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DAMODARAM SANJIVAYYA NATIONAL LAW UNIVERSITY

VISAKHAPATNAM, A.P., INDIA

PROJECT TITLE

Patentability Disqualification Under Section 3 (D) Of Indian Patent Act

SUBJECT

INTELLECTUAL PROPERTY RIGHTS

NAME OF THE FACULTY

Dr. P. Sree Sudha

Y.KEERTHI
2014049, 7th Semester

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CERTIFICATE

TITLE OF SUBJECT: INTELLECTUAL PROPERTY RIGHTS

NAME OF FACULTY: Dr. P. Sree Sudha

I KEERTHI . Y hereby declare that this project case study: Patentability


Disqualification Under Section 3 (D) Of Indian Patent Act. Submitted by me is an
original work undertaken by me. I have duly acknowledged all the sources from which the
ideas and extracts have been taken. The project is free from any plagiarism issue.

PLACE: Vishakhapatnam.

(Signature of the student)

Roll no: 2014049

Semester-4

Section-A

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TABLE OF CONTENTS

1. ABSTRACT
2. INTRODUCTION
3. PATENT SYSTEM IN INDIA
4. PROCEDURAL ASPECTS
5. EFFECTS
6. ENFORCEMENT
7. OWNERSHIP
8. DISQUALIFICATION OF PATENT
9. CASE LAWS
10. CRITICISM OF SEC 3(D) ACT
11. CONCLUSION
12. BIBLIOGRAPHY

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ABSTRACT

SUBJECT: INTELLECTUAL PROPERTY RIGHTS

PROJECT TOPIC: PATENTABILITY DISQUALIFICATIONS UNDER SECTION 3 (D)


OF INDIAN PATENT ACT

Patent system is a contract between the inventor and authority whereby the inventor gets
exclusive rights for a period of 20 years in return for disclosing full details of the invention.
The main purpose of patent system is to encourage innovation and eventually results in
technological development. The present Patents Act, 1970 came into force in the year 1972,
amending and incorporating the existing laws relating to Patents and Designs act 1911 in
India. The Patent (amendment) Act 2005 came into force from 1st January 2005,which
brought changes in the previous patent system of India wherein product patent was extended
to all subjects of technology consisting of food, drugs, chemicals and micro organisms.
Moreover, Section 3(d) introduced in to the said amendment act 2005 and introduces
pharmaceutical product patents in India for the first time. The Patent (amendment) Act 2005
defines what invention is and makes it clear that any existing knowledge or thing cannot be
patented.

The provision defines that a ‘novelty’ standard - which, along with ‘non-obviousness’ or
‘inventive step’ and industrial applicability, are the three prerequisites for ‘patentability’.
“Discovery” essentially refers to finding out something which already existed in nature but
was unknown or unrecognized..

SECTION 3(D)

The mere discovery of a new form of a known substance which does not result in the
enhancement of the known efficacy of that substance or the 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, is not patentable

SUBMITTED BY:

Y.KEERTHI

ROLL NO: 2014049

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INTRODUCTION

PATENT :-

Limited legal monopoly granted to an individual or firm to make, use, and sell its invention,
and to exclude others from doing so. An invention is patentable if it is novel, useful, and non-
obvious. To receive a patent, a patent application must disclose all details of the invention so
that others can use it to further advance the technology with new inventions. Patentable items
fall under four classes:-

(1) Machine: apparatus or device with interrelated parts that work together to perform the
inventions designed or intended functions,

(2) Manufacture: all manufactured or fabricated items

(3) Process: chemical, mechanical, electrical or other process that produces a chemical or
physical change in the condition or character of an item, and

(4) Composition of matter: chemical compounds or mixtures having properties different from
their constituent ingredients.

