PhD Coursework for Life Science 2017

1. IP & Life Science Innovations
Dr. Sabuj Kumar Chaudhuri
DLIS, University of Calcutta
Email>>>sabujkchaudhuri@gmail.com
Web>>> http:// www.sabujkc.webs.com
20 December 2017 1

2. Disclaimer
I am not lawyer. I can not give
you any legal advice
20 December 2017 2

3. What is Creativity ?
20 December 2017 3

5. • Myth #1: Only some people are
creative
• Myth #2: Only certain kinds of
ideas are creative

6. Four Creative Diversity
Principles
• Creative Diversity Principle
#1: All people are creative.
• Creative Diversity Principle
#2: Creativity is diverse.
• Creative Diversity Principle
#3: Creative diversity is
described by four key
variables:
1. Creative level
2. Creative style
3. Motive
4. Opportunity
• Creative Diversity Principle
#4: There is no ideal kind of
creativity.

7. Discovery Vs Invention
December 20, 2017 7

8. Invention & Innovation
20 December 2017 8

9. 20 December 2017 9

10. Creativity protected by IP:
From Morning to Night
December 20, 2017 10

11. Journey through the Valley of Death
20 December 2017 11

12. 20 December 2017 12
Creation of New Idea (Invention)
Conceptualization of New Idea
(Decision to innovate) (many
stages)
Valley ofDeath
Commercialization of New Idea
(Innovation)
Diffusion in the Society

13. 20 December 2017

14. Creating a Climate of Invention & Innovation
20 December 2017 14

15. Primary Players in Global innovation
20 December 2017 15
India’s Position in GII, 2016 is 66th. It was 81st in 2015

16. 20 December 2017
Science of Innovation

17. Who is Leading Innovation ?
20 December 2017

18. Should you protect your
invention ?
20 December 2017 18

19. Inventors Should protect their
inventions
20 December 2017 19

20. Why IP is required ?
• To protect your Creativity / Invention
• To get an economic return on funding
invested in R & D
• To get a reward or recognition as it is the
fruit of your hard labour, effort and time
• To own your invention/creative works
• To create of an intellectual asset for
licensing or selling
• To deter others from using your
invention20 December 2017 20

21. IPR as an Umbrella
Protecting your Creativity
20 December 2017 21

22. What happens if you do not
protect your inventions?
• Somebody else might
patent them
• Competitors will take
advantage of your
invention
• Possibilities to license, sell
or transfer technology will
be severely hindered
• Time, effort, labour will be
lost
• Funders will be
discouraged
20 December 2017 22

23. IPR or Trade Secret ?
20 December 2017 23

24. Patent Vs Trade Secret
20 December 2017 24

25. Few Basic Concepts
• Property Tangible
• Different understandings Intangible
• Intellectual property (IP)
• Intellectual Property Rights
(IPR)
20 December 2017 25

26. IPR
Industrial Property
Patent
Industrial Design
Trademark
Geographical Indications (GI)
Utility Models
Undisclosed information, including trade secrets
and test data
Artistic & Literary Property
Copyright
Sui generis System (“Latin Word means “of its own kind”)
Database
Integrated Circuit
Plant Breeders’ Right (PBR)
CLASSIFICATION OF IPR
20 December 2017 26

27. Rationale of Patent
20 December 2017 27

28. What is a Patent ?
A grant by a government
to an inventor or his assignee
conferring upon a right to exclude others
from making ,using, selling,offering for
sale and importing his invention
for a limited period of time
in lieu of the disclosure of the invention in
a patent specification.
20 December 2017 28

29. Each type of protection and
what it protects
• Patents (utility/design) . . . protect . . . Inventions
• Trademarks . . . protect . . . Identifying Signs & Symbols
• Designs . . . protect . . . Ornamental Design of Product
• GIs . . . protect . . . Identifying place names with product
• Trade Secrets . . . protect . . . Confidential Information
• Copyrights . . . protect . . . Creative Expressions of Creators
• PBRs . . . protect . . . DUS plant variety
• IC layout designs . . . protect . . . Original design of IC
• Databases . . . protect . . . Uniqueness of database20 December 2017 29

