GUIDELINES FOR EXAMINATION OF BIOTECHNOLOGY APPLICATIONS FOR PATENT

1. INTRODUCTION
Biotechnology exploits biological materials, living or non-living, and is broadly classified
as classical and modern biotechnology. The age-old fermentation process for producing
alcohol, isolation of antibiotics from moulds or other micro-organisms are only a few
examples of classical biotechnology. Modern biotechnology started with the gene splicing
technology or genetic engineering which developed in the late seventies of the last century.
By using genetic engineering, many useful things like human insulin, human growth factors,
monoclonal antibodies, etc. have been developed.
The biotechnological inventions therefore include products and/ or processes of geneengineering technologies, methods of producing organisms, methods of isolation of microorganisms from culture medium, methods of mutation, cultures, mutants, transformants,
plasmids, processes for making monoclonal antibodies, cell lines for making monoclonal
antibodies, etc. While on the one side, biotechnological inventions have resolved many
problems and branched out to several fields, on the other side, they have invoked many
debates. The application of genetic engineering in plants and animals has resulted in
exciting and yet debatable technological developments such as transgenic plants, animals
and isolation of human genes for using them to produce medicaments.
Scientists across the world are using bioinformatics tools, ingenious techniques andgenomes of organisms to probe the mysteries of biological processes and the living world
thereby generating vast amounts of information which may provide the keys to new medical
treatments, improved crops and so on.
However, there are some issues relating to patentability of biotechnological inventions
which are of serious concern to the users of Patent System such as novelty, obviousness,
industrial applicability, extent of disclosure and clarity in claims. In addition, a few special
issues have also evolved such as those relating to moral and ethical concerns,
environmental safety, issues relating to patenting of ESTs (Expressed Sequence Tags) ofpartial gene sequences, cloning of farm animals, stem cells, gene diagnostics, etc. Thus, thepatenting of inventions in the field of biotechnology poses challenges to the applicants forpatents as well as to the Patent Office. Therefore, there is an urgent need to put in place
Guidelines to establish uniform and consistent practices in the examination of patentapplications in the field of biotechnology and allied subjects under the Patents Act, 1970.
Thus the guidelines are intended to help the examiners and controllers of the Patent Officeso as to achieve uniformity and consistency.
However, these guidelines do not constitute rule making. In case of any conflict between
these guidelines and the provisions of the Patents Act, 1970 and the Patents Rules, 2003,
the said provisions of Act and Rules will prevail over these guidelines. The guidelines are
subject to revision from time to time based on interpretations by a Court of Law, statutory
amendments and valuable inputs from the stakeholders.
12. BRIEF HISTORY OF PATENTING OF BIOTECHNOLOGY IN INDIA
Till 2002, as per the prevailing practice in the Patent Office, patents were not granted forinventions relating to (a) living entities of natural or artificial origin, (b) biological materials
or other materials having replicating properties, (c) substances derived from such materials
and (d) any processes for the production of living substances/entities including nucleic acids.
However, patents could be granted for processes of producing non-living substances bychemical processes, bioconversion and microbiological processes using micro-organisms or
biological materials. For instance, claims for processes for the preparation of antibodies orproteins or vaccines consisting of non-living substances were allowable.
In 2002, the Hon’ble Calcutta High Court, in its decision in ‘Dimminaco AG v. Controller
of Patents and Designs’, opened the doors for the grant of patents to inventions where thefinal product of the claimed process contained living microorganisms. The court concluded
that a new and useful art or process is an invention, and where the end product (even if it
contains living organism) is a new article, the process leading to its manufacture is aninvention. The Dimminaco case was related to a process for the preparation of a live vaccine
for protecting poultry against Bursitis infection. The Controller of Patents had refused theapplication for grant of patent on the ground that the vaccine involved processing of certain
microbial substances and contained gene sequence. The Controller had decided that thesaid claim was not patentable because the claimed process was only a natural process
devoid of any manufacturing activity and the end-product contained living material.
The Hon’ble High Court held that the word “manufacture” was not defined in the statute
therefore, the dictionary meaning attributed to the word in the particular trade or businesscan be accepted if the end product is a commercial entity. The court further held that there
was no statutory bar in the patent statute to accept a manner of manufacture as patentableeven if the end product contained a living organism. The court asserted that one of the mostcommon tests was the vendibility test. The said test would be satisfied if the invention
resulted in the production of some vendible item or it improved or restored the former
conditions of the vendible item or its effect was the preservation and prevention fromdeterioration of some vendible product. The court further stated that the vendible productmeant something which could be passed on from one man to another upon transaction ofpurchase and sale. In other words, the product should be a commercial entity.
The subsequent major step, which further opened the arena of grant of patents in thefield of biotechnology, was in the year 2002 when the Patents Act, 1970 was amended by
the Patents (Amendment) Act, 2002 where biochemical, biotechnological andmicrobiological processes were included within the scope of chemical processes for the
grant of patent. The definition of “invention” was also changed to “any new product orprocess involving an inventive step and capable of industrial application” thereby deleting
the word “manner of manufacture” as mentioned in the earlier Act.
India joined the Budapest Treaty on the International Recognition of the Deposit ofMicroorganisms for the Purposes of Patent Procedure on 17th December 2001.
Consequently, section 10 of the Act was amended in 2002 to provide for deposition of the2

biological material and its reference in the patent application in case the invention relates toa biological material which is not possible to be described in a sufficient manner and which
is not available to the public. The Patents Act, 1970 was amended by the Patents(Amendment) Act, 2005 paving the way for the grant of product patents in any field oftechnology including biotechnology with certain exceptions keeping in view the national
policy to protect the public interest. The Act, as amended, recognizes the International
Depository Authorities (IDAs) under the Budapest Treaty.
3. BIODIVERSITY RELATED ISSUESThe Biological Diversity Act, 2002 (hereinafter referred to as BD Act) provides amechanism for access to the genetic resources and benefit sharing accrued therefrom.
Section 6 of the BD Act came into force on 1st July 2004, and prescribes that obtaining IPRs
from the utilization of biological resources in India is subject to the approval of the National
Biodiversity Authority (hereinafter referred to as NBA).
To facilitate this access and benefit sharing and in order to prevent any unauthorized useof the biological resources of India, in 2005 suitable amendments were made in Section 10of the Patents Act, 1970, wherein disclosure of the source and geographical origin of thebiological material was made mandatory in an application for patent when the said material
is used in an invention. In addition, a declaration by the applicant regarding the required
permission from the competent authority was inserted in Form 1 of the Patents Rules, 2003.
Therefore, the issues related to the BD Act and those related to mandatory disclosure of
the source and geographical origin constitute an essential element of examination of
biotechnology related subject matters.
In view of the above background, the guidelines for the examination of patentapplications in the field of biotechnology and allied subjects within the Patent Office havebecome essential in order to establish uniform and consistent practice. The guidelines as set
out below are supplemental to the practices and procedures followed by Patent Office as
published in the ‘Manual of Patent Office Practice and Procedure’.
4. PROVISIONS COVEREDThe following sections of the Patents Act, 1970 are emphasised in the context of
examination of applications in biotechnology and allied fields:
I.

