Annexure-2

GUIDELINES FOR PROCESSING PATENT

APPLICATIONS OF AYUSH SYSTEMS AND RELATED
INVENTIONS

COVER PAGE

Photograph of medicinal plant (like Ashwagandha, Guduchi

etc.) having Geo-tagging granted by IP office along with
specific designed logo, will placed on the cover page.

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 I. Introduction

Ayush systems of healthcare include Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa-
Rigpa and Homoeopathy. Ministry of Ayush has mandate to develop Ayush systems. These
guidelines are intended to provide clarity to the filing and processing patent applications of Ayush
systems and related inventions. In this context, it may be noted that in the year 2012, Indian Patent
office has also issued guidelines on “GUIDELINES FOR PROCESSING OF PATENT
APPLICATIONS RELATING TO TRADITIONAL KNOWLEDGE AND BIOLOGICAL
MATERIAL.”

India has played a pivotal role in the decade old efforts of developing countries on the
global platform for bringing the protection of traditional knowledge at the center stage of the
International Intellectual Property System. These efforts have resulted inter alia in setting up of an
Inter-Governmental Committee (IGC) on Intellectual Property, Traditional Knowledge, Genetic
Resources and Folklore by WIPO and the Doha Ministerial Declaration of the year 2001 wherein it
was decided to establish a relationship between the TRIPS Agreement and the UN Convention on
Biological Diversity (CBD) on the issue of Access to Genetic Resources and the fair and equitable
sharing of the benefits arising from their utilization. In view of these global initiatives, it is envisaged
to establish a robust system of Intellectual Property related to Ayush systems of healthcare in the
country. Thus, “GUIDELINES FOR PROCESSING PATENT APPLICATIONS OF AYUSH
SYSTEMS AND RELATED INVENTIONS” are framed to dissipate comprehensive information on
patent filing and processing. The present guidelines do not replace the existing “Guidelines for
processing of patent applications relating to Traditional Knowledge and Biological Material”, rather
these guidelines are intended to complement them and are focused on Ayush systems of healthcare
for better understanding of Ayush stakeholders.

II. Ayush systems of healthcare –

Ayush system of medicine includes Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa-Rigpa and
Homoeopathy. Government of India has a dedicated Ministry of Ayush for reviving the profound knowledge
of our Ayush systems and ensuring the optimal development and propagation of the Ayush systems of healthcare.
Ministry of Ayush has taken various initiatives for the promotion and propagation of Ayush products, research and
education in Ayush system within the country and across the globe.

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Area of Scope for Ayush related inventions –
 Ayush product(s) and Equipment(s) / Device(s) used in Ayush systems
 Food recipes/ Nutraceuticals described in Ayush systems

Product and processes in the aforementioned areas deserve IPR protection subject to qualifying the
criteria of patentability under Section 2 (1) (j) and Section 3 of the Patents Act, 1970.

III. Existing Provisions and Procedure for Protection of Traditional Knowledge (TK), Ayush
systems and related inventions
Indian law has adequate provisions for the protection of TK. By its very definition, TK is in
the public domain and hence, any application for patent relating to TK does not qualify as an
invention under section 2 (1) (j) of the Patents Act, 1970, which defines that "invention means a new
product or process involving an inventive step and capable of industrial application". Further, under
section 3(e) of the Patents Act "a substance obtained by a mere admixture resulting only in the
aggregation of the properties of the components thereof or process for producing such substances" is
not an invention and hence, not patentable. The Indian Patents Act also has a provision under Section
3 (p), wherein "an invention which, in effect, is traditional knowledge or which is an aggregation or
duplication of known properties of traditionally known component or components" is not an
invention and hence, not patentable, within the meaning of the Patents Act. Additionally, sections 3
(b), (c), (d), (f), (h), (i) and (j) are of relevance with respect to the patent applications based on Ayush
systems and related inventions.
The following sections of the Patents Act, 1970 are emphasized in the context of
examination of applications based on Ayush systems and related inventions:
S.no. Sections of Details
the Patents
Act, 1970
1. Section 2 I. Section 2 (1) (ac) "capable of industrial application", in relation to
an invention, means that the invention is capable of being made or
used in an industry;
II. Section 2 (1) (j) "invention" means a new product or process
involving an inventive step and capable of industrial application;
III. Section 2 (1) (ja) "inventive step" means a feature of an invention
that involves technical advance as compared to the existing
knowledge or having economic significance or both and that makes