30. Rights of patentees:- Under
Section 48
• The patentee has exclusive right to
prevent an unauthorized person from
:- * making * using
– * selling * offering for sale,
or
– * importing
• the patented article or process.
20 December 2017 30

31. Nature of a patent
• Creation of human Intellect
• Patent is a negative right
• Intangible property
• Exclusive rights given by the Govt.
• Comes with limitations and exceptions
• Both product and process patents are
allowed
• Time-bound (20 years)
• Territorial
There is no international20 December 2017 31

32. Components of a Typical Patent Document
Bibliographic Information
+
Text with Claims
+
Drawings
A patent application is made for one
invention only (UNITY OF
INVENTIONS).
Multiple inventions need multiple patent
applications.20 December 2017 32

33. Bibliographic Information
• Country of
publication
• National Patent
Classification
• International Patent
Classification
• Title
• Abstract
• Inventor
• Applicant
• Application no.
• Serial No.
• Date of Application
• Priority date
• Priority No.
• Priority Country
• Reference cited by
Examiner
20 December 2017 33

34. Claims
20 December 2017 34

35. Claims
• define the territory of protection
• Claims are generally 2 types
• Independent Claim or Main Claim
• Dependent Claims
• – Claims narrow enough to avoid prior
art
– Claims broad enough to hamper
design around
If any of the claims is infringed the
whole patent is infringed
20 December 2017 35

36. Specification/Disclosure
• Provisional
specification
• Complete
specification
20 December 2017 36

37. Provisional Specification
• Should be filed as soon as
inventive idea comes in mind
• Changes in Provisional
Specification is possible through
post dating of application but in that
case priority date is also shifted.
20 December 2017 37

38. Advantages of Provisional
Specification
• To get Priority for invention
• Get extra time for further developments
• Disclose to interested person to obtain
financial support
• Explore commercial feasibility
• Avoid further expenses if no commercial
feasibility
20 December 2017 38

39. Field of invention
Trespassers will be prosecuted
Alternative path
20 December 2017 39

40. Field of invention
Trespassers will be prosecuted
Alternative path
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Royalty,
Licensing,
and
Agreements
IDEA
20 December 2017 40

41. Field Of Invention: Patent Ecology
20 December 2017 41

42. Your Invention
20 December 2017 42

43. Function of A Specification: establish your invention in the existing
patent ecology
20 December 2017 43

44. Criteria to get a Patent
Novelty
Inventive
Step
Industrial
Application
Deposition of Microorganisms
to an IDA
Patent
20 December 2017 44

45. Two IDAs in India
• International Depositary
Authority Microbial
Culture Collection
(MCC) National Centre
for Cell Science (NCCS)
University of Pune
Campus, Ganeshkhind
Pune-411007,
Maharashtra
• International Depositary
Authority Microbial Type
Culture Collection and
Gene Bank (MTCC)
Institute of Microbial
Technology (IMTECH)
Council of Scientific and
Industrial Research
(CSIR) Sector 39-A
Chandigarh - 160 036
(Union Territory)
20 December 2017 45

46. 20 December 2017 46

47. Patents on 7 Life Science
Breakthroughs
20 December 2017 47

48. Contd...
Aspirin Warfarin
20 December 2017 48

49. Contd...
Streptomycin Tagamet (Cimetidine)
20 December 2017 49

50. Contd...
Zantac (Ranitidine) Losec (Omiprazole)
20 December 2017 50

51. Contd...
Polymerase Chain
Reaction (PCR) Oncomouse
20 December 2017 51

52. First Patent on A Life Form
Louis Pasteur
US Patent No.-141072 dated
July 22, 1873
20 December 2017 52

53. First Patent on a Genetically Modified
Microorganisms
First patent to Ananda Mohan Chakrabarty for a
genetically modified Pseudomonas bacterium that
would eat up oil spills.
US Patent No. 4259444
20 December 2017 53