Section 2 (1) (j): Novelty, inventive step & industrial applicability of products orprocesses,

II.

Section 3 (b): Inventions contrary to morality or which cause serious prejudice tohuman, animal or plant life or health or environment,

III.

Section 3 (c): Discovery of any living thing or non-living substance occurring in
nature,3

IV.

Section 3 (d): Mere discovery of new form of known substance which does not resultin enhancement of known efficacy or mere discovery of any new property or newuse for a known substance,

V.

Section 3 (e): Mere admixture resulting only in aggregation of the properties,

VI.

Section 3 (h): Method of agriculture and horticulture,

VII.

Section 3 (i): Method of treatment and diagnosis,

VIII.

Section 3 (j): Plants and animals in whole or any part thereof other than microorganisms, but including seeds, varieties and species, and essentially biologicalprocesses,

IX.

Section 3 (k): Computer programs per se and algorithms, mathematical methods,

X.

Section 3 (p): Inventions which are in effect traditional knowledge,

XI.

Section 10 (4): Sufficiency of disclosure and the best method of performing theinvention, andXII.

Section 10 (5): Unity of invention and clarity, succinctness and support of the claims.
5. CLAIMS OF BIOTECHNOLOGICAL INVENTIONS

The details of wording of claims, clarity, support and sufficiency of the disclosure are
discussed under appropriate headings. However, for better understanding of the issues
related to novelty and inventive step, it is felt that we should begin with a preliminary
discussion of claims of biotechnology related inventions which are usually filed in patentapplications of the relevant fields.
Usually the biotechnology applications comprise the claims relating to the following
subject matters:(a) Polynucleotides or gene sequences (product and/or process),(b) Polypeptides or protein sequences (product and/or process),(c) Vectors (e.g., plasmids) (product and/or process),(d) Gene constructs or cassettes and gene libraries,(e) Host cells, microorganisms and stem cells (product and/or process), transgenic cells,(f) Plants and animals tissue culture (product and/or process)(g) Pharmaceutical or vaccine compositions comprising microorganisms, proteins,polynucleotides (product and/or process),(h) Antibodies or antigen binding fragments thereof (monoclonal or polyclonal),
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(i) Diagnostic kits and tests, and(j) Diagnostic tests (products/process) such as a test for the detection of a mutation in agene/protein which might be associated with a particular condition such as protein
expression or a disease.
6. PRIOR ART SEARCH
While conducting a prior art search, the Examiner should design a comprehensive
search strategy by combining various search parameters including key words, IPC,
sequences, etc. and thorough search should be carried out in patent as well as non-patent
databases.
If a patent application discloses sequence listing of nucleotides and/or amino acids
as per Rule 9 (1) of the Patents Rules 2003, the same shall also be filed in electronic form.
To facilitate the processing of patent applications, the sequence listings should be filed incomputer readable format. The examiner should carry out the sequence search on thecommercial databases available to the office and freely available databases using diverse
search tools such as BLAST, FASTA, etc.
7. NOVELTY
In the case of biotechnological inventions the assessment of novelty shall be carriedout in the same manner as for other inventions. For the purpose of ascertaining novelty
during the examination, the prior art is to be construed as prescribed under Section 13 (readwith Sections 29 to 34) of the Act. The Manual of Patent Office Practice & Procedure has set
out the guidelines for assessment of novelty of inventions (Chapter 8, Para 08.03.02) that
may be referred to.
According to Section 2 (1) (j) of the Act, an "invention" means a new product orprocess involving an inventive step and capable of industrial application. An invention will
be patentable only if it is new in the light of prior art, or is not anticipated by prior art. The
prior art includes all information and knowledge relating to the invention, which is available
in any publication before the date of priority of the patent application. For the purpose of
examination, an invention will not be new if it forms part of the prior art or has entered the
public domain. For anticipation, such publication must be before the date of priority of thepatent application. Also, any application for patent filed in India, but published after thedate of filing of a subsequent application for patent in India claiming the same subjectmatter shall be treated as a prior art (i.e. prior claiming) to the said subsequent application
provided that the previous application has earlier priority date.
7.1. PRODUCT-BY-PROCESS CLAIMS
A claim to a product obtained or produced by a process is anticipated by any priordisclosure of that particular product per se, regardless of its method of production.
Examples of ‘Product-by-process’ claims–(a) A polypeptide/compound which is the product of the method according to claim X.
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(b) A transgenic microorganism obtained by the method ….characterized in that …..”(c) A plasmid obtained by the method of ……
Such claims are admissible only if the products themselves fulfil the requirement ofpatentability over the prior art. The claimed products cannot be considered novel merely
due to the novelty in the processes by which they are produced, but rather novelty can
only be established, if technical evidences are provided showing that the modifications in
the processes result in other products which are distinct with regard to their properties
over the products known in the prior art. Such technical evidences may vary from case tocase.
7.2. SEQUENCE CLAIMS
A claim to a polynucleotide sequence that was available, e.g. as part of a library
before the priority date, lacks novelty, even if activity or function of the said sequence ofthe polynucleotide has not been previously determined. A claim to a specific fragment ofpolynucleotide may be considered to be novel, but subject to fulfilment of the inventive
step and non-patentability under relevant clauses of Section 3 of the Act.
A prior disclosure of the same sequence as the claimed sequence, even without any
indication of its activity, would prima facie constitute anticipation to the novelty of theclaimed sequence. The reasoning is that the earlier sequence inherently possesses theactivity of the claimed sequence. If any sequence of a polynucleotide/polypeptide from aprior art does not exactly match with the claimed sequence ofpolynucleotide/polypeptide, then the subject-matter of such claims cannot be said to be
anticipated by the prior art sequence. However, such sequence ofpolynucleotide/polypeptide of the prior art would be relevant for deciding inventive step or
non-patentability under relevant clauses of Section 3 of the Act.
7.3. COMBINATION/COMPOSITION CLAIMS
Quite often, the claims of combination of products of biotechnology escape thequestion of novelty and are dealt under the inventive step or relevant clauses of Section 3 of
the Act. However, sometimes it may happen that the combination has already fallen in the
public domain and hence, to be dealt under novelty.
ILLUSTRATIVE EXAMPLE:
Claim: A composition useful against diphtheria toxin, comprising anti-diphtheria antibodies
together with acceptable preservatives and stabilizers, wherein the antibodies are obtained
from chicken egg yolk (IgY).
Prior art discloses a composition useful against the diphtheria toxin comprising antibodies
obtained from chicken egg yolk, physiologically acceptable carrier and other additives &adjuvants. The prior art further discloses a process for preparing egg yolk antibodies by
employing the same steps right from an immunization of a chicken with a diphtheria antigen
to antibodies purification as claimed in the present invention.