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 the invention not obvious to a person skilled in the art
IV. Section 2 (1) (l)"new invention" means any invention or technology
which has not been anticipated by publication in any document or
used in the country or elsewhere in the world before the date of
filing of patent application with complete specification, i.e.,the
subject matter has not fallen in public domain or that it does not
form part of the state of the art;
2. Section 3 I. Section 3 (a) an invention which is frivolous or which claims
(Inventions anything obviously contrary to well established natural laws;
not II. Section 3 (b) an invention the primary or intended use or commercial
patentable) exploitation of which could be contrary to public order or morality or
which causes serious prejudice to human, animal or plant life or
health or to the environment;
III. Section 3 (c) the mere discovery of a scientific principle or the
formulation of an abstract theory or discovery of any living thing or
non-living substance occurring in nature;
IV. 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.
Explanation.—For the purposes of this clause, salts, esters,
ethers, polymorphs, metabolites, pure form, particle size, isomers,
mixtures of isomers, complexes, combinations and other derivatives
of known substance shall be considered to be the same substance,
unless they differ significantly in properties with regard to efficacy;
V. Section 3 (e) a substance obtained by a mere admixture resulting
only in the aggregation of the properties of the components thereof or
a process for producing such substance;
VI. Section 3 (h) a method of agriculture or horticulture;
VII. Section 3 (i) any process for the medicinal, surgical, curative,
prophylactic diagnostic, therapeutic or other treatment of human
beings or any process for a similar treatment of animals to render

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 them free of disease or to increase their economic value or that of
their products.
VIII. Section 3 (j) plants and animals in whole or any part thereof other
than micro- organisms but including seeds, varieties and species and
essentially biological processes for production or propagation of
plants and animals;
IX. Section 3 (k) a mathematical or business method or a computer
programme per se or algorithms;
X. Section 3 (p) an invention which in effect, is traditional knowledge
or which is an aggregation or duplication of known properties of
traditionally known component or components.

Applications related to Ayush systems and related inventions are critically examined with
respect to requirements of full and particular disclosure of the invention, its operation or use and the
method by which it is to be performed along with the best method of performing the invention by
way of working examples known to the applicant in the complete specification as provided under
Section 10 (4) (a) & (b) and Section 10 (5) of the Patents Act, as below:
S.no. Sections of the Details
Patents Act,
1970
1. Section 10 (4) Every complete specification shall—
(a) fully and particularly describe the invention and its operation or
use and the method by which it is to be performed;
(b) disclose the best method of performing the invention which is
known to the applicant and for which he is entitled to claim protection;
and
(c) end with a claim or claims defining the scope of the invention for
which protection is claimed;
(d) be accompanied by an abstract to provide technical information on
the invention:

Provided that—
(i) the Controller may amend the abstract for providing
better information to third parties; and
(ii) if the applicant mentions a biological material in the specification

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 which may not be described in such a way as to satisfy clauses (a) and
(b), and if such material is not available to the public, the application
shall be completed by depositing the material to an international
depository authority under the Budapest Treaty and by fulfilling the
following conditions, namely:—
(A) the deposit of the material shall be made not later than the date of
filing the patent application in India and a reference thereof shall be
made in the specification within the prescribed period;
(B) all the available characteristics of the material required for it to be
correctly identified or indicated are included in the specification
including the name, address of the depository institution and the date
and number of the deposit of the material at the institution;
(C) access to the material is available in the depository institution only
after the date of the application of patent in India or if a priority is
claimed after the date of the priority;
(D) disclose the source and geographical origin of the biological
material in the specification, when used in an invention.
2. Section 10 (5) The claim or claims of a complete specification shall relate to a single
invention, or to a group of inventions linked so as to form a single
inventive concept, shall be clear and succinct and shall be fairly based
on the matter disclosed in the specification.

Note: I, the source and geographical origin of the biological material used in the invention shall be
disclosed in the specification in accordance with section 10 (4) (D) of the Patents Act.