In most of the world, patents are granted on the 'first to apply' basis, with a protection period
of 7 years (India) to 20 years(European Union). In the US, they are granted for 17years on the
'first to invent' basis. Responsibility of identifying, locating, and suing the patent violators,
however, rests solely with the patent holder; patent law provides only means of prosecution
and determination of just compensation.1

Under the World Trade Organization's (WTO) TRIPS Agreement, patents should be available
in WTO member states for any invention, in all fields of technology, provided they are new,
involve an inventive step, and are capable of industrial application. Nevertheless, there are
variations on what is patentable subject matter from country to country, even among WTO
member states. 2TRIPS also provides that the term of protection available should be a
minimum of twenty years. The additional qualification utility patent is sometimes used
(primarily in the US) to distinguish the primary meaning from these other types of patents.
Particular species of patents for inventions include biological patents, business method
patents, chemical patents and software patents.

1
http://www.businessdictionary.com/definition/patent.html
2
https://www.indiaoppi.com
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PATENT SYSTEM IN INDIA

Patent system is a contract between the inventor and authority whereby the inventor gets
exclusive rights for a period of 20 years in return for disclosing full details of the invention.
The main purpose of patent system is to encourage innovation and eventually results in
technological development.

The present Patents Act, 1970 came into force in the year 1972, amending and incorporating
the existing laws relating to Patents and Designs act 1911 in India. The Patent (amendment)
Act 2005 came into force from 1st January 2005,which brought changes in the previous
patent system of India wherein product patent was extended to all subjects of technology
consisting of food, drugs, chemicals and micro organisms. Moreover, Section 3(d) introduced
in to the said amendment act 2005 and introduces pharmaceutical product patents in India for
the first time. The Patent (amendment) Act 2005 defines what invention is and makes it clear
that any existing knowledge or thing cannot be patented. 3

The provision defines that a ‘novelty’ standard - which, along with ‘non-obviousness’ or
‘inventive step’ and industrial applicability, are the three prerequisites for ‘patentability’.
“Discovery” essentially refers to finding out something which already existed in nature but
was unknown or unrecognized. Therefore, discoveries are excluded from patent protection
under section 3 of the Indian Patent Act 1970.

SECTION 3(D) STIPULATES THAT-

The mere discovery of a new form of a known substance which does not result in the
enhancement of the known efficacy of that substance or the 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, is not patentable.4

US RAISED OPPOSITION TO SECTION 3(D) OF THE INDIAN PATENT ACT

Section 3(d) of the Indian patent act 1970 does not allow patent to be granted to inventions
involving new forms of a known substances unless it differs significantly in properties with

3
http://www.mondaq.com
4
https://www.indiaoppi.com

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regards to therapeutic efficacy. Thus, the Indian patent act does not allow ever- greening of
patents. This is a cause of concern to the US pharmacy companies.

MERE DISCOVERY OF A NEW FORM OF KNOWN SUBSTANCE

A mere discovery of a new property of known substance is not considered patentable. For
instance, the paracetamol has antipyretic property. Further discovery of new property of
paracetamol as analgesic cannot be patented. Similarly, ethyl alcohol is used as solvent but
further discovery of its new property as anti knocking, thereby making it usable as fuel,
cannot be considered patentable.5

MERE DISCOVERY OF ANY NEW USE OF KNOWN SUBSTANCE

For instance, new use of Aspirin for treatment of the cardio-vascular disease, which was
earlier used for analgesic purpose, is not patentable. However, a new and alternative process
for preparing Aspirin is patentable. Similarly, the new use of methyl alcohol as antifreeze in
automobiles is not patentable. The use of methanol as a solvent is known in the prior art. A
new use has been claimed in this claim as antifreeze which is not allowable.

The main objective of this section is to prevent several pharmaceutical companies from
obtaining patents on old medicines which are just a mere increment or trivial improvement
of the known substances and also a refusal to the patent on discovery of new form or new
use of old drugs.6

The most recent case, Novartis AG v Union of India decided by Supreme Court of India in
2013 where the case began in the year 1997 with patent application filed by the petitioner
before Chennai patent office related to drug name GLIVEC which was slightly a different
version of their 1993 patent for ANTI LEUKAEMIA drug. In this case the Assistant
Controller of Patent and design, Chennai Patent Office rejected the application under section
3(d) of the Indian patent act 1970. Consequently the petitioner challenged the
constitutionality of section 3(d) before High Court at Madras.

