the slide include all aspects of IPR in india.
-Basics of IPR
-IPR regime in Indian Constitution
-procedure of application
-Current issues related to IPR
-India's Changing IPR and Effects
-Personalities of Indian IPR
2. Lets define
“The application of science and technology to living
organisms, as well as parts, products and models there of,
to alter living or non-living materials for the production of
knowledge, goods and services”
Biotechnology!
(Source: “A framework for biotechnology statistics”, OECD, Paris, 2005)
According to European Commission,
biotechnology can be divided into
3 major streams.
3. Green Biotechnology
The use of genetically
altered plants or animals to
produce more
environmentally-friendly
farming solutions as an
alternative to traditional
agriculture, horticulture,
and animal breeding
processes.
Red Biotechnology
Refers to the use of
organisms in genetic
engineering processes in
order to design and
manufacture
pharmaceutical products
like antibiotics and
vaccines.
White Biotechnology
Encompasses the
application of
biotechnology-based tools
to traditional industrial
processes to make
intermediate and end-
products more efficiently
with less
environmental impacts by
making use of renewable
resources.
4. What is Intellectual Property?
• Examples of intellectual property
– Include an author's copyright on a book
– A distinctive logo design representing a soft drink company and its products,
– Unique design elements of a web site
– A patent on the process to manufacture chewing gum.
Intellectual property is an
intangible creation of the
human mind, usually
expressed or translated into a
tangible form that is assigned
certain rights of property.
5. What is IPR?
A general term covering Patents,
Copyright, Trademark, Industrial
designs, Geographical indications,
Protection of layout design of
integrated circuits and Protection
of undisclosed information (trade
secrets).
It refer to the legal ownership by a
person or business of an
invention/discovery attached to
particular product or processes
which protects the owner against
unauthorized copying or imitation.
(Source: Business Guide to Uruguay Round, WTO, 1995)
6. Types of IPR
• Patents
• Trademarks
• Registered Design
Industrial design rights, Supplementary protection certificates for
pharma’ products , Database rights, Copyright, Domain names
• Trade secrets
• Circuit design rights
• Plant breeders' rights or Plant
variety rights
7.
8. Patents
• A patent is an exclusive right granted by law to
applicants / assignees to make use of and exploit
their inventions for a limited period of time
(generally 20 years from filing).
• The patent holder has the legal right to exclude
others from commercially exploiting his invention
• In return for exclusive rights, the applicant is obliged
to disclose the invention to the public in a manner
that enables others, skilled in the art, to replicate
the invention.
• The patent system is designed to balance the
interests of applicants and the interests of society
9. Conditions to be patentable
Novelty
• The patenting invention should be novel or a satisfy -able improvement in old
patents.
• Information related to patents should be disclosed to public and should be
available in prior
Inventiveness
• A patent should be inventive
• It should be decided on the material contained in unpublished patents. The
complexity or the simplicity of an inventive step not have any bearing on the
grant of a patent.
Usefulness
• An invention must possess utility for the grant of patent
• No valid patent can be granted for an invention devoid of utility
An invention must satisfy the following three conditions of:
10. Where to Apply?
• A patent application can be filed online or
offline at respective patent offices which has
specific territorial jurisdiction
• Territorial jurisdiction is decided by place of
residence of applicant or place of invention or
address of a office given by foreign applicant
11. Where to apply?
Patent office Territorial Jurisdiction
Mumbai Gujarat, Maharashtra, MP, Goa,
UT’s daman & Diu, Dadra &
Nagar Haveli
Delhi Haryana, HP, J&K, Punjab,
Rajasthan, UP, NC Delhi,
Chennai AP, Kerala, Telangana, TN, PY,
Lakdives
Kolkata (Head office) Rest of India
13. Hierarchy of patent office in India
Controller General of Patents,
Designs, Trademarks & GI
Assistant Controller of patents &
Designs
Deputy Controller of Patents &
Designs
Joint Controller of Patents & Designs
Senior Joint Controller of patents &
Designs
Examiners of
Patents and
Designs
18. Compulsory patenting
• CL are made to prevent the abuse of patents as
monopoly & to make way for commercial
exploitation of the invention
• Any person can make an application for grant of CL. It
is given for a term of 3 yrs
• Cl is given for requirements of public, if product not
available for reasonable price, if patented work is not
in territorial jurisdiction of India
19. CL maybe granted under certain specific
circumstances such as:
• Where a dependent patent is blocked;
• Where a patent is not being worked;
• Where the invention is of public interest such as foods
or medicines and other essential commodities.
