Annual Meeting of American Intellectual
Property Law Association (AIPLA), 2011
Biotechnology Patenting in India and Related
Issues
May 13, 2011
San Francisco
Rajashree Sharma
Partner-Corporate Law Group
1
New Delhi, India
Roadmap
1.
Introduction
2.
Evolution of Indian Patents Act
3.
Biotechnology & Scope of Patent Law in India
4.
A summary overview on biotechnology patenting activity
in India
5.
Biotechnology Patent Prosecution: Guidelines & Basic
Considerations
6.
Patentability of Biological Material (s)
7.
Patentability of Micro-organism (s)
8.
Patent law and Conservation of Biological Diversity
(CBD)
9.
Patent law and Traditional Knowledge
10.
Biotech patent jurisprudence in India
2
11.
Conclusion
1. Introduction
 Biotechnology is a culmination of human intervention and
natural processes
 Ever since a genetically engineered micro-organism was
granted patent, the field of biotechnology gained enormous
significance
 Evolution of patent law on biotechnology dates back to
seventh century
 Global adoption of the patent system started in Venice as
the first patent law was enacted in 1494
 The requirements enshrined in the Venetian Statute such
as utility, novelty and non-obviousness are still the basis of
modern patent law around the world
Cont….
3
Introduction
 Under the patent regime around the world the significance
of biotechnology and its inventions are recognized and
protected
 The TRIPS-level patent protection is an incentive
mechanism to enhance biotechnology innovation in India
 Patent protection on novel biotechnology products can be
obtained by prosecuting the patent applications in an
articulate manner
 The trend of filing biotechnological patents in India has a
steady growth
2007-08-2774
2008-09 -1884
2009-10-2700
4
2. Evolution of Indian Patents Act

British rulers enacted the first ever patent law in Indiathe Act VI of 1856 based on the British patent law of 1852

Consolidated Indian Patents and Designs Act, 1911 was

enacted after several modifications in 1859, 1872 and
1888.
The Patents Act 1970 was enacted highlighting
universally accepted requirements of patentability such as
novelty, inventive step and industrial application.

The Indian Patents Act, 1970. The patents granted under
the Act are operative in the whole of India.
Patents Act, 1970
1999
2002
2005 (product)
Patents Rules, 2003
Amended in
2005
2006
5
3. Biotechnology & Scope of Patent Law in
India
 Indian patent practice and jurisprudence with respect to
the patenting of biological materials are relatively new
and thus not so well settled and/or uniform.
 The Indian Patents Act, 1970 as in force, does not
describe, in an inclusive manner, what is patentable
u n d e r b io t e c h n o l o g y d i s c i p l in e . R a t h e r , S e c t io n 3
includes a list of inventions considered not patentable.
 Additional hurdles like mandatory disclosure of biological
material, prior approval from the Biodiversity Board and
access & benefit issues under the Indian Patent regime exist.
Cont…..
6
Biotechnology & Scope of Patent Law in
India

a.
b.
c.
d.
e.
Apart from TRIPS consisting criteria, Indian patent law
has a long list of exceptions to patentability
e.g., frivolous, simple combination of known elements;
methods for curative & prophylactic treatments;
traditional knowledge considered as not patentable
New requirement: not found in TRIPS - New use of a
known substance considered non-patentable. Salts, Esters,
ethers, Polymorphs, Metabolites, Pure form, Particle size,
Isomers, mixtures of isomers, complexes, composition,
derivatives too are considered non-patentable ‘unless
they differ significantly in properties with regard to
efficacy’ or if they ‘do not result in the enhancement of
known efficacy of the substance’
New requirement: not found in TRIPS - mere admixture
– e.g., root-nodule bacteria of leguminous plants, use in
combination does not improve natural functioning
non disclosure of origin and source of biomaterial 7
widens the scope of grounds for opposition and revocation
4. A summary overview on biotechnology
patenting activity in India