Permission from National Biodiversity Authority (NBA):

a) In Form-1 of the Patent Rules, 2003, the applicant is required to furnish a declaration "the
invention as disclosed in the specification uses the biological material from India and the
necessary permission from the competent authority shall be submitted by me/us before the grant of
patent to me/us". However, it is observed that the wording of this declaration is not in line with the
mandate of the BD Act. The BD Act states that NBA approval/registration (based on the class of
the applicant) is required only when the invention is BASED on research or information on
biological resources accessed from India. Applicant for patent is not required to obtain NBA
approval merely for using the biological resources from India in his work. For eg. If the invention

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 is for a modified device for dispensation of an ayurvedic medicine, then the NBA permission
would not be ideally required for merely by the mention of ayurvedic medicine which can be
dispensed using the device in the Patent specification. Applicant shall be required to give the
declaration only when the invention is based on research on biological resources obtained from
India. For e.g., Invention is an extract of certain specific plants obtained from India which could be
useful for the treatment of a disease.

b) Implications for Non- disclosure or wrong mention of the source or geographical origin of
biological material under the Patents Act, 1970-

Applications for patents based on TK and/or biological material can be refused under section 15 if
not complying with the provisions of the Patents Act or as an outcome of pre-grant opposition under
Section 25 (1) and granted patents can be revoked in post-grant opposition under Section 25 (2) of the
Patents Act, 1970. Granted patents may be revoked under Section 64 (1) as well.

Non- disclosure or wrong mention of the source or geographical origin of biological material used
for an invention in the complete specification also forms a ground for pre- and post- grant oppositions
as well as a ground for revocation under Sections 25 (1) 25 (2) and 64 (1) respectively of the Patents
Act, 1970.

IV The recent Amendments notified as the Biodiversity Amendment Act, 2023 is coming into
force from 1 April 2024.

Provisions of Biodiversity Act, 2002 as amended by the Biological Diversity (Amendment) Act, 2023
in relation to use of biological resources in inventions:

S.no. Sections of the Biodiversity Details

Act, 2002 as amended by the
Biological Diversity
(Amendment) Act, 2023
1. Section 2 (c) ‘(c) “biological resources” include plants, animals,
micro-organisms or parts of their genetic material
and derivatives (excluding value added products),
with actual or potential use or value for humanity,
but does not include human genetic material;';
2. Section 2 (p) “value added products” means products which may
contain portions or extracts of plants and animals in
unrecognizable and physically inseparable form.

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 3. Section 6 (1) Any person or entity covered under sub-section (2)
of section 3 applying for an intellectual property
right, by whatever name called, in or outside India,
for any invention based on any research or
information on a biological resource which is
accessed from India, including those deposited in
repositories outside India, or traditional knowledge
associated thereto, shall obtain prior approval of the
National Biodiversity Authority before grant of such
intellectual property rights.
(1A) Any person covered under section 7 applying
for any intellectual property right, by whatever
name called, in or outside India, for any invention
based on any research or information on a biological
resource which is accessed from India, including
those deposited in repositories outside India, or
traditional knowledge associated thereto, shall
register with the National Biodiversity Authority
before grant of such intellectual property rights.
(1B) Any person covered under section 7 who has
obtained intellectual property right, by whatever
name called, in or outside India, for any invention
based on any research or information on a biological
resource which is accessed from India, including
those deposited in repositories outside India, or
traditional knowledge associated thereto, shall
obtain prior approval of the National Biodiversity
Authority at the time of commercialization.

The Biological Diversity (Amendment) Act, 2023 has a penal provision in this regard under section 55
(1) which provides that “If any person or entity covered under sub-section (2) of section 3 or section 7
contravenes or attempts to contravene or abets the contravention of the provisions of section 3 or
section 4 or section 6 or section 7, such person shall be liable to pay penalty which shall not be less

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 than one lakh rupees, but which may extend to fifty lakh rupees, but where the damage caused exceeds
the amount of penalty, such penalty shall be commensurate with the damage caused, and in case, the
failure or contravention continues, an additional penalty may be imposed, which shall not exceed one
crore rupees and such penalty shall be decided by the adjudicating officer appointed under section
55A”.

IV. Guidelines for processing of patent application:

Overview of patent application procedure (source: www.ipindia.gov.in)

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a. Filing of patent application –
 An application for a patent for an invention may be made by any of the following persons either
alone or jointly with any other person:
- True and first inventor
- True and first inventor’s assignee
- Legal representative of any deceased true and first inventor or his/her assignee
 A patent application can be submitted through online or physical mode at four locations of Indian
Patent Office viz. Kolkata, Delhi, Chennai and Mumbai.
 For more details, “Manual of Patent Office Practice And Procedure” may be referred (available at
https://ipindia.gov.in/writereaddata/Portal/Images/pdf/Manual_for_Patent_Office_Practice_and_Pr
ocedure.pdf )

b. Screening and classification -

All patent applications relating to Ayush systems and related inventions are screened as
"Traditional Knowledge" by dedicated team at Indian Patent Office. The team accords appropriate
IPC classification for such TK applications so that these applications can be properly routed for
examination to the respective groups such as Chemistry, Pharmaceuticals, Agrochemicals,
Biotechnology, Microbiology, Biochemistry, Food, Mechanical, etc. e.g., C07D, C07G5/00 (for
Chemical), A61K, A61L (for Pharmaceuticals), A01N (for Agrochemcials), C12S, C12N,
C07K4/00; 14/00 (for Biotechnology), C12N, C12P, C12Q (for Microbiology), C12F, C12G (for
Biochemistry), A23C, A23L (for Food), B25F (for Mechanical), etc.

