IP and Biotechnology

UNIT 5 IP AND BIOTECHNOLOGY

Structure
5.1 Introduction
Objectives
5.2 Intersection of Biotechnology and IPR
5.3 Definition of Invention
5.4 Criteria for Patentability
Novelty
Inventive Step
Industrial Application
5.5 Exclusions from Patentability
5.6 Defences in Patent Law
Protection to Innocent Bystanders
Farmers’ Rights
Experimental Defence
5.7 Summary
5.8 Terminal Questions
5.9 Answers and Hints
Appendix A: European Union Directive on Biotechnology

5.1 INTRODUCTION
Biotechnology is one of the most talked about topics in recent years in the intellectual
property field. There are many dimensions to this debate. The important one is the
ethical issue regarding patenting of life forms. Another issue circles around the
patentability criteria fulfilled by these kinds of subject matters. Since the
micro-organisms or higher life forms already exist in the nature, can mere isolation or
modifications created in them make them patentable?
Many of the biopharmaceuticals, which are subjects of patent applications are using
the genetic resources from the biodiversity-rich countries and are processed/
manufactured in developed countries. Of concern to less developed countries, which
are often the actual sources of these products, is that they may not be getting their due
rewards in the process of commercialising these products.
Different countries have designed and modified their patent laws in order to address
these issues.
In the course on Industrial Property (MIP-002) you have already learnt about the
different tools of IPR applicable to biotechnology. In this Unit we will discuss various
issues faced by IP system in accommodating Biotechnology inventions in its
framework. The efforts regarding genetic resource sharing will be discussed in the
next Unit.
Objectives
After studying this unit, you should be able to:

• cite different issues raised by biotechnology inventions;

• analyse critically the condition of patentability in light of biotechnology
inventions;
• explain briefly the views taken by different countries in respect to biotechnology
inventions; and
• discuss the provisions in the international conventions on intellectual property in
light of biotechnology.

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Technology Advances and
IPR 5.2 INTERSECTION OF BIOTECHNOLOGY AND IPR
Due to the rapid growth of biotechnology industry, there is an increasing trend of
commercial exploitation of biotechnology innovations. This has triggered the efforts
of industries to fit in organic subject matters like natural extracts, modified life forms
or derived substances into the IPR regime, more particularly in the patent system.
There are also some efforts to develop new legal frameworks to meet demands of
these new technologies. The biological resources in Nature are being looked upon as
repository of valuable genetic resources to be tapped and harnessed for commercial
profits. This in turn has resulted into various industries looking into the segment of
communities working closely with natural resources like agriculturists, plant or animal
breeders, herbalists and traditional healers.
This trend gives rise to two main issues of controversy. The first is whether life forms
may be given patent protection and in doing so, should a distinction between lower
and higher life forms be made. Should the conditions of novelty and inventive step be
diluted or retuned in order to grant such patents or a sui generis system should be
adopted to provide IPR protection for such inventions?
The second, still wider issue under discussion however, is about the ownership of
these resources. The sovereign control over access to genetic resources, equitable
profit sharing among the resource providers, technology and capacity building of the
resource providing states, due respect towards the traditional and cultural practices of
indigenous people are some of the points debated widely.
The interconnectivity of intellectual property issues, environmental issues and
indigenous rights issues make it a very difficult task to frame rules for one aspect,
ignoring others.
The main stakeholders in all these debates are mainly the users of natural resources.
They can be categorised in three main classes:

