GUIDELINES FOR PROCESSING OF PATENT APPLICATIONS RELATING TO TRADITIONALKNOWLEDGE AND BIOLOGICAL MATERIAL
It has been reported that the Indian Patent Office is granting patents on the use of
traditional knowledge (TK) of India, particularly relating to the Ayurveda, Unani and Siddha
systems of medicine, etc and patents have been granted on inventions related to biologicalresources obtained from India without taking adequate care to observe the mandate of law.
This is inspite of the fact that other international patent offices are denying/objecting to the
grant of such patents on the basis of prior art evidence retrieved from the Traditional
Knowledge Digital Library (TKDL).
2.
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 centre stage of theInternational Intellectual Property System. These efforts have resulted inter alia in setting upof 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 andthe fair and equitable sharing of the benefits arising from their utilization. Further, India has
been able to conclude TKDL Access (Non-Disclosure) Agreements with several international
patent offices including USPTO, EPO, JPO etc. Consequently, many patent applications
concerning India's traditional knowledge have either been cancelled or withdrawn or claims
have been amended in several international patent offices. Negotiations are also under way
for establishing an international legally binding instrument on protection of TK.
3.
Indian law has adequate provisions for the protection of TK and Biological Resources.
Traditional knowledge, by its very definition, 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 "asubstance 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 andhence, not patentable. The Indian Patents Act also has a unique 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 aninvention 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
related to TK and/or biological material.
4.
On the issue of Biological resources, section 6 (1) of the Biological Diversity Act, 2002
provides very clearly that "no person shall apply for any intellectual property right, bywhatever name called, in or outside India for any invention based on any research or1

information on a biological resource obtained from India without obtaining the previous
approval of National Biodiversity Authority before making such application; provided that, if aperson applies for a patent, permission of the National Biodiversity Authority may beobtained after the acceptance of the patent but before the sealing of the patent 1 by thepatent authority concerned; provided further that the National Biodiversity Authority shalldispose of the application for permission made to it within a period of ninety days from thedate of receipt thereof. The Indian Patent Law complements this provision of the Biological
Diversity Act, 2002 by making it mandatory for the applicant of a patent to submit adeclaration under Form-1 (Application for Grant of Patent) of the Patent Rules 2003 to theeffect that "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." The Biological Diversity Act, 2002 has a penal provisionin this regard under section 55 (1) which provides that "whoever contravenes or attempts tocontravene or abets the contravention of the provisions of the section 3 or section 4 orsection 6 shall be punishable with imprisonment for a term which may extend to five years,
or with fine which may extend to ten lakh rupees and where the damage caused exceeds ten
lakh rupees such fine may commensurate with the damage caused, or with both."5.
Moreover, applications for patents based on TK and/or biological material
contravening the provisions of law can be refused under section 15 or in pre-grant opposition
under clauses (d), (f) and (k) of Section 25 (1) and granted patents can be revoked in post-grant
opposition under clauses (d), (f) and (k) of Section 25 (2) of the Patents Act, 1970. Nondisclosure 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
opposition under clause (j) of Sections 25 (1) and 25 (2) respectively of the Patents Act, 1970.
6.
In view of the above facts and the sensitivity and importance of the issue, it isimperative that due care and diligence be exercised while processing patent applications
relating to TK and/or biological materials and in post-grant proceedings thereto. Accordingly,
the following guidelines are issued for strict compliance by all Examiners and Controllers:
Screening:7.
It should be ensured that all patent applications relating to Traditional Knowledge (TK)
are correctly identified, screened and classified as "Traditional Knowledge" by RECS Section.
The RECS in-charge should take due care that no case relating to TK is wrongly screened andclassified. Additionally, the person in-charge of screening should accord 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 (forChemical), A61K, A61L (for Pharmaceuticals), A01N (for Agrochemcials), C12S, C12N,
C07K4/00; 14/00 (for Biotechnology), C12N, C12P, C12Q (for Microbiology), C12F, C12G (for1With effect from 01-01-2005, in the Patents Act, 1970, the process of grant of patent has been modified to replace
acceptance and subsequent grant and sealing of patent by a process of grant of patent.
2Biochemistry), A23C, A23L (for Food), B25F (for Mechanical), etc. The screening of an
application as “Traditional Knowledge” is an administrative process for facilitating theexamination and to indicate that the subject-matter of the application is important and has
relevance in the context of traditionally known substances, articles or processes for preparing
them or their use.
