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Research & Reviews: Journal of AYUSH
Volume 1, Issue 2, August 2012, Pages 50-62
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ISSN: 22782214 STM Journals 2012. All Rights ReservedPage 50
Patenting of Siddha Formulations: Scope and Issues
Dr . G. S. Lekha*Patent Attorney (IN/PA), Indian Patent Office, India
*Author for Correspondence:E-mail:[email protected],Tel: + 91-9940557147
1. INTRODUCTION
Siddha, one among the indigenous systems of
medicine, owes its origin to medicinal ideas
and practices of a class of Tamil sages called
siddharsperfectedor holy immortals. It
is a way of life that emphasizes positive health
and explains the human body as a miniature of
the universe. The fundamentals of the system
embrace five elements and three humors,
emphasize emotional, mental, spiritual and
physical elements of a person and claim to
treat the person as a whole in this context. The
system is routed in social context that sees the
world in terms of social and spiritual relations
between all life forms.
Siddha medicine system unlike other systems
is a complex system of science in so far as it
has included in the works of medicine,
alchemy, yoga, rejuvenation, Varma,etc., with
a view to elevate them in the long run to the
level of spiritualism.
The siddha system of medicine is a living
science system which has survived through
centuries and cannot be condemned as
unscientific only because we are ignorant of its
scientific basis. We may discover and explain
with reference to scientific terminology for the
appraisal of modern world. Knowledge in this
system is not static and is inherently dynamic
in nature and evolves in response to challenges
posed by the environment. Application of
ABSTRACT
Siddha system, one among the indigenous systems of medicine, is being practiced in India since time
immemorial. It includes principles of positive health and therapeutic measures relating to physical,
mental, social and spiritual welfare of human beings. While it is a good sign that western countries
began to appreciate this ancient wisdom integral to the Indian heritage, the recent past has witnessed
attempts from corporate world and pharma business outfits trying to misappropriate this knowledge
and resources associated with Indian traditional practice. Moreover, countries worldwide have been
striving intensively, many a time by unfair means, to mine the plant wealth of our country on account of
its high demand as a major source of potential drugs and the economic significance of these plant-
based compounds. Hence, conservation of biodiversity and protection of knowledge associatedtherewith inter alia various aspects of traditional medicine practices have become very significant and
critical for us. Protection of traditional knowledge has become a topic of national and international
debate owing to inflated bioprospecting and the issues regarding depletion of biodiversity. This
manuscript highlights the scope of research in the field and the issues on patenting of indigenous
products; discusses noteworthy defensive endeavors such as resolution made by the government of
India and WTO suggestions in this regard. The aim of this review article is to advance theresponsiveness in respect of indigenous knowledge protection.
Keywords: Misappropriation, prior informed consent, access benefit sharing, biopiracy,
bioprospecting, bioequilibrium, alchemy
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current intellectual property (IP) protection
norms for an element of traditional knowledge
having inherent adaptation to cultural
characteristics and community goals is an
issue and necessitates a legal mechanism for
protection of traditional knowledge.
This paper discusses the concept of
formulations in siddha system and addresses
the issues regarding westernization of
indigenous medicine. Further, the allied scope
of research and the issues on patenting of the
natural products have been exemplified and
the endeavors being made for the protection of
indigenous medicine from misappropriation
are highlighted.
2. CONCEPT OF FORMULATIONS
The source of pharmaceutical preparations in
siddha system comprises herbs, metals,
minerals and living things. It includes a
complex system of medicine providing all
obligatory elements to the human body. As per
the key sorting in siddha texts, 32 varieties of
internal medicines and on account of modes of
application 32 varieties of external medicines
are being elucidated and practiced since years
[1].Lakhs of formulations are available in
siddha literature; though a few are
documented; countless others are still in the
form of scripts and palm leaves, classified in
nature.
Unlike other systems of medicine, which arepredominantly synthetic in nature, siddha
formulations are in natural form and contain in
unison the active principles, inactive fibers,
debris, etc.; they do not attempt to haul out the
active principles and are disinclined to the
concept of employing drugs as chemicals. This
adds an additional value to these drugs by way
of either neutralizing the toxic material, if any,
or facilitating the excretion of unwanted
chemicals by entrapping them with fibers,
debris, etc. The inorganic substances occurring
in nature have to be brought into atomic form
for their effective usage as medicines. The
siddhars developed the knowledge of
transforming inorganic substances into atomic
and ionic form via organized processes, which
can be easily absorbed in the system and result
in highly efficacious products.