c. Examination:

The patentability criteria for examination of Patent application are Novelty and Inventive
step (non-obviousness) and industrial application. In every case related to TK and/or biological
material, the Examiner of patent application shall carry out a thorough search for anticipation in TK
and/or other databases. If any citation is made from TK database in the Examination Report, then
copy of the citation (English translated) may be asked by the applicant from the patent office as
mentioned in Examination Report. List of some databases to be referred for Ayush systems and
traditional knowledge are given at Annexure-II.

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 d. Guiding principles for assessment of patent applications:

While considering the Ayush based inventions, the following guiding principles must be
followed –

Guiding If the subject-matter as claimed relates to extracts/alkaloids and/or isolation of

Principle 1: active ingredients of plants, which are naturally/inherently present in plants,
such claims cannot be considered as novel and/or inventive when use of such
plants is pre-known in Ayush systems. However, processes for obtaining above
mentioned extracts/isolates may be considered patentable subject to the
requirements of novelty and inventive step.

When the subject-matter of claims relates to product claims referring to extracts of plant materials
containing undefined active ingredients, such claims cannot be said to be novel if the use of such plants or
specific plant part is pre-known in Ayush systems.

However, if the claims relate to product claims referring to alkaloids and/or active principles
obtained from the plants or specific plant part and structures of the said alkaloids and/or active principles
are characterized, which do not form the part of the prior art, such claims cannot be said to involve an
inventive step, since the use of said plant materials and their therapeutic effects are known in Ayush
systems.

Thus, it is considered that the prior art motivates the person skilled in the art to isolate the
individual ingredients such as alkaloids, flavonoids, phyto- steroids, etc.

Illustration 1: Patent application claims relate to an aqueous extract of Withania somnifera plant for the
management of stress.

Prior art (TK): Discloses use of Ashwagandha (Withania somnifera) for the treatment of stress related
disorders in Ayurveda and Unani systems of medicine.

Analysis: The claims of alleged invention relate to an extract of Withania Sominfera plant. Based on the
prior art, it can be objected that the aqueous extract of Withania somnifera would be useful in treatment
of chronic stress disorders such as insomnia, gastric ulcers, hyperacidity, restlessness and depression.
Therefore, the subject-matter of claims is not considered as novel over the description in Ayush systems.

Illustration 2: Patent application claims relate to an alkaloid, Chamaemeloside, derived from Roman or
German chamomile for the treatment of Cancer, Diabetes mellitus, Arthritis, Acne vulgaris, Eczema and
for wound healing.

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Prior art (TK): Discloses use of German chamomile (from which Chamaemeloside is derived) in wound
healing and for the treatment of cancer, diabetes mellitus, arthritis, acne vulgaris and eczema in Ayurveda
and Unani systems of medicine. The prior art does not disclose the Chamaemeloside.
Analysis: The claims of alleged invention relate to Chamaemeloside derived from Roman or German
chamomile. Based on the prior art, it can be objected that German or Roman chamomile (from which
Chamaemeloside is derived) has already been used alone or in combination with other ingredients for
afore-mentioned indications and therefore, the prior art motivates the person skilled in the art to isolate
and identify the active ingredient such as Chamaemeloside, which has the same therapeutic effects.
Hence, the product arrived at by isolation and characterization cannot be considered to involve an
inventive step in the light of prior art .However, the process of isolation (which is not claimed in this
illustration) could have been considered as inventive and patentable, subject to the patentability criteria.
The fact that a product claim is not patentable due to existence of prior art does not necessarily mean that
a process for isolation of the product is not patentable. Such processes could be patentable if they satisfy
the provisions of the Patents Act.

Illustration 3: Process for the extraction of berberine from leaves of Coscinium fenestratum, wherein an
improved yield of berberine is obtained.

Prior art (TK): The process of isolation of berberine from stem is disclosed in the prior art.

