As profit is the motivating factor in the pursuit of industrial microbiology, less efficient
methods are discarded as better ones are discovered. Indeed a microbiological method
may be discarded entirely in favor of a cheaper chemical method. This was the case with
ethanol for example which up till about 1930 was produced by fermentation. When
cheaper chemical methods using petroleum as the substrate became available in about
1930, fermentation ethanol was virtually abandoned. From the mid-1970s the price of
petroleum has climbed steeply. It has once again become profitable to produce ethanol by
fermentation. Several countries notably Brazil, India and the United States have officially
announced the production of ethanol by fermentation for blending into gasoline as gashol
Free Communication of Procedures in
Industrial Microbiology:
Many procedures employed in industrial microbiology do not become public property for
a long time because the companies which discover them either keep them secret, or else
patent them. The undisclosed methods are usually blandly described as ‘know-how’.
The reason for the secrecy is obvious and is designed to keep the owner of the secret one
step ahead of his/her competitors. For this reason, industrial microbiology textbooks
often lag behind in describing methods employed in industry. Patents, especially as they
relate to industrial microbiology, will be discussed below.
PATENTS AND INTELLECTUAL PROPERTY RIGHTS IN
INDUSTRIAL MICROBIOLOGY AND BIOTECHNOLOGY:
All over the world, governments set up patent or intellectual property laws, which have
two aims. First, they are intended to induce an inventor to disclose something of his/her
invention. Second, patents ensure that an invention is not exploited without some
reward to the inventor for his/her innovation; anyone wishing to use a patented
invention would have to pay the patentee for its use.
The prerequisite for the patentability of inventions all over the world are that the
claimed invention must be new, useful and unobvious from what is already known
in ‘the prior art’or in the ‘state of the art’. For most patent laws an invention is
patentable:
a. if it is new, results from inventive activity and is capable of industrial application,
or
b. if it constitutes an improvement upon a patented invention, and is capable of
industrial application.
For the purposes of the above:
a. an invention is new if it does not form part of the state of the art (i.e., it is not part of
the existing body of knowledge);
b. an invention results from inventive activity if it does not obviously follow from the
state of the art, either as to the method, the application, the combination of methods,
or the product which is concerns, or as to the industrial result it produces, and
c. an invention is capable of industrial application if it can be manufactured or used
in any kind of industry, including agriculture.
In the above, ‘the art’means the art or field of knowledge to which an invention relates
and ‘the state of the art’means everything concerning that art or field of knowledge
which has been made available to the public anywhere and at any time, by means of a
written or oral description, or in any other way, before the date of the filing of the patent
application.
Patents cannot be validly obtained in respect of:
a. plant or animal varieties, or essentially biological processes for the production of
plants or animals (other than microbiological processes and their products), or
b. inventions, the publication or exploitation of which would be contrary to public
order or morality (it being understood for the purposes of this paragraph that the
exploitation of an invention is not contrary to public order or morality merely
because its exploitation is prohibited by law).
Principles and discoveries of a scientific nature are not necessarily inventions for the
purposes of patent laws.
It is however not always as easy as it may seem to show that an invention is ‘new’,
‘useful’, and ‘unobvious’. In some cases it has been necessary to go to the law courts to
decide whether or not an invention is patentable. It is therefore advisable to obtain the
services of an attorney specializing in patent law before undertaking to seek a patent. The
laws are often so complicated that the layman, including the bench-bound microbiologist
may, without proper guidance, leave out essential details which may invalidate his claim
to his invention.
The exact wording may vary, but the general ideas regarding patentability are the
same around the world. The current Patent Law in the United States is the United States
Code Title 35 –Patents (Revised 3 August, 2005), and is administered by the Patents and
Trademarks Office while the equivalent UK Patent Law is the Patent Act 1977.
An examination of the patent laws of a number of countries will show that they often
differ only in minor details. For example patents are valid in the UK and some other
countries for a period of 20 years whereas they are valid in the United States for 17 years.
International laws have helped to bridge some of the differences among the patent
practices of various countries. The Paris Convention for the protection of Industrial
Property has been signed by several countries. This convention provides that each
country guarantees to the citizens of other countries the same rights in patent matters as
their own citizens. The treaty also provides for the right of priority in case of dispute.
