Guidelines for processing of Patent applications By Jaikumar Pareta

GUIDELINES FOR PROCESSING OF PATENT APPLICATIONS BY JAIKUMAR PARETA

GUIDELINES FOR PROCESSING OF PATENT APPLICATIONS RELATING TO TRADITIONAL
KNOWLEDGE 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 biological
resources obtained from India without taking adequate care to observe the mandate of law.

1. 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 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. 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concerning India's traditional knowledge have either been cancelled or withdrawn or claims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 "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 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 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
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, by
whatever name called, in or outside India for any invention based on any research or
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information on a biological resource obtained from India without obtaining the previous
approval of National Biodiversity Authority before making such application; provided that, if a
person applies for a patent, permission of the National Biodiversity Authority may be
obtained after the acceptance of the patent but before the sealing of the patent1 by the
patent authority concerned; provided further that the National Biodiversity Authority shall
dispose of the application for permission made to it within a period of ninety days from the
date 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 a
declaration under Form-1 (Application for Grant of Patent) of the Patent Rules 2003 to the
effect 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 provision
in this regard under section 55 (1) which provides that "whoever contravenes or attempts to
contravene or abets the contravention of the provisions of the section 3 or section 4 or
section 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 is
imperative 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 and
classified. 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 (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
1 With 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.
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Biochemistry), A23C, A23L (for Food), B25F (for Mechanical), etc. The screening of an
application as “Traditional Knowledge” is an administrative process for facilitating the
examination 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 not
found 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 be
done by the Group Leader (GL) forthwith.
9. If an application is wrongly screened and classified as "Traditional Knowledge", only the
Technical 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 and
Examiner 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 a
thorough search for anticipation in TKDL and/or other databases. If any citation is made from
TKDL database, then copy of the citation (English translated) should be sent along with the
examination report.
14. Assessment of Novelty and Inventive step:
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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 final
gate keeper of the patent system. While considering the traditional knowledge based
inventions, the following guiding principles must be followed in assessing the novelty and
inventive 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, such
claims 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 plant
materials 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, such
claims cannot be said to involve an inventive step, since the use of said plant materials and
their 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 the
prior art, it can be objected that the 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
teaching 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 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
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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 and
characterization of the same cannot be considered to involve an inventive step in the light of
prior 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 Unani
systems of medicine.
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).
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 the
prior 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 this
known active ingredient would be effective for the treatment of same disease.
Illustration 1: Patent application claims relate to a combination of five constituents, one of
these 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.
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Analysis: The claim of alleged invention relates to a composition comprising five constituents
and 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 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 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 claimed
by 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 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
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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 Principle 6: In case individual ingredients are 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 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, 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).
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 a
disease (cold and/or influenza) related to reduced immunity.
Prior art (TKDL): Discloses independent use of said plants for the treatment of cold and
influenza 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, the
use of theanine comprised in tea and extracts thereof, for prevention and/or treatment of cold
and/or influenza was known from popular medicine 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 of
section 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 examined
with respect to requirements of full and particular disclosure of the invention, its operation or
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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 the
invention is not disclosed in the specification, an objection shall be raised thereof in
conformity 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 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". 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 the
application, 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 is
affirmative, the Examiner/Controller should raise the objection in the FER about the
requirement 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, the
patent 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 and
geographical 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 the
description that the biological material used in the invention is not from India and should clearly
specify 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 specification
is 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 India
or 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, which
is reproduced herein below:
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It has been observed that during the examination of applications pertaining to the Biological
materials 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 the
present application. In view of this, the following directions are issued for strict compliance of
the concerned Controllers and Examiners:
“Exemption to medicinal plants from the provisions of the Biological Diversity Act, 2002 given
by 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 are
very 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 and
approval 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 under section 11 (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 of
the 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 the
website 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).