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Analysis: The claim lacks novelty, as being anticipated by the said prior art which discloses
all the features of claimed composition useful against the diphtheria toxin. Thus, theclaimed subject matter lacks novelty.
8. INVENTIVE STEPThe Manual of Patent Office Practice & Procedure has set out the guidelines forassessment of Inventive Step of inventions (Chapter 8, Para 08.03.03) that may be referred
to. An invention should possess an inventive step in order to be eligible for patent
protection. As per the Patents Act, an invention will have inventive step if the invention
involves (a) technically advanced as compared to existing knowledge or (b) having economic
significance or (c) both, and that makes the invention not-obvious to a person skilled in theart.
ILLUSTRATIVE EXAMPLE:
Claim: An isolated DNA sequence encoding a mature human IL-3 protein having a proline
residue at position 8 of the mature polypeptide, said protein possessing bone marrowproliferation-inducing activity in a human bone marrow proliferation assay.
Difference with prior art is that the claimed compound at position 8, there was a proline
moiety whereas in the prior art compound in the same position there was a serine
molecule.
Analysis: Primate IL-3 are part of family proteins which are similar in their amino acidsequences, but are minor variants or point mutations of each other. A single variation in theamino acid sequence does not normally change the activity and function of the protein
unless the single variation is in a critical region of the protein. The applicant could notprovide any evidence that the protein coded by the claimed DNA was any different fromthat of the prior art in its chemical properties. Thus, the inventive step cannot be
acknowledged.
The claimed subject-matter would lack inventive step if it is obvious to a person
skilled in the relevant art in view of a single prior art or a mosaic of the relevant prior art
documents.
ILLUSTRATIVE EXAMPLE 1:
Claim: An improved process for the production of galactooligosaccharides (GOS) of highyield and purity comprising the steps of: (i) isolating Bullera singularis and Saccharomycessp. (ii) immobilizing the B. Singularis and Saccharomyces sp; (iii) hydrolysis of lactose by theimmobilized microbial cells, said reaction being carried out until galactose content being atleast 65 % and (iv) optionally concentrating the galactooligosaccharides solution.
Prior Art: D1 discloses a process for the production of galacto-oligosaccharides from lactose
using immobilized B. singularis cells. D1 does not explicitly teach the combined use of B.
Singularis and Saccharomyces sp. in the production of galacto-oligosaccharides.

7

D2 discloses the use of Saccharomyces sp. for the production of galacto-oligosaccharides
from lactose. It further discloses that Saccharomyces sp. uses lactose as a carbon source &approximately it removes 92% of glucose from the GOS mixture by fermentation without
losing the GOS content.
Analysis: Since it is evident from D2 that Saccharomyces sp. consume glucose, one ofordinary person skilled in the art would be motivated to use Saccharomyces sp. in
combination with B. singularis to solve the problem of separation of saccharides and also,
reducing the competitive inhibition of beta-galactosidase enzyme by glucose, which leading
to high yield & purity of GOS. Thus, the claimed subject-matter lacks inventive step.
ILLUSTRATIVE EXAMPLE 2:
Claim: A culture independent method of removal of plasmids from live and multiplying
plasmid containing bacteria comprising the following steps: (a) preparing an aqueous firstsuspension of sub-micronic silver particles; (b) estimating MIC (minimum inhibitory
concentration) of the silver particles for the bacteria to determine the inhibitory
concentration of the particles suspension for the bacteria; (c) adding in a reaction vessel,
the first suspension and growth medium of the bacteria to obtain a second suspension
containing sub-MIC concentration of silver particles; (d) introducing the bacteria in thereaction vessel under conditions favouring the multiplication of the bacteria, for 12 to 48
hrs., to obtain subsequent generations of the bacteria and (e) testing the bacterial
generations for absence of plasmids to obtain a generation of plasmid free bacteria.
Prior art discloses a method in which an antimicrobial activity of silver nano-particles against
E. coli was investigated as a model for Gram-negative bacteria. Bacteriological tests were
performed in LB medium on solid agar plates and in liquid systems supplemented withdifferent concentrations of silver nano-sized particles. To examine the effect of silver
nanoparticles on Gram-negative bacteria, approximately 105 colony-forming units (CFU) of
E. coli strain were cultured on LB agar plates supplemented with silver nano-sized particles
in the concentrations of 10 to 100 µg cm-3. Silver-free LB plates cultured under the same
conditions were used as a control. The plates were incubated for 24 hours at 37 OC. E. coli
bacteria were grown in 100 cm3 of liquid LB medium supplemented with 10, 50, & 100 µg ofthese particles per cm3 of medium. Growth rates & bacterial concentrations were
determined by measuring optical density (OD) at 600 nm each 30 min (OD of 0.1
corresponds to a concentration of 108 cells per cm3). The size and morphology of the silver
nanoparticles were examined by transmission electron microscopy (TEM). The results
confirmed that the treated E. coli cells were damaged, showing formation of “pits” in thecell wall of the bacteria, while the silver nanoparticles were found to accumulate in thebacterial membrane. A membrane with such morphology exhibits a significant increase inpermeability, which leads to leaking of intracellular substances (that is admitted by theapplicant on page 16, 3rd paragraph in the specification of the present invention). The TEM
micrograph also shows coagulation of nano-sized particles at the bacterial surface.
Analysis: Prior art discloses each and every aspect of claimed invention right from theselection of E. coli strain, preparation of silver nanoparticles, culturing of the bacterial strain
with different concentration of silver nanoparticles, conditions for bacterial growth andassessment of effect of silver nanoparticles on gram negative bacteria. Prior art does not8explicitly teach removal of plasmid from bacteria; however, it teaches that the silver
nanoparticles were responsible for significantly increasing the permeability of bacterial cell
membrane that leads to leaking of intracellular substances (which may include plasmids)
from E. coli. Thus, the teaching of cited art would motivate a person having ordinary skill in
the art with reasonable expectation of success to provide an alternative method for removalof plasmids from plasmid containing bacteria in order to solve the problem faced withplasmid containing bacteria using varied concentration of silver nanoparticles, as theseparticles effectively increase bacterial cell membrane permeability leading to removal of
intracellular substances, which may include plasmids. Thus, the claimed subject-matter lacks
inventive step in view of prior art.
If the claimed invention relates to a polynucleotide/polypeptide having
mutation(s) in a known sequence of polynucleotide/polypeptide, which does not result inan unexpected property whatsoever, then the claimed subject-matter lacks inventive
step.
ILLUSTRATIVE EXAMPLE 1:
Claim: Pro-insulin having a C-peptide encompassing only two amino acids selected from ArgLys, Lys-Lys and Lys-Arg*.
(*Human Pro-insulin is comprised of three chains, A, B and C, in the insulin the two chainsare combined eliminating the third chain, i.e. the C–chain consisting of thirty amino acids).
Prior art discloses natural Pro-insulin having 30 amino acids C-peptide, Pro-insulin with Cpeptide as short as two amino acids (Arg-Arg).
Analysis: The claim was held to be prima facie obvious. The applicant argued that the yieldof claimed Pro-insulin having a C-peptide expressed in yeast is 1.6 to 2.0 mmol/l whereas
the yield of the prior art Pro-insulin with a C-chain of Arg-Arg is only 1.0 mmol/l. Such a
difference in change did not constitute ‘unexpected property’ and hence, the subject-matteris held to be obvious.
ILLUSTRATIVE EXAMPLE 2:
Claim: A recombinant DNA sequence of SEQ ID NO: X encoding human interferon α2polypeptide.
Prior art discloses a nucleic acid sequence of SEQ ID NO: X1 encoding human interferon α1
polypeptide.
Analysis: The claimed human interferon α2 is structurally close to the prior art’s humaninterferon α1. However, the alleged invention can be held non-obvious, because of the factthat the claimed human interferon is thirty times more potent in its antiviral activity than itsprior art analogue.

