INTELLECTUAL PROPERTY RIGHTS IN BIOTECHNOLOGY BY - MS. BHUVANESHWARI.G & MR. GOWTHAM.M
INTELLECTUAL PROPERTY RIGHTS
IN BIOTECHNOLOGY
AUTHORED BY - MS. BHUVANESHWARI.G,
Final year B.COM LLB (HONS) of Vels University VISTAS
&
CO-AUTHOR - MR. GOWTHAM.M,
Assistant Professor of Vels University VISTAS
ABSTRACT
The main objective
of this paper is to highlight the importance of intellectual property in
relation with biotechnology. The areas of biotechnology deals with mainly pharmaceuticals,
nanotechnology, plant variety, patent protection for the invention etc. The
field of biotechnology is blooming in the world of science and medicine with
the new inventions & innovation. These new invention and innovations are
the sign for rise in patent filing. Hence patent filing are rise in state and
many people realize the value of intellectual property protection for their
inventions. As the invention is unstoppable and these recent invention,
innovations in the field of biotechnology are considered as budding stage of
the field. Hence by protecting these inventions, ensures trust among the inventors
and motivate others to invent further in this field and other field as well.
Intellectual property rights does not solely concern with field of
biotechnology they are relatable to other fields. So inventions from all the
field in a country can lead to better economy by providing open market to
country it gets opportunity to increase GDP and growth of the nation.
Key words: biotechnology, nanotechnology, pharmaceuticals, plant
variety, invention, prior art, GDP growth, inventors etc.
INTRODUCTION
Intellectual property is the right
which is granted for the inventors of the products. Intellectual Property
Rights has covered inventors or say protected their products getting infringed
by other individuals. IPR is not given for a mere discovery of the existing product
but it is granted for inventor for using his intellect to create that product.
In short it clearly emphasise that the product created by inventor should
possess some inventive or innovative quality in nature and it should not be
against any public morality. An intellectual property is at times described as
“knowledge goods”. An IP is an invisible and intangible right granted to the
intellect of the inventor.
By granting this right to inventors
it clearly makes a statement that it is exclusive rights to inventors. Due to
this exclusive rights many inventors are getting attracted to invent the new
products and file the IPR for their work.so technically this boost the
countries reputation and economy.
Example; Many inventors from India
invents many products in various field and files the IPR protection for the
same then other countries want to invest in India thinking that they have
various new inventions and they are getting developed and attracting large
number of investments increases the economy of the country and keeps the
country supreme and reputed.
HYPOTHESIS.
From the title we can say that this
paper discuss about the intellectual property rights (i.e.) patentable subject
matter in the field of biotechnology and challenges faced in their field. This
paper would highlight the major challenges in the field of biotechnology.
Types of Intellectual property
Fig1.1
Above image represents the types of
intellectual property which are used day by day by various researchers,
innovators & creators etc.
1.
Patent: A patent is an exclusive right granted for an invention,
which is a product or a process that provides, in general, a new way of doing
something, or offers a new technical solution to a problem.
2.
Trademark:
A
trademark can be any word, phrase, symbol, design, or a combination of
these things that identifies your goods or services. It’s how customers
recognize you in the marketplace and distinguish you from your competitors.
3.
Geographical
indication: A geographical indication (GI) is a sign used
on products that have a specific geographical origin and possess qualities or a
reputation that are due to that origin. In order to function as a GI, a sign
must identify a product as originating in a given place.
4.
Industrial
Design: An industrial design may consist of three
dimensional features, such as the shape of an article, or two dimensional
features, such as patterns, lines or colour.
5.
Layout
design: Layout design is the process of arranging visual
and textual elements on-screen or on-paper in order to grab a reader’s
attention and communicate information in a visually appealing way
6.
Plant
variety protection:
Plant variety protection
provides legal protection of a plant variety to a breeder in the form of Plant
Breeder’s Rights (PBRs). PBRs are intellectual property rights that provide
exclusive rights to a breeder of the registered variety
7.
Copyright: Copyright
law protects creators of original material from unauthorized duplication or
use.
The above mentioned are the types if
intellectual property and their general meanings to it. In this paper we are
going to discuss only about patent and its usage of patent in biotechnology. As
biotechnology part concern cells, micro-organism, bacteria etc using this the
inventors invent or create the medicine or using same they test. So in order to
protect this the patent is used as protection in them.
TRIPS
AGREEMENT CONCEPT
The intellectual
property rights are developing in recent days particularly in the field of
commerce demanded the level of protection and enforcement of these rights and
they varied greatly throughout the world.
So these
variations which prevailed across the world made conflicts and created tensions
between nations hence resulting in international conflicts. New globally agreed
upon trade standards for intellectual property were considered as the
systematic approach to resolve the dispute. These standard enhanced the
protection of intellectual property before the nation.
