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IP & Life Science Innovations
Dr. Sabuj Kumar ChaudhuriDLIS, University of Calcutta
Email>>>[email protected]
Web>>> http:// www.sabujkc.webs.com
20 December 2017 1
Disclaimer
I am not lawyer. I can not give
you any legal advice
20 December 2017 2
What is Creativity ?
20 December 2017 3
• Myth #1: Only some people are
creative
• Myth #2: Only certain kinds of
ideas are creative
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.
Discovery Vs Invention
December 20, 2017 7
Invention & Innovation
20 December 2017 8
20 December 2017 9
Creativity protected by IP:
From Morning to Night
December 20, 2017 10
Journey through the Valley of Death
20 December 2017 11
20 December 2017 12
Creation of New Idea (Invention)
Conceptualization of New Idea
(Decision to innovate) (many
stages)Valley of Death
Commercialization of New Idea (Innovation)
Diffusion in the Society
20 December 2017
Creating a Climate of Invention & Innovation
20 December 2017 14
Primary Players in Global innovation
20 December 2017 15
India’s Position in GII, 2016 is 66th. It was 81st in 2015
20 December 2017
Science of Innovation
Who is Leading Innovation ?
20 December 2017
Should you protect your
invention ?
20 December 2017 18
Inventors Should protect their
inventions
20 December 2017 19
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
IPR as an Umbrella
Protecting your Creativity
20 December 2017 21
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
IPR or Trade Secret ?
20 December 2017 23
Patent Vs Trade Secret
20 December 2017 24
Few Basic Concepts
• Property Tangible
• Different understandings Intangible
• Intellectual property (IP)
• Intellectual Property Rights
(IPR)
20 December 2017 25
IPRIndustrial Property
PatentIndustrial Design
Trademark
Geographical Indications (GI)
Utility Models
Undisclosed information, including trade secrets
and test data
Artistic & Literary PropertyCopyright
Sui generis System (“Latin Word means “of its own kind”)Database
Integrated Circuit
Plant Breeders’ Right (PBR)
CLASSIFICATION OF IPR
20 December 2017 26
Rationale of Patent
20 December 2017 27
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
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
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
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 international
Patent
20 December 2017 31
Components of a Typical Patent DocumentBibliographic Information
+
Text with Claims
+
Drawings
A patent application is made for oneinvention only (UNITY OFINVENTIONS).
Multiple inventions need multiple patent
applications.20 December 2017 32
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
Examiner20 December 2017 33
Claims
20 December 2017 34
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 infringed20 December 2017 35
Specification/Disclosure
• Provisional specification
• Complete specification
20 December 2017 36
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
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
Field of invention
Trespassers will be prosecuted
Alternative path
20 December 2017 39
Field of invention
Trespassers will be prosecuted
Alternative path
TO
L L GAT
E
TO
L L GAT
E
CLAIM
CLAI
M
CLAIM
CLAIM
CLAIM
CLAIM
CLAIM
CLAIM
CLAI
M
CLAI
M
Royalty,Licensing, and Agreements
IDEA
20 December 2017 40
Field Of Invention: Patent Ecology
20 December 2017 41
Your Invention
20 December 2017 42
Function of A Specification: establish your invention in the existing
patent ecology
20 December 2017 43
Criteria to get a Patent
Novelty
Inventive Step
Industrial Application
Deposition of Microorganisms to an IDA
Patent
20 December 2017 44
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
20 December 2017 46
Patents on 7 Life Science
Breakthroughs
20 December 2017 47
Contd...
Aspirin Warfarin
20 December 2017 48
Contd...
Streptomycin Tagamet (Cimetidine)
20 December 2017 49
Contd...
Zantac (Ranitidine) Losec (Omiprazole)
20 December 2017 50
Contd...
Polymerase Chain
Reaction (PCR) Oncomouse
20 December 2017 51
First Patent on A Life Form
Louis Pasteur US Patent No.-141072 dated
July 22, 1873
20 December 2017 52
First Patent on a Genetically Modified
MicroorganismsFirst 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
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
Did you ever think of IPR behind the
Roses you receive on Valentine's Day ?
20 December 2017 55
AnimalsResearchers 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
Harvard’s oncomouse
20 December 2017 57
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 195520 December 2017 58
Velcro Patent in USPTO in 1955
20 December 2017 59
Inventing Velcro...
20 December 2017 60
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
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
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 varieties20 December 2017 63
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
Protection of Plant Varieties
and Farmers’ Right Act 2001
(PPV&FR Act)
20 December 2017 65
Plant Breeders’ Rights (PBR)
• Criteria for obtaining PBR- DUSDistinct from the existing,commonly known varieties,
Uniform or sufficientlyhomogenous and
Stable (i.e. subsequentplantings of the varietymust demonstrate thesame characteristics as theparent crop).
Total 2892 plantvariety have beenregistered till 17thst
June 2017
20 December 2017 66
Contd...
• DUS Centres in
India
• Application
forms for new
variety
registration
• Fees for
Application
20 December 2017 67
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
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
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
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
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
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
• 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
• 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
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
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
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
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
Sample Patent Application Front page
20 December 2017 80
You should look into the following:
Applicant
Inventor
Title
Abstract
Filing Date
Priority Date
Description
Claims
Designated States20 December 2017 81
Different Searches
20 December 2017 82
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
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
Stage 1 Ideation
Patent Search then ResearchFree 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
Kind Codes for Understanding
Patent Documents
• US Kind Codes
• Based on WIPO
S 16
• Espacenet Kind
Codes
20 December 2017 86
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
Using more than one type
of protection
20 December 2017 88
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
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
Time matters !
• First to
file (FTF) in all
countries
including India
• First to
invent (FTI) in
the USA
20 December 2017 91
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
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
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
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
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
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
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
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
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 notebook20 December 2017 100
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
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
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. 115,00020 December 2017 103
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
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
INTERNATIONAL FILING
ROUTES
UNDER
PARIS
CONVENTION
UNDER
PCT
20 December 2017 106
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
Revocation of a patent
1. Non disclosure or wrongly mentioning the source of geographical origin of biological materialused for invention;
2. knowledge oral or
otherwise available
with in local or
indigenous
community
10820 December 2017
PARIS CONVENTION Vs PCT
20 December 2017 109
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
20 December 2017 111
Thank You
20 December 2017 112
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
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
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
Why Bioprospecting ?
20 December 2017 116
Biopiracy in the Name of
Bioprospecting
20 December 2017 117
Unmet need of Health
Innovation
20 December 2017 118
Patent Makes Medicines
Unaffordable
20 December 2017 119
Access to Medicine
20 December 2017 120
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
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
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
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
Innovation of Bio-electronic Tattoo
20 December 2017 125
Reference
• Chirag TannaFounder and
Owner, INK IDEE
Thane (W) 400602
20 December 2017 126
Improve our world with your inventions!20 December 2017 127
Thank You
20 December 2017 128