99. INDUSTRIAL APPLICATIONAs per Section 2(1) (ac) of the Act, the expression “capable of industrial application”,
in relation to an invention, means that the invention is capable of being made or used in anindustry”. Further, Section 64 (1) (g) of the Act provides that a patent is liable to be revoked
if the invention is not useful.
To be patentable an invention must be useful and capable of industrial application.
The specification should disclose the usefulness and industrial applicability of an invention ina distinct and credible manner unless the usefulness and industrial applicability of theinvention is already established, either in explicit or in implicit manner.
In the context of the gene sequences, it may be said that whatever ingenuity is
involved in discovering a gene sequence, one cannot have a patent for it or a protein
encoded by it unless it is disclosed how it can be used. It is therefore necessary to consider
whether the invention claimed has a useful purpose, and whether the specification
identifies any practical way of using it.
ILLUSTRATIVE EXAMPLE 1:
Claim: A polypeptide in substantially isolated form comprising a contiguous sequence of atleast 10 amino acids encoded by the genome of hepatitis C virus (HCV) and comprising anantigenic determinant, wherein HCV is characterized by: (i) a positive stranded RNA
genome; (ii) said genome comprising an open reading frame (ORF) encoding a polyprotein;and (iii) said polyprotein comprising an amino acid sequence having at least 40% homology
to the 859 amino acid sequence X.
Upon examination it was found that the above claim was sufficiently enabled and its
use was properly established in the specification. Therefore, claim 1 was allowable.
Another claim of the specification read as “A polypeptide in substantially isolated
form whose sequence is shown in any one of SEQ IDs 1, 3 to 32, 36, 46 and 47, or whose
sequence is encoded in a polynucleotide selectively hybridisable with the polynucleotide asshown in any one of SEQ IDs 1, 3-32, 36,46 or 47."
Upon examination, it was seen that the said claim covered an almost vast number ofpolypeptides for which no use was established and the said claim therefore, was notallowable on the ground that it lacked industrial applicability.
The use of claimed subject-matter (e.g. a gene or a protein) disclosed in thespecification should not be merely speculative, rather the said use should be specific,
substantial and credible for establishing industrial applicability of the claimed subjectmatter.
ILLUSTRATIVE EXAMPLE 2:
Claim 1: A V28 protein (V28) having a function as a receptor (of a kind known as 7TM).
Claim 2: A method of verifying the function of a V28 protein as claimed in claim 1.
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Analysis: The function of V28 protein as a receptor was based on prediction upon various
structural elements in the deduced amino acid sequence and homology to known 7TM
receptors but the specification disclosed no ligand. The use of the invention is disclosed in
the specification, which is however based on a proposed function of the V28 protein as a
receptor that is not sufficiently disclosed in the specification. Thus, the use disclosed in theapplication is speculative, i.e. is not specific, substantial and credible and as such is notconsidered industrially applicable.
9.1. FRAGMENTS/ESTs
Fragments/ESTs (Expression Sequence Tag) are allowable if they in addition to otherconditions satisfy the question of usefulness and industrial application. An EST whose use isdisclosed simply as a ‘gene probe’ or ‘chromosome marker’ would not be considered tohave an industrial application. A credible, specific and substantial use of the EST should be
disclosed, for example use as a probe to diagnose a specific disease.
10. SECTION 3 (B): INVENTIONS CONTRARY TO MORALITY OR WHICH CAUSESERIOUS PREJUDICE TO HUMAN, ANIMAL OR PLANT LIFE OR HEALTH OR ENVIRONMENT
Biotechnology deals with living subject matters and involves alteration of genomic
materials of an organism. Such change may influence or may have a deep impact upon theenvironment or the human, animal or plant life or may involve serious questions about
morality. Hence, adequate care should be taken while examining the inventions vis-a-vis
their primary or intended use or commercial exploitation and it should be carefully dealt
so that the subject-matter must not be contrary to public order, morality or causes serious
prejudice to human, animal or plant life or health or to the environment. A few nonlimiting examples may further clarify the issues: (a) a process for cloning human beings oranimals; (b) a process for modifying the germ line of human beings; (c) a process formodifying the genetic identity of animals which are likely to cause them suffering without
any substantial medical or other benefit to man or animal, and also animals resulting fromsuch process; (d) a process for preparing seeds or other genetic materials comprisingelements which might cause adverse environmental impact; (e) uses of human embryos forcommercial exploitation.
11. SECTION 3(C): SCIENTIFIC PRINCIPLES OR ABSTRACT THEORY OR DISCOVERY OF
LIVING THINGS OR NON-LIVING SUBSTANCES
According to Section 3 (c) of the Act, the mere discovery of a scientific principle or
the formulation of an abstract theory or discovery of any living thing or non-living substanceoccurring in nature is not a patentable invention. Products such as microorganisms, nucleic
acid sequences, proteins, enzymes, compounds, etc., which are directly isolated fromnature, are not patentable subject-matter. However, processes of isolation of theseproducts can be considered subject to requirements of Section 2 (1) (j) of the Act.