Hence General
Agreement of Tariff and Trade [GATT] was the only multilateral mechanism then
established to oversee commercial aspect until the World Trade Organisation
[WTO] overtook the same in 1995.GATT started from round one to eight
contributed to the ease the trade related problems mainly tariff oriented and helped
the other countries to enhance their relations with other countries. First five
rounds of GATT focused mainly on tariff aspect problems and dispute then sixth
round included discussions on anti-dumping measures which control the dumping
of goods into their territory by other nations that could harm their economies.
The eighth round of GATT was game changing
round were members of GATT felt that GATT lacked coherent institutional
structure and it only dealt with trade in goods alone and it did not have any
dispute resolution board to resolve the dispute quickly. So in eighth round
which is also called as the Uruguay round where members decided to replace the
GATT with WTO. The main purpose for which WTO created to look of intellectual
property issues, trading of goods including services, agriculture, and textile
as well by not making any favoritism to any developed nations and suppressing
under developed nations. All 123 members took part in Uruguay round. WTO is
made much stronger than GATT where WTO has adopted various principle to
develop the under developed nations and certain tariff reliefs to them. Right
now WTO has 164 members in its organizations’ which is of 90% of world
population.
PATENT
As per Halsbury’s
laws of England the word patent is used denoting a monopoly right in respect of
an invention. In Telemecanique &
controls limited Vs Schneider Electric industries, 2002 (37) PTC 632 Delhi high
court observed that patent created a statutory monopoly protecting the
patentee against any unlicensed user of the patented device. ‘A monopoly of the patent is the reward of
the inventor.’
Patent is an
exclusive right granted practically a monopoly right conferred by the patent
office on an inventor to exploit his invention subject to the provision of the
patents act, 1970 for a limited period of time. During this period, the
inventor is entitled to exclude anyone else from commercially exploiting his
invention. According to section 2(1) m patent means a patent for any invention
granted under this act.
The object of the
patent is laid down by the court in this case Bishwananth Prasad Radhey shyam Vs Hindustan Metal Industries (1979) 2
SCC 511 in this case radheyshyam finds new invention meanwhile Hindustan
does the same with new step induced. In
this case the object of patent was laid that it encourage scientific research
new technology and industrial process. It has another object that it grant an
exclusive right and monopoly to disclosure the invention at patent office.
According to 2(j) Invention defines the term invention. It means that new product or process
inventive step and capable of application. The invention should be of
absolute novelty as neither it has been published nor used in any part of the
world.
IMPORTANT PROVISONS OF THE INDIAN PATENT ACT.
The patent act is
the highly debatable and deals with the list of exclusions that are non-patentable
that do not satisfy the conditions. In F.Hoffmann-la
Roche ltd Vs Cipla ltd the court stated that they may otherwise meet the
test of invention and ‘inventive step’ but may still not be granted patents as
a matter of policy. According to section 3 the below mentioned things are not
considered as inventions within the meaning of the act-
1. An invention which is frivolous or which claims
anything obviously contrary to the well established natural law;
E.g. pre
natural laws
2. An invention primary or intended use or commercial
exploitation of which could be contrary to public order or morality or which
causes serious prejudice to human, animal or plant life or health or to the
environment;
E.g.
bioterrorism
3. The mere discovery of scientific principle or the
formulation of or discovery of any living thing or non-living substance
occurring in nature;
E.g. Newton’s
Theory
4. The mere discovery of new form of a known substance
which does not result in the enhancement of the know efficiency of that
substance or the mere discovery of any 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 like the salts,
esters, ethers, polymorphs, metabolites, pure form etc.
E.g. Novartis
Vs UOI
Imatinibmesylate (salt) by Novartis invent something
inducing salt and when it goes for patent the same gets rejected by patent
board saying the things which are already in existence are not patentable.
5. 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;
E.g. soft
drink
6. The mere arrangement or re arrangement or duplication
of known devices each functioning independently of one another in a known way;
E.g.
improvement of anything or combined things
7. A method of agriculture or horticulture;
E.g.
improvement of soil, but agriculture apparatus can get patent
8. Any process for the medicinal, surgical, curative,
prophylactic (diagnostic, therapeutic) or other treatment of human beings or
any process for a similar treatment of animal to render them free of disease or
to increase their economic value or that of their products;
E.g surgical
process
Mayo
collaborative Vs Promotheus
In this case Mayo collaborative finds an instrument
and using same they perform surgery and they wants to get patent for the
process of the surgery but patent board denied same by citing this provision
9. Plants and animals in whole or any part thereof other
than micro-organism but including seeds, varieties and species and essentially
biological processes for production or propagation of plants and animals
10. A mathematical
or business method or a computer program per se or algorithm;
11. A literary, artistic, musical, artistic work, dramatic
or any other aesthetic creation whatsoever including cinematographic works and
television productions;
12. A mere scheme or rule or method of performing mental act or method of playing game;
E.g. chess
and Sudoku
13. A presentation of information;
E.g.
timetable and calendar
14. Topography of integrated circuits;
15. An invention which in effect is traditional knowledge
or which is an aggregation or duplication of known properties of traditionally
known component or components.