The ideology behind the customized
formulations which is being practiced in
siddha is the circumvention of side
effects/after effects; administration of a
synthetic compound (a chemical)
indiscriminately results in further imbalance of
physical system, while the natural products
containing five elements in a balanced ratio
assist the physical system in a positive way.
Hence, the westernization of our indigenous
medicine may result in some of the grave
consequences like adverse drug reactions as
that of modern system of medicine.
3. SCOPE OF RESEARCH
As per the concept of Indian medicine, mindand body are interlinked, which is in conflict
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with the modern methodology as these
systems are holistic in approach. The
formulations and treatment methods in siddha
system are tailor made and should be modified
in accordance with the climate, habitat and
individual body conditions. The
phytochemical contents of the plants also
show discrepancy with the climatic condition,
soil. etc., and hence fluctuation in the
phytochemical ratio is also one of the reasons
for inconsistent efficacy of the drug and
reduction in success rate; the quality control of
the final product as well as individual
components is an exigent task of this system.
Research in this field is the obligation for
better understanding of mechanism of action
of drugs being used and chemical reactions
taking place during drug processing to
determine the chemical nature of the final
product as well as to ascertain the active
principles responsible for the particular action
of the drug and the molecules responsible for
toxicity reduction. It is worthwhile to
incorporate proper portfolio of retrospective
study in the pharmacological field of
indigenous medicine owing to grey areas in
the pharmacological aspect of research and
commercialization which includes
modification in route of administration,
modification in the form of drug (for
portability and palatability), enhancement of
shelf-life of the drug, etc.
Standardization of siddha formulations is alsomandatory in order to conquer the
secondary/toxic effects while drug
processing/large scale production. Even
though there are guidelines for GMP (good
manufacturing practices), suitable drug
consistency measures and phytochemical
analysis may be employed so as to obtain
viable and efficacious products. However,
there are improved technological interventions
for quality production, processing, packaging,
storage, transport, delivery and other related
parameters for commercialization of the
products; standardized commodities are
limited in the field.
There is no bar on researchers to take out a
patent on the substantially improved version of
indigenous knowledge or on development of
new drugs based on traditional medicine
principles. In that way, a few Indian patents
were also awarded and commercialized. In this
domain, the patent on reconstituted product of
curcumin (BioCurcumax) is granted on the
basis of relevant inventive step enhanced
bioavailability and efficacy; shortly, the
product was licensed and exported to the
United States and Japan.
4. PATENTING
The basic principle of patent system is to
create an incentive to innovation and grant of
limited monopoly to true and first inventor as
a reward for launch of new invention and
useful innovation which benefits the public. In
the context of patenting the products oftraditional knowledge, there is a strong
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objection imposed by Section 3(p) of Indian
Patents Act, 1970. However, the product or
process which comprises proper inventive
step, i.e., technical advancement as compared
to the existing knowledge such as
enhancement of efficacy, discovery of new
industrial application or the innovation having
economic significance is patentable as per
Indian Patents Act.
Despite inclusion of the IP regime and modern
commercialization techniques to these
traditional systems, securing patents for such
products is a complicated task; suitable legal
arrangements for the prevention of
misappropriation and protection of traditional
knowledge must be put in place. The main
aspiration is the creation of an incentive to
innovation in the field of traditional
knowledge; protection and conservation of
biodiversity and deed of commercial interest
out of our own biodiversity; and finally the
assurance of the countrys heritage in this
regard.
4.1. Challenges and Issues in Patenting
Whilst discussing the protection of traditional
medicine within the current IP norms, plenty
of challenges are being posed, as the
knowledge in this system evolves over a long
period of time, stretching over generations and
may not meet the criteria of novelty or
inventive step required for patenting.
Moreover, it is a collective or community
resource and this knowledge may be held bymultiple communities and it becomes difficult
to determine title holders, critical in accessing
the traditional knowledge via scientific
methods and assessments. Hence, IP-based
protections are limited in this field [2].