The applicant in the present appeal contented on two issues:

 Section 3(d) is unconstitutional as it violates the provision of the TRIPS agreement.

5
https://www.lexology.com
6
https://www.indiaoppi.com

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 The Indian patent act doesn't define the term 'efficacy' and provides unguiede power
on the Controller. Hence it is arbitrary, illogical and vague

In response to the above contention the court held that:

 The WTO's Dispute Settlement provides the exclusive remedy and a comprehensive
dispute mechanism for violation of TRIPS Agreement. The High Court looked into
the conflict between the international law and municipal law and decided that
municipal law prevails in such conflict. Moreover, in India, international treaties are
not directly enforceable.

 The court also rejected the second contention that the provision is providing unguided
power to the patent controller being arbitrary on the basis of the term 'efficacy' was
undefined and therefore the court observed that "Efficacy means the ability to
produce a desired or intended result. Hence, the test of efficacy in the context of
section 3(d) would be different, depending upon the result the product under
consideration is desired or intended to produce. In other words, the test of efficacy
would depend upon the function, utility or the purpose of the product under
consideration. Therefore, in the case of medicine that claims to cure a disease, the test
of efficacy can only be 'therapeutic efficacy'.

Therefore it is found that the Novartis’ patent application for the beta-crystalline form of
Imatinib Mesylate (polymorph B) did not pass the test of section 3(d) as it did not have any
enhanced therapeutic efficacy. The Supreme Court thereby upheld the observation of the
High Court and Indian Patent office and rejected the patent application filed by the petitioner.

The provision under section 3(d) has been approved by WHO Public Health, Innovation and
Intellectual Property Rights Report, 2006, that countries can adopt legislation and
examination guidelines requiring a level of inventiveness that would prevent ever-greening
patents from being granted. The ruling of the Novartis’s case in Indian patent law represents a
major victory for community’s access to inexpensive medicines in developing countries and
influences the access of medicines to the poor.

If Novartis had succeeded the case, patenting on drugs would have likely been approved
more widely in India, restricting generic competition and thus also hindering access to
reasonable medicines in the developing world. Moreover the practice is anti competitive in its
effect as the practice will enable pharmaceutical MNCs to eliminate competition from the

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generic manufacturers and charge exorbitant prices for their patented drugs. This in turn will
cause adverse effect to public interest in developing countries since many essential drugs
become inaccessible to the general public on account of unaffordable pricing.

PROCEDURAL ASPECTS

Who Can File A Patent Application?

An application for a patent for an invention can be made by any of the following persons
either alone or jointly with another:

i. true and first inventor


ii. his /her legal assignee
iii. legal representative of deceased inventor or assignee

Foreign Filing License:

No person resident in India shall, except under the authority of the written permit can file any
application outside India for the grant of a patent unless:

i. An application for a patent for the same invention has been made in India not less
than 6 weeks before the application is filed outside India, and
ii. Either no secrecy direction has been given under Section 35(1) in relation to the
application in India or all such directions have been revoked.

A request for foreign filing license may be filed on prescribed form with detailed description
of the invention and the drawings, if any, and the prescribed fee.

EFFECTS

A patent does not give a right to make or use or sell an invention. Rather, a patent provides,
from a legal standpoint, the right to exclude others from making, using, selling, offering for
sale, or importing the patented invention for the term of the patent, which is usually 20 years
from the filing date[ subject to the payment of maintenance fees. From an economic and
practical standpoint however, a patent is better and perhaps more precisely regarded as

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conferring upon its proprietor "a right to try to exclude by asserting the patent in court", for
many granted patents turn out to be invalid once their proprietors attempt to assert them in
court. A patent is a limited property right the government gives inventors in exchange for
their agreement to share details of their inventions with the public. Like any other property
right, it may be sold, licensed, mortgaged, assigned or transferred, given away, or simply
abandoned.

