LECTURE NOTES ON MCB 407.

2 2020/2021

BIODIVERSITY
Biodiversity refers to the number of species of organisms inhabiting a particular
ecosystem and their evenness of distribution or the variety of species of organisms
inhabiting an environment. The earliest classification placed living organisms into two
simple categories, plants and animals. When the microscope was discovered in about
the middle of the 16th century, it enabled the observation of microorganisms for the first
time. Living organisms were then divided into plants, animals, and protista
(microorganisms). From the 1960s and the 1970s, Whittaker’s division of living
organisms into five groups was the accepted grouping. The classification was based on
cell-type: prokaryotic or eukaryotic, organizational level: single-celled or multi-cellular,
and nutritional type: heterotrophy and autotrophy. On the basis of these characteristics,
living organisms were divided into five groups: Monera (bacteria), Protista (algae and
protozoa), Plants, Fungi, and Animals. The current classification of living organisms is
based on the work of Carl R. Woese of the University of Illinois. Greater knowledge of
molecular basis of cell function led to today’s classification based on the sequence of
ribosomal RNA (rRNA) in the 16S of the small subunit (SSU) of the prokaryotic
ribosome, and the 18S ribosomal unit of eukaryotes. The rRNA sequence is used for the
following reasons:
(i) 16S (or 18S) rRNA is essential to the ribosome, and found in all living things;
(ii) Its function is identical in all ribosomes
(iii) Its sequence changes very slowly with evolutionary time, and it contains variable
and stable sequences which enable the comparison of closely related as well as
distantly related species.
The classification is evolutionary and attempts to link all livings organisms with
evolution from a common ancestor. The 16S ribosomal RNAs meet these criteria, as
ribosomes are involved in protein synthesis in all living organisms. According to the
currently accepted classification living things are placed into three groups: Archaea,
Bacteria, and Eukarya. Archaea and Bacteria are prokaryotic, while Eukarya are
eukaryotic. Bacteria are described in two compendia, Bergey’s Manual of Determinative
Bacteriology and Bergey’s Manual of Systematic Bacteriology. The Bergey’s Manual of
st
Determinative Bacteriology was 1 published in 1923, is designed to facilitate the
identification of a bacterium whose identity is unknown using the normal methods of
identification The Bergey’s Manual of Systematic Bacteriology records the accepted
published descriptions of bacteria and classifies them into taxonomic groups. The
Bergey’s Manual of Systematic Bacteriology is based on 16S RNA sequences following
the work of Carl Woese and organizes the domain Bacteria into 18 groups (or phyla;
singular, phylum).

TAXONOMIC GROUPING OF INDUSTRIAL MICROORGANISMS

The microorganisms currently used in industrial microbiology and biotechnology are
found mainly among the bacteria and eukarya, the processes used in industrial
microbiology and biotechnology are dynamic. Many organisms in Archaea are able to
grow under extreme conditions of temperature or salinity. These conditions may be
exploited in industrial processes where such physiological properties may put a member
of the Archaea at an advantage over contaminants. Plants and animals as well as their
cell cultures are also used in biotechnology.
Microorganisms have the following advantages over plants or animals as inputs in
biotechnology:
i. Microorganisms grow rapidly in comparison with plants and animals. The generation
time (the time for an organism to mature and reproduce) is about 12 years in man,
about 24 months in cattle, 18 months in pigs, 6 months in chicken, but only 15 minutes
in the bacterium, E. coli. The consequence is that biotechnological products which can
be obtained from microorganisms in a matter of days may take many months in
animals or plants.
ii. The space requirement for growth microorganisms is small. A 100,000 liter fermenter
can be housed in about 100 square yards of space, whereas the plants or animals
needed to generate the equivalent of products in the 100,000 fermenter would require
many acres of land.
iii. Microorganisms are not subject to the problems of the changes of weather which
may affect agricultural production especially among plants.
iv. Microorganisms are not affected by diseases of plants and animals, although they
do have their peculiar scourges in the form of phages and contaminants, but there are
procedures to contain them.
The huge diversity of organisms that differ in their sources of energy, their sources of
cell carbon or nitrogen, their metabolic pathway, the end products of their metabolism,
and their ability, to attack various naturally occurring organic compounds. They perform
different roles and possess several cellular and genetic characteristics. They focus on
variation in their DNA rather than in their phenotype. These microorganisms are defined
as a group of strains that share more than 70% of their genome. They are characterized
by melting the genomic DNA, measuring the rate at which they re-anneal, a rate
determined by the similarity of the organisms genomes.