Above all, patenting of indigenous products
results in several issues like undesirable effect
on biodiversity and bioequilibrium. Patent
rights over the products of indigenous
community may even prevent the local
communities from accessing it. At that point,
local communities feel undermined and
exploited [3]. Principally,creation of IP rights
on knowledge acquired from biodiversity will
result in bioprospecting, which is the rigorous
process of depleting natural resources with no
guarantee of successful results.
Bioprospecting, however, is often just a handy
term used by researchers to obtain unlimited
access to valuable genetic resources at a
throwaway price [4]. Bioprospecting results in
depletion of biodiversity and has a great
impact on bioequilibrium of the environment
either directly or indirectly [3].
4.2. Issues on Commercialization
While attempting to commercialize a product
belonging to siddha system, the issues
regarding portability of the drug and shelf life
of the drug arises, as most of the herbal
medicines are in unsophisticated form, having
short shelf life and the addition of
preservatives for the purpose of marketing
results in the reduced efficacy of the drug.
Meanwhile, in the case of preparations likeBhasma, Chendoora,Karuppu,etc., there is no
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Research & Reviews: Journal of AYUSH
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eccentricity of the natural products also
recedes and palatal pleasures often lead to
mental agony. Therefore, there is an immense
necessity for the prevention of
misappropriation and protection of our
traditional medicine.
4.4. Examples of Misappropriation
There are many instances of patenting of our
wellknown herbs turmeric, neem, hoodia,
pepper,bitter-gourd, brinjal, etc., in US Patent
and Trademark Office (USPTO) and European
Patent Office (EPO). There are a few sagas of
successful revocation of some of those patents;
the turmeric case was a landmark judgment
case which was successfully challenged by
CSIR and the USPTO revoked this patent in
1997. Litigation against these granted patents
results in loss of several billions of dollars. In
the face of that, any conservative measures
may be extended to prevent the monopoly
holders from enforcement of their rights in the
place of our own biodiversity.
Here is a short account of patents granted/filed
on wellknown siddha formulations, which are
not yet revoked or opposed/withdrawn by the
submission of prior-art evidence. The patents
cited on this prospect, for all intents and
purposes thrash out the patenting activity of
natural products per se or the minor
modifications thereof and the knowledge
associated therewith.
4.4.1.Aloe vera
Aloe vera is a wellknown herb of indigenous
system of medicine and has a wide range of
dermal and ophthalmic applications. While
describing the general characteristics of the
plants in siddha text, various modes of
application ofAloe vera pulp for skin diseases
have been mentioned. The exudates from the
gel of Aloeshave ophthalmologic application
for quite a few eye diseases and it is one of the
components of multiple ophthalmic
preparations in siddha [8].
The published works in India in this arena
include positive influence of Aloe veraon the
synthesis of glycosaminoglycans (GAGs) and
thereby beneficially modulate wound healing
[9].
A number of cosmetic preparations based on
Aloes are being patented and commercialized.
A US patent numbered 5487899, granted on
January 30, 1996, claimed the usage of Aloe
veramucilage preferably withAloepulp fibers
in the ratio of approximately 1:1 in a
bandaging mixture for its wound healing
property. Another US patent numbered
6013259 granted on January 11, 2000, claimed
an ophthalmic composition comprising Aloe
Vera gel, diluted in ophthalmological
acceptable carriers for the treatment of the dry
eye syndrome, inflammations, ulcerations,
alkaline or acid burns and infections in eyes.
In these cases, it is obvious that there is no
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4.4.4. Shi laj it
Asphaltum or shilajit is a wonder drug of
indigenous system of medicine having wide
range of therapeutic and nutraceutic
applications [14]. A US patent numbered
5405613,granted onApril 11, 1995, claimed a
composition comprising iron shilajit in a
multi-vitamin and/or mineral preparation in
which shilajit makes up between 0.4% and
10% by weight of the total composition and
the composition is in the form of a solid
formulation for oral administration.
4.4.5. Anti-diabetics
A US patent numbered 6,451,355 granted on
September 17, 2002, Claimed a composition
for treating Diabetes to be taken in oral doses
comprising an effective amount of a
pulverized seed Fenugreek and an effective
amount of bile from the gallbladder of a
Ruminant mammal.