54. Plants
In 1930, the United States
began granting patents for
plants and in 1931, the first
plant patent was issued to
Henry Bosenberg for his
climbing, ever-blooming rose
by the USPTO (Patent No.-
PP00001 dated 18th August,
1931). Under patent law, the
inventor of a plant is the
person who first appreciates
the distinctive qualities of a
plant and reproduces it
asexually.20 December 2017 54

55. Did you ever think of IPR behind the
Roses you receive on Valentine's Day ?
20 December 2017 55

56. Animals Researchers at Harvard Medical
School in the early 1980s produced
a genetically modified mouse
(oncomouse) that was highly
susceptible to cancer, by introducing an
oncogene that can trigger the growth of
tumors. Harvard College sought patent
protection in the United States and
several other countries. The USPTO in
12th April, 1988 granted a patent no.
4,736,866 to Harvard College claiming
"a transgenic non-human mammal
whose germ cells and somatic cells
contain a recombinant activated
oncogene sequence introduced into
said mammal.”
20 December 2017 56

57. Harvard’s oncomouse
20 December 2017 57

58. Nature Inspired Patent-Velcro
( "velvet" and "crochet)
Common Cocklebur
(Xanthium strumarium)
Burrs clung to dog
Georges de Mestral, a Swiss engineer formally
patented it in 1955
20 December 2017 58

59. Velcro Patent in USPTO in 1955
20 December 2017 59

60. Inventing Velcro...
20 December 2017 60

61. Things to Remember for Life Sc. Patents
1. Reference to such biological material shall be
made in the specification within 3 months from
the date of filing
2. Further, the source and geographical origin of
the biological material specified in the
Specification shall also be disclosed.
3. Approval obtained from Biodiversity Authority,
wherever applicable.
4. Accession number of IDA and other details of the
depository are given, if applicable
5. DNA sequence listing (in electronic form only)
shall be mentioned at appropriate place in the
specification.
20 December 2017 61

62. Legal Frameworks for Life Sciences & IPR
• The Convention on Biological Diversity (CBD) in
1992,
• The Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS) in 1994,
• Union Internationale Pour La Protection Des
Obtentions Vegetales” (UPOV- International
Convention for the Protection of New Varieties of
Plants) (1961),
• The Budapest Treaty on the International
Recognition of the Deposit of the Micro-organisms
for the Purposes of Patent Procedures (1980)
20 December 2017 62

63. Before Biodiversity Act, 2002
• Unprotected flow of
knowledge from
gene-rich India to
capital rich west, and
protected flow in
reverse direction
(Read Patented)
• Agrobiodiversity
loss, genetic
erosion, loss of
traditional varieties
20 December 2017 63

64. Biodiversity Act, 2002 &
Biological Resources
• “Biological Resources”
means plants, animals
and microorganisms or
parts thereof, their
genetic material and by-
products with actual or
potential use or value
does not include human
genetic material [Chapter
I Clause 2(b) and 2(c)].
20 December 2017 64

65. Protection of Plant Varieties
and Farmers’ Right Act 2001
(PPV&FR Act)
20 December 2017 65

66. Plant Breeders’ Rights (PBR)
• Criteria for obtaining PBR- DUS
Distinct from the existing,
commonly known varieties,
Uniform or sufficiently
homogenous and
Stable (i.e. subsequent
plantings of the variety
must demonstrate the
same characteristics as the
parent crop).
Total 2892 plant
variety have been
registered till 17thst
June 2017
20 December 2017 66

67. Contd...
• DUS Centres in
India
• Application
forms for new
variety
registration
• Fees for
Application
20 December 2017 67

68. Who Can Make An Application
• under Section 14
• any person claiming to be the breeder of the variety; or
• any successor of the breeder of the variety; or
• any person being the assignee of the breeder of the
variety in respect of the rights to make such application;
or
• any farmers or group of farmers or community of farmers
claiming to be the breeder of the variety; or
• any person authorized in the prescribed manner by a
person specified under clauses (a) to (vi) to make
application on his behalf; or
• any university or publicly funded agricultural
institution claiming to be the breeder of the variety.
20 December 2017 68