In addition to the
aforesaid, no patent is to be granted in respect of an invention relating to
atomic energy (section 4 of Indian
Patent Act). From the above list we
can derive invention which are non-patentable and same will be rejected by the
patent board.
BIOTECHNOLOGY
Biotechnology is the use of biology
to develop new products, methods and organisms intended to improve human health
and society. Biotechnology is also called as biotech and it had existed since
the beginning of the civilisation. In olden day fermentation process, ageing to
produce foods, isolates etc. were prevalent and in recent days these methods
are utilized in present days like
process of ageing to produce food like wine, and fermentation process of milk
into curd, isolates are nothing but communicable diseases where the disease
gets transferred from infectious person to sound person. So from then to now
the biotechnology process evolved and is playing vital role in curing diseases
and helping mankind to recover. It’s not only helping mankind but it also
developed pharmaceutical industry which serves for the country during hard
times like COVID19 and it had even expanded the marked to the global range and
it does contribute to the economy. The generi-based industry has made strides
in reverse engineering, quality, production in accordance with regulations,
market development and above all meeting in IPR challenges.
However early applications of biotech
let to the development of products such as bread to vaccines. The discipline
has evolved significantly over last century in ways that manipulate the genetic
structure and biomolecular process of living organisms. With the development of genetic engineering in
the 1970s, research in biotechnology with other related areas such as medicine,
biology etc. developed instantly because it brought out changes in the
organisms’ genetic material i.e. DNA. The term biotechnology is vast and its
dynamic growth is reached to the extent that it almost covers all the aspect or
areas of fields like;
·
Agricultural
biotechnology
·
Transgenic animals
·
Health care
·
Bio fuels
·
Biotechnology
·
Environmental
biotechnology
·
Genetic Engineering
·
Forensic science
·
Gene therapy
·
Food preservation
·
Bioremediation
·
Molecular diagnostics
·
Pharmaceuticals
·
Bioinformatics
·
Law
From the above we can clearly observe
that biotechnology is the most important field which is currently evolving and
will evolve further and for this sake this has to be protected by the law. Law
for biotechnology may sound awkward but both are different subject meet at
points when an invention happens and when the same gets breached or used for
illegal purpose. So the importance of biotech is as important as its
protection.
CHALLENGING
ASPECT OF BIOTECHNOLOGY
In each and every field there are
many challenges which that field has to face in order to shine. So in the field
of biotechnology there are many challenges or the risk it has to undergo before
any discovery is made and patent grant is also curtail. The risk are as below;
1. High
level of Risk
2. Affordability
3. Privacy
4. Societal
concerns
5. Laboratory
safety
6. Bioterrorism
7. IP
Issue
8. High
R&D costs
9. Low
research productivity.
Each and every things which are
listed above is actually concern to the biotechnology. For example Privacy is
major as the lab involves many people and invention founds inside the
laboratories have to be private in order for its productivity and for the fruitfulness
of the research. The IP concern in biotechnology is major as not all the
inventions are patentable in nature. Only certain products are patentable in
nature.
PATENTABLE
PRODUCTS IN BIOTECHNOLOGY.
In above stated concern there is IP
issues which refers to patent grant some biological material, or some
genetically modified biological invention alone. As the one has to state his
invention in an elaborate manner which is one of the primary requirement in the
patent grant process. So when a biotech company tries to invent eventually they
make investment in setting up of research and development (herein after
referred as R&D). The R&D team does the research and take time and
money to do certain invention but when the same is ready and sent to patent office
they in turn refuse citing section 3 provisions, then the resource spent on
R&D would be waste.
So for this, certain biological
products are patentable but only they have been;
·
Distanced from their
natural environment
·
Have been synthetically
or made recombinant and produced
·
Even method and process
that use or test biological material can be patented.
A patent can protect wide range of
biological inventions like;
·
Plasmids
·
Isolated bacteria
·
Protozoa
·
Plasmids
·
Viruses
·
Prions
·
Cell lines
·
Hybridomas
·
Proteins which are
distanced
·
Polypeptides
·
Process of enzymology
·
Apparatus
·
Composition of enzymes
·
Genetic engineering
·
Fermentation process
·
Testing process
·
Diagnosis process
·
Use of organisms to
produce foods and beverages
·
Mutagenesis
·
Genetic vectors
·
Any genetically modified
organisms (GMO) like proteins, bacteria, cells etc.