• Commercial users;
• Traditional users; and
• Academic users.
The commercial users of genetic resources involve the research wings of life science
industries. These may include pharmaceutical industries (drug discovery, screening of
bioactive compounds from germplasm), agro-technologists (cultivating plants and
crops with desirable traits), chemical and petrochemical industries (developing
commercial application from organic raw compounds).
These users either make use of the knowledge of traditional users or individually
discover the applications of extracted products by screening process. For both these
approaches, the commercial users are depending on the natural resources and require
access to physical samples of biological material for research and product
development.
Transformation of naturally occurring substances into useful products is a long,
tedious process involving large technological and economic investment. Even after
development of these products, they need to undergo many examinations and trials in
order to be declared fit for utilisation. Many such products get rejected even at the last
stages of trials, and all the investments made in such product development are wasted.
Hence when any such product passes all the regulatory tests and obtains market
authorisation, the organisation producing this product would naturally wish to recoup
all the investments that have gone in product development. For this reason the
organisations are keen to obtain legal protection against any one trying to free-ride on
the developed product by copying it. You must remember here that once a product
goes through all the approval processes and hits the market, the reverse engineering or
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copying the chemical formula is quite simple and inexpensive matter. Hence IP and Biotechnology
deterrence against such practices is sought by protecting the products by strong
protections like patents.
The traditional users include the local and indigenous communities, who use natural
resources for various purposes in their every day life. Close proximity with nature
over generations has given them invaluable experience, through which they have
assimilated the knowledge about peculiar properties of naturally occurring substances
and life forms. Each community develops its own know-how and practices regarding
use of the natural resource, which are passed on from generation to generation through
the efforts of traditional healers or tribal elders.
A close association of these communities with nature also implies that they might
have developed methods to manage these genetic resources in sustainable way and
made sure that they are available for coming generations. Apart from the substance
and curative properties, which the traditional users derived from the biological
resources available to them, these resources may also have a cultural or spiritual
significance to their communities. The closeness of traditional users to natural
resources often heightens their sensitivity towards any action taken by outsiders to
commercially exploit their traditional practices and sometimes even look upon them
as disrespect to their traditions.
Protection of traditional knowledge using legal instruments may also be unacceptable
to these traditional users. Another complication arising in case of traditional
knowledge is due to its diverse nature. The same know-how can be developed by
traditional users of different communities independently in different parts of the
world. In such cases, even the legal instruments would be facing conflict in
establishing the ownership of such know-how.
The academic users seek access to natural resources for varied purposes. Some of
these may be more close to commercial uses in form of applied scientific research;
while others would be directed towards pure discoveries and acquisition of new
knowledge (e.g. taxonomic studies). The academic users can act as a bridge between
the traditional users and the commercial users facilitating the transfer of traditional
knowledge into commercially viable product. Most of the academic users conduct the
search within institution of higher education. Sometimes there can be internal
economic pressures to seek intellectual property protection for any organic
innovations emerging out of the research in order to generate revenue and to enhance
the reputation of the institution, who employees the academic user.
All these factors are playing a crucial role in shaping up of intellectual property laws
of different countries in response to biotechnology inventions.

SAQ 1 Spend "

2 min.
Due to unusual nature of biotechnology inventions, what considerations need to be
given in deciding their patentability?

Since most of the biotechnology inventions involve subject matters already existing in
the nature, the definition of invention needs to be critically looked into.

5.3 DEFINITION OF INVENTION

For granting a patent to any invention, it is expected that it qualifies to be an invention
and not mere discovery of the already existing things. In light of biotechnology
patenting, it would be interesting to have a close look at the meaning of invention as
interpreted in different industrial property related legislations and conventions.
If we start with the pioneering convention on industrial property viz. Paris
Convention, it does not expressly spell out the definition of invention, or even for that
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Technology Advances and matter, the patentable subject matters. However, in its Article 1(3) it specifies the
IPR broad scope of industrial property. It states that the industrial property not only
applies to industry and commerce but also applies to agricultural and extractive
industries and to all manufactured or natural products e.g. wines, grain, tobacco leaf,
fruit, cattle, minerals, mineral waters, beer, flowers and flour.
This means that the Paris Convention expects its members to take a broader and
flexible approach in which the mere fact that the subject matter involves a natural
product or a living thing does not mean that it is not an industrial property. This can
be interpreted as Paris Convention does allow biological inventions as patentable
subject matters. But the member states are given free choice to define invention in
their national laws.
The TRIPS Agreement goes beyond Paris Convention to spell out the definition of
patentable subject matter in its Article 27(1). It states that excluding the matters listed
in Article 27(2) and (3), the patents shall be available for any inventions, whether
products or processes, in all fields of technology, provided that they are new, involve
inventive step and are capable of application.
But here again, the explicit definition of invention is not given. The member States are
allowed to use their discretion in defining the term. However, the obligation of TRIPS
member States to comply with Paris Convention compels them to take broader and
flexible view in defining the scope of industrial property, patent being part of it.
Further, the invention in the context of technology is understood to encompass things
which have some practical application in the industrial field. You should also
remember that whatever definition is adopted by the member states, it should be
compliant with the directive of the Agreement that the patent protection should be
available to all products in all fields of technology.
There is a built-in limitation on the definition of invention within the TRIPS
Agreement. The definition of invention in national laws must include things with
practical and industrial utility. This leads to a question, as to what amounts to a
sufficient practical or industrial utility in order to distinguish an invention from a
discovery. This point is more pertinent in the context of patenting the genes, gene
fragments and proteins.
In this reference some scholars, like Prof. Carlos Correa note that "nothing in TRIPS
Agreement obliges WTO Members to follow an expansive approach in respect of
patenting of substances existing in nature, such as genes, cells or plants as such. In
effect, the TRIPS Agreement specifies the requirements that an invention must meet in
order to be patentable, but it does not provide a definition of what an invention is.
This leaves WTO Members free to determine what should be deemed an invention.
Many laws in developing countries (e.g. Argentina, Brazil and Andean Group)
exclude the patentability of materials found in nature, even if isolated … The
exclusion may ban the patenting of genes, cells or any other sub-cellular part found in
∗
nature, or isolated there from."