69. India’s International Obligations
India has been a WTO member since
1 January 1995
India joins TRIPS on January 1, 2005
India joins Paris Convention on
September 7, 1998
India joins PCT on 7 December 1998
India joins Budapest Treaty on
December 17, 2001 for the Deposit of
Microorganisms in recognized IDA20 December 2017 69

70. TRIPs & its Implications in Life Sc.
Patenting
Article 27.3(a) of the TRIPs, mentions that
Members may exclude from
patentability
diagnostic, therapeutic and surgical
methods for the treatment of humans ,
animals & plants
• notice plant is omitted in recent
amendment to comply TRIPS
20 December 2017 70

71. Contd...
Article 27.3(b) of the TRIPs, mentions that
WTO Members may exclude from patent
protection: (Optional)
Plants
Animals
Essentially biological processes for the
Production of plants or animals
Plant varieties
WTO members must provide protection for: (Compulsory)
Micro-organisms (by patents)
Non-biological processes (by patents)
Microbiological processes (by patents)
Plant varieties (by an IP system that may be
Patents, a sui generis alternative, or a combination)20 December 2017 71

72. Following are Patentable in India
1. Process / method of preparing Genetically
Modified Organisms
2. The living entity of artificial origin such as micro-
organism, vaccines are considered patentable.
3. The biological material such as recombinant DNA,
Plasmids and processes of manufacturing
4. Gene sequences, DNA sequences without having
disclosed their functions are not patentable for
lack of inventive step and industrial application.
5. The processes relating to micro-organisms or
producing chemical substances using such
micro-organisms are patentable.
20 December 2017 72

73. Non patentable Inventions
• Frivolous subject matter
• Contrary to well established natural
Laws
• Contrary to public order
• Contrary to morality
• Causing serious prejudice to
human, animal or plant life
• Causing serious prejudice to health
20 December 2017 73

74. • Causing serious prejudice to the
environment
• Mere discovery of a scientific
principle
• Formulation of an abstract theory
• Discovery of a living thing
• Discovery of a non living thing
occurring in nature
Non patentable Inventions
20 December 2017 74

75. • Any treatment of animals.
• A plant or part of a plant.
• An animal
• Biological process for producing or
propagating a plant or an animal. (Note:
new microorganisms are patentable).
• A mathematical or business method.
• An algorithm or a computer program per se.
• Any copyright work.
• Inventions related to atomic energy
Non patentable Inventions
20 December 2017 75

76. Contd...
(a) mere discovery of a new form of a known substance
which does not result in the enhancement of the known
efficacy of that substance;
(b) the mere discovery of any new property of a known
substance;
(c) the mere discovery of new use for a known substance;
(d) the mere use of a known process unless such known
process results in a new product or employs at least on
New reactant;
(e) the mere use of a known machine or apparatus.
20 December 2017 76

77. Contd...
• A substance
obtained by a mere
admixture resulting
only in the
aggregation of the
properties of the
components thereof
or a process for
producing such
substance is not an
invention.
• An admixture
resulting in
synergistic properties
is not considered as
mere admixture, e.g.,
a soap, detergent,
lubricant and polymer
composition etc, and
hence may be
considered to be
patentable.
20 December 2017 77

78. For Other Jurisdictions
Patentability of claims to methods of
medical treatment of humans
• Allowed in –> US, Australia
• Not Allowed in –> EPO, China,
Canada, Singapore, Indonesia, New
Zealand
20 December 2017 78

79. Why Patent Information ?
• Avoid duplicating R &D
• Determine the patentability of your
inventions
• Avoid infringing other inventors’ patents;
• Exploit technology from patent applications
that have never been granted, are not valid
in certain countries, or from patents that are
no longer in force
• To understand future direction of research
• To Identify possible collaborators
• To Identify key trends20 December 2017 79

80. Sample Patent Application Front page
20 December 2017 80

81. You should look into the following:
Applicant
Inventor
Title
Abstract
Filing Date
Priority Date
Description
Claims
Designated States20 December 2017 81