A patent, being an exclusionary right, does not necessarily give the patent owner the right to
exploit the invention subject to the patent. For example, many inventions are improvements
of prior inventions that may still be covered by someone else's patent. If an inventor obtains a
patent on improvements to an existing invention which is still under patent, they can only
legally use the improved invention if the patent holder of the original invention gives
permission, which they may refuse.

Some countries have "working provisions" that require the invention be exploited in the
jurisdiction it covers. Consequences of not working an invention vary from one country to
another, ranging from revocation of the patent rights to the awarding of a compulsory license
awarded by the courts to a party wishing to exploit a patented invention. The patentee has the
opportunity to challenge the revocation or license, but is usually required to provide evidence
that the reasonable requirements of the public have been met by the working of invention.

ENFORCEMENT

Patents can generally only be enforced through civil lawsuits (for example, for a U.S. patent,
by an action for patent infringement in a United States federal court), although some
countries (such as France and Austria) have criminal penalties
for wanton infringement. Typically, the patent owner seeks monetary compensation for past
infringement, and seeks an injunction that prohibits the defendant from engaging in future
acts of infringement. To prove infringement, the patent owner must establish that the accused
infringer practices all the requirements of at least one of the claims of the patent. (In many
jurisdictions the scope of the patent may not be limited to what is literally stated in the
claims, for example due to the doctrine of equivalents).

An accused infringer has the right to challenge the validity of the patent allegedly being
infringed in a counterclaim. A patent can be found invalid on grounds described in the
relevant patent laws, which vary between countries. Often, the grounds are a subset of

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requirements for patentability in the relevant country. Although an infringer is generally free
to rely on any available ground of invalidity (such as a prior publication, for example), some
countries have sanctions to prevent the same validity questions being relitigated. An example
is the UK Certificate of contested validity.

Patent licensing agreements are contracts in which the patent owner (the licencor) agrees to
grant the licensee the right to make, use, sell, and/or import the claimed invention, usually in

return for a royalty or other compensation. It is common for companies engaged in complex
technical fields to enter into multiple license agreements associated with the production of a
single product. Moreover, it is equally common for competitors in such fields to license
patents to each other under cross-licensing agreements in order to share the benefits of using
each other's patented inventions.

OWNERSHIP

In most countries, both natural persons and corporate entities may apply for a patent. In the
United States, however, only the inventor(s) may apply for a patent although it may
be assigned to a corporate entity subsequently and inventors may be required to assign
inventions to their employers under an employment contract. In most European countries,
ownership of an invention may pass from the inventor to their employer by rule of law if the
invention was made in the course of the inventor's normal or specifically assigned
employment duties, where an invention might reasonably be expected to result from carrying
out those duties, or if the inventor had a special obligation to further the interests of the
employer's company.

The inventors, their successors or their assignees become the proprietors of the patent when
and if it is granted. If a patent is granted to more than one proprietor, the laws of the country
in question and any agreement between the proprietors may affect the extent to which each
proprietor can exploit the patent. For example, in some countries, each proprietor may freely
license or assign their rights in the patent to another person while the law in other countries
prohibits such actions without the permission of the other proprietor(s).

The ability to assign ownership rights increases the liquidity of a patent as property. Inventors
can obtain patents and then sell them to third parties. The third parties then own the patents
and have the same rights to prevent others from exploiting the claimed inventions, as if they
had originally made the inventions themselves.

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DISQUALIFICATION OF PATENT

Section 3 of the Act, deals with non patentable inventions.

a. Inventions which are frivolous or contrary to well established natural laws.