The TRIPS Agreement itself expressly allows some exclusions from patentability in
Article 27(2) and (3). Especially 27(3) gives freedom to the member States to exclude
in their national laws animals, plants and essentially biological processes for
production of animals or plants from patentability. But this exclusion does not apply
to micro-organisms and non-biological and microbiological processes. If considered
the other way round, Articles 27(3)(b) demands that micro-organisms and non-
biological and microbiological processes should be treated as patentable subject
matter if they are new, involve inventive step and have industrial application.

∗
Source : C. Correa, “ Access to Plant Genetic Resources and Intellectual Property Rights”
in the book “Perspectives on Intellectual Property. IP in Biodiversity and Agriculture”, vol.9,
edited by Peter Drahos and Michael Blakeney (2001) Sweet & Maxwell and Queen Mary
8 Intellectual Property Research Institute (University of London), London
The European Directive on Biotechnology (98/44/EC) is another important document IP and Biotechnology
relating to protection of biotechnology inventions in the European Union Countries.
The text of this Directive is given in Appendix A. This documents comprehensively
spells out the criteria for patentability and exclusion there of regarding biotechnology
patenting. However, this document also does not spell out explicitly the definition of
invention just like in the TRIPS Agreement. The Directive sets out general obligation
to protect Biotechnology inventions under national patent laws of the member
countries.
Article 3(1) states that inventions which are new, involve inventive step and are
susceptible of industrial application shall be patentable even if they concern products
consisting of or containing biological material. Further clarification on this issue can
be obtained from Article 3(2), which expressly provides that Biological material
which is isolated from its natural environment or produced by means of a technical
process may be the subject of an invention even if previously occurred in nature.
Hence, though there is no explicit definition of invention, this Article makes it clear
that materials such as genes that have been isolated from the environment may form a
basis of an invention. Synthesised biological materials even if identical to the ones
existing in nature would also qualify to be patentable inventions.
The patentable inventions exclude the human body, at any stage of its formation and
development, and the simple discovery of one of its elements including partial or
complete sequence of a gene according to Article 5(1). However, Article 5(2) goes
ahead to explain that an element isolated from the human body or otherwise produced
by means of technical process (which may include sequence or partial sequence of
genes) may constitute patentable invention, even if the structure of that element is
identical to that of a natural element. Only condition for this clause is that the
industrial application of the sequence or partial sequence of the gene must be
disclosed in the patent application. (Article 5(3)).
In this way, by explicitly clarifying what constitutes patentable invention in
biotechnology area, the Directive removes any ambiguity regarding subject matter of
inventions.
Different national laws and courts take varied position on the definition applicable to
biotechnology inventions. The most significant one to be considered is the US
position. In the US Patent law, 35 USC 101 define Inventions Patentable as:
Whoever invents or discovers any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement thereof, may obtain patent
therefor, subject to conditions and requirements of this title.
This definition implies invention means both invention and discovery. Pure scientific
discoveries are not patentable because of the need to show their utility and that the
discovery comprises some process, machine, manufacture or composition of matter.
In the field of biotechnology the landmark decision in the US was given by the
Supreme Court in Diamond versus Chakraborty (1980) where the judgment stated that
the patentable subject matter could include anything under the sun that is made by
man. In this case the Supreme Court rejected the argument that an engineered
bacterium, being life form, was not patentable.
In the US, the broad and flexible approach towards granting biotechnology patent has
gone to an extent to easily encompass the higher life forms like genetically modified
mice under the regime of patents.
The Canadian Courts took a different view in the case of same genetically modified
mouse. They rejected the patent for higher life form.