82. Different Searches
20 December 2017 82

83. What is Prior Art ?
Prior Art = Prior Knowledge
- ANY information in the public
domain… that has been
disclosed to the public in any
form about an invention
before a given date.
- Includes video recordings, news
paper & magazine articles,
speeches, journal papers,
patents, etc.
- If it is public ANYWHERE in
the world, it is prior art!
20 December 2017 83

84. Let us see how to get a patent
on your invention: What a
Researcher Must Know
Stage 1
• Ideation with an inspiration for
something new to solve a problem
Stage 2
• Research & Development
Stage 3
• Patenting
20 December 2017 84

85. Stage 1 Ideation
Patent Search then Research
Free sites
ipindia.nic.in
• www.uspto.gov
• www.jpo.go.jp
• www.ep.espacenet.com
• www.wipo.int/ipdl/en
• Google Patents search
• IP-Discover
• www.patent.gov.uk
• www.freepatentsonline.com
• www.ipaustralia.gov.au
•
Paid sites
• Thompson Reuters
• Patseer
• www.cas.org
• www.derwent.com
• Thompson Innovation
• Proquest
• “Patent, Publish and
Prosper” rather than
“Publish, or Perish”
20 December 2017 85

86. Kind Codes for Understanding
Patent Documents
• US Kind Codes
• Based on WIPO
S 16
• Espacenet Kind
Codes
20 December 2017 86

87. How to Search ?
• Identify a few starting
patents
• Search with all
possible alternative
terms
• Search with wild
cards, quotation
marks etc
• Identify and search in
common classes
• Search with reference
to inventor/assignee
Search ideas confidentially20 December 2017 87

88. Using more than one type
of protection
20 December 2017 88

89. Possible Inventive Steps
in Life Sciences
For process Patents:
• Use of different starting material (more
economical, easily available, ease of
handling, eco-friendly etc)
• Less number of steps,
• Simplicity,
• Less number of equipment,
• Economical,
• Improved purity,
• Ease of isolation, purification etc.
20 December 2017 89

90. Contd...
For product Patents:
• Improved bioavailability
• Faster onset of action,
• Improved pharmacokinetics,
• Improved patient compliance,
• Improved specificity for target tissue,
• Improved safety profile,
• Improved efficacy.
20 December 2017 90

91. Time matters !
• First to
file (FTF) in all
countries
including India
• First to
invent (FTI) in
the USA
20 December 2017 91

92. Stage 2 : R & D>Understand
your Invention
• The first and foremost thing is to
differentiate whether you invention is
a product or a process.
• A product patent is different from
process patent. Product patents
claim the product and whereas
process patents claim the process
for making the product.
20 December 2017 92

93. What is Invention as per
IPA ?
• "Invention"
means a new
product or
process
involving an
inventive step
and capable of
industrial
application.
Section 2(1)(j)
• "Inventive step" means
a feature of an invention
that involves technical
advance as compared to
the existing knowledge
or having economic
significance or both and
that makes the invention
not obvious to a person
skilled in the art.
• Section 2(1)(ja)
20 December 2017 93

94. Who is the inventor?
• The key question
in determining
inventorship:
would the invention
have occurred
without the
purported inventor’s
contribution?
20 December 2017 94

95. Co-author vs. co-inventor
Co-author does not
mean co-inventor
Unless the co-author
provided a
contribution that had a
material effect on the
final concept of a
claimed aspect of the
invention, the co-
author is not an
inventor.
20 December 2017 95

96. Who can apply for a Patent ?
• either alone or
• jointly with any other person:
• True and first inventor
• True and first inventor‘s assignee
• Legal representative of deceased true and
first Inventor or his/her assignee
• Assignee can be a natural person or other
than a legal person such as a registered
company, a research organization, an
educational institute or Government.
20 December 2017 96