ILLUSTRATIVE EXAMPLE 1:
Claim: Bacillus sp. IN123 comprising rDNA (ribosomal DNA) sequence represented as SEQ ID
NO: 1 (deposition No. XXXXXX).
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Analysis: The subject-matter of claim falls within the scope of Section 3 (c) of the Act, as it
attempts to claim an isolated Bacillus sp. IN123 (i.e. a living substance) occurring in nature(i.e. from soil as disclosed in the specification). Thus, what is claimed in the claim is treatedas a discovery of a living thing occurring in nature and hence, not patentable.
ILLUSTRATIVE EXAMPLE 2:
Claim: A novel agent for promoting cardiac development activity, said agent having SEQ ID
NO: 1, wherein the agent is obtained from the perivitelline fluid of horseshoe crab,
Tachypleus gigas.
Analysis: The subject-matter is not patentable under Section 3 (c) of the Act, because theclaim attempts to claim an agent, which is isolated from perivitelline fluid of embryos ofhorseshoe crab, Tachypleus gigas (i.e. a peptide which is non-living substance occurring in
nature). As per Section 3 (c) of the Act, a non-living substance occurring in nature is notpatentable subject-matter and thus, it is not patentable.
ILLUSTRATIVE EXAMPLE 3:
Claim: An isolated peptide that is structural equivalent of a cupredoxin or cytochrome that
can inhibit parasitemia in malaria-infected red blood cells and intracellular replication of amalarial parasite in malaria-infected human red blood cells.
Analysis: The subject-matter of claim falls within the scope of Section 3 (c) of the Act,
because the disclosure does not clearly indicate what modifications/alterations/deletions
are made in the wild-type peptides. In fact, the definition of a word “isolated” used in claims
refers to materials, which are substantially or essentially free from components, which
normally accompany the materials as they found in their natives states. Thus, the subjectmatter of claim is considered to be isolated non-living substances occurring in the natureand functional features for said isolated peptide is considered inherent to a cupredoxin or acytochrome proteins, which is not patentable as per Section 3 (c) of the Act.
12. SECTION 3(D): DISCOVERY OF NEW FORM OF KNOWN SUBSTANCE WHICH
DOES NOT RESULT IN ENHANCEMENT OF EFFICACY
Section 3 (d) of the Act requires that any minor modifications in the already existing
substance in the prior art are not patentable unless the improved property/efficacy of themodified substance is established.
ILLUSTRATIVE EXAMPLE:
Claim: Pre-protein A being one of the factors which primarily control glucose metabolism inmammals having C-peptide, wherein said C-peptide comprises two amino acids selectedfrom XY, YZ and ZX.
Analysis: Prior art discloses modified protein A having C-peptide, wherein said C-peptide
consists of amino acids XX. The applicant failed to demonstrate any therapeutic efficacy as aresult of claimed modification over the prior art. Hence, the subject-matter of claim is notpatentable under Section 3 (d) of the Act.
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The inventions relating to three-dimensional or crystal structure of a polypeptide
attracts the provision of Section 3 (d) of the Act unless it is proved that such polypeptide
differs significantly in the properties with regards to therapeutic efficacy.
ILLUSTRATIVE EXAMPLE:
Claim: A crystal of a peptide consisting of SEQ ID NO: A, wherein said crystal comprises anasymmetric unit, said asymmetric unit comprises four molecules of said peptide per Zn 2+
and further wherein the crystal belongs to space group X, Y, Z.
Analysis: The amorphous forms of peptide of SEQ ID NO: A are known. The applicant failed
to demonstrate any significant improvement in properties with regards to the therapeutic
efficacy over the known amorphous peptide. Hence, it is not allowable under Section 3 (d)of the Act.
13. SECTION 3 (E): MERE ADMIXTURE RESULTING ONLY IN AGGREGATION OF THE
PROPERTIES OR A METHOD OF MAKING SUCH MERE ADMIXTURE
It is a well accepted principle of Patent Law that mere placing side by side of oldintegers so that each performs its own proper function independently of any of the others
is not a patentable combination, but that where the old integers when placed together
has some working interrelation producing a new or improved result, then there ispatentable subject matter in the idea of the working inter relations brought about by thecollocation of the integers.
In Ram Pratap v Bhaba Atomic Research Centre (1976) IPLR 28 at 35, it was held thata mere juxtaposition of features already known before the priority date which have been
arbitrarily chosen from among a number of different combinations which could be chosen
was not a patentable invention.
Section 3(e) of the Act reflects the legislative intent on the law of patenting of
combination inventions in the field of chemical as well as biotechnological sciences.
ILLUSTRATIVE EXAMPLE:
Claim: A composition of innovative combination of dormant spore of naturally occurring
Paecilomyces lilacinus and Arthrobotrys sp. fungus with enzymes, fats and growthpromoting molecules to control plant-parasitic nematodes.
Analysis: The subject-matter of claim falls within the scope of Section 3 (e) of the Act. Upon
examination, it is found that the claim is directed to a composition of two known fungal
species. The said two species used in the alleged invention are known for their nematodebio-control activity. The specification is silent on advantages of a combinative effect of these
two fungal species over the sum of their individual effects. Thus, the subject-matter of theclaim is not patentable under Section 3 (e) of the Act.