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Technology Advances and Hence, there is no harmonized definition of invention for being patentable subject
IPR matter and the cases are being dealt with as per national laws and their interpretations
by the judiciary.

5.4 CRITERIA FOR PATENTABILITY

As we have already discussed, in every patent law, usually three conditions are to be
fulfilled for being patentable subject matter. They are:

• Novelty;
• Inventive Step (non-obviousness); and
• Industrial Application (usefulness).
Let us now discuss the interpretation and applicability of these three criteria for
biotechnological patenting.

5.4.1 Novelty
The rationale behind the requirement of novelty of patentable inventions is to avoid a
patent monopoly over something that is already in the public domain; so as to protect
the right of the public to practice something that is already known. The difficulty
faced in dealing with biotechnology patents is, however, due to varying definitions of
state of the art or prior art in different countries. For example the United Kingdom
considers all matter which has at any time before the priority date of an invention
been made available to public (whether in the UK or elsewhere) by written or oral
description, or by use or in any way to be the state of the art.
Hence, the traditional medicines practiced in any community would be considered as
state of the art under this world-wide novelty criterion.
But the results would differ in case of the United States or Australia, where mixed
novelty criterion is applied. In these States, knowledge or use of the inventions in the
patent area (within the boundaries of these States) and printed publication anywhere
(in the world) comprise the state of the art. A traditional medicine disclosed orally
within the closed circles of the community in any country other than these States
would be fulfilling the novelty criterion as per this definition.
Another complication arising in case of biotechnology inventions is in case of isolated
biological materials by extracting or purifying from their natural environment. This
can be illustrated by taking example of traditional knowledge of Amazonian Indians
that the bark of Cinchona tree has beneficial anti-fever properties. Now, these tribes
would not have known that quinine as C20H24N2O2 compound rendered these
properties to the Cinchona bark. They would also not know about the quinine sulphate
tablets. From the perspective of patent law, while traditional knowledge of this tribe
taught that the bark would work as anti-fever treatment, it did not make available the
active compound in its isolated form. On this basis, the claims directed towards the
bark of Cinchona tree or its use to treat fever would lack novelty; but claims directed
towards and limited to isolated active ingredients outside its natural environment
would be novel.

" Spend SAQ 2

3 min.
What efforts are on in the developing countries to bring traditional knowledge into
state of art in the States adopting mixed-novelty criterion?