A microbial diversity study relies on the 70% genome by using genetic markers to
characterize microbial diversity composition by using the 16S RNA sequence of
bacteria. Once the microbial species is defined, the diversity of a microbial community
can be measured. Microbial diversity is the richness and evenness in a defined area.
Variation at many levels of biological organization from the allele at a particular genetic
locus to community composition among biomes. Cultural techniques to characterize the
composition of microbial communities has led to the development of culture-
 independent methods base on the genetic characterization of microbial
communities and has allowed the detection of non culturable species with a more
detailed description.

METHODS USED TO CHARACTERIZE MICROBIAL COMMUNITIES INVOLVE:

1. Polymerase chain reaction (PCR) to amplified rDNA gene from community DNA.

2. Assay the products to characterize the diversity of the community rDNA genes.

3. Cloning followed by DNA sequencing

4. Analyzing the PCR-amplified genes by restriction enzymes.

5. The resulting fragments are separated by gel electrophoresis to produce a

banding pattern.

6. Metagenomics uses the DNA sequences of fragments of DNA from a natural

microbial community.

Screenings of samples have led to the identification of various novel

biomolecules including enzymes and antibiotics.

PATENT ISSUES

INTELLECTUAL PROPERTY: Intellectual Property (IP) is the collective name for new and
unique ideas, products and creations resulting from human creativity and innovation. It
differs from other forms of property because it is intangible—that is, it is a product of
the human imagination (mind or intellect). The World Intellectual Property Organisation
(WIPO) defines IP as ―rights relating to
1. Literary, artistic and scientific works;
2. Performances of performing artists, phonograms and broadcasts;
3. Inventions in all fields of human endeavour;
4. Scientific discoveries; (v) industrial designs;
5. Trademarks, services marks and commercial names and designations;
Protection against unfair competition; and all other rights resulting from intellectual
activity in the industrial, scientific, literary or artistic fields.
CATEGORIES OF INTELLECTUAL PROPERTY
Intellectual property is mainly divided into two broad categories;
I. Industrial property: Industrial property covers those created and used for industrial or
commercial purposes. It includes patent, industrial designs, trademarks, service marks,
commercial names and designations
II. Copyright: Copyright deals with intellectual property of creative work. It includes
Literary works such as novels, poems and plays, films, musical works; artistic works
such as drawings, paintings, photographs and sculptures, and architectural designs.
Rights related to copyright include those of performing artists in their performances,
producers of phonograms, and those of broadcasters in their radio and television
programs.
INTELLECTUAL PROPERTY RIGHTS (IPR): Intellectual Property Right is the legal rights
given to the inventor or creator to protect his invention or creation for a certain period of
time. The concept of intellectual property is based on the idea that one should have the
proprietary rights in something which he creates by applying his skill, labour and
intellect.
Intellectual property laws reward creators of intellectual property by preventing others
from copying, performing, or distributing their works without permission. It is a strong
tool to protect investments, time, money, effort invested by the inventor/creator of an IP,
since it grants the inventor/ creator an exclusive right to fully utilize his invention/
creation for a given period of time. These rights are not given for the physical creation
of the objects but for the intellectual efforts applied to such creation.

AIM OF IPR: The main aim is to safeguarding creators and other producers of
intellectual goods and services by granting them legal rights to control the use of their
Intellectual Property for a certain period of time.

OBJECTIVES OF IPR: IP law and enforcement is generally similar in nature from country
to country but will vary in points of detail. All over the world, governments set up
intellectual property laws for several compelling reasons -
1. To help strike a balance between the interests of the inventor and the public interest,
providing an environment in which creativity and invention can flourish, to the benefit of
all.
2. To provide incentives for people to invest time and money in research and
development to produce scientific and creative works that benefit the society at large.
3. The legal protection of these new creations encourages the expenditure of additional
resources, which leads to further innovation.
4. The progress and well-being of humanity rests on its capacity for new creations in the
areas of technology and culture.
5. The promotion and protection of intellectual property spurs economic growth, creates
new jobs and industries, and enhances the quality and enjoyment of life
6. To eliminate the infringement, improper exploitation and abuse of university‘s
intellectual assets belonging to the university or other persons;
7. To optimize the environment and incentives for research and for the creation of new
knowledge;