Following from this, once an applicant has filed a patent in one of the member countries
on a particular invention, he may within a certain time period apply for protection in all
the other member countries. The latter application will then be regarded as having been
filed on the same day as in the country of the first application. Another international
treaty signed in Washington, DC came into effect on 1 June, 1968. This latter treaty, the
Patent Cooperation Treaty, facilitates the filing of patent applications in different
countries by providing standard formats among other things.
A wide range of microbiological inventions are generally recognized as patentable.
Such items include vaccines, bacterial insecticides, and mycoherbicides. As will be seen
below however, micro-organisms per se are not patentable, except when they are used as
part of a ‘useful’ process.
On 16 June, 1980 a case of immense importance to the course of industrial
microbiology was decided in the United States Court of Customs and Patent Appeals. In
brief, the court ruled that “a live human-made micro-organism is patentable”.
Dr. Ananda Chakrabarty then an employee of General Electric Company had introduced
into a bacterium of the genus Pseudomonas two plasmids (using techniques of genetic
engineering discussed in Chapter 7) which enabled the new bacterium to degrade
multiple components of crude oil. This single bacterium rather than a mixture of several
would then be used for cleaning up oil spills. Claims to the invention were on three
grounds.
a. Process claims for the method of producing the bacteria
b. Claims for an inoculum comprising an inert carrier and the bacterium
c. Claims to the bacteria themselves.
The first two were easily accepted by the lower court but the third was not accepted on
the grounds that (i) the organisms are products of nature and (ii) that as living things they
are not patentable. As had been said earlier the Appeals Court reversed the earlier
judgment of the lower court and established the patentability of organisms imbued with
new properties through genetic engineering.
A study of the transcript of the decision of the Appeals Court and other patents
highlights a number of points about the patentability of microorganisms.
First, microorganisms by themselves are not patentable, being ‘products of nature’and
‘living things’. However they are patentable as part of a useful ‘process’i.e. when they
are included along with a chemical or an inert material with which jointly they fulfill a
useful purpose. In other words it is the organism-inert material complex which is
patented, not the organism itself. An example is a US patent dealing with a bacterium
which kills mosquito larva granted to Dr L J Goldberg in 1979, and which reads thus in
part:
What is claimed is:
A bacterial larvicide active against mosquito-like larvae comprising(this author’s
italics):
a. an effective larva-killing concentration of spores of the pure biological strain of
Bacillus thuringiensis var. WHO/CCBC 1897 as an active agent; and
b. a carrier….
It is the combination of the bacterial larvicide and the carrier which produced a unique
patentable material, not the larvicide by itself. In this regard, when for example, a new
antibiotic is patented, the organism producing it forms part of the useful process by
which the antibiotic is produced.
Second, a new organism produced by genetic engineering constitutes a ‘manufacture’
or ‘composition of matter’. The Appeals Court made it quite clear that such an organism
was different from a newly discovered mineral, and from Einstein’s law, or Newton’s law
which are not patentable since they already existed in nature. Today most countries
including those of the European Economic Community accept that the following are
patentable: the creation of new plasmid vectors, isolation of new DNA restriction
enzymes, isolation of new DNA-joining enzymes or ligases, creation of new recombinant
DNA, creation of new genetically modified cells, means of introducing recombinant
DNA into a host cell, creation of new transformed host cells containing recombinant
DNA, a process for preparing new or known useful products with the aid of transformed
cells, and novel cloning processes. Patents resulting from the above were in general
regarded as process, not substance, patents. (The above terms all relate to genetic
engineering and are discussed in Chapter 7.) The current US law specifically defines
biotechnological inventions and their patentability as follows:
“For purposes of (this) paragraph …. the term ‘biotechnological process’means:
(A) a process of genetically altering or otherwise inducing a single- or multi-celled
organism to-(i) express an exogenous nucleotide sequence,
(ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide
sequence, or
(iii) express a specific physiological characteristic not naturally associated with
said organism;
(B) cell fusion procedures yielding a cell line that expresses a specific protein, such as
a monoclonal antibody; and
(C) a method of using a product produced by a process defined by subparagraph (A) or
(B), or a combination of subparagraphs (A) and (B).”