13

14. SECTION 3 (H): METHOD OF AGRICULTURE AND HORTICULTURE
According to Section 3 (h) of the Act, a method of agriculture or horticulture is notconsidered as patentable subject matter. While deciding patentability under Section 3 (h),conventional methods performed on actual open fields should be construed as method of
agriculture/horticulture.
ILLUSTRATIVE EXAMPLE:
Claim: A method of growing leguminous plants as inter-cropping for improving fertility ofsoil by augmenting nitrogen content of the soil.
Analysis: The subject-matter of the claim is agriculture method and hence, falls within thescope of Section 3 (h) of the Act.
15. SECTION 3 (I): METHOD OF TREATMENT
According to Section 3 (i) of the Act, any process for the medicinal, surgical, curative,
prophylactic, diagnostic, therapeutic or other treatment of human beings or any process fora similar treatment of animals to render them free of disease or to increase their economic
value or that of their products is not an invention. In the context of Section 3 (i), the Manualof Patent Office Practice & Procedure states that this provision excludes from thepatentability the followings:(a) Medicinal methods: As for example a process of administering medicines orally,or through injectables, or topically or through a dermal patch.
(b) Surgical methods: As for example a stitch-free incision for cataract removal.
(c) Curative methods: As for example a method of cleaning plaque from teeth.
(d) Prophylactic methods: As for example a method of vaccination.
(e) Diagnostic methods: Diagnosis is the identification of the nature of a medical
illness, usually by investigating its history and symptoms and by applying tests.
Determination of the general physical state of an individual (e.g. a fitness test) is
considered to be diagnostic.
(f) Therapeutic methods: The term “therapy’’ includes prevention as well as
treatment or cure of disease. Therefore, the process relating to therapy may beconsidered as a method of treatment and as such not patentable.
(g) Any method of treatment of animal to render them free of disease or to increase
their economic value or that of their products. As for example, a method of treating
sheep for increasing wool yield or a method of artificially inducing the body mass ofpoultry.

14

(h) Further examples of subject matters excluded under this provision are: any
operation on the body, which requires the skill and knowledge of a surgeon andincludes treatments such as cosmetic treatment, the termination of pregnancy,
castration, sterilization, artificial insemination, embryo transplants, treatments forexperimental and research purposes and the removal of organs, skin or bonemarrow from a living donor, any therapy or diagnosis practiced on the human or
animal body and further includes methods of abortion, induction of labour, controlof estrus or menstrual regulation.
(i) Application of substances to the body for purely cosmetic purposes is not therapy.
(j) Patent may however be obtained for surgical, therapeutic or diagnostic
instrument or apparatus. Also the manufacture of prostheses or artificial limbs andtaking measurements thereof on the human body are patentable.
Sometimes the claims are so drafted that a combination/composition of drugs incertain dosage forms is claimed, but the claimed subject-matter relates to application oradministration of individual drugs in simultaneous, sequential or concomitant manner. In
such cases, although the claims are directed to a combination/composition of drugs, but theclaimed invention resides in the method of administration of individual drugs in the said
manner and thus, it falls within the scope of section 3 (i) of the Act.
ILLUSTRATIVE EXAMPLE:
Claim: A method of monitoring drug response in a patient suffering from cancer treatedwith a combination of Gemcitabine and P1446A, comprising detection of a gene signature
with at least two drug response markers, wherein the said drug response markers are
selected from the group consisting of P21, REV3L, FGF5, PTK7, POLH, P27 and SSTR2.
Analysis: The subject-matter of claim is directed to method of diagnosis of human beings oranimals, which are statutorily barred from the patentability under Section 3 (i) of the Act.
Hence, the subject-matter of claim is not patentable.
16. SECTION 3 (J): PLANTS & ANIMALS IN WHOLE OR ANY PART, SEEDS, VARIETIES,SPECIES OTHER THAN MICROORGANISMS & ESSENTIALLY BIOLOGICAL PROCESSES ARENOT PATENTABLE SUBJECT MATTER
According to Section 3 (j) of the Act, plants and animals in whole or any part thereof
other than micro-organisms but including seeds, varieties and species and essentiallybiological processes for production or propagation of plants and animals are not patentable
inventions.
Although, microorganisms are excluded from non-patentability list, a conjoined
reading with Section 3 (c) of the Act implies that only modified microorganisms, which do
not constitute discovery of living thing occurring in nature, are patentable subject matter
under the Act.

15

Claims relating to essential biological processes of growing plants, germination ofseeds, of development stages of plants and animals shall be objected under Section 3 (j) of
the Act.
ILLUSTRATIVE EXAMPLE 1:
Claims: A therapeutic composition for treating an immune-related disorder in a mammalian
subject, the composition comprises as an effective ingredient ex vivo educated autologous
NK T cells capable of modulating Th1/Th2 cell balance toward anti-inflammatory cytokine
producing cells and optionally comprising pharmaceutically acceptable carrier, diluent,excipient and/or additive.
Analysis: The claimed subject-matter falls within the scope of Section 3 (j) of the Act for
claiming ex vivo educated autologous NK T cells in the form of therapeutic composition.
Although the claim is directed to a composition, but there is nothing like a composition; infact the educated autologous NK T cells alone would be treated as a final product, because
other ingredients are kept as optional. Just by wording a claim as a composition claim
comprising additional one or more routine ingredients (for example pharmaceutically
acceptable carriers) has no effect on the final product and it does not exclude the claim
from falling within the scope of Section 3 (j) of the Act.
ILLUSTRATIVE EXAMPLE 2:
Claim: A method of producing at least one of substantially pure hybrid seeds, plants andcrops, comprising the steps of (i) producing a male parent which is male fertile, (ii) breeding
the male parent with a female parent which is substantially male sterile, and (iii) harvesting
seeds from the female parent which contain pure hybrid seeds.
Analysis: The claimed method involves the step of cross breeding for producing pure hybrid
seeds, plants and crops. Thus, it is an essentially biological process and not allowable under
Section 3 (j) of the Act.
17. SECTION 3 (K): MATHEMATICAL OR BUSINESS METHOD OR A COMPUTERPROGRAMME PER SE OR ALGORITHMS
According to Section 3 (k) of the Act, a mathematical or business method or acomputer programme per se or algorithms are not patentable inventions. Bio-informatics isa relatively young science and has emerged from the combination of information
technology and biotechnology. Thus, the determination of patentability of inventions
relating to bioinformatics requires special attention vis-a-vis exclusions under Section 3 (k)of the Act.
ILLUSTRATIVE EXAMPLE 1:
Claim: A data processing method, wherein a first chemical substance is a compound; asecond chemical substance is nucleic acid, protein or a complex thereof; a first characteristic
amount is expressed as a vector comprised of more than one type of chemical substanceinformation of the first chemical substance; a second characteristic amount is expressed asa vector comprised of more than one type of biological information of the second chemical
16