Mostly foreign application, however considerable increase
in Indian applications
To translate the discovery into a patentable subject
matter, the discovered component must be substantially
changed through human intervention into a form in which
it does not occur in nature, or employed in a process
resulting into technical advancement and/or economic
significance
Inventions filed for grant of patent recombinant DNA molecule,
recombinant vaccine, monoclonal antibodies, recombinant therapeutic
molecules, diagnostic kits, recombinant vectors, Isolated Nucleic acid
encoding a gene, Method of preparation of recombinant hormones, DNA
related inventions such as preparing plasmids, vectors etc, bioleaching,
biotransformation, biological treatment of waste, gene and somatic cell
therapy, pluripotent stem cells derived from regenerative tissue,
recombinant microbes expressing chimeric HIV protein, regulation of
cell mediated immune response, recombinant interleukin IL-18
inhibitors, plastid transformation vectors, Waste water and sewage
treatment using microorganism, conjugate vaccine against cholera and
tetanus, peptide based immunotherapy for atherosclerosis, mixed cell
8
gene therapy, bone regeneration by gene therapy and treatment
of
flower.
I. Non-Patentable Inventions








Ordre public and morality exception - Section 3 (b)- .
As per the section an invention would not be
patentable if it is immoral or against public order,
harmful to human, animal or plant life or harmful to
environment.
Discovery of living things or non living substances in
nature - Section 3 (c)
Plants and animals in whole or any parts thereof other
than micro-organisms but including seeds, varieties
and species - Section 3 (j)
Essentially biological processes for the production or
propagation of plants and animals– Section 3 (j)
Any Process for the medicinal, surgical, curative,
prophylactic, diagnostic or therapeutic or other
treatment of human beings or animals to render them
free of disease or to increase their economic value or
that of their products – Section 3(i)
New use or new property of known substance –
Section 3(d)
Methods of agriculture or horticulture – Section 3(h)
Traditional knowledge – Section 3(p)
9
II. Patentable Inventions
 Modified Microorganism and process therefor.
 Isolated nucleic acids encoding gene, first time isolation of
a molecule; novel peptides, peptide analogs, proteins,
vaccines, antibodies, Primers, and cDNA
 Recombinant:
DNA,
RNA,
Amino
Acids,
antibodies, oligonucleotides, primers, and genes, and
Process therefor;
 DNA related inventions such as preparing plasmids,
vectors etc.;
 Composition/formulation thereof.
 Bioprobes, Biosensors
 Diagnostic/Equipment kits, Research Tools
 Cell lines-A cell line is patentable if artificially produced
 Hybridoma technology: patents are also allowed on
hybridoma technology, but not on protoplast fusion (on
ethical issues).
 Expressed sequence tags (ESTs), can be patented if it has a
use, such as if it works as a probe
Cont…..
10
II. Patentable Inventions
 Methods of enzyme Purification.
 Environment cleaning using biological materials such as
solid or liquid waste (industrial/domestic) treatment, water
treatment, mitigation of air pollution, bio-remediation.
 Treatment of plants.
 Process for preparing product using modified or known
organism (extraction, fermentation etc.)
 Biological material such as rDNA, plasmids are patentable
provided they are produced by substantive human
intervention
 Processes for producing chemical and biological substances
using microorganisms including lower plants and animals
are patentable
11
5. Biotechnology Patent prosecution:
Guidelines & Basic Considerations
 No formal bio-guidance with regard to biotechnological
patent application
 Some reference in Manual of Patent Practice and Procedure
(MPPP) is there however inadequate
 No mention of gene or DNA in the Patents Act 1970.
 The biological material such as recombinant DNA, plasmids
and processes of manufacturing thereof are patentable
provided they are produced by substantive human
intervention
 Gene sequences, DNA sequences without having disclosed
their functions are not patentable for lack of inventive step
and industrial application.
 Cloning human beings or animals, processes for modifying
the germ line, genetic identity of human beings or animals,
uses of human or animal embryos for any purpose are not
12
patentable as they are against public order and morality
Cont……..
5. Biotechnology Patent prosecution:
Guidelines & Basic Considerations
 During prosecution, the establishment of the biological
function of a biotech invention, it is preferable to include
biological experimental data / efficacy data – both in vitro
as well as in vivo to support the efficacy of a claimed
invention over the prior art
 The specific sequence IDs of the genetic material being
claimed must have been described sufficiently in the
accompanying description so as to enable a person skilled
in the art to identify and work upon such material
(submission of SEQ ID in electronic as well as in paper
form is also mandatory). Insufficient disclosure as well as
enablement objections could be raised.
 Additionally, the reference to more than one SEQ IDs
requires establishing unequivocally that more than one
sequence of IDs is so correlated with another that they
constitute a single inventive concept.
13
Cont……
5. Biotechnology Patent prosecution:
Guidelines & Basic Considerations
A. Types of Objections Raised under First Examination report