97. Jurisdiction of Patent Application
• Indian Patent Office
functions from four
locations viz. Kolkata,
Delhi, Chennai and
Mumbai.
• i)Place of residence,
domicile or business of the
Applicant
• ii) Place from where the
invention actually
originated.
• iii) Address for service in
India for foreign
collaborator
20 December 2017 97

98. Type of Patent Applications
1. Ordinary Application, i.e., an Application
which has been filed directly in the Indian
Patent Office.
2. Convention Application.
3. PCT Application.
4. Divisional Application, which can result
from division of a Patent Application.
5. Patent of Addition, which may be filed
subsequent to the Filing of an Application
for Patent, for an improvement or
modification.
20 December 2017 98

99. Ownership of invention
An inventor is generally
entitled to the benefit of
their invention. In the
absence of expressed
terms relating to ownership
of invention in a contract of
employment, an invention
made by an inventor (who
is an employee), in the
course of employment, is
owned by the employer
20 December 2017 99

100. Laboratory Notebooks
Laboratory notebooks are
of particular importance
when United States patent
protection is sought due to
the “first to invent” system.
In the United States,
novelty (and priority) of an
invention can be assessed
according to the date an
invention was first
conceived and/or reduced
to practice, provided that
there is trustworthy
corroborating documentary
evidence to support this
date, for example, a
laboratory notebook
20 December 2017 100

101. Publications may Destroy Novelty
• Any publications published
in a journal of a learned
society or
• Exhibited before in an
authorized manner as
designated by the
Government within one year
from the date of such filing
may be permissible with a
great caution.
• Publications existing
on the date of filing of
complete specification
would be considered as
a prior art.
20 December 2017 101

102. Stages - Filing To Grant Of Patent
PUBLICATION OF APPLICATION
REQUEST FOR EXAMINATION
GRANT OF PATENT
3rd Party Representation
Revocation/Amendment
OPPOSITION
• PROMPTLY AFTER 18 MONTHS FROM P.D.
• WITHIN 48 MONTHS FROM F.D.
• ALL OBJECTIONS TO BE COMPLIED WITHIN 12
MONTHS
• IF P.S.IS FILED C.S. TO BE FILED WITHIN 12MONTHS
• WITHIN 12 MONTHS
FILING OF APPLICATION
PROVNL. / COMPLETE
Decision of
Controller
EXAMINATION-ISSUE OF FER
Appeal
Appellate Board20 December 2017 102

103. Patent Fees in India
• No professional hired
(only government fee):
• For Individual - Rs. 5,600
• For Small entity - Rs. 14,000
• For Large entity - Rs. 28,000
• Patent expert / firm
hired (includes both
government + estimated
expert fee):
• For Individual - Rs. 92,600
• For Small entity - Rs. 101,000
• For Large entity - Rs. 115,000
20 December 2017 103

104. Contd...
• Before grant of patent
• Filing fee - Rs 1600 (for 30 or less page application with maximum 10
claims)
• Request for examination - Rs 4000
• Post grant of patent
• Maintenance fee for 3rd to 6th year from date of filing - Rs 800 per
year (No fee for 1st and 2nd year)
• Maintenance fee for 7th to 10th year from date of filing - Rs 2400 per
year
• Maintenance fee for 11th to 15th year from date of filing - Rs 4800
per year
• Maintenance fee for 16th to 20th year from date of filing - Rs 8000
per year
• Thus a very conservative estimate suggest that, one has to pay
Rs 82400 official fees for filing and maintaining a
patent for its entire life term of 20 years.20 December 2017 104

105. E-filing:
1. The Patent Office provides the facility to file a
Patent Application online from the native place of
the agent of the applicant or applicant through efiling.
2. For e-filing, applicant / agent must have a digital
signature. For the first time, applicant / agent has to
register as a new user and has to create login ID and
password on the Patent office portal.
(http://www.ipindia.nic.in).
• This is mandated by the As explained in Section 39
of the Indian Patent act:
“Residents not to apply for patents outside India
without prior permission20 December 2017 105