For example: inventions relating to perpetual motion alleged to be giving output


without any input is not patentable as it is contrary to natural law. Merely making in
one piece, articles, previously made in two or more pieces is frivolous. Mere
usefulness is not sufficient (Indian Vacuum Brake co. Ltd vs. Laurd (AUR 1962 CAK
152).

b. Inventions whose primary or intended use or commercial exploitation could be


contrary to public order or morality (such as something against accepted norms of a
culture in a society), or which causes serious prejudice to human, animal or plant life
or health or to the environment.

For example terminator technology which involves inserting a gene sequence in a


seed to stop germination or growing recombinant plants leading to disappearance of
butterflies.

c. The mere discovery of a scientific principle or the formulation of an abstract theory or


discovery of any living thing or non-living substances occurring in nature. However
isolation of living thing or non-living substances is patentable as it involves human
technical intervention.
d. Mere discovery of a new form of a known substance which does not result in the
enhancement of the known efficacy of that substance, or mere discovery of any new
property, or new use of a known substance, or mere use of known process, machine,
or apparatus unless such known process results in a new product or employs at least
one new reactant.

Explanation to Section 3 (d): "Salts, esters, ethers, polymorphs, metabolites, pure


form, particle size, isomers, mixtures of isomers, complexes, combinations, and other

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derivatives of known substance shall be considered to be the same substance, unless
they differ significantly in properties with regard to efficacy.

It may be seen from section 3(d) that new use of a known substance is not
permissible. It means that claims for second medical use are not allowed in India.
Further, derivatives of known substances are considered to be the same substance
unless they "differ significantly in properties with regard to efficacy".

The term "efficacy" under section 3 (d) has been held vague, as it does not indicate
the kind of efficacy required under the provision. It is also ambiguous because it is
unclear whether the phrase "enhancement of known efficacy" is the same as the
phrase "technical advance" under section 2 (1), (ja).

However, the explanation provided to section 3 (d) does not rule out the grant of
patent to derivatives, complexes, combinations, isomers and so on, if enhancement of
its efficacy as a consequence of its properties can be shown.

a. Substances obtained by mere admixture such as physical admixture are not patentable
under the Act.

However, compositions consisting of combination preparations comprising of two or


more known active ingredients are patentable if "synergism" or super additive effect
is shown clearly, for example pharmaceutical compositions or any other chemical
compositions

b. The mere arrangement or re-arrangement or duplication of known devices each


functioning independently of one another in a known way.

h. Methods of agriculture or horticulture.

For example a method of producing a new form of a known plant even if it


involved a modification of the conditions under which natural phenomena
would pursue their inevitable course is not patentable. (N.V. Philips
Gloeiammpenfabrieken’s Application 71 RFC 192).

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i. Processes for medical, surgical, curative, prophylactic, diagnostic, therapeutic,
or other treatment of human beings or animals or plants that would render
them free of disease or to increase their economic value.

In United Kingdom, a method for treating an old animal with an enzyme two
hours prior to butchering was allowed to be patented as the treatment
increased the economic value of the animal by making the meat soft (Swift
Application RPC 37, 1962). Such a process would not be patentable under the
Indian Patent system.

The words ‘diagnostic & therapeutic’ has to be read as diagnosis of diseases in


human beings and animals. Accordingly, method of screening antibodies for a
specific activity is permissible.

j. Plants and animals in whole or any part thereof other than microorganisms but
including seeds, varieties and species and essentially biological processes for
production or propagation of plants and animals. For example clones and new
variety of plants are not patentable. But process/method of preparing
genetically modified organisms is patentable subject matter.
k. Computer program per se, a mathematical method or a business method or
algorithms.
l. Literary, dramatic, musical or artistic work or any other aesthetic creations
including cinematographic works and television productions are not patentable
as they are covered under the copyrights, design and entertainment laws.
m. Scheme/rule/method of performing a mental act or method of playing a game.
n. Presentation of information.

Unfortunately neither the Act nor the Rules defines a mathematical method, or
a business method or a computer program per se or algorithm. Under such
circumstances, one has to rely on the practices built up under Articles 52(1),
52(2) and 52(3) of the EPC, where similar provisions corresponding to the
Indian Act under section 3(k), 3(m), and 3(n) exists.