NATURE OF INTELLECTUAL PROPERTY: Intellectual properties have their own peculiar

features and some common characteristics that distinguish them from other property.
They are naturally, proprietary in nature and can be bought and sold, mortgaged and
licensed just like any other type of property. Other characteristics are stated below:
A. Intangible: The intangibility of intellectual property makes it possible for many people
to use it without authorization. For instance only one person can drive a car at a time,
but if an author publishes a book; many people can read the work at the same time. As
such, Intellectual property is much easier to copy than it is to create.
B. Territorial: One of the basic characteristics of intellectual property since it is a
creation of statutes; is that it is confined to the territory where it is created even though
the importance transcends national boundaries. Patent rights are essentially territorial in
nature. It is as a result of this recognition that intellectual property a convention
provides protection of intellectual property which carries out wide variety of activities
and services.
C. Giving an exclusive right to the owner: The creator or author of an intellectual
property enjoys rights inherent in his work to the exclusion of anybody else. Intellectual
property law is an area of law which deters others from copying or taking unfair
advantage of the work or reputation of another and provides remedies where this arises.
D. Assignable: Since they are rights, they can obviously be assigned (licensed). It is
possible to put a dichotomy between intellectual property rights and the material object
in which the work is embodied. Intellectual property can be bought, sold, or licensed or
hired or attached.
E. Independence: Different intellectual property rights subsist in the same kind of object.
Most intellectual property rights are likely to be embodied in objects.
F. Subject to Public Policy: They are vulnerable to the deep embodiment of public policy.
Intellectual property attempts to preserve and find adequate reconciliation between two
competing interests. On the one hand, the intellectual property rights holders require
adequate remuneration and on the other hand, consumers try to consume works without
much inconvenience. Intellectual property right expires after a specified period. This
permits the rest of society to benefit from the work after the creator has had an
opportunity to earn a fair reward. G. Divisible (Fragmentation): Several persons may
have legally protected interests evolved from a single original work without affecting the
interest of other right holders on that same item. Because of the nature of indivisibility,
intellectual property is an inexhaustible resource. This nature of intellectual property
derives from intellectual property‘s territorial nature. For example, an inventor who
registered his invention in Ethiopia can use the patent himself in Ethiopia and License it
in Germany and assign it in France. This notable feature of intellectual property rights is
that as different as they are, they exist independently of each other.
H. Volatility: Finally, intellectual property is indeed volatile. Before printing was invented,
literally works require no protection; they resided in the memory of the author.
Trademarks only became important when society moved on from one in which
individual traded their products. Moreover the intense demand of intellectual property
protection is as a result of technological development in area of production of goods
and services. Intellectual property is no doubt fields that evolve all the time responding
to the process of periodic, even daily creation as individuals and communities take up
challenges presented by their social and physical environment.
Advantages of intellectual property right
The advantages of intellectual property right are as follows;
1 Encouraging and safeguarding intellectual and artistic creations.
2. Disseminating new ideas and technologies quickly and widely.
3. Helps to promote investment.
4. Providing consumers with the results of creation and invention.
5. Provide increased opportunities for the distribution of the above effected across the
countries in a manner proportionate to the national levels of economic and industrial
development.