History of use of fenugreek seeds for diabetes
can be traced out from 1550 BC onwards; the
report brought out by ICMR on 1988
elucidates the scientific validation of
fenugreek seeds for diabetes [15]. Animal
products like Gorosanam (ox bile),
Myrosanam (bile of sheep) are indicated for
diabetes and their usage in combination with
other ingredients as a potent anti-diabetic drug
is still in practice in siddha system [1]. The
above quoted patent is only aggregation of
known properties of traditionally known
components and should positively be opposed
on the basis of grounds in Section 3(e) of
Indian Patents Act, 1970.
A US patent numbered 5886029 claimed a
pharmaceutical composition with Pterocarpus
marsupium and Gymnema sylvestre as main
components and smaller quantities of
Cinnamomum tamala, Syzygium cumini,
Trigonella foenum graecum, Azardirachta
indica, Ficus racemosa, and Tinospora
cordifolia for the treatment of diabetes. All
these drugs are well known for hypoglycemic
effect and the claimed invention is only
aggregation of known properties of
traditionally branded components.
Another patent in this line is US 5900240,
granted on May 4, 1999, which claimed an
edible composition for use as a hypoglycemic
agent in mammals comprising 300600 mg of
a mixture of at least three herbs selected from
the group consisting of Syzygium cumini,
Gymnema sylvestre, Momordica charantiaand
Solanum melongena, each of the foregoing
herbs being present in approximately equal
amounts. All these granted patents, which are
publicly known components, aggregation of
known properties can be revoked and the
monopoly rights may be terminated.
Meanwhile, it is extremely difficult and costly
for developing countries to monitor and
challenge IPRs issued all around the world.
4.5. Bio-piracy and Need for Protection
The above quoted patents are a few relevantexamples of bio-piracy appropriation of
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indigenous communities knowledge on bio-
resources by unauthorized users, where no
credit was prearranged to the rightful owners
of the knowledge, as they are sourced mainly
from India; and the enforcement of these
patents can prevent the commercial
exploitation of these indigenous products by
Indians.
Some of the indigenous herbs are being
dynamically exploited for the manufacture of
modern drugs and commercialized by foreign
companies. Examples of these kinds are
Atropa belladona for atropine, Rouwolfia
serpentina for reserpine, Ephedra gerardiana
for ephedrene, Claviceps purpurea for
ergotrene, Cinchona officinalis for quinine,
Digitalis purpurea for digoxin, Pappaver
somniferum for morphine, Catharanthus
roseus for vincristine, Erythroxylon coca for
cocaine [7]. These plants are plagiarized,
commercially abused, exploited to the full
extent and at present they are about to become
extinct.
In reality, busy selling of the green gold of
India for peanuts is on the arena. The debates
about benefit sharing will go on and on, and
the corporations and research institutes will
continue to exploit local communities for their
traditional knowledge [4]. The corporate world
and pharma business outfits trade in the bio-
resources and knowledge associated with
Indian traditional practice, become pioneer in
the manufacture of multiple commerciallyviable products and retail them at a lofty value
even to Indians. The net result is that multi
national companies have become affluent with
the use of Indian traditional knowledge and
bio-resource and India is trailing several
billions, biodiversity and facing adverse
effects in terms of health and environment.
We could have prevented the depletion of
biodiversity and thereby adverse effect on the
environment like global warming, if we had
enacted a proper legislation for protection of
traditional knowledge and conservation of
biodiversity. At present, with respect to
conservation of biodiversity, National
Biodiversity Authority (NBA) can thwart
foreigners from commercial utilization of
biological resources, wherein the Biological
Diversity Act, 2002, does not encompass the
shield for misappropriation of knowledge
associated thereto and hence stealing of
traditional knowledge is still rampant and
ubiquitous.Simultaneously, there is a colossal
necessity to prevent further misappropriation
by enacting proper legislation for protection of
this indigenous knowledge. The urge for
protection results in multiple painstakingness
at the national and international levels though
they are yet completely successful.
4.6. Highlights on the Horizon
Protection of traditional knowledge is
currently a topic of international debate, and
discussions have been taking place in various
inter-governmental bodies like CBD, WIPO,
FAO, WTO and UNCTAD [16]. On this front,in the WTO forum on TRIPs, five modes of
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traditional knowledge protection have been
advocated: (1) use of existing IP laws to
protect traditional knowledge through
facilitating changes on it; (2) appropriate
benefit-sharing arrangements (includes PIC
and disclosure of utilization of traditional
knowledge); (3) institution of sui generis
system for protection of traditional knowledge;
(4) use of contract laws based on bilateral
agreements on a case-to-case method; and (5)
use of environmental legislations such as
biodiversity legislations for building
provisions for traditional knowledge
protection. The first one clearly involves a
defensive approach to traditional knowledge
protection while the others are carry elements
of proactive protection that entail benefit
sharing [2].