5.4.2 Inventive Step

The invention should involve inventive step; it is not supposed to be obvious. But the
key issue in modern technology is what is obvious and to whom? The test of non-
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obviousness is always with reference to a person skilled in the art. This is a legal
fiction according to which the person skilled in the art is said to be not a Nobel Lauriat IP and Biotechnology
but a normally qualified practitioner. Such person is aware of general knowledge
related to the state of the art where he or she is working in, but is supposed to have
access to all elements of this state of the art. However, this person is not supposed to
possess any inventive capability. The advanced fields like biotechnology have now
forced the IP practitioners to redefine the term “person skilled in the art”. The
traditional “person” is now being replaced by a “team” of several persons. In a
decision of European Patent Office Boards of Appeals concerning the production of
erythropoïetin, the person, skilled in the art was replaced by the team of three persons
viz. “a researcher having Ph.D. with several years of expertise in the field of genetics
or biochemistry, with the assistance of two laboratory technicians dealing with known
techniques in the considered field.”
This can be further discussed by considering a similar example of medicine, which is
traditionally known but not documented. In case of mixed-novelty criterion States, the
medicinal use of the natural resource does not form the part of state of the art (or prior
art). Hence the healing properties of the medicinal plant can make an invention, which
possesses inventive step. But same medicine, in case of States with worldwide novelty
criterion, will make the healing properties a state of the art, which is available to the
person skilled in the art and lack inventive step. Hence the inventive step criterion is
also very much case and territory dependent.
Another complication arises in case of biotechnology inventions involving isolation. If
traditional knowledge teaches that the oil extracted from the leaves of a plant have
antiseptic effect, will the researcher who first identifies and separates the active
ingredients be able to claim a patent limited to that isolated ingredient?
Such isolated ingredient does fulfil the criterion of novelty, even if it is a part of
traditional knowledge because the traditional knowledge does not equivocally teach
the claimed invention viz. the isolated and purified active ingredient. But its
inventiveness is disputable.
If the traditional knowledge is excluded on the basis of oral disclosure, the person
skilled in the art is legally not in the know of this teaching. Hence he or she can claim
the inventiveness in searching and isolating the ingredient responsible for the
antiseptic properties from the extracted oil. After all, if the prior art is interpreted as
having no teaching (legally) then making of such invention itself establishes its
inventiveness.
However, if the oral traditional knowledge is treated to be prior art, then inventiveness
is not proven easily.
Then the question to be answered will be, without the benefit of hindsight knowledge
of the invention, but with the knowledge that the oil has antiseptic properties, was it
obvious to look for the presence of active ingredient in the extracted oil? If it was
obvious for the person skilled in the art to look, were there any difficulties that needed
inventiveness to overcome in identifying the active ingredient? If the inventor applies
mere routine scientific, industrial techniques and processes to reach known or obvious
goals, a serious issue as to whether there is any inventive step, in the absence of
unexpected problems and difficulties should arise. In case of so-called biopiracy, there
is an urgent need to open the question of prior art base, that would be instrumental to
attack on the basis of lack of inventive step.

5.4.3 Industrial Application

Another mandatory criteria for patentable invention is that it should have usefulness
or industrial application.
Many of the inventions, though fulfilling the novelty and inventive step criteria fail to
be patentable since there is no direct utility evidenced.

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Technology Advances and Obviously, different national laws have different yardsticks to decide this criterion.
IPR The European biotechnology Directive in its Article 5(3) makes it clear that the
industrial application of a sequence or partial sequence of a gene must be disclosed in
the patent application.
This obligation of disclosure makes the utility criterion clear in case of European
patent system. The same approach is taken by the US system in regard to the utility of
invention. So in the biotechnology field, the European and US approaches are
matching.
However, the utility criterion of patentability is being utilised in some cases for
extending the patent term of a certain pharmaceutical products.
The European Patent Convention (EPC) in its Article 54 allows for first use in the
medical field for a known product as well as second medical indication for a known
product patentable.
In these cases, the product is not new but its new application in the field of medicine
is claimed for patent. For example, consider a chemical compound ‘x’ is patented for
some non-medical use. Afterwards a medical application of this compound is
revealed. In such case, the medical claim can be separately patented and is granted a
full term of new patent. In the meantime, if its second medical use is found out, then
such second claim can also be filed for a separate patent and can enjoy the entire term
of protection for this second claim, though the first application patent term gets over.
All such provisions, though beneficial for businesses, seem to dilute the patentability
norms.

" Spend SAQ 3

3 min.
Along with these three patentability criteria, disclosure of invention is another
mandatory criterion. What are the arrangements for biotechnology invention
disclosure?

Let us now discuss some exclusions from patentability with reference to

biotechnology patents.