106. INTERNATIONAL FILING
ROUTES
UNDER
PARIS
CONVENTION
UNDER
PCT
20 December 2017 106

107. Patent Infringement
 The word
"infringement" means an
encroachment upon the
domain of a patentee
that is described by the
claims of her/his patent.
 If a patent is
compared to real
property, the claims are
the fence posts on the
fence around the
property.
20 December 2017 107

108. Revocation of a patent
1. Non disclosure or
wrongly mentioning
the source of
geographical origin
of biological material
used for invention;
2. knowledge oral or
otherwise available
with in local or
indigenous
community
10820 December 2017

109. PARIS CONVENTION Vs PCT
20 December 2017 109

110. PCT Filing Fees
 FILING in PCT Contracting States (152
on 1 December 2017)
 WIPO
1,330 Swiss francs
EPO
1 219.00 EUR
USPTO
$136720 December 2017 110

111. 20 December 2017 111

112. Thank You
20 December 2017 112

113. 3D Printing ,Life sciences &
IP-Challenges Ahead
• 3D printing
technology has
transformed the life
sciences industry.
• However, the current
intellectual property is
unable to fully
address the unique
challenges presented
by 3D printing.20 December 2017 113

114. Bioethics & Patenting
“we were concerned about
the issue of patenting
human genes. Most,
although not all, eminent
scientists recognized that
human genes should not be
monopolized by
patents…Some twenty
years ago, I explained that
patenting human genes
was lunacy, and I was not a
lone voice.”
• -James Watson (1962)
20 December 2017 114

115. Bioprospecting
• Bioprospecting can be
defined as “the
systematic search for
genes, compounds,
designs, and organisms
that might have a
potential economic use
and might lead to a
product development”.
Significantly Reduce
R & D Investment20 December 2017 115

116. Why Bioprospecting ?
20 December 2017 116

117. Biopiracy in the Name of
Bioprospecting
20 December 2017 117

118. Unmet need of Health
Innovation
20 December 2017 118

119. Patent Makes Medicines
Unaffordable
20 December 2017 119

120. Access to Medicine
20 December 2017 120

121. Novartis Glivec Case Study
• Glivec (imatinib mesylate), produced by the pharmaceutical
company Novartis, is prescribed in the case of Chronic Myeloid
Leukemia, one of the most common blood cancers in eastern
countries. After more than a decade of legal battles surrounding its
patentability, the Supreme Court of India gave its final decision on
April 1st of 2013, rejecting the appeal of the Swiss giant drug
manufacturer. In 2006, the Indian Patent Office first refused Glivec’s
patent under Section 3(d) of the Indian Patent Act arguing that it was
only a modified version of an existing drug, Imatinib, and therefore
that the drug was not innovative. Novartis replied filing legal
challenges against the Indian government but the final verdict in
April of 2013 ends the battle. Indeed, the Supreme Court stated that
even if the bioavailability of the drug was improved, it did not
demonstrate enhanced efficacy and that Glivec was not patentable.
20 December 2017 121

122. Contd...
• Imatinib, sold under the brand
names Gleevec and Glivec, is
a medication used in the
treatment of multiple cancers,
most notably Philadelphia
chromosome-positive
(Ph+) chronic myelogenous
leukemia (CML) and
also gastrointestinal stromal
tumors (GIST). Compared to
older drugs imatinib has a
relatively benign side effect
profile, allowing many
patients to live a normal
lifestyle.
20 December 2017 122

123. Contd...
• Indian companies
can now roll out a
generic and a
much cheaper
version of the life
saving cancer
drug, which is a
big blow to
Western pharma
firms.
20 December 2017 123

124. Access & Benefit Sharing (ABS)
• Bioprospectors
to alter nature's
handiwork for
commercial profit.
A major strategy
for private
exploitation in this
area is to obtain
the patent rights to
an organism or its
component parts.20 December 2017 124

125. Innovation of Bio-electronic Tattoo
20 December 2017 125

126. Reference
• Chirag Tanna
Founder and
Owner, INK IDEE
Thane (W) 400602
20 December 2017 126

127. Improve our world with
your inventions!20 December 2017 127

128. Thank You
20 December 2017 128