substance; and the first characteristic amount and the second characteristic amount are
map-transformed using a multivariate analysis technique or a mechanical leaning method so
as to increase a correlation between first space expressing the first characteristic amountand second space expressing the second characteristic amount.
Analysis: The claimed invention is considered as a mathematical method or computer
programme per se in so far as that it relates to data processing of certain technicalparameters of chemical and biological substances, but does not lead to any productwhatsoever. Various references to chemical and biological substances therein are only
to the meaning of data itself and do not relate to any technical implementation
details for carrying out the methods. Hence, the subject-matter of claim falls within thescope of statutorily non-patentable inventions under Section 3 (k) of the Act.
ILLUSTRATIVE EXAMPLE 2:
Claim: A computer-assisted method of generating a compound that inhibits the glutamine
formation active site activity of a glutamine synthetase polypeptide, wherein said test
compound is capable of inhibiting the interaction between an adenylated catalytic triad siteof the glutamine formation active site and a -glutamyl phosphate intermediate, or of
inhibiting the interaction between an de-adenylated catalytic triad site of the glutamine
formation active site and a -glutamyl phosphate intermediate, the method comprising thesteps of: (a) providing a three-dimensional structure of a glutamine formation active site ofa glutamine synthetase polypeptide; and (b) designing, based on the three-dimensional
structure, a test compound capable of inhibiting the interaction between the glutamine
formation active site and a -glutamyl phosphate intermediate.
Analysis: The claimed method is considered as a mathematical method or computer
programme per se as it relates to a method of designing the inhibitory compound based on
three dimensional structures, but does not lead to a real product whatsoever. Thus, thesubject-matter of claim falls within the scope of statutorily non-patentable inventions under
Section 3 (k) of the Act.
18. SECTION 3(P): TRADITIONAL KNOWLEDGE RELATED INVENTIONS
According to Section 3 (p) of the Act, an invention which, in effect, is traditional
knowledge or which is an aggregation or duplication of known properties of traditionallyknown component or components is not a patentable subject matter.
For the examination of TK related subject matters, separate guidelines havealready been issued by the Office of CGPDTM.
ILLUSTRATIVE EXAMPLE:
Claim: Serum of pigeon possessing the anti-paralysis activity.
Analysis: The use of pigeon serum for the treatment of paralysis (as it possess anti-paralytic
activity) is a traditional knowledge in India or is an aggregation or duplication of known
properties of traditionally known component. It is clearly evident from D1 (Mahawar et al.,“Animals and their products utilized as medicines by the inhabitants surrounding the17Ranthambhore National Park, India”, Journal of Ethnobiology and Ethnomedicine, 2006,
2:46, see entire document especially Table I), which discloses the use of pigeon blood fortreating paralysis.
19. SUFFICIENCY OF DISCLOSURE, CLARITY & SUPPORT OF THE CLAIMS & UNITY OF
INVENTIONS
Section 10 (4) of the Act requires that every complete specification shall fully andparticularly describe the invention and its operation or its use and the method by which it is
to be performed. Every specification shall also disclose the best method of performing theinvention known to the applicant for which he is entitled to claim protection. A complete
specification shall end with a set of claim(s) defining the scope of invention for which
protection is sought.
As per Section 10 (5) of the Act, the claim(s) shall be clear and succinct and shall be
fairly based on the matter disclosed in the specification.
The purpose of the disclosure and the claims are not same and yet mutually
supportive. Whereas, the disclosure of the specification constitutes the essential
component of the quid pro quo of the patent system, the claims notify the public theforbidden area.
While assessing the sufficiency of disclosure, the examiner must be careful toensure that at least one method for performing the invention must be described so thatthe whole subject-matter that is claimed in the claims, and not only a part of it, must be
capable of being carried out by a skilled person in the relevant art without the burden of
an undue amount of experimentation or the application of inventive ingenuity. If theskilled person, following the directions given in the specification has to find out somethingthat is new in order to reproduce the invention, the disclosure is insufficient.
Where the claims in an application are broad and indeterminate and of a speculative
character, the claims will be treated as not supported by the description.
If the specification discloses a listing of a wide range of unrelated diseases aspotential future therapeutic or diagnostic targets of a claimed gene or the protein that it
encodes, the claims of such gene are known as Claims having laundry list. It is possible thatthe gene may play an important role in the treatment of one or more of the listed diseases;
it is unlikely that gene or its product will have a role in all of the diseases. Such claims are
generally made when the activity of the protein has not been fully characterised, andtherefore any potential uses of the protein are speculative. Even if the function of thepolypeptide has been characterised, and its association with one type of disease has been
ascertained, this is not enough to support the use of the polypeptide in the diagnosis ortreatment of numerous other unrelated diseases. Therefore, if there is no evidence in thespecification as filed that the gene or polypeptide is of therapeutic or diagnostic use in eachdifferent disease listed, then the specification is insufficient.
When claims seek to protect things that are not identified by the applicant at thetime of filing the application, but that may be identified in the future by carrying out theapplicant’s process, such claims are not patentable on the ground of insufficiency of18

description. Thus, the claims reach through to things, which are not yet identified by theapplicant.
In Raj Praksh v Mangatram Chowdhury AIR 1978 Del 1 at 9, it was observed
following Farbewerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning a
Corporation etc. Vs. Unichem Laboratories and Ors”., AIR1969Bom255: the complete
specification must describe “an embodiment” of the invention claimed in each of theclaims and the description must be sufficient to enable those in the industry concerned tocarry it into effect without their making further inventions “and the description must be
fair, i.e. it must not be unnecessarily difficult to follow”.
An insufficient complete specification cannot become sufficient because of generaldevelopments in the state of the art after the filing date. The relevant date for complying
with the requirement for sufficiency is the date of complete specification. In other words, acomplete specification should provide enough information to allow a person skilled in theart to carry out substantially all that which falls within the ambit of what is claimed.
Analogues or variants of polynucleotides or polypeptide sequences, in the form of
additions, substitutions or deletions, could extend to an almost infinite number of variants.
In such cases, the claim should be restricted to variants sharing a common specific activity
with each other that are disclosed in the specification. The said activity disclosed should not
be predictable in nature.
When DNA sequences are claimed on the basis that they hybridise with a specifically
identified probe and that they possess a certain activity, the claim will not be supported if
the hybridisation conditions are not specifically disclosed and if the skilled person needs toperform an undue experimentation to achieve the desired result.
Claims to antibodies that may have therapeutic or diagnostic potential areunsupported if a role for the target protein in a specific disease has not been identified
and proved by sufficient data.
ILLUSTRATIVE EXAMPLE:
Claim: A method comprising: (i) contacting polypeptide X with a compound to be screened
and determining whether the compound affects the activity of the polypeptide and (ii)formulating any active compound into a pharmaceutical composition.
Analysis: Any method that merely screens existing materials does not give rise to products
and claims resulting from such methods ‘reach through’ to as yet unidentified materials. In
the absence of any knowledge of any relationship, either from the specification or from
common general knowledge, the skilled person would not know how to produce and use
the compounds. It would require an undue burden of experimentation to screen undefinedcompounds for the desired activity. There will also be a lack of support where the functionof the compounds identified is not specified.