By seeing above, interested person
may ask can DNA be patented. The answer is no. Patents are not available for
DNA till date as gene are not made by other person nor invented it is just
present in human body in nature. Only RDNA (i.e.) Recombinant DNA is patented.
The Recombinant DNA US 4,237,224 –
COHEN AND BOYER BY UNIVERSITY OF CALIFORNIA
Stanley Cohen’s and Herbert Boyer’s
invention were patented and became an anchor in Stanford’s highly successful
technology licensing programme which indeed bought in total of about $200
million in licensing revenue. The invention was on how to split the pieces of
DNA from different sources derived in molecular genetics. This patent was
prosecuted by legendary Bert Rowland of Townsend. But patent was issued for the
Recombinant DNA.
INVENTIONS
IN ACCORDANCE WITH TRIPS
In biotechnology not all the products
invented and submitted before patent board is patented and accepted. Meanwhile
many patents applications were rejected due to non-technical aspect in
invention. So before patent board submitting the patent application for the
biotech invention is highly complex, it should be elaborated in detail format
and the invention has to prove its non-obviousness and technical advancement
then the patent may considered. So it completely depends upon the facts of the
cases and invention. Due to these issues the legal protection in case of
biotechnology is highly complex and challenging.
Article 27 of the TRIPS Agreement
states which invention that government should make eligible for patenting, and
some exclusions from patenting. So broadly speaking of article 27(3) (b)
exclude some kinds of inventions from patenting i.e. plants, animals and mainly
biological process but some micro- organisms and microbiological process have
to be made eligible for patent. So with the advancement in biomedical research
the patent granters have granted patent to certain research or inventions,
which indeed encourage research and development like GMO, genetic engineering,
and even certain technology like genome editing and CRISPR-Cas9. Genome editing
is also called gene editing which is group of technologies that gives scientist
the ability to change an organisms DNA. These technology allow genetic material
to be added, removed, induced or altered at particular locations in the genome.
In this process the CRISPR-CAS9 is the well-known process which is made for
clustered regularly interspaced short palindromic repeats and it is associated
with protein 9.
So with fine and modern techniques of
genetic engineering by biotechnologists the microorganisms like bacteria,
fungi, and viruses which were used as raw materials then but now converted into
products.
NOVELTY
All bio patents are granted for its
invention and not for discoveries it is highly difficult to say whether new
invention is innovation in biotechnology or a scientific discovery. So based on
this we can say patent for biotechnology is utility patent. So basically the
utility patent functions as prohibition to other companies, third parties, or
any other individual from making use of patent without proper authorization. So
most people preferring patent is mostly utility patent. This utility patent
allows the inventors to give exclusive commercial rights to produce and utilize
the latest technology covered by patent. So obtaining the utility patent is
highly difficult as it’s loaded with monetary benefit to inventor. Thus Indian
patent law considers the microorganism as patentable, there is so much fuss in
the patentability of microorganisms claiming to be lacking novelty element in
it.
OVERCOMING
THESE OBSTACLE
An IPR invention to a company is
considered as a goodwill to the company which creates the brand name. As modern
India demands new technology, strong focus on science and growth so the biotech
companies knowing these things will concentrate on the patent grant at any
cost. Many btech companies obviously relies on IPR. So to overcome these issues
the government need to develop clear and strict IPR polices. Spreading
awareness to the inventors regarding their rights, duties and their
infringement issues. So that inventors will never miss an opportunity to
protect their rights.
There should be facilitation cells to be
installed for ensuring the rights of the inventor by the government. However
this is enabled in TRIPs agreement where Biotechnology patent facilitation cell
is provided by the TRIPs agreement for protecting the new plant variety by
means of patent or sui generis.
CONCLUSION.
When an invention is made it comes
with lots of issues like whether the invention gets patented, whether the
invention remains as private, whether invention goes for moral cause or for
immoral cause. So in order to avoid this government has to formulate the clear
cut policy and clarify certain things which are necessary for patent grant. And
there should be strict rules when the same invention is used for bio terrorism
and bio piracy. And many scientist and inventors to be made aware of their
rights for user friendly smooth business. These technology, inventions are
necessary to lead better tomorrow.
REFERENCES
Webliography.
4. https://blog.ipleaders.in/non-patentable-inventions/#:~:text=Explanation%E2%80%93%20Mere%20discovery%20of%20something,micro%2Dorganism%20is%20not%20patentable.
Bibliography
1. Patent procedures and practices by Shail Jain& R.K
Jain
2. Guide to Patent Law by Manish Arora
3. Law
Relating To Intellectual Property Rights by VK Ahuja