8.
In the rare situation that the screening and/or classification by the RECS Section is notfound to be appropriate in respect of applications relating to TK during
allotment/examination, it should be immediately brought to the notice of the Group Leader
by the concerned Examiner/Controller and re-screening and/or re-classification should bedone by the Group Leader (GL) forthwith.
9.
If an application is wrongly screened and classified as "Traditional Knowledge", only theTechnical Head shall be competent for re-screening and/or re-classification of the same to any
other screening field on the recommendation of the concerned Group Leader.
10.
System Administrator should create separate screening fields in the Module namely,
TK-Chemical, TK-Biotechnology and TK-Mechanical.
Allotment:
11.
In the concerned Group, the Group Leader shall himself/herself act as the Controller for
all applications related to TK. The Group Leader/Controller shall ensure that the provisions
related to the protection of TK and/or biological material are fully complied with. The
concerned Group Leader shall select one suitable Examiner from within his/her Group for
dealing with all applications relating to TK. The concerned Group Leader/Controller andExaminer should endeavor to continuously upgrade their knowledge about TK and/or
Biological Resources.
12.
Any application/case already under process including pre-grant opposition relating to
TK shall be re-allotted to the identified pair in the respective Group. Whenever any
Examiner/Controller comes across a case related to TK, he/she shall bring to the notice of GL
for re-allotment.
Examination:
13.
In every case related to TK and/or biological material, the Examiner shall carry out athorough search for anticipation in TKDL and/or other databases. If any citation is made fromTKDL database, then copy of the citation (English translated) should be sent along with theexamination report.
14.

Assessment of Novelty and Inventive step:3

The patents Act warrants that the subject-matter claimed in a patent application must be novel.
The inventive step is another cardinal principle of patentability. Often it is said to be the finalgate keeper of the patent system. While considering the traditional knowledge based
inventions, the following guiding principles must be followed in assessing the novelty andinventive step:
Guiding Principle 1: If the subject-matter as claimed relates to extracts/alkaloids and/or
isolation of active ingredients of plants, which are naturally/inherently present in plants, suchclaims cannot be considered as novel and/or inventive when use of such plants is pre-known
as part of teachings of Traditional Knowledge.
When the subject-matter of claims relate to extracts of plant materials containing undefined
active ingredients, such claims cannot be said to be novel if the use of such plants or plantmaterials is pre-known as a part of teaching of TK. However, if the claims relate to alkaloids
and/or active principles obtained from the plant materials and structures of the said alkaloids
and/or active principles are characterized, which do not form the part of the prior art, suchclaims cannot be said to involve an inventive step, since the use of said plant materials andtheir therapeutic effects are known from the teaching of TK. Thus, the prior art motivates the
person skilled in the art to isolate the individual ingredients such as alkaloids, flavonoids, phytosteroids, etc.
Illustration 1: Patent application claims relate to an extract of Withania plant for the
management of stress.
Prior art (TKDL): Discloses use of Withania somnifera roots and not Withania plant extract 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 plant. Based on theprior art, it can be objected that the extract of Withania somnifera would be useful intreatment 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 theteaching of prior art obtained from TKDL.
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.
Prior art (TKDL): Discloses use of German chamomile (from which Chamaemeloside is derived)in wound healing and for the treatment of cancer, diabetes mellitus, arthritis, acne vulgaris andeczema 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 orGerman chamomile. Based on the prior art, it can be objected that German or Romanchamomile (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
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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 isolation andcharacterization of the same cannot be considered to involve an inventive step in the light ofprior art obtained from TKDL.
Guiding Principle 2: Combination of plants with known-therapeutic effect with further plants
with the same known-therapeutic agents wherein all plants are previously known for treating
the same disease is considered to be an obvious combination.
Illustration 1: Patent application claims relate to a composition comprising of Calendula
officinallis, Aloe vera and Centellae asiatica as healing agent and for treatment of wound.
Prior art (TKDL): Discloses independent use of Calendula officinallis, Aloe vera and Centellae
asiatica for the treatment of wound and as a Cicatrizant/healing agent in Ayurveda and Unanisystems of medicine.
Analysis: The claims of alleged invention were on a composition. Based on the prior art, it canbe objected that the combination of these plants would be obvious for the treatment of skindiseases and healing of wounds. The combination of a plant with a known therapeutic effectwith 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 thaneach of the medicinal plants when applied separately (additive effect).