Objections relating to non compliance of criteria for
patentability such as lack of novelty and/or obviousness;
community/folklore knowledge available, non-sufficient
disclosure; non-compliance of Biological Diversity Act
requirements; lack of functional aspects and information
required under Section 8 of the Act
B. Few Examples of Objections Raised Generally

Claims do not sufficiently define the invention;

Distinguishing features as compared to prior art given are not
clear;

Disclosure is insufficient;

SEQ should be filed in electronic form;

Claims fall under section 3(i);

Claims fall under section 3(j).

Obtaining permission from NBA

Disclosure of deposition of biological material used in the
invention

Invention that falls under 2(1)(j)

Use claims (generally not considered, need skilful wording14
).
Cont..
5. Biotechnology Patent prosecution:
Guidelines & Basic Considerations
C. Some examples of allowed claims in biotech inventions

Novel Modified Microorganism:-The present invention
relates to a modified microorganism comprising a mutation
that disrupts the expression of the nucleotide sequence
defined herein as SEQ ID No. 15. It also relates to bacterial
genes and proteins, and their uses. More particularly, it
relates to their use in therapy, for immunization and in
screening for drugs.

Nucleic Acid Molecule:-A nucleic acid molecule comprising
a sequence of nucleotides that encodes an HPV31 L1
protein as set forth in SEQ ID No. 4, the nucleic acid
comprising sequence of nucleotides as set forth in SEQ ID
NO: 2 or SEQ ID NO. 3 wherein the sequence being codonoptimized for high level expression in a yeast (P-237941)

Cell Line:-A method of producing human oral cancer cell
line which comprises ……….
15
5. Biotechnology Patent prosecution:
Guidelines & Basic Considerations
D. Some examples of rejected claims in biotech inventions
 Claims related to Methods for identifying tumors that are
responsive to treatment with anti-ErbB2antibodies. After
determination that the patient suffers from cancer (such as,
Castration- Resistant Prostate Cancer-CRPC or ovarian cancer)
that is positive for HER2 phosphorylation, the patient will
receive a loading dose of 840 mg of rhuMAb 2C4 on day 1 of
cycle 1 (first 21-day treatment period), followed by 420 mg on
day 1 of each subsequent 21-day cycle, as continuous intravenous
infusion. Applicant submitted that improvement lies in new
amounts of rhuMAb (420 and 840 mg)

The controller refused the application under section 3(d)
(new use of known substance) as being dosage and 3(i)
method of treatment that the said MAb are already known
16
as described in the description.
6. Patentability of Biological Material (s)
(Disclosure and Enablement Requirements) Section 10(4) of the
Patents Act, 1970 (as in force)
If the invention mentions a new biological material in the
specification and such material is not available to public, the
applicant has to deposit said biological material in the
International Depository Authority recognized under
Budapest Treaty before filing of the application.
 DEPOSITORY NO.
 SEQ
 Functional aspects of biologics for ex. application /
use of biologics Source of material (in case generic
material is not used)*
 Geographical origin (in case generic material is
not used)*
 CBD compliance [prior approval of NBA is
necessary for applying for patent and for material
transfer
(* The disclosure is mandatory only if any specific material imparting the
specific property is required to work the invention. In case the material
such as proteins/peptides/amino acids prepared synthetically can substitute
17
the live material to work the invention, appropriate statements may be
.
7 Patentability of Micro-organism (s)

Microbiological inventions include new products,
processes, uses and compositions involving biological
materials

Inventions cover methods to isolate and obtain new
organisms, improve their character, modify them and
find their new and improved uses.