5.5 EXCLUSIONS FROM PATENTABILITY

The strongest debate going on in case of biotechnology patenting is the ethical issue.
Can a life form be patented and made a monopoly ownership of a single person?
Different nations have reacted to this issue in varied ways depending on cultural and
societal considerations in these countries.
TRIPS Agreement in its Article 27(2) states that, Members may exclude from
patentability inventions, the prevention within their territory of commercial
exploitation of which is necessary to protect ordre public or morality, including to
protect human, animal or plant life or health or to avoid serious prejudice to the
environment, provided that such exclusion is not made merely because the
exploitation is prohibited by their law.
It means that every member state is given free choice to apply the exclusion from
patentability for such subject matters that may prejudice morality in their territory.
Obviously, this exclusion is not obligatory.
This criterion does not exist in the American system, as such. Even in other countries,
use of this criterion has become significant only after the trend of patenting life forms
started. The beginning was with the patenting of transgenic animals.

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The granting of an American patent in 1988 concerning the transgenic mouse or IP and Biotechnology
Harvard (Onco-) Mouse was very controversial and gave rise to a very strong,
emotional reaction in the US, even though the USPTO only applied an earlier
Supreme Court decision in the Diamond versus Chakraborty case of 1980, concerning
a genetically modified bacteria used for the degradation of hydrocarbons.
When the European Patent Office had to examine the Harvard case, its first decision
was a rejection of the patent application, on July 14, 1989; the grounds for this
rejection were articles 53(b) (non-patentable subject matter) and 83 (insufficiency of
disclosure). Article 53(a) (violation of ordre public and morality) was only cited by
the Examining Division but was not specified as a ground for rejecting the patent
application. (Please remember that till this time, the EU Biotechnology Directive was
not enforced).
The Board of Appeal considered carefully article 53(a) confirming that it should also
be considered by the Examining Division as a possible ground for rejection. In order
to determine whether an invention covering a transgenic animal was contrary to ordre
public and morality, the Board of Appeal gave some guideline. It consisted in
balancing on one hand the suffering of the animal and the risk for the environment
and, on the other hand, the benefit for mankind. Depending upon the relative weight
of each side, the invention was, or was not, contrary to ordre public. In the case of the
Onco-Mouse (which was an animal used in laboratories to testing new medicines
against cancer), the benefit for mankind prevailed and the patent was granted.
The questions worth taking into consideration regarding decisions on ordre public/
morality are: Are the patent examiners, who are recognised as excellent technicians, in
the right place to appreciate this criterion which is probably closer of philosophy, or
religious opinions? Is the examination of the patent application the right time to
appreciate this criterion, while, according to article 27(2) of the TRIPS Agreement, it
is the commercial exploitation which has to be considered. Such exploitation may
occur in some cases many years after the examination when the norms of morality
might have changed.
Another important point to be considered in case of moral issues is that, just
restriction on patentability need not always be enough to stop such inventions from
being worked. The glaring example in this case is of human cloning. Almost all the
patent laws expressly exclude human cloning from patentable subject matter list.
However, there is no binding obligation on the researchers to stop research in the
field, if they choose to go ahead, without applying for patent or bothering about
obtaining one. Such issues are better dealt with other instruments of law outside the
intellectual property framework.
Other exclusions from patentability apart from ordre public and morality are medical
treatment exclusion; animal, plant and essential biological processes exclusion. These
are considered to be essential to ensure the benefits of these subject matters for public
good.

5.6 DEFENCES IN PATENT LAW

Article 30 of TRIPS Agreement provides for the exceptions to the patent rights
conferred.
It states that the members may provide limited exceptions to the exclusive rights
conferred by a patent, provided that such exceptions do not unreasonably conflict with
a normal exploitation of the patent and do not unreasonably prejudice the legitimate
interests of the patent owner, taking account of the legitimate interests of third parties.
In respect of biotechnology inventions, three main types of defences need to be
provided protection to

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Technology Advances and • Innocent Bystanders;
IPR
• Farmer’s Rights; and
• Experimental Defence.

5.6.1 Protection to Innocent Bystanders

The biotechnology inventions involve the subject matters, which have the ability to
reproduce themselves unlike any mechanical inventions. Hence, even after taking due
care of protecting the invention in a restricted area, it is possible that some patented
life form or exactly similar one is produced at some other place. For example, there
may be a variety of plant, which may be genetically modified and duly patented. It is
possible in nature that similar kind of mutation in the gene can occur accidentally and
such mutant variety would exhibit same characteristics as the patented one. Now, in
such case, the innocent grower of such mutant variety should not be held responsible
for patent infringement.