Illustration 2: Patent application claims relate to a composition comprising Ginger, Radish,Celery and Black seed for enhancing male fertility.
Prior art (TKDL): Discloses independent use of Ginger, Radish, Celery and Black seed as
Aphrodisiac and Spermatogenic in Ayurveda and Unani systems of medicine.
Analysis: The claims of alleged invention relate to a composition. Though none of the prior arts
disclose a composition comprising a combination of the four extracts as claimed in the present
application, it can be objected from prior art documents that the use of the single ingredients
ginger, radish, celery and black seed as aphrodisiac and/or spermatogenic is well-known in theprior art.
Guiding Principle 3: In case an ingredient is already known for the treatment of a disease,then it creates a presumption of obviousness that a combination product comprising thisknown active ingredient would be effective for the treatment of same disease.
Illustration 1: Patent application claims relate to a combination of five constituents, one ofthese being a 1:2 watery extract of Cucumis melo containing catalase and superoxide
dismutase; along with Pimiemta racemosa, Citrus aurantifolia, Coenzyme Q-10 and Pyridoxine
Chlorhydrate for the treatment of vitiligo.
Prior art (TKDL): Discloses usefulness of only one of the constituents, watery extract of Cucumis
melo for its anti-vitiligo property in the Unani system of medicine.
5Analysis: The claim of alleged invention relates to a composition comprising five constituentsand not on 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 merits can not be acknowledged.
Guiding Principle 4: Discovering the Optimum or Workable Ranges of Traditionally known
ingredients by Routine experimentation is not inventive.
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 notinventive since the selection of optimum or workable range is well within the expectation of aperson skilled in the art.
Illustration 1: Patent application claims relate to a formulation comprising at least two of thefollowing: 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 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 (TKDL): 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 unpatentable in so far as the alleged invention is
obvious over Agasthiyar (TKDL) which taught a composition of extracts of two of the claimed
plants, Karanj and Heena formulated as oil for topical treatment of ulcers and wounds.
Although cited art does not specifically teach adding the ingredients in the percentages claimedby the applicant, however the amount of specific ingredient in a composition is clearly a result
effective parameter that a person of ordinary skill in the art would routinely optimize.
Guiding Principle 5: In case multiple ingredients are known to have the same therapeutic
activity as per traditional knowledge, taking out one single 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 (TKDL): Discloses use of Zingiber zerumbet (bitter ginger) along with few otheringredients 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 theprior art disclosure, the multi-component formulation comprising Zingiber zerumbet have thesame 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 same6

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 canbe objected for lacking in inventive step.
Guiding Principle 6: In case individual ingredients are already known for the treatment of adisease as a part of Traditional Knowledge, then it is obvious that a combination productcomprising these known ingredients with further plants with the same known therapeutic
effect would be more effective than each of the medicinal plants when applied separately(additive effect).
Illustration 1: Patent application claims relate to a composition comprising of Calendula
officinallis, Aloe vera and Centellae asiatica as healing agent and for treatment of wound.
Prior art (TKDL): Discloses use of said plants for the treatment of wound and as a
Cicatrizant/healing agent in Ayurveda and Unani systems of medicine.
Analysis: The claim of alleged invention relates to a composition. In view of the prior art, thecombination of these plants would be obvious for the treatment of skin diseases and healing ofwounds. The combination of a plant with a known therapeutic effect with further plants withthe same known therapeutic effect, wherein all plants are previously known for treating thesame disease is considered to be an obvious combination. It would normally be expected thatsuch combinations of medicinal plants would be more effective than each of the medicinal
plants when applied separately (additive effect).
Illustration 2: Patent application claims relate to a composition comprising of theanine (Tea)and a herb selected from Sankhapuspi, Satavari or a mixture thereof for the treatment of adisease (cold and/or influenza) related to reduced immunity.
Prior art (TKDL): Discloses independent use of said plants for the treatment of cold andinfluenza and as immuno-potentiator in Ayurveda and Unani systems of medicine.
Analysis: The claims of alleged invention relate to a composition. In view of the prior art, theuse of theanine comprised in tea and extracts thereof, for prevention and/or treatment of cold
and/orinfluenza
was
known
from
popularmedicine
since
ages.