New micro-organisms isolated for the first time from
the natural surrounding can only be patented if they
differ in character from the known micro-organisms
and find a new or improved use or function. Claims to
micro-organisms have been allowed on the grounds that
they are the products of micro-biological processes

In the Dimminaco AG vs. Controller of Patents, the
Calcutta High Court held in 2002 that a patent on a
micro-organism is valid. The court ruled that the Act
did not preclude a living end product from being
patented. As a result, a large number of patents have
18
been granted to microorganisms since then
8. Patent law and Conservation of Biological
Diversity
ABS Issues & Biotechnology Patents

Mandatory disclosure in patent application of source and
geographical origin of biological material and traditional
knowledge used in invention(S.10(4)(d) of Indian Patents
Act, 2005

Amended Patents Act also provides for pre-grant
opposition and revocation of granted patents of grounds
of non-disclosure or wrongful disclosure of source or
geographical origin of biological resources
and
traditional knowledge (S.25(1) & S.64)

NBA’s prior approval is required before seeking patent
based on biological material and TK obtained from India
Sec 6(1).

Gate - keeping in accessing biological resources

ABS provisions in Biodiversity Act, 2002. Several
19
guidelines have come up from time to time w.r.t. ABS.
9. Patent law and Traditional Knowledge
 Section 3(p) excludes from patentability “an invention
which, in effect, is traditional knowledge or which is an
aggregation or duplication of known properties of
traditionally known component or components.”
 disclosure requirements mandate inclusion of the source
and geographical origin of biological material used in the
claimed invention, and interested parties may oppose or
petition to revoke an Indian patent on the ground that the
invention claimed therein is anticipated “having regard to
the knowledge, oral or otherwise, available within any
local or indigenous community in India or elsewhere . . .
 Access to its the online database contains translations of
manuscripts and textbooks in five languages Traditional
Knowledge Digital Library (TKDL), that contains
translations of manuscripts and the online database
textbooks in five languages
Cont……
20
Patent law and Traditional Knowledge
A.
Prior art & enablement

The TKDL allows examiners to compare
applications with existing traditional knowledge

New patent applications need to demonstrate significant
improvements and inventiveness compared to prior art in
their field. If the medical use of an herb is a traditional
practice, and thereby public knowledge, it is considered
prior art under regulations.

The patent applicant may still be granted a patent on a
new method for industrial-scale production of the active
ingredient of the herb, for example, if this process is new
and inventive
patent
example-jeevani, a medicine based on the traditional
medicinal knowledge, an extract of arogyappacha plant
[Trichopus zeylanicus]
21
10. A. Biotech patent jurisprudence in India
Dimminaco AG v Controller of Patents and Designs

Dimminaco AG filed a process patent application for a
vaccine for infectious bursitis in poultry. It claimed a
lyophilized microorganism

Application rejected on the grounds: the vaccine
involved processing of certain microbial substances;
this was only a natural process devoid of any
manufacturing activities

On appeal, the Calcutta high court considered the
dictionary meaning of
“manufacture” and
“substance” and reversed the decision passed by the
controller.

The Court held that law does not bar processes where
the end-product is living
cont
…
22
10. A. Biotech patent jurisprudence in India
Dimminaco AG v Controller of Patents and Designs

No statutory bar to accept a manner of manufacture as
patentable even if the end product contains a living
organism.