Measures to prevent grant of IP rights to non-
customary holders includes defensive
endeavor made by the central government in
this regard the development of database on
traditional knowledge called traditional
knowledge digital library (TKDL). After
losing several patents on medicinal plants to
the West because of governments reluctance
to share traditional knowledge, India has
decided to allow international patent offices to
access its TKDL for examining patent claims
[17]. India has already entered into TKDL
access agreement with leading patent offices
such as EPO, USPTO, UKPTO in 2009-2010,
and afterwards with Canada (CIPO), Germany
(DPMA), Australia (IP Australia), Japan (JPO)and so on, in order to reveal the codified
traditional knowledge with the obligation to
consider the data as prior artwhile carrying
out search and examination of filed patents.
Prior art is meant to encompass everything that
has been published, presented or otherwise
disclosed to the public on or before the date of
patent application. Consequently, maintenance
of confidentiality in traditional knowledge is
an unsettled issue.
The concept of TKDL includes transcription
of verse and prose which describes the
formulations in Ayurveda and siddha
manuscripts and data relating to postures in
Yoga and is being extended to enable
codification of community-owned traditional
knowledge also. Now the part of traditional
knowledge is in well-structured and codified
form and wires the opposition of unethical
patent claims in order to safeguard the
indigenous knowledge. On the other hand,
codification of traditional knowledge into
digital libraries is not a complete solution to
misappropriation [6]. On this prospect, the
government of Kerala released a sui generis
legislation for protection of traditional
knowledge on 27th June 2008, called as
Kerala IPR policy that endeavors rights
creation on traditional knowledge. But there
was also some debate about the constitutional
validity of the legislation.
At the national level, though there have been
efforts, such as amendment of Patents Act in
1999, highlighting few restrictions onapplication for intellectual property rights
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based on biological resources and associated
traditional knowledge, Biodiversity Bill, 2000,
emphasizing access to benefit sharing, concept
of prior informed consent, policies on
protection of traditional knowledge, systems
of contract, recognition of customary laws,
which are basically concerned with the
intention of protection of traditional
knowledge, they are yet to be completely
successful.
There are international agreements also which
aim at sharing the benefits arising from the
utilization of genetic resources in a fair and
equitable way, adopted by the Convention on
Biological Diversity in the tenth conference of
the parties of CBD inNagoya, Japan, and the
enforcement is on probe.
It is also true that exclusions from
patentability of traditional knowledge-based
products in one country, for instance, would
not exclude others from granting it a patent
[16]. It was notified in the Expert Meeting
Recommendations at the Multilateral Level
held in UNCTAD (United Nations Conference
on Trade and Development) from 30th
October to 1st November, 2000. Therefore,
any national-level mechanisms and legal
provisions to prevent biopiracy require
international recognition for their effective
implementation and enforcement in other
countries.
5. CONCLUSIONS
Patenting the products of traditional
knowledge is a topic of international debate
and hence a comprehensive sui generis
legislation for the protection of traditional
knowledge which includes conservation of
biodiversity and compensation to the
community concerned is the need of the day.
The existing IP systems of protection and
databases on traditional medicine may act as
excellent defensive measures, but they do not
confer any positive benefit to the community
concerned. On the other hand, a proactive
policy of protecting traditional knowledge can
ensure accrual of benefits to the local
communities. If anyone is really serious about
the protection of traditional knowledge, it
needs to have an open mind to look at the
issue from the perspective of local and
indigenous communities and the appropriate
credit should be given to the community
concerned. Moreover, we should encourage
the conservation and sustainable use of
biodiversity and also enable the communities
to continue using traditional knowledge for
their livelihood in the context of traditional life
style.
In due course, the improvements made on
indigenous medicinal formulations in order to
meet the criteria of patentability may result in
serious consequences to the community with
reference to healthcare.
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Hence, westernization of our indigenous
medicines should be prohibited but its
potential to prove its worth through scientific
tests of verifiability and reproducibility should
be encouraged.
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