Third, the patenting of a microbiological process places on the patentee the obligation
of depositing the culture in a recognized culture collection. The larvicidal bacterium,
Bacillus thuringiensis, just mentioned, is deposited at the World Health Organization
(WHO) International Culture depository at the Ohio State University Columbus Ohio,
USA. The rationale for the deposition of culture in a recognized culture collection is to
provide permanence of the culture and ready availability to users of the patent. The
cultures must be pure and are usually deposited in lyophilized vials.
The deposition of culture solves the problems of satisfying patent laws created by the
nature of microbiology. In chemical patents the chemicals have to be described fully and
no need exists to provide the actual chemical. In microbiological patents, it is not very
helpful to describe on paper how to isolate an organism even assuming that the isolate
can be readily obtained, or indeed how the organism looks. More importantly, it is
difficult to readily and accurately recognize a particular organism based on patent
descriptions alone. Finally, since the organism is a part of the input of microbiological
processes it must be available to a user of the patent information.
Culture collections where patent-related cultures have been deposited include the
American Type Culture Collection, (ATCC), Maryland, USA, National Collection of
Industrial Bacteria (NCIB), Aberdeen, Scotland, UK, Agricultural Research Service
Culture Collection, Northern Regional Research Laboratory (NRRL), Peoria, Illinois,
USA. A fuller list is available in the World Directory of Cultures of Micro-organisms. Culture
collections and methods for preserving microorganisms are discussed in Chapter 8 of
this book.
Fourth, where a microbiologist-inventor is an employee, the patent is usually assigned
to the employer, unless some agreement is reached between them to the contrary. The
patent for the oil-consuming Pseudomonas discussed earlier went to General Electric
Company, not to its employee.
Fifth, in certain circumstances it may be prudent not to patent the invention at all, but
to maintain the discovery as a trade secret. In cases where the patent can be circumvented
by a minor change in the process without an obvious violation of the patent law it would
not be wise to patent, but to maintain the procedure as a trade secret. Even if the nature of
the compound produced by the microorganisms were not disclosed, it may be possible to
discover its composition during the processes of certification which it must undergo in
the hands of government analysts. The decision whether to patent or not must therefore
be considered seriously, consulting legal opinion as necessary. It is for this reason that
some patents sometimes leave out minor but vital details. As much further detail as the
patentee is willing to give must therefore be obtained when a patent is being considered
seriously for use.
In conclusion when all necessary considerations have been taken into account and it
is decided to patent an invention, the decision must be pursued with vigor and with
adequate degree of secrecy because as one patent law states:
…. The right to patent in respect of an invention is vested in the statutory inventor,
that is to say that person who whether or not he is the true inventor, is the first to
file…(the) patent application.
Cited By Kamal Singh Khadka
Msc Microbiology
Assistant Professor in PU,RE-COST, PNC, LA, NA.
Pokhara, Nepal.
REFERENCES:
Microbial Biotechnology: Fundamentals of Applied Microbiology
books.google.com.np/books?isbn=0521842107
Modern Industrial Microbiology Biotechnology
www.cenicana.org/investigacion/seica/imagenes.../modern_indutrial.pdf
Journal of Industrial Microbiology and Biotechnology
www.scimagojr.com/journalsearch.php?q=16085&tip=sid
Journal of Industrial Microbiology and Biotechnology
www.scimagojr.com/journalsearch.php?q=16085&tip=sid
Microbiology - Wikipedia, the free encyclopedia
en.wikipedia.org/wiki/Microbiology
Microbial Biotechnology - All Issues - Wiley Online Library
onlinelibrary.wiley.com › ... › Microbial Biotechnology
Biotechnology-Industrial Microbiology or Biomedical Engineering ...
www.canadavisa.com › ... › International Students
site.iugaza.edu.ps/tbashiti/files/2010/02/Introduction-2.ppt
pdf230.kolibooks.com/modern-industrial-microbiology-and-biotechnolo...
www.biotechnologyforums.com › Education and Careers › Careers.
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