Analysis: In the process as disclosed in this invention, the yield of berberine per gram of leaves and the
purity of berberine obtained is significantly higher as compared to the prior art. Further, the present
invention uses low temperature and minimum chemicals to obtain high purity berberine, which is not
disclosed in the prior art. So, inventive merits can be acknowledged and the process is patentable.

Guiding In case combination of ingredients from plants/minerals/animal origin/ existing

Principle 2: formulations already known for the treatment of a disease as a part of Traditional
Knowledge, then it is obvious that a combination product comprising these known
ingredients with further ingredients from plants/minerals/animal origin/ existing
formulations with the same known therapeutic effect would be more effective than
each of the ingredient when applied separately (additive effect). However, specific
ratios leading to unexpected technical effect of such combinations may be
considered to establish non-obviousness.

Illustration 1: Patent application claims relate to a composition comprising of Calendula officinalis, Aloe
vera and Centella asiatica as healing agent and for treatment of wound.

Prior art (TK): Discloses independent use of Calendula officinalis, Aloe vera and Centella asiatica for
the treatment of wound and as a Cicatrizant/ healing agent in Ayurveda and Unani systems of medicine.

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Analysis: The claims of alleged invention were on a composition. Based on the prior art, it can be
objected that the combination of these plants would be obvious for the treatment of skin diseases and
healing of wounds. The combination of a plant with a known therapeutic effect with further plants with
the same known therapeutic effect, wherein all plants are previously known for treating the same disease
is considered to be an obvious combination. It would normally be expected that such combinations of
medicinal plants would be more effective than each of the medicinal plants when applied separately
(additive effect). However, if such combination demonstrates unexpected synergistic effect, it may be
considered to establish non-obviousness.

Illustration 2: Patent application Claims relate to synergistic anti-acne topical composition comprising of
extracts of Symplocos racemosa- 0.5 gm, Salmalia malabarica- 0.5gm, Picrorhiza kurroa-0.5gm, Vitex
negundo -0.5gm, Embelia ribes-3gm, Terminalia chebula- 3gm, and Terminalia bellerica-2gm.

Prior art (TK): Discloses formulations comprising one or more of the ingredients selected from
Symplocos racemosa, Salmalia malabarica, Picrorhiza kurroa, Vitex negundo, Embelia ribes, Terminalia
chebula, and Terminalia bellerica for different uses including skin disorders.
Analysis: The cited prior art, though disclosing the different ingredients recited in the claims for the
treatment of same indication, do not disclose the exact combination of the ingredients in the claimed ratio.
In view of the synergistic data provided in specification, the inventive step has been convincingly
established and distinguishing the invention from the prior art.

Note- Synergism is the interaction of two or more substances to produce a combined effect greater than the sum of
their individual effects. Experimental results should prove that the combined action of all the given ingredients

is greater than the sum of their individual effects. A brief about synergism along with illustrations on
synergistic data is given at Annexure III.

Guiding In case an ingredient is already known for the treatment of a disease, then it
Principle 3: creates a presumption of obviousness that a combination product comprising this
known active ingredient would be effective for the treatment of same disease.
However, unexpected technical effect of such combinations may be considered to
establish non-obviousness.

Illustration 1: Patent application claims relate to a combination of two constituents of water extract of
Cucumis melo, along with Citrus aurantifolia, for the treatment of vitiligo.

Prior art (TK): Discloses usefulness of only one of the constituents, watery extract of Cucumis melo for
its anti-vitiligo property in the Unani system of medicine.

Analysis: The claim of alleged invention relates to a composition comprising two constituents and not on

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a single constituent, the watery extract Cucumis melo for its anti-vitiligo property. Based on said cited
documents, it can be objected that if one ingredient here, Cucumis melo, was already known for the
treatment of vitiligo, then it is necessarily expected that a combination comprising this known active
ingredient must be effective for treating vitiligo. As long as no surprising (superior) effect of the claimed
combination vis-a-vis the already known product comprising Cucumis melo, inventive step cannot be
acknowledged.

Illustration 2: Patent application claims relate to a combination of three constituents containing Maghz-
e-Karanjwa (Caesalpinia bonduc (Tinn.), Gaozaban (Onsoma bracteatum Wall.) and Kasni (Cinchorium
intybus) as one of the constituent, for the treatment of worm infestation and anemia.
Prior art (TK): Maghz-e-Karanjwa (Caesalpinia bonduc (Tinn.) is already known for the treatment for
worm infestation only.
Analysis: The combination of three constituents has shown unexpected and synergistic effect in the
treatment of worm infestation and anemia. In view of the data provided in respect of unexpected and
synergistic effect, the inventive step may be considered for distinguishing invention from the traditional
knowledge.