• An export market is not being supplied; or
• The working of any other patented invention which
makes a substantial contribution is prevented; or
• The establishment of commercial or industrial activities
in the country is unfairly prejudiced
20. Govt.’s Supreme Power
• Any patent issued by India can be used by gov. for its
purpose with a order
• If gov. uses an invention before patenting it in India
no royalty need to be paid to patentee. Otherwise an
agreement on royalty is made by Gov. and party in
HC
• Gov. can also undertake any patents if its contrary to
public interest of gov or policies
21. Competition Policy of India
• Competition Act, 2002- a succesor of
The Monopolies and Restrictive Trade
Practices Act, 1969 (MRTP)
• the prohibition of the anti-competitive
practices and agreements by way of
exerting dominance and abusing this
right relates directly to the Agri-
biotechnology community in India
• Prohibition of terminator or the generic
use restriction technologies (GURT) by
Section 4 of CP Act 2002, DBT issued a
circular for banning GURT based on this
act
22. • Bt gene developed & patented by Monsanto was sold in
India at Rs.900 for 450gms of seeds
• MRTP Commission was approached to investigate on
2006 and found that ‘commodity is overpriced’
• followed by various state governments imposing price
controls under the Seed Control Order under Essential
Commodities Act
• SC of India has not considered it fit to interfere with the
orders of the MRTP Commission.
Competition Policy of India
Monsanto: the Microsoft of Agriculture
23. • Provide for the establishment of an
effective system for protection of plant
varieties, the rights of farmers and plant
breeders and to encourage the
development of new varieties of plants
• Ensures high quality seeds for farmers
• Respects activities of natural breeding
and selection by farmers and ensure the
rights of farmers
• Protect plant breeders right and thus
boost development of new variety of
palnts
Plant Variety & Farmer’s Rights Act, 2001
24. Duration of protection
• For trees and vines – 18 yrs.
• For other crops - 15 yrs.
• For extant varieties - 15 yrs
Exemptions
• Farmers’ Exemption:
Farmer shall be entitled to
produce, save, use, sow, re-
sow, exchange, share or sell his
farm produce including seed of
a variety protected under this
Act.
• Researcher’s Exemption:
(i) the use of registered variety
for conducting experiment.
(ii) the use of variety as an
initial source of variety for the
purpose of creating other
varieties
Plant Variety & Farmer’s
Rights Act, 2001
25. PPV & FR AUTHORITY, INDIA
• The authority regulates plant registration in India
• A plant variety (not wild) can be registered as a new variety
or as transgenic variety or extant variety
• Registration can be done by farmer, breeder, research
institutes, University
• Registration can be done by sending Seeds, Leafs, Live plants
or propagating material to regional or head office of
authority
• The seed samples received by the Authority will be properly
tested for its purity and germination.
• A part of the seed sample will be sent to the test centre for
conduct of tests
• A part of it will be kept by the Authority in the National Gene
Bank to maintain the seed samples of the registered varieties
for their entire period of protection
• Authority issues specific guidelines to test each variety of
plant
• Comprises Chairman, commissioner, registrar, assistant
registrar
26. TRIPS Agreement
• The Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS) is an international agreement by WTO
that sets down minimum standards for many forms of IP
regulation as applied to nationals of other WTO Members. It
was negotiated at the end of the Uruguay Round of the General
Agreement on Tariffs and Trade (GATT) in 1994.
• Specifically, TRIPS requires WTO members to provide
– copyright rights, covering content producers including performers
producers of sound recordings & broadcasting organizations
– GI, including appellations of origin
– industrial designs; IC layout-designs
– Patents, new plant varieties
– TM and Trade secrets
• TRIPS also specifies enforcement procedures,
remedies, and dispute resolution procedures.
27. • In 2001, developing countries,
concerned that developed
countries were insisting on an
overly narrow reading of TRIPS,
initiated a round of talks that
resulted in the Doha Declaration.
The Doha declaration is a WTO
statement that clarifies the
scope of TRIPS, stating for
example that TRIPS can and
should be interpreted in light of
the goal "to promote access to
medicines for all.“
• DD also ensured that developing
nations can issue CL on
inventions related to HIV/AIDS
and other epidemics
Doha
Declaration•It also challenges TRIPS and allowed developing
countries to make its own regime for IPR
•It enabled countries to acquire patent under
emergency situations it faces
•The a of amendment of trips is currently
extended since only 45 member nations are
accepting the amendment
•Since then all developed countries including
India stood along with Doha declaration
28. The Copyright Act1957
1958
The Copyright Rules
1970
The Patents Act
1999 International Copyright Order
The TM Act
The GI of Goods Act
2003 The Patents Rules
The TM Rules
The PPV and FR Rules
2000 The Semiconductors IC Layout-Design Act
The Designs Act
2001
The Designs Rules
The Semiconductors IC & LD Rules
The PPV and FR Act
2002 The GI of Rules
The Biological Diversity Act
The TM Rules
2004 The Biological Diversity Rules
2010 IPAB Rules and procedures
Rules &
Laws :
IPR in
India
29. IPR & Corporate monopoly
''Granting exclusive patent
rights amounts to stealing
economic options of daily
survival from the
developing world”
-Dr. Vandana Shiva-
30. India’s new IPR policy
• After series of Modi-Obama visits America promised of $ 4
billion investment
• The attack on India’s intellectual property rights became
intense after 2012, when the Indian patent controller
allowed local production of an expensive cancer drug
which reduced its price by 97 percent (Novartis, Imatinib).