The
immunoadjuvant/immunomodulatory potential of Asparagus racemosus (Satavari), aqueous
exctracts/Evolulus alsinoides (Sankhapuspi) was also disclosed in prior art documents.
Therefore, nothing inventive could be seen in the additional use of immunopotentiating herbs
to treat these diseases. A combination of these plants would be obvious as an immunopotentiator and for the treatment of common cold and a variety of other diseases.
15. While deciding the patentability of the claimed subject matter, the relevant clauses ofsection 3, particularly sections 3 (c), (e), (i), (j) and (p) of the Patents Act, for TK and/or
biological material should be strictly followed.
16. The applications related to TK and/or biological material shall also be critically examinedwith respect to requirements of full and particular disclosure of the invention, its operation or7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) of the Patents Act,17.
If the source and geographical origin of the biological material used in theinvention is not disclosed in the specification, an objection shall be raised thereof inconformity with section 10 (4) (a) & (b) of the Patents Act.
NBA permission:
18.
In Form-1 of the Patent Rules 2003, the applicant is required to furnish adeclaration "the invention as disclosed in the specification uses the biological material
from India and the necessary permission from the competent authority shall be submitted byme/us before the grant of patent to me/us". This provision of declaration in paragraph 9 (in) of
Form-1 came into force from 01-01-2005 and every application submitted thereafter should
mandatorily have either the affirmative or cancelled out declaration. Where the applicant
leaves the declaration unattended, the RECS section should insist upon a fresh Form-1 wherein
it should be clearly indicated. If such omission is noted during any stage of processing of theapplication, the Examiner/Controller should raise an objection in this regard.
19.
If the above declaration in Form-1 regarding the use of biological material from India isaffirmative, the Examiner/Controller should raise the objection in the FER about therequirement of permission from NBA in the matter, if already not submitted. If the objection
has not been raised in the FER, the same may be raised at any stage thereafter. In any case, thepatent should not be granted unless the NBA permission is submitted by the applicant.
20.
On the other hand, if the declaration in Form-1 regarding the use of biological material
from India is cancelled out by the applicant and the specification also states that the source andgeographical origin of the biological material is not from India, the specification should be
amended by way of incorporation of a separate heading/paragraph at the beginning of thedescription that the biological material used in the invention is not from India and should clearlyspecify the country of source and geographical origin of the same.
21.
Where the declaration in Form-1 is cancelled out but the disclosure in the specificationis that the source and/or the origin of the biological material is from India, then NBA permission
is required.
22.
Therefore, no patent shall be granted without the necessary permission from the
National Biodiversity Authority in cases where the invention uses biological material from Indiaor the source and/or the origin of the biological material is from India as per the disclosure in
the specification.
23. The directions given in circular No. 1 of 2012 by CGPDTM should be strictly followed, whichis reproduced herein below:
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It has been observed that during the examination of applications pertaining to the Biologicalmaterials diverse yardsticks are adopted by different Patent Officer/Controller as regards the
exemption from obtaining permission from NBA in r/o the claimed biological resource in thepresent application. In view of this, the following directions are issued for strict compliance ofthe concerned Controllers and Examiners:“Exemption to medicinal plants from the provisions of the Biological Diversity Act, 2002 givenby the notification issued by the Ministry of Environment and forests Notification dated 26th
October 2009 is available only if they are traded as commodities and the said provisions arevery much applicable if the biological resources are used as ingredients for medicine. As such,any interpretation by the Controllers/Examiners of the Office of CGPDTM to see this as an
exemption from the Biological Diversity Act would be wrong.
Controllers/Examiners are directed to ensure strict compliance with the aforesaid order andapproval of NBA should be sought for any biological resources derived from India and used in
an invention for which patent application is filed.”
Publication of list of TK related patent applications:24.
The System Administrator shall publish the list of all pending patent applications
related
to
TK,
which
are
published
undersection11(A)of
the Patents Act, in a separate link on the official website of CGPDTM. This list should be
updated automatically on the website as per screening field in the module on real time basis.
The list should display at least the following fields: application number, date of filing, title ofthe invention and name of applicant (indexed in the order of date of filing).
25. A list of patents granted on applications related to TK should also be published on thewebsite for all such patents granted from 1st July 2012. This list should also be updated
automatically on the website as per screening field in the module on real time basis. The list
should display at least the following fields: application number, patent number, date of filing,date of grant, title of the invention and name of patentee (indexed in the order of date of
grant).
[End of document]

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