FORMS OF INTELLECTUAL PROPERTY RIGHTS

The whole concept of IPR can be broadly divided in three categories i.e.
Intellectual property rights related to trade, industry and, commerce;
Intellectual property rights related to original thoughts and expression and;
Some matters incidental to intellectual property rights. There are eight different forms of
intellectual property rights recognized by WIPO
i. IPR related to trade, industry and commerce
IPR related to trade, industry and commerce can be classified as follows patent,
industrial design, trade mark, and trade secrets.
PATENT
Patent originates from the latin word ―patere, which means ―to lay open (i.e., to make
available for public inspection). A patent is a type of intellectual property right granted
by the government of a country to the patent owner allowing him to exclude others from
commercially exploiting or using a particular invention within that country. It is a
document, issued, upon application granted for any invention (any new or useful
process or method, device, article of manufacture) which satisfies various requirements
and is related with inventing technical solution to technical problems. It is the only way
in most countries to protect a new and useful invention and it must generally be applied
for before any public disclosure of the invention. A person who has got a patent right
has an exclusive right. The exclusive right is a true monopoly whereby the invention
cannot be commercially made, used, distributed or sold. without the patent owner‘s
consent. The monopoly right to exploit the invention is given to the patentee in
consideration of full discloser of the invention.
TYPES OF PATENT
There are three types of patents:
I. Utility patents: Is the type of patent, granted to anyone who invents or discovers any
new and useful processes: A patentable invention must be useful, i.e. the invention
should achieve what you say it will? This utility‘requirement is analogous to an
invention being industrially applicable. Utility patents in biotechnology can be classified
as product patents, process patents and use patents. Product patents cover nutrient
media, organisms, cultures etc. Process patents cover fermentation methods, methods
of cultivating or altering organisms. Use patents cover new methods of using previously
known compounds. Utility patents can be obtained only by satisfying the statutory
conditions.
II. Design patent: Is the type of patent granted to anyone who invents a new, original,
and ornamental design for an article of manufacture.
III. Plant patent: Is the type of patent, which may be granted to anyone who invents or
discovers and asexually reproduces any distinct and new variety of plant, including
mutants, hybrids, cultivated sports, and newly found seedlings.
CONDITIONS FOR PATENTABILITY
An invention must meet several criteria if it is to be eligible for patent protection. A
patent is awarded for an invention, which satisfy the requirements of;
i. Novelty: The requirement of novelty is the primary focus of the law of patents. To be
patentable, an invention must be novel‘or new. An Invention is new, if it does not form
part of the state of the art. The art means the field of knowledge to which an invention
relates and the state of the art means everything concerning that field of knowledge
must not have been publicly disclosed in any form, anywhere in the world as at the date
of the first filed patent application.
ii. Inventive step: To be granted a standard patent, an invention must involve an
inventive step‘. This means that the invention must be more than an obvious‘extension,
variation or combination of prior public knowledge which could be brought about by a
non-inventive person skilled in the field of the invention. Any variation between the
invention and what is currently known about that technology must make a substantial
contribution‘to the working of the invention.
iii. Industrial Applicability: The final condition of Patentability to consider is capability of
industrial application. It is not every invention which is new or results from an inventive
activity that can be patented. For an invention to be patentable, it must be of a kind
which can be applied for practical purposes, not be purely theoretical. They are to
provide incentive for creativity for persons involved in industrial endeavours. Therefore,
an invention will not be patentable, if it is not industrially applicable. Industrial
applicability is defines as an invention capable of industrial application if it can be
manufactured or used in any kind of industry including agriculture.
WHAT CANNOT BE PATENTED
The following are generally not patentable:
1. An invention, which is frivolous or which claims anything obvious or contrary to the
well-established natural law. An invention, the primary or intended use of which would
be contrary to law or morality or injurious to public health
2. A discovery, scientific theory, or mathematical method
3. A mere discovery of any new property or new use for a known substance or of the
mere use of a known process, machine, or apparatus unless such known process results
in a new product or employs at least one new reactant.
4. A substance obtained by a mere admixture resulting only in the aggregation of the
properties of the components thereof or a process for producing such substance
5. A mere arrangement or re-arrangement or duplication of a known device each
functioning independently of one another in its own way
6. A method of agriculture or horticulture
7. Any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic
or other treatment of human beings or any process for a similar treatment of animals to
render them free of disease or to increase their economic value or that of their products
8. An invention relating to atomic energy
9. An invention, which is in effect, is traditional Knowledge
It is however not always as easy as it may seem to show that an invention is new‘,
useful‘, and unobvious‘.
PROCEDURES FOR OBTAINING A PATENT
A patent is granted by the national government and the procedure to apply for one can
be quite expensive. The application undergoes a rigorous examination process that can
take several years. Once issued, the patent term may vary depending upon the type of
patent. An application for a patent for an invention may be made by a person, who
claiming to be true and first inventor of the invention or his assignee or by a legal
representative of any deceased person who immediately before his dealt was entitled to
make such an application.
STAGES TO OBTAIN A PATENT
1. Filling of an application form: Before filling the patent application, the inventor must
deposit a sample of officially approved material declaring that it is free from dispute of
novelty and can be used by others when it becomes legally free. The first task in
drafting a patent application is the identification of the invention. This involves
summarizing all the necessary features which in combination solve a particular
technical problem. However, there are typically three basic requirements to be complied
with in the drafting of a patent application. Firstly, there is a requirement that the
application should relate to one invention only, or to a group of inventions so linked as
to form a single general inventive concept. Patent application is filled according to the
territorial limits. This must be done in a prescribed form along with the prescribed fees
in the appropriate patent office and should be accompanied by a provisional or a
complete specification.
i) Filling of provisional and complete specification: A specification is an accurate
description of the patent stating how the invention can be carried out by the method
best known to the applicant. The description should disclose the invention in a manner
sufficiently clear and complete for the invention to be evaluated, and to be carried out by
a person having ordinary skill in the art.
The specification must contain the following:-
Title sufficiently indicating the subject matter.
Relevant drawings.
Full and particular description of the invention.
Details of the operation or use and the method by which it is to be performed.
Disclosure of the best method of performing the invention.
Claims defining the scope of the invention substantiated by the disclosure.
Abstract providing technical information on the invention.
Declaration as the inventor ship of the invention.