Another example is growing of patented varieties of plants in the field neighbouring

the ones where these plants are actually planted. In such case, the owner of the
neighbouring field should not be held responsible for patent infringement if he does
not make any special attempts to cultivate this patented variety in his field.

5.6.2 Farmers’ Rights

For centuries, farmers have been cultivating various plant varieties and their efforts in
selecting and promoting the best breed have made it possible to achieve today’s
quality products. All the farmers have been growing the harvest in their fields and
using it for consumption after saving the best seeds for the next plantation. This
practice should be allowed to continue even in the patenting era. At least the right of
the farmer to preserve seeds for private use should be allowed. This has been
incorporated in the UPOV Convention as well.

However the new terminator-gene technology in plant varieties stops this practice.
The seeds of such farm products are not capable of propagating themselves and the
farmers are forced to buy new seeds for every harvest. It is up to the national laws to
decide upon allowing such genetically modified variety – either patented or not
patented.

5.6.3 Experimental Defence

This defence is a must to achieve the broader goal of patenting viz. incentive to
inventors and promotion of technological development. Many patentable inventions
are based on some other inventions already patented. In biotechnology inventions, this
trend is further enhanced. In order that the scientists continue to research and improve
on the technology, it is must that they are provided an environment, where they can
work freely without the fear of allegations of patent infringement. Most of the national
laws including Canadian, UK, US patent laws do provide for such defence. Most of
the developing countries are also incorporating these provisions in their Acts.

From the discussion in this Unit, you must have realised that the biotechnology
invention protection is a challenging task for the law makers and the IP practitioners.
The world is gearing up to address the issues and provide solutions through amending
their laws or by framing new ones.

Let us now summarize the points we discussed.

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 IP and Biotechnology
5.7 SUMMARY
• The emergence of biotechnology inventions have made it necessary to interpret
the patentability criteria, including the definition of invention, in this new light.

• Being related to naturally occurring substances, biotechnology inventions demand

clearer distinction between invention and discovery.

• The novelty criterion is diluted in life-science inventions, since most of the

subject matters already exist in the nature.

• The inhomogeneity in the definition of prior art (mixed-novelty to worldwide

novelty) among the national laws give rise to confusion regarding patentability of
inventions based on traditional knowledge.

• This novelty criterion further complicates the decisions regarding determination

of inventive step in the invention.

• The person skilled in the art is now being replaced by a team of persons skilled in
the art due to advances in the technology and the broad base of state of the art.

• To accommodate the interests of the businesses, practices like allowing first

medical use of known compound and second medical indication of known product
as patents have been taking place.

• The ordre public or morality has been widely talked about in case of patenting of
higher life forms, however such practices should be dealt with legal framework
outside the intellectual property.

• Some defences like bystander’s protection, farmer’s right and research defence
should be provided against any allegations of biotechnology infringement.

5.8 TERMINAL QUESTIONS Spend 15 min.

1. What are the issues raised by patenting of onco-mouse?

2. Can the IP system be a useful tool to prevent unethical practices?
3. Biotechnology patents have diluted the patenting norms. Comment.

5.9 ANSWERS AND HINTS

Self Assessment Questions
1. Since subject matters of biotech inventions are life forms already existing in the
nature, the novelty criterion and the very definition of invention needs to be
reconsidered.
2. Development of Traditional Knowledge Digital Library (TKDL) is one such effort
taken up by the developing countries. The traditional knowledge (mainly
medicine related) is being translated from ancient languages into English and
other European languages and is being made available to all patent examination
offices. This effort is converting so far unknown traditional knowledge into
published form, which is a criterion for state of the art (prior art) in some States.
3. Since inventions in biotech patents may involve living forms, mere documentary
disclosure may not suffice. For this purpose, international depositories for
microorganisms are established. They are governed by the provisions of Budapest
treaty as discuss in MIP-002 course.
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Technology Advances and Terminal Questions
IPR
1. Refer Sec. 5.3 and 5.5.
2. Refer Sec. 5.5.
3. Refer Sec. 5.3 and 5.4.

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