One of the common test is vendibility test (In other words
the product should be a commercial entity)

The MPPP states that a “living entity of artificial origin
such as micro-organism, or vaccines are considered
patentable

This landmark judgment opens up new opportunities for
obtaining patents related to live microorganisms subject to
fulfilling basic criteria for patenting
23
cont…..
Biotech patent jurisprudence in India
B. Speaking Roses International Inc. vs. Controller-General of
Patents And Anr.
 Speaking Roses international Inc., had on September 19,
2002, applied for a patent for “providing an image on an
Organic Product, being flowers”
 The first ground of rejection was that the application was in
contravention of Section 3(j) of the Patents Act, 1970. As
per sub-clause (j), such exclusion extends to “Plants and
animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and
essentially biological processes for production or
propagation of plants and animals.
 The court held that the patent sought was not for any
flowers or organic products, but for providing an Image on
an organic product. Hence it was not a plant that was being
sought to be patented.
 Image was to be created by a mechanical process and not a
biological one. Therefore, the claim did not fall within the
24
scope of the aforesaid Section3(j).
Patent grant Procedure
FILING OF APPLICATION
PROVNL. / COMPLETE
PUBLICATION OF APPLICATION
REQUEST FOR EXAMINATION
EXAMINATION-ISSUE OF FER
Early publication on request
• WITHIN 48 MONTHS FROM filing date
3rd Party Representation
• ALL OBJECTIONS TO BE COMPLIED WITHIN 12
MONTHS
GRANT OF PATENT
• WITHIN 12 MONTHS
OPPOSITION
Decision of
Controller
Appeal
Appellate Board
Revocation/Amendment
25
11. Conclusion

The patenting of biological material are relatively new to
India.

Standardized practice has yet to be satisfactorily
established with respect to patenting or non-patenting of
biological inventions

If a claim of an invention is related to a novel and
inventive and modified genetic material, wherein such
genetic material is identified by its protein or amino acid
sequences at least in the description and in the claims,
such genetic material is capable of industrial application,
then the Patent Office generally accepts such invention as
patentable

Inventions are subject to the fulfillment of the relatively
broad criteria.

Patenting of biological material in India is still decided on
a case-by-case basis.
cont…..
26
11. Conclusion

India’s post-TRIPS patent laws include certain provisions
to make biotechnology patenting more attractive

The allowable claims disclosed in the preceding slide that
the biotech patent can be obtained in diverse areas
provided

To grant a patent the description/enablement
requirements be complied with and prosecute articulately.

India being one of the bio-diversity rich countries, it would,
thus, be prudent to reap the due benefits from its rich bioresources with an enabling provision for patent protection
in biotechnological innovations and inventions
27
THANK YOU FOR YOUR
ATTENTION
Ms. Rajashree Sharma
Partner
CORPORATE LAW GROUP
1101-1104, Kailash Building, 26,
Kasturba Gandhi Marg, New Delhi-110001
Tel : 91-11-43621000 (100 Lines) Extn. 208
Mob : 91-11-9811882548
Fax : 91-11-23357721
www.clgindia.com
28
Amendments of use & treatment claims
HEPATITIS C VIRUS VACCINE
PATENT NO. 218516
1. Original claims were 59. During prosecution we deleted certain
claims and merged and amended Use/ treatment claims in to 1
claim and restricted the claims to 19 only. Further, with the help of
omnibus claim we covered a novel nucleic acid and a
pharmaceutical composition thereof substantially as described in
the specification with reference to examples, drawings and sequence.
2. A nucleic acid as claimed in preceding claims and a pharmaceutical
composition thereof is useful for treating or preventing HCV
infected subjects.
Claims amended in appln. for vaccines for staphylococcal infection
3. A pharmaceutical composition, comprising protein as claimed in
previous claims in an effective amount in the range of 1 to 1000 µg
preferably to 5 to 500 µg and more preferably 10 to 100 µg and
pharmaceutically and physiologically acceptable carrier to be used
as a vaccine in managing Staphylococcal infections.
4. A vaccine comprising of protein of amino acid sequence of SEQ ID
No: 3,4, or 5, a method for producing the same and the
pharmaceutical composition thereof useful for managing
staphylococci associated infections substantially such as herein29
described.
Response to the objection on biological
material
A VACCINE FOR STAPHYLOCOCCAL INFECTION
PATENT NO. 232694