A program producing technical effect or program having technical character is


permissible in EPO as it is not program per se. Accordingly, software related

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inventions may be patentable if accompanied by a novel and non-obvious
technical effect which adds to the art of technology.

o. Topography of integrated circuits.


p. An invention falling within the scope of traditional knowledge such as the use
of herbal medicines.

Inventions relating to atomic energy are not patentable under section 4. Such
applications are referred to the Department of Atomic Energy. The decision of the
Department of Atomic Energy is final and no appeal lies to the decisions of the
Department of Atomic Energy.

With the amendments effected patents are now granted for inventions relating to both
product and process. The invention must relate to a machine, article or substance
capable of industrial application, or the process of manufacture of an article. A patent
may also be obtained for an improvement of an article or of a process of manufacture.
Further, with regard to medicine or drug patent is now granted for the product and
process of manufacturing the substance.

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CASE LAWS

Turmeric Patent

Turmeric is a tropical herb grown in east India. Turmeric powder is widely used in India as a
medicine, a food ingredient and a dye to name a few of its uses. For instance, it is used as a
blood purifier, in treating the common cold, and as an anti-parasitic for many skin infections.
It is also used as an essential ingredient in cooking many Indian dishes. In 1995, the United
States awarded patent on turmeric to University of Mississippi medical center for wound
healing property. The claimed subject matter was the use of "turmeric powder and its
administration", both oral as well as topical, for wound healing. An exclusive right has been
granted to sell and distribute.

The Indian Council for Scientific and Industrial Research (CSIR) had objected to the patent
granted and provided documented evidences of the prior art to USPTO. Though it was a well
known fact that the use of turmeric was known in every household since ages in India, it was
a herculean task to find published information on the use of turmeric powder through oral as
well as topical route for wound healing. Due to extensive researches, 32 references were
located in different languages namely Sanskrit, Urdu and Hindi. Therefore, the USPTO
revoked the patent, stating that the claims made in the patent were obvious and anticipated,
and agreeing that the use of turmeric was an old art of healing wounds. Therefore, the TK
that belonged to India was safeguarded in Turmeric case.

BASMATI PATENT

The US patent office granted a patent to ‘RiceTec’ for a strain of Basmati rice, an aromatic
rice grown in India and Pakistan for centuries .Rice is the staple food of people in most parts
of Asia, especially India and Pakistan. For centuries, the farmers in this region developed,
nurtured and conserved over a hundred thousand distinct varieties of rice to suit different
tastes and needs. In 1997, in its patent application Ricetec also acknowledged that "good
quality Basmati rice traditionally come from northern India and Pakistan...Indeed in some
countries the term can be applied to only the Basmati rice grown in India and Pakistan."
However, the company then went on to claim that it had invented certain "novel" Basmati
lines and grains "which make possible the production of high quality, higher yielding
Basmati rice worldwide."

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The Indian Government had pursued to appeal only 3 claims out of 20 claims made in the
original patent application of RiceTec Inc. What were being challenged were only claims
regarding certain characteristics of basmati (specifically starch index, aroma, and grain
dimensions). It is to be noted that WTO Agreement does not require countries to provide
Patent protection to plant varieties. It only requires countries to legislate so that plant
varieties are protected in some manner (not necessarily through patents). However, US being
a strong proponent of Patent protection of plant varieties allowed the patent application.
Three strains development by RiceTec are allowed patent protection and they are eligible to
label its strain as “Superior Basmati Rice”. Therefore, in Basmati case, RiceTec altered the
strain through crossing with the Western strain of grain and successfully claimed it as their
invention and the case is an example of problems illustrated in TRIPS with regards to
patenting biotechnological processes.