Guiding Discovering the optimum or Workable Ranges of Traditionally known ingredients

Principle by Routine experimentation is not inventive.
4:

In case of inventions relating to selection of optimum or workable range of ingredients, this is to

be borne in mind that the selection of a particular range of known ingredients is not inventive since the
selection of optimum or workable range is well within the expectation of a person skilled in the art.

Illustration 1: Patent application claims relate to a formulation comprising at least two of the following:
an extract of Pongamia pinnata (in the range of 2 to 20%), an extract of Lawsonia alba (in the range
of 5 to 15%), an extract of Dhatura alba (in the range of 2 to 20%) and an extract of Cocos nucifera (in
the range of 20 to 60%) for the management of chronic ulcer, diabetes ulcer, and the management of
bleeding in cuts and wounds.

Prior art (TK): Discloses use of said plants for the treatment of ulcer/wound in Ayurveda, Unani and
Siddha systems of medicine.

Analysis: The claims of alleged invention relate to a composition comprising plant parts in a specified
ratio. The claims can be objected as not patentable in so far as the alleged invention is obvious over
Agasthiyar (TK) which taught a composition of extracts of two of the claimed plants, Karanj and Heena
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formulated as oil for topical treatment of ulcers and wounds. Although, cited art does not specifically
teach adding the ingredients in the percentages claimed by the applicant, the amount of specific ingredient
in a composition is clearly a result affecting variable, which a person skilled in the art would routinely
optimize.

Guiding In case multiple ingredients are known to have the same therapeutic activity
Principle 5: as per traditional knowledge, taking one component out of them cannot be
considered as inventive.

Illustration 1: Patent application claims relate to an extract of Zingiber zerumbet (bitter ginger) for
inflammation and also for allergic disorder like Asthma.

Prior art (TK): Discloses use of Zingiber zerumbet (bitter ginger) along with few other ingredients for
the treatment of inflammation and Asthma in Unani system of medicine.

Analysis: The claims of alleged invention relate to an extract of Zingiber zerumbet. As per the prior art
disclosure, the multi-component formulation comprising Zingiber zerumbet have the same therapeutic
activity (i.e. anti-bronchial asthmatic), therefore it is not surprising that one single component namely
Zingiber zerumbet taken out of them again would have the same therapeutic activity. Hence, a person
skilled in the art would have been motivated to arrive at the invention without exercise of inventive skills
and thus, the claims of alleged invention can be objected for lacking in inventive step.

Guiding If the subject matter of the claims relates to inventions regarding equipment /
Principle 6: device used in Ayush systems, then such inventions may be patentable if novel
and inventive over the prior art.

Illustration 1: Advanced automated system or device for Therapeutic Emesis (Vamana Karma)
comprising a frame holding primary and secondary sinks connected with sensing elements for pH,
temperature, weight, volume & a display unit along with vomitus collecting bag and its method for
fabrication.

Prior art (Ayurveda): Procedure for performing Vamana Karma is disclosed in Ayurveda but it does not
disclose any device along with sensors, for doing such procedure.

Analysis: The claims relate to advanced automated system or device for Therapeutic Emesis (Vamana
Karma) and its method for fabrication. As per the prior art (Ayurveda), the procedure for performing
Vamana Karma is well documented however, an automated device for conducting Vaman Karma,
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comprising pH, temperature, and volume sensors for analyzing the vomitus and hygienically conducting
the said karma was not known and can be considered patentable.

******

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 Annexure –I
Form-1 of the Patent Rules, 2003

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19
20
21
 Annexure-II

List of some databases to be referred for Ayush systems and traditional knowledge –

1. Ayush Research Portal (https://ayushportal.nic.in )

2. Database of Ayurvedic, Unani, Siddha and Sowarigpa Formulations (https://www.tkdl.res.in
)
3. Foundation for Revitalisation of Local Health Traditions (FRLHT) Indian Medicinal Plant
Database (https://www.medicinalplants.in )
4. e-Charak portal has been jointly developed by the National Medicinal Plants Board
(NMPB), Ministry of Ayush, Government of India and Centre for Development of
Advanced Computing (C-DAC) (https://echarak.in/echarak/main.do ). It is an e-Channel for
Herbs, Aromatic, Raw material and Knowledge and a platform to enable information
exchange between various stakeholders involved in the medicinal plants sector.
5. Tribal Digital Document Repository by Ministry of Tribal Affairs, Govt. of India.
(https://repository.tribal.gov.in)
6. The Biological Diversity (Amendment) Act, 2023,
https://egazette.gov.in/WriteReadData/2023/247815.pdf
7. The Patent Act, 1970. https://ipindia.gov.in/writereaddata/Portal/ev/sections-index.html
8. The Patent Rules, 2003. https://ipindia.gov.in/writereaddata/Portal/ev/rules-index.html