Objection
In page 8 of the complete specification you have
mentioned the accession number of the protein but have
not mentioned the date anywhere as u/s 3 (p) and 10(4) (d)
you have to mention the date of accession within the
prescribe time and also mention with u have obtained
permission from NBA for the material claimed.
Response
With regard to your fresh objection raised vide your mail
dated February 20, 2009, we humbly wish to submit that
according to Section 10 (d) (ii), the application shall be
completed by depositing the material to an international
depository authority if the applicant mentions a biological
material in the specification which may not be described
in such a way as to satisfy clause (a) and (b), and if such
material is not available to the public. We feel that the
protein should not be considered as biological material for
depositing as such. Moreover, in view of the disclosure
30 of
SEQ, the requirement may be considered as complied
Table Depicting Some of the Biotech Patents Granted in India
PATENT
NO
APPLICATION
NO
PATENTEE
TITLE
236079
370/MUM/2004
Reliance Life
Sciences Pvt.
Ltd.
Method for synthesis of human
recombinant insulin with improved
process efficiency
231288
168/MAS/1999
Indian Institute
of science
A method of treating sunflower
plants
228492
1882/DELNP/2004
Pfizer Products
Inc.
"Polynucleotide molecule
comprising a nucleotide sequence
that is the streptomyces avermetilis
avec allele
228182
2554/CHENP/2005
Monsanto
Technology LLC.
DNA constructs and methods to
enhance the production of
commercially viable transgenic
plants
218516
740/CHENP/2004
Istituto di
Ricerchi di
Biologia
Molecolare
P. Angeletti spa
Hepatitis c virus vaccine
213334
423/MUMNP/2004
N-ZYME
BIOTEC
GMBH
Method for production of
recombinant proteins in
31
microorganisms
Table Depicting Some of the Biotech Patents Granted in India
213289
826/MUM/2002
Cadila
Healthcare
Limited
Recombinant DNA molecule
encoding a novel human
interferon alpha 2b like
polypeptide method for producing
it in pichia and its use
208063
IN/PCT/2001/58/C
HE
Novo Nordisk
A/S
A method for preparing a yeast
strain
199578
566/DEL/2002
University of
Delhi
A process of obtaining
recombinant lambdoid
bacteriophage and the resultant
novel phage display
system"
210988
IN/PCT/2001/01140
/MUM
Meristem
Therapeutics
Chimeric expression promoters
originating from
commelina yellow mottel virus and
cassava vein mosaic
virus
235741
1274/DEL/2002
DBT
A pair of oligonucleotide primers
for specific
amplification of the hupb gene of
mycobacterium species"
Biointex
Composition for use against one or
more pathogens able to cause32
diseases to vegetal material/plant
246612
507/MUMNP/2007
Table Depicting Some of the Biotech Patents Granted in India
218518
1353/CHE/2004
227691
3456/DEL/2005
224221
183/MUMNP/2004
243799
246347
96972
Kerala Forest
Research
Institute
"Biofertilizer cum
biofungicide/biobactericide
composition b5"
Speaking Roses
International
Inc.
Providing an image on an organic
product, wherein the organic
product is plant, flower, fruit or
portion thereof.
Lee, Young-Min
genetically stable jev cdna based
on Japanese encephalitis virus
(jev)"
All India
Institute of
Medical
Sciences
oligonucleotides for detection of
Leishmaniasis and methods
thereof"
The Maharaja
Sayajirao
University Of
Baroda
improvements in or relating to the
purification of sewage and like
organic wastes by employment of
activated sludge
33
1908/delnp/2005
1598/del/2003
96972
A bio-pesticide based on
nucleopolyhedrovirus for the
management of teak pest hyblaea
puera