1919.1. UNITY OF INVENTION
According to Section 10 (5) of the Act, 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. In the field of gene technology it is quite common for a patentapplication to claim, a large number of polynucleotide and polypeptide sequences. This
raises problems at the various phases of the application such as publication stage,
examination especially the searching stage. In particular, it is not always clear whether
claimed sequences relate to a single invention, or to a group of inventions linked so as toform a single inventive concept.
Lack of unity may be evident in an application in the following ways:`A priori’, i.e., before consideration of prior art, if the claims falling in different
groups do not share a same or corresponding technical feature.
`A posteriori’, i.e., after a search of the prior art, if the shared technical feature fails
to make a contribution over the prior art.
Examples of a priori determination of prior art is given as herein below:
ILLUSTRATIVE EXAMPLE OF A PRIORI DETERMINATION OF UNITY OF INVENTION:
1)

2)

3)

A DNA construct for improved expression of a heterologous or homologous
polypeptide comprising: (a) isolated DNA sequence (SEQ ID NO: A) or a portion
thereof which retains promoter activity adapted for recombinant protein expression,(b) DNA sequence encoding the desired polypeptide such that said DNA sequence isin operative association with said promoter and is expressed under the control of thesaid promoter, wherein said isolated DNA sequence is a constitutive promoter for
citrate synthase (citA) gene from filamentous fungi Aspergillus niger.
A DNA construct for improved expression of a heterologous or homologous
polypeptide comprising: (a) a promoter sequence according to SEQ ID NO: B or a
portion thereof which retains promoter activity, (b) DNA sequence encoding thedesired polypeptide such that said DNA sequence is in operative association withsaid promoter and is expressed under the control of the said promoter.
A DNA construct for improved expression of a heterologous or homologous
polypeptide comprising: (a) a promoter sequence according to SEQ ID NO: C or a
portion thereof which retains promoter activity, (b) DNA sequence encoding thedesired polypeptide such that said DNA sequence is in operative association withsaid promoter and is expressed under the control of the said promoter.
Analysis: The subject-matter of claims 1-3 does not relate to a single invention, or toa group of inventions linked so as to form a single inventive concept as per Section
10 (5) of the Act. Thus, claims 1-3 contain following groups of inventions:Group-I: Claim 1 directed to a DNA construct for improved expression of aheterologous or homologous polypeptide comprising isolated DNA sequence (SEQ ID
NO: A),

20

Group-II: Claim 2 directed to a DNA construct for improved expression of aheterologous or homologous polypeptide comprising isolated DNA sequence (SEQ ID
B) andGroup-III: Claim 3 directed to a DNA construct for improved expression of aheterologous or homologous polypeptide comprising isolated DNA sequence (SEQ ID
NO: C).
Upon examination, it is found that the DNA sequences as described SEQ ID NO: A, B
& C do not share any common structural feature. Therefore, as there is no special technicalfeature, which could serve as basis for unifying the above-said groups of inventions, each ofthese groups has to be considered as a separate invention. Thus, these three groups are said
to lack unity a priori.
ILLUSTRATIVE EXAMPLE OF A POSTERIORI DETERMINATION OF UNITY OF INVENTION:
1)

2)

A composition comprising a combination of X and Protein Y to identify a gene forprostate cancer, wherein X is selected from a group of hetero-cycles as depicted informula 1 [Formula 1 given]
A composition comprising a combination of X and Protein Z to identify a gene forprostate cancer, wherein X is selected from a group of hetero-cycles as claimed inclaim 1.
Analysis: Claims 1-2 contain the following inventions or group of inventions, which
are not so linked as to form a single general inventive concept as required u/s 10 (5)of the Patents Act, 1970 (as amended):Group I: Claim 1 drawn to a composition comprising a combination of X and Protein Y
to identify a gene for prostrate caner, wherein X is selected from a group of heterocycles as depicted in formula 1.
Group II: Claim 2 drawn to a composition comprising a combination of X and Protein
Z to identify a gene for prostrate caner, wherein X is selected from a group of heterocycles as claimed in claim 1.

The above said groups are linked by the technical feature “X”. Upon prior art search,
it is found that “X” is already known in the prior art. Thus, this feature is not a special
technical feature, because it does not constitute advancement over the prior art. The unityof invention is treated to be fulfilled only when there is a technical relationship among
inventions involving one or more of the same or corresponding special technical features.
Thus, claims 1 & 2 failed to meet the requirements of Section 10 (5) of the Act.
Consequently, the application may be objected for lacking unity a posteriori.
20. DEPOSIT OF BIOLOGICAL MATERIAL
If the invention relates to a biological material which is not possible to be describedin a sufficient manner and which is not available to the public, the application shall becompleted by depositing the material to an International Depository Authority (IDA) underthe Budapest Treaty. The deposit of the material shall be made not later than the date of21

filing of the application in India and a reference of the deposit shall be given in thespecification within three months from the date of filing of the patent application in India.
All the available characteristics of the material required for it to be correctly identified orindicated are to be included in the specification including the name, address of thedepository institute and the date and number of the deposit.
Depositary Authorities: Reference to IDA under the Budapest Treaty under Section
10 (4) should be read with Section 2 (1) (aba) of the Act.
21. BIODIVERSITY RELATED ISSUES
It has been discussed in the beginning that biodiversity related matters play a vitalrole in the patentability of the biological substances. The Biological Diversity Act, 2002
provides mechanism for conservation of biological diversity, sustainable use of its
components and fair and equitable sharing of the benefits arising out of the use of biologicalresources, knowledge and for matters connected therewith or incidental thereto.
In order to prevent misappropriation of biological resources and traditional
knowledge of India, the Biological Diversity Act requires that access to the biologicalresources of India is subject to the equitable benefit sharing through the approval of
National Biodiversity Authority (NBA). No Intellectual Property Rights (IPRs), including
patents based on research or information on biological resources obtained from India shallbe granted without the approval of the NBA.
The Patents Act provides interfaces with the process of obtaining patents and accessto and benefits sharing from utilization of Indian biological resources. Thus, disclosure of thesource and geographical origin of a biological material used in an application for a patenthas been made mandatory as per Section 10 (4) of the Act. Also, Section 3 (p) of the Act
prohibits patenting of any invention which, in effect, is traditional knowledge.
With respect to the patenting of inventions related to traditional knowledge andbiological material obtained from India, the instructions issued by the Controller General Of
Patents, Designs and Trademarks should be strictly followed.
[End of document]22