The specification ends with a claim or claims. For the application to precede it must
contain claims which determine the scope of the protection. The claims must be clear
and concise and fully supported by the description. This third basic requirement is
important since the claims are the basis of interpretation of patent protection. It is from
the claims that third parties are able to know what they may do and what they may not
do. The claims may not be significantly broader or different from that which has been
described.
If the application is filed by the assignee, it must be accompanied with the proof of the
right to make the application. Every patent application made in Nigeria shall contain:
a. A petition or request for a patent signed by the applicant or his agent and containing
the applicant‘s full name and address; The patent application generally contains the title
of the invention, as well as an indication of its technical field;
b. It must include the background and a description of the invention, in clear language
and enough detail that an individual with an average understanding of the field could
use or reproduce the invention.
c. A specification, including a claim or claims in duplicate; such descriptions are usually
accompanied by drawings, plans or diagrams and, if any, in duplicate; where
appropriate
d. A declaration signed by the true inventor requesting that he be mentioned as such in
the patent and giving his name and address;
e. A signed power of attorney or authorization of agent if the application is made by an
agent; an address for service in Nigeria if the applicant‘s address is outside Nigeria and
the prescribed fee.
2. Publication of the application: The patent application shall not be opened to the
public for eighteen months after the date of filing, or the date of priority, whichever is
earlier. Normally every patent application is published after 18months of filling the
application and objections are invited.
3. Examination of the application: Prior to examination as to form, the application is
checked to ensure that all the requirements necessary to accord the application a filing
date, have been satisfied. This is a fundamental check since if a filing date is not
established, the application will be treated as if it had not been filed, and it proceeds no
further. The filing date is important in the general scheme of things since it constitutes
the date from which certain actions are calculated, such as the term of the patent, and,
where appropriate, determines the priority date of any subsequent application in another
country under the terms of the Paris Convention for the Protection of Industrial Property.
The filing date (or priority date) is also relevant to the evaluation of novelty and
inventive step. Examination is taken up if the applicant or any other interested person
makes a request in the prescribed manner for such examination within 48 months from
the date of filling of the patent application. The applicant is given the opportunity to
remove any objections raised during the examination, and if he fails to do so within a
specified time, the Patent Office will refuse the grant of a patent. The application for
patent can be withdrawn at least three (3) months before the first publication and the
application withdrawn after the date of publication cannot be refilled as it is already laid
open for public inspection.
4. Acceptance and advertisement of complete specification: when the examination
process has reached a conclusion favourable to the applicant, that is to say all the
necessary requirements as to form and substance have been fulfilled, and assuming no
opposition has been filed or that any opposition has been unsuccessful, the Patent
Office will grant a patent on the application. The details of the patent are entered into
the Patent Register and also advertise it in the official gazette. From the date of the
advertisement of the acceptance of the complete specification and until the date of
sealing of the patent, the applicant will have the like privileged and rights as if a patent
for the invention has been sealed on the date of advertisement.
5. Opposition to the grant of patent: Any person interested in opposing the grant of the
patent may give notice to the controller of such opposition within 4 months from the
date of advertisement of the acceptance on the grounds like:-
a. The invention was wrongly obtained by the inventor/applicant
b. The invention, as claimed in any claim of the complete specification has been
anticipated in a specification filed for another patent earlier.
c. The invention as claimed in any claim was publicly known/used before the priority
date of the claim
d. The subject of the patent is not an invention, within the meaning of the art
e. The information furnished is false.
Geographical origin of biological material is not disclosed or falsely disclosed.
6. Grant and sealing of patent: After the opposition, a patent shall be granted, if the
applicant makes a request in the prescribed manner for a grant of patent. The request
has to be made within six months from the date of advertisement of the acceptance of
the complete specification, and the patent so granted shall be sealed with the seal of the
patent office and the date of the sealing of the patent shall be entered in the register.
Process of filing a patent