The controller refused to grant patent to American
pharmaceutical company, Gilead, for an extremely
expensive drug for hepatitis C. The drug costs $ 1000 a pill
in the US, while it can be produced locally at $ 1 a pill.
• India is on a “priority watch list” in America’s special 301
report, that identifies countries which do not provide
"adequate and effective" protection of IPR or "fair and
equitable market access to US persons that rely upon IPR.”
31. India’s new IPR policy
• It’s a globally acknowledged fact
that India’s existing IPR policy
regime, although against US & EU,
has been a lifesaver for not just
Indians, but also people from other
developing countries
• Cancer drug Glivec, sold by Swiss
Pharma company Novartis for more
than Rs one lakh, is now available
in the generic from for about Rs
8,800 and its price is likely to fall
further
• Affordable Care Act (ACA), US by
Obama
32. How India’s
New IPR Policy
can cause a
genocide in S.Africa
India’s new IPR policyWith Indian generic companies entering in
voluntary licensing agreements with Gilead
Sciences, the price of the drug was brought down
from $1,000 per pill to $900 for a 12-week course
for Indian patients.
33. Cipla is known for offering generic anti-retrovirals
at $304 a year, or less than a dollar a day, when
Pfizer was charging nearly $12,000 dollars per
patient, per annum.
How India’s
New IPR Policy
can cause a
genocide in S.Africa
34. Minister
Aaron
Motsoaledi
says,
“Yes, I called it genocide because I was showing the number of
people in sub-Saharan Africa who depend on generic anti-
retrovirals, specially generics from India. I was showing them how
many people will die if the policies change.” For instance, out of
the 8 million people who are on anti-retrovirals in the world, 6
million are in Sub-Saharan Africa, most of them alive because of
generics from India. If these six million do not have access to
affordable generic anti-retrovirals, all of them will be gone. I
mean, that’s genocide
35. Electrified the
global health
community a by
producing cocktails
of AIDS medicines
for $1 per day.
Dr. Yusuf K. Hamied
the modern world
Robin Hood
Now it is 20 cents per
day, & more than 6
million people in
developing world now
receive treatment.
36. In the past Indian companies
would have launched generic
versions in the developing
world at lower rates, but in
2005 India adopted WTO-
TRIPS obligations, making it
difficult for Indian companies
to make generics of patented
drugs. But the country held
on to crucial rights, including
the right to grant a
compulsory licence to local
manufacturers in case of
health emergencies
37. The seeds of
Vandana Shiva
She started The Navdanya is a
movement for Earth Democracy based
on the philosophy of
'Vasudhaiv Kutumbakam' .
To protect the India's biodiversity based
food heritage through Bija Swaraj, Ann
Swaraj, Bhu Swaraj and Gyan swaraj
Through 'Bija Swaraj' they have created
122 Community Seed Banks in 18 states
of India and Bhutan.
They also distributed the seeds of hope
to the farmers after disasters like
Odisha Super Cyclone, Tsunami, Floods
in Uttarakhand, Phailin in Odisha, Earth
quack of Nepal disaster without any
money in return.
38. The seeds of
Vandana Shiva
• Since 1991 they have been campaigning against GM crops and food in
India. Working with citizens' movements, grassroot organisations,
NGOs and governments, they have made significant contributions to
the Convention on Biological Diversity (CBD) and the Biosafety
Protocol.
• During the WTO Hong Kong Ministerial, Navdanya joined 740 other
organisations in presenting their opposition to the WTO's stance on
GMOs.
• Biopiracy: Navdanya started the campaign against biopiracy with the
Neem Campaign in 1994 and mobilised 1,00,000 signatures against
neem patents and filed a legal opposition against the USDA and WR
Grace patent on the fungicidal properties of neem (no. 436257 B1) in
the European Patent Office (EPO) at Munich, Germany.
• The patent on Neem was revoked in May 2000 and it was reconfirmed
on 8 March 2005 when the EPO revoked in entirety the controversial
patent, and adjudged that there was “no inventive step” involved in
the fungicide patent, thus confirming the ‘prior art’ of the use of
Neem.
39. The seeds of
Vandana Shiva
• The next victory against "biopiracy" for Navdanya came in October 2004 when
the European Patent Office in Munich revoked Monsanto’s patent on the
Indian variety of wheat “Nap Hal”.
• This was the third consecutive victory on the IPR front after Neem and
Basmati(Taxmati by Ricetec). Monsanto was assigned a patent (EP 0445929
B1) on wheat on 21 May 2003 by the European Patent Office in Munich under
the simple title “plants”.
• On January 27, 2004 Research Foundation for Science Technology and Ecology
(RFSTE) along with Greenpeace and Bharat Krishak Samaj (BKS) filed a petition
at the European Patent Office (EPO), Munich, challenging the patent rights
given to Monsanto on Indian Landrace of wheat, Nap Hal. The patent was
revoked in October 2004.
• Now leading a no GMO banana campaign against GM banana with enriched
iron
40. That s all folks
Thank youCirrhosis.pptx by Arun Viswanthan is licensed under a Creative Commons Attribution 4.0 International License.