NEEM PATENT

The patent for Neem was first filed by W.R. Grace and the Department of Agriculture, USA
in European Patent Office. The said patent is a method of controlling fungi on plants
comprising of contacting the fungi with a Neem oil formulation. A legal opposition has been
filed by India against the grant of the patent. The legal opposition to this patent was lodged
by the New Delhi-based Research Foundation for Science, Technology and Ecology
(RFSTE), in co-operation with the International Federation of Organic Agriculture
Movements (IFOAM) and Magda Aelvoet, former green Member of the European Parliament
(MEP)4. A tree legendary to India, from its roots to its spreading crown, the Neem tree
contains a number of potent compounds, notably a chemical found in its seeds named
azadirachtin. It is used as an astringent in so many fields.

The barks, leaves, flowers, seeds of neem tree are used to treat a variety of diseases ranging
from leprosy to diabetes, skin disorders and ulcers. Neem twigs are used as antiseptic tooth
brushes since time immemorial. The opponents' submitted evidence of ancient Indian
ayurvedic texts that have described the hydrophobic extracts of neem seeds were known and
used for centuries in India, both in curing dermatological diseases in humans and in
protecting agricultural plants form fungal infections. The EPO identified the lack of novelty,
inventive step and possibly form a relevant prior art and revoked the patent. Apart from this,
several US patents were recently taken out Neem-based emulsions and solutions.

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CRITICISM OF SECTION 3(D) OF INDIAN PATENT ACT 1970

Section 3(d) specifically disallows patent protection for mere discovery of known substances
unless such substance express substantial efficacy in the known substance. In effect of this
provision it expressly excludes such substances having incremental innovations. The
provision is disputed as being violative of TRIPS agreement not only on the ground that the
provision does not provide any specific guidelines for incremental innovation but also lake
the standard protection to all categories of inventions as provided by TRIPS. Novartis’s case
further pointed out that the TRIPS agreement gives WTO members the option of providing
patent rights more generous than the basic criteria mandated by TRIPS but does not allow
members to go in the opposite direction by implementing stricter requirements for obtaining a
patent. The court defines the scope of the term efficacy as therapeutic efficacy. However the
scope of the term is unclear as to what count as therapeutic efficacy. The court fails to give
the rationale as to why subject matter lacks enhanced efficacy. Consequently, because of the
interpretation aforesaid mentioned any kind of incremental innovation will not get patent
protection in India.

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CONCLUSION

Notwithstanding the compatibility of section 3(d) with TRIPs agreement, it has been
comprehended that the words of the relevant section is inadequate as it lacks clarification.
The act does not specifically define the scope of enhanced efficacy nor is there any guidelines
stated in that effect. Therefore it is important to alter the wordings of section 3(d) to clarify
the meaning of enhanced efficacy. However, the significant provisions in TRIPS clearly
indicate that member nations have been given significant flexibilities to frame patent laws
which reflect their social and economic needs. Article 27.1 of the TRIPS agreement does not
provide any definition for the term invention, inventive steps and industrial application and
therefore the member countries are provided flexibility to establish the criteria of
attentability. In the absence of a precise definition of patentability, there is nothing to prevent
the Section 3(d) from using an “efficacy” requirement, i.e. a higher level of inventiveness for
determining patentability of new forms of known substances. Accordingly, in order to acquire
patent protection in India, the substance has to go beyond establishing the novelty, inventive
steps, non obviousness and industrial application test set forth in TRIPS agreement and also
fulfill the additional improved efficacy incorporated under section 3(d). It is concluded that
Section 3(d) does not violate the TRIPS mandate rather prevents frivolous patenting without
neglecting valuable incremental innovations in pharmaceuticals and is very well compatible
with TRIPS agreement.

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BIBLIOGRAPHY

BOOKS:

MANUAL EXAMINATION PROCEDURE

INDIAN PATENT LAW AND PRACTICE

THE TRIPS AGREEMENT: DRAFTING HISTORY AND ANALYSIS

INTERNET SOURCES

HTTP://WWW.IPINDIA.NIC.IN

HTTPS://WWW.INDIAOPPI.COM

HTTP://WWW.SSRANA.IN

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