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 Annexure-III

Brief about synergism along with illustrations on synergistic data

Section 3(e) precludes patenting of "a substance obtained by a mere admixture resulting
only in the aggregation of the properties of the components thereof or a process for producing
such substance". In order to assess whether the invention falls under Section 3(e), it is
examined whether there is synergistic effect of claimed composition which is more than the
combined effect of each component of the composition when used individually.

Synergism is the interaction of two or more substances to produce a combined effect

greater than the sum of their individual effects. The Guidelines for examination of patent
applications in the field of Pharmaceuticals provides insight that "if the functional interaction
between the features achieves a combined technical effect which is greater than the sum of the
technical effects of the individual features, it indicates that such a composition is more than a
mere aggregation of the features" and does not fall within the ambit of mere aggregation of
features. Some illustrations demonstrating the assessment of presence of synergism are as
follows:

Illustration 1: Patent application claims relate to a composition comprising tamarind seed

polysaccharide (TSP) in combination with an extract of Helichrysum italicum. The treatment
with TSP according to the said patent application is effective in stimulating the antimicrobial
response, especially when administered topically to the skin and to the mucosa.

Analysis: The claims of alleged invention relate to a composition of two active ingredients,
namely tamarind seed polysaccharide and extract of Helichrysum italicum. The complete
specification contained the following experimental data regarding the expression of beta
defensin by normal human epidermal keratinocyte. Beta defensin are host defense peptides
having the ability to kill a broad range of microorganisms including bacteria, yeast and viruses.
Products Concentration DEFB2 expression (pg/ml)
Negative ref. (control) - 0
Positive ref. (LPS) 5 mcg/ml 12
Tamarind Seed Polysaccharide (TSP) 0.2% 40*
Helichrysum italicum extract (HIE) 0.2% 21
HIE + TSP 0.2% + 0.2% 140*

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*p < 0.001 vs. control
It is apparent from the table that the combined effect of Helichrysum italicum extract and
Tamarind Seed Polysaccharide (140 pg/ml) is higher than the sum of their individual effects
(40 pg/ml + 21 pg/ml), thereby indicating synergism between them.

Illustration 2: Patent application claims relate to a composition comprising Vaccinium

myrtillus extract and Echinacea sp.extract.

Analysis: The claims of alleged invention relate to a composition of two active ingredients,
namely Vaccinium myrtillus extract and Echinacea sp.extract. The complete specification
contained the following experimental data regarding the re-epithelialisation of ulcers by the use
of Vaccinium myrtillus extract and Echinacea sp.extract, when used individually and in
combination.
Treatment Re-epithelialisation
7 days 14 days 28 days
Placebo 0.02 +/- 0.01 0.01 +/- 0.03 +/-
0.01 0.02
Vaccinium myrtillus 0.3% 0.10 +/- 0.03 0.23 +/- 0.50 +/-
0.13* 0.23*
Echinacea sp.extract 0.3% 0.01 +/- 0.01 0.20 +/- 0.35 +/-
0.02* 0.02*
Vaccinium myrtillus 0.3% + 2.14 +/- 0.73** 4.9 +/- 8.30 +/-
Echinacea sp.extract 0.3% 1.01** 1.10**
*P<0.05; **P<0.001 Student's "t" test

The provided data clearly demonstrates that the re-epithelialisation achieved using the
composition comprising Vaccinium myrtillus and Echinacea sp. extract is much higher than the
sum of re-epithelialisation achieved when these two ingredients are used individually, indicating
a synergistic effect between them

Illustration 3: Patent application claims relate to a composition comprising extract of

Andrographis paniculata and Ginkgo biloba extract for the treatment of neurodegenerative
disorders.