Benefits in protecting patent: Patents provide incentives to individuals by offering them

recognition for their creativity and material reward for their marketable inventions.
These incentives encourage innovation, which assures that the quality of human life is
continuously enhanced.
Rights of a patent owner: Some types of intellectual property are automatically
protected by law from the moment of their creation whereas other types require the
creator to request a specific grant of rights from a government agency before they can
be protected by law. A patent owner has the right to decide who may – or may not – use
the patented invention for the period in which the invention is protected. The patent
owner may give permission to, or license, other parties to use the invention on mutually
agreed terms. The patentee may also sell the right to the invention to someone else, who
will then become the new owner of the patent and also has the right to take legal action
against the infrigerers. Once a patent expires, the protection ends, and an invention
enters the public domain, that is, the owner no longer holds exclusive rights to the
invention, which becomes available to commercial exploitation by others.
Transfer of patent: A patent is an exclusive property of the inventor and hence can be
transferred from the original patented to any other person by assignment, grant of
license or operation of law. The IPA requires that the assignment, licence or a creation of
any other interest in a patent must be in writing, clearly specifying all the terms and
conditions governing the rights and obligations of the parties and the document must
be registered in the prescribed manner within the prescribed time. The person getting
such entitlement in a patent has to apply in writing to the controller of the registration of
the title.
Is a patent granted in one country enforceable in other countries? No, there is nothing
like a global patent or a world patent. Patent rights are essentially territorial in nature
and grating a patent in one country of the union does not force other countries to grant
the patent for the same invention. The refusal of the patent in one country does not
mean that it will be terminated in all the countries
Duration and Lapse of Patent: Every patent in Nigeria shall lapse at the end of the
twentieth (20) years from the date of the filing of the relevant patent application. Date of
patent is the date on which the application for patent is filed. A patent shall also lapse if
the prescribed annual fees are not duly paid in respect of it, provided that a grace period
of six (6) months shall be allowed for the payment of the fees; and if the fees and the
prescribed surcharge are paid within that period, the patent shall continue as if the fees
had been duly paid.

PATENT INFORMATION
Is the information relating to the invention disclosed in a patent document. It provides
the vital resources of information to companies and research institute across the world.
The patent document provides information on the following:
i. What is the technology field of the invention?
ii. Which technical problem is solved and how?
iii. What is the prior act?
iv. Who is the inventor?
v. When and where the application for the patent was filled
vi. Name and the address of the inventor

IMPORTANCE OF PATENT INFORMATION

Patent information is very relevant to researchers, inventors in industries, organisations,
and universities. Use of patent information provides
i. Current awareness- To researcher, organisation and university, source of patent
information enables them to avoid duplication of research, to find ready solutions to
technical problems in on-going research and to keep up to date with the developments
in technology field.
ii. Avoiding duplication effort and infringement –searching worldwide patents literature
should always be done at the start of any R & D efforts to avoid wasteful and costly
duplication.
iii. Licensing opportunity- even if an invention is still protected by a patent, it may be
possible to negotiate a licence for its manufacture or importation
iv. Inspiration- To the industries, patent information enables them to improve on existing
technology, increase production and to identify suitable technologies for adaptation
while to the business enterprises such information helps to identify new products for
marketing and to find out patent owners.