Analysis: The claims of alleged invention relate to a composition of two active ingredients,
namely extract of Andrographis paniculata and Ginkgo biloba extract. The complete
specification contains the following experimental data regarding the comparative effect of the
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claimed composition and its components when used individually, on Experimental
Autoimmune Encephalomyelitis (EAE) in 20 transgenic mice. Clinical signs of the disease are
recorded daily on the basis of the following scores:
0 : no signs of EAE
1: limp tail
2: weakness of hind legs or abnormal gait
3: complete paralysis of hind legs
4: complete paralysis of hind and fore legs
5: death

The mean clinical data are calculated by adding the daily scores of the mice belonging to
the same treatment group and dividing by the number of mice.

Group Incidence Score Average Of Maximum Scores

(Maximum)
CONTROL 20/20 (100%) 5 3.9 +/- 0.1
Andrographis 7/20 (35%) 4 2.9 +/- 0.1*
paniculata extract
Ginkgo biloba extract 4/20 (20%) 5 3.3 +/- 0.1
Andrographis 12/20 (60%) 2 2.2 +/- 0.1**
paniculata extract +
Ginkgo biloba extract
* p<0.05 Student's t-test
** p<0.01 vs. control

Based on the data provided in the above given table, the combination of Andrographis
paniculata extract and Ginkgo biloba extract exhibits no incidence of death and much lower
maximum scores indicating less severe clinical signs of disease compared to the scores
achieved using Andrographis paniculata extract and Ginkgo biloba extract when used
individually, thereby indicating the presence of synergism between the two components.

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Illustration IV: Patent application claims relate to a herbal anthelmintic formulation comprising
dried extract powder of Trichosanthes dioica seeds, dried extract powder of Prunus persica leaves,
carbopol, microcrystalline cellulose, dibasic calcium phosphate, polyethylene glycol – 400 and
sodium benzoate.

Analysis: The claims of alleged invention relate to a formulation of two active ingredients, namely
dried extract powder of Trichosanthes dioica seeds and dried extract powder of Prunus persica
leaves. The complete specification provides the following exemplary formulations:

Ingredients (Weight Per Tablet -500 mg)

Ingredients Quantity
F1 (1:1) F2 (3:1) F3 (1:3)
Trichosanthes dioica seeds 200 mg 300 mg 100 mg
dried extract powder
Prunus persica leaves dried 200 mg 100 mg 300 mg
extract powder
Carbopol (Sigma-Aldrich) 20 mg 20 mg 20 mg
Microcrystalline cellulose 40 mg 40 mg 40 mg
Dibasic calcium phosphate 30 mg 30 mg 30 mg
PEG- 400 7.5 mg 7.5 mg 7.5 mg
Sodium benzoate 2.5 mg 2.5 mg 2.5 mg
(0.5%) (0.5%) (0.5%)

The following experimental data was provided in the complete specification regarding the
anthelmintic activity of the claimed formulation and its components when used individually, on
round worms, Ascaridia galli.

S.No Treatment Dose Mean Mean lethal

paralysis time time (min) ±
(min) ± SEM SEM
1 (Positive control) Piperazine citrate 500 20mg/ml 19.14 ± 0.20 25.00± 0.26
mg Tablet
2 (Negative Control) 25 ml 2 % DMSO in 25ml No Paralysis No death
PBS
 3 Trichosanthes dioica seeds dried 20mg/ml 32.06 ± 0.41 45.14 ± 0.20
aqueous extract 500mg
4 Prunus persica leaves dried aqueous 20mg/ml 31.18 ± 0.23 42.11 ± 0.13
extract 500mg
5 Formulation (F1) Tablet ( 200mg + 20mg/ml 17.40 ±0.25* 22.58± 0.17*
200mg)
6 Formulation (F2) Tablet 20mg/ml 25.16 ± 0.12 31.00 ± 0.30
(300mg+100mg)
7 Formulation (F3) Tablet 20mg/ml 29.26 ± 0.22 33.11 ± 0.27
(100mg+300mg)

Based on the data provided in the above given table, the formulations F1, F2 and F3 containing
dried extract powder of Trichosanthes dioica seeds and dried extract powder of Prunus persica
leaves exhibited anthelmintic activity. All worms were paralyzed and eventually killed by the all
test formulations. F1 formulation (200mg+200mg) i.e. 1:1 ratio of both plants extracts, exhibited
maximum efficacy by taking shortest paralysis and lethal times as shown in above given table.
The mean paralysis time and mean lethal time exhibited by F1, F2 and F3 was lower than that
exhibited by either Trichosanthes dioica seeds dried aqueous extract or Prunus persica leaves
dried aqueous extract, thereby indicating the presence of synergism between the two components.