LIMITATIONS OF PATENTS
a. Cost
b. Time
c. Loss of information
d. Infringers
e. Exploitation of invention by inventor

PATENT INFRINGEMENT
A patent is infringed when any of the granted exclusive rights are dealt with by an
unauthorised user during the term of the patent. The exclusive rights of a patentee are
to make, hire, sell or otherwise dispose of a product, or offer to do any of the above, or
keep a product for the purpose of doing any of the above, or to use a method or process
to do any act mentioned above in respect of a product. Whether a patent has been
infringed is a question of fact. It must be proved that the alleged infringer has done an
act which involves each and every feature of at least one claim of the patent. The
infringing act must have occurred after the date of publication of the patent application
and enforcement proceedings must commence within 3 years from the day on which
the relevant patent is granted; or within 6 years from the day on which the infringing act
was done. A patent may also be indirectly infringed. This may occur where a product
has knowingly been supplied to a third party who will use it in a way that will infringe
the patent. In this scenario, the supply of the product would constitute indirect or
contributory‘ infringement.

Patenting of biotechnological invention

As in other fields of technology, there is a need for legal protection in respect of
biotechnological inventions. Such inventions are creations of the human mind just as
much as other inventions, and are generally the result of substantial research, inventive
effort and investment in sophisticated laboratories. Typically, enterprises engaged in
research only make investments if legal protection is available for the results of their
research. As with other inventions, there is an obvious need for the protection of
biotechnological inventions, not only in the interest of inventors and their employers, but
also in the public interest in order to promote technological progress.
The first patent dealing with microbiology was granted to Louis Pasteur that was a
claim to a biologically pure culture of a microorganism, a yeast culture as a composition
of matter.
A wide range of microbiological inventions are generally recognized as patentable. Such
items include vaccines, bacterial insecticides, and mycoherbicides. However, micro-
organisms per se are not patentable, except when they are used as part of a ‗useful‘
process.
Challenges in Patenting Microorganisms
Inventors in the field of biotechnology are faced with several obstacles when seeking
protection for their inventions. These obstacles do not exist to the same degree in other
areas of technology.
The first is the problem of whether there really is an invention rather than a discovery. If,
for example, a microorganism as yet unknown is isolated by a sophisticated process, it
may be argued that such a microorganism is not an invention but is a scientific
discovery. The counter-argument would be that the isolation requires an important
intervention by man using a highly sophisticated process, and that therefore the result is
a solution of a technical problem. It may also be argued that the isolated
microorganism is not different from a chemical substance extracted from nature, which
is patentable subject matter.
The second obstacle is the existence of express legislative provisions that exclude
certain categories of biotechnological inventions from patent protection, in particular,
for reasons of public order and morality. Those provisions have their origin in
developments which took place in Europe 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. Dr. Ananda Chakrabarty (an Indian born America
scientist) then an employee of General Electric Company had introduced into a
bacterium of the genus Pseudomonas two plasmids which enabled the new bacterium
to degrade multiple components of crude oil could not be patented because the existing
US law before 1980 did not permit to patent the live forms.
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.
Later on the patent were amended that transgenic plants and animals can be protected
through patent claim and in 1990 the Appeals Court reversed the earlier judgment of the
lower court and established the patentability of organisms imbued with new properties
through genetic engineering. The court ruled that ―a live human-made micro-organism
is patentable‖. This single bacterium rather than a mixture of several would then be
used for cleaning up oil spills.
Patents on the microorganisms are not usually held by the scientist who makes the
break, but by corporations. Biotechnology is a sophisticated system requiring precision
instruments that are expensive. So it will not be possible for the scientist to do
experiments on his own. 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.
Patenting of microorganisms
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. Although not all questions
have been answered yet at the international level, a number of legal issues with respect
to patent protection for biotechnological inventions have been addressed.
The Appeals Court and other patents highlight a number of points about the
patentability of microorganisms.
1) 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 fulfil a
useful purpose. In other words it is the organism-inert material complex which is
patented, not the organism itself. In this regard, for example, a new antibiotic is
patented, when the organism producing it forms part of the useful process by which the
antibiotic is produced. 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 current US law specifically defines biotechnological inventions and their
patentability as follows: 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).‖
2) the patenting of a microbiological process places on the patentee the obligation

of depositing the culture in a recognized culture collection. The deposition of culture

solves the problems of satisfying patent laws created by the nature of microbiology.
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. 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),
Pretoria, Illinois, USA. 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.
In chemical patents the chemicals have to be described fully and no need exists to
provide the actual chemical.
1. Finally, since the organism is a part of the input of microbiological processes it must
be available to a user of the patent information.