INTELLECTUAL PROPERTY RIGHTS IN BIOTECHNOLOGY

1. Protection in Biotechnology,
Protection of Other Biological Materials,
Convention on Biological Diversity,
International Treaty on Plant Genetic Resources
for Food and Agriculture
and
National Biodiversity Protection Initiatives
NAMITHA M R
2015664502
M.Tech. in Land and Water Management Engineering
AEC & RI, Kumulur
TNAU

2. AGRICULTURAL BIOTECHNOLOGY
• Encompasses a range of research tools used by scientists to
understand and manipulate the genetic make-up of
organisms for use in agriculture (crops, livestock, forestry and
fisheries).

3. Genetic
Engineeringcloning
bioinformatics
tissue culture
micro
propagation
artificial
insemination
embryo
transfer
AGRICULTURAL
BIOTECHNOLOGY

4. Major benefits of Biotechnology Research
1. Overcome production constraints that are more difficult or
intractable with conventional breeding.
2. Create crops that resist pests and diseases, replacing toxic
chemicals that harm the environment and human health.
3. Provide diagnostic tools and vaccines that help control
devastating animal diseases.
4. Create new products for industrial uses

5. Contd…
5. Can offer both direct and indirect health benefits:
– Direct benefits: Improving the nutritional quality of foods
(e.g. Golden Rice), reducing the presence of toxic compounds
(e.g. cassava with less cyanide) and reducing allergens in
certain foods (e.g. groundnuts and wheat).
– Indirect benefits: Reduced pesticide use, lower occurrence of
mycotoxins (caused by insect or disease damage), increased
availability of affordable food and the removal of toxic
compounds from soil.

6. Economic Implications of BT and GMO
• Biotechnology have economic impacts on
farmers, consumers and society as a whole

7. Economic impacts of transgenic crops
• Overall economic impacts of transgenic crops will depend on
factors like:
– Impact of the technology on agronomic practices and yields
– Consumers’ willingness to buy foods and other products
derived from transgenic crops
– Regulatory requirements and associated costs.
– Industry concentration in the production and marketing of
transgenic crop technology

8. Contd…
• Transgenic crops will only be widely adopted if they provide
economic benefits for farmers
• Technologies that are embodied in a seed, such as transgenic
insect resistance, may be easier for small-scale, resource-poor
farmers to use than more complicated crop technologies
• On the other hand, some biotechnology packages, particularly in
the livestock and fisheries areas, require a certain institutional
and managerial environment to function properly

9. Socio-Economic Issues
• Types of decisions that governments have to make relating
to the socio-economic issues are:
– whether to import GM ingredients, or manufacture foods
and products containing GM ingredients;
– whether to allow GM seeds to be planted commercially;

10. Contd…
– policy on research in agricultural biotechnology - setting a
balance between public and private investment.
– appropriate laws and regulatory mechanisms to ensure
GM food products cannot harm the health of people,
animals, environment or pollinate non-GM crops; and
– whether food containing GM produce should be labeled.

11. The EU/US Dispute
• US is the world’s largest grower of GM crops.
• GM crop activity in EU member states is minimal, partly
because the EU only ended a six-year moratorium on
growing GM crops in 2003
• Individual applications to import GM seeds into the EU need
the approval of all 25 member states.
• Some EU member states such as Austria, Germany and Italy,
remain strongly opposed to growing GM crops.

12. V/s
• Europe’s approach is based on the precautionary principle.
• Though commercial GM crops are banned, processed food in
the EU is allowed to contain GM ingredients, but any food
product whose GM content exceeds 0.9 per cent needs to be
labelled.
• This is because of another principle underlying EU policy –
that the general public should be able to choose whether to
consume GM food or not.

13. Contd…
• Many large European supermarkets have chosen to remove
GM ingredients from their products.
• Campaigners in Europe want even stronger legislation to
ensure that GM produce is kept separate from non-GM
produce at every stage of production
• They can accept the ‘co-existence’ of GM with non-GM
products as long as they are clearly separated.

14. Contd…
• US policy-makers believe that the precautionary principle is a
hindrance to technology development and, ultimately, to
trade.
• They claim: that the EU ban is a barrier to trade costing US
farmers several hundred million dollars a year in potential
exports to Europe; that it has no scientific basis; and that it is
preventing the development of an industry that could benefit
the world’s poorest people.

15. Biosafety Procedures in India
• India has acceded to the Biosafety Protocol on 17th January
2003. GMOs are regulated in India under the purview of the
1986 Indian Environment (Protection) Act.
• Ministry of Environment and Forests has notified the Rules
for the Manufacture, Use, Import, Export and Storage of
Hazardous Microorganisms/Genetically Engineered
Organisms or Cells under this act.

16. Contd…
• Presently, there are six competent authorities.
– Recombinant DNA Advisory Committee (RDAC),
– Institutional Biosafety Committees (IBSC),
– Review Committee on Genetic Manipulation (RCGM)
– Genetic Engineering Approval Committee (GEAC),
– State Biotechnology Coordination Committee (SBCC)
– The District Level Committee (DLC)

17. Contd…
• RCGM established under the Department of Biotechnology
supervises research activities including small scale field trials
• GEAC, established under the Ministry of Environment and
Forests gives approvals for large scale releases and
commercialization of GMOs
• IBSC oversees the researches and to interface with the RCGM
in regulating it.

18. Contd…
• Bt. Cotton is the first and only transgenic crop approved
by GEAC for commercial cultivation in 6 States namely
Andhra Pradesh, Gujarat, Karnataka, Madhya Pradesh,
Maharashtra and Tamil Nadu.

19. IPR Issues in Biotechnology
• R & D in biotechnology is extremely time consuming and
requires huge investment
• There are, however, no internationally accepted
guidelines for the management of IPR

20. Legislative Framework
• TRIPS excludes biological processes for the production of
plants or animals as a patentable subject matter, but
patents can be granted to the microorganisms, non-
biological, and microbiological processes used in the
production of plants and animals.

21. Contd…
• IPR protection is granted only for invention and not for
discoveries
• In biotechnology innovations, it is difficult to say whether
the new life form in the form of gene, DNA, cell etc. is a
scientific discovery or a technological invention.

22. Contd…
• Consideration of industrial application is yet another
obstacle for securing patents for inventions in biotechnology
• However, in India there are several ethical issues too related
to patenting of life forms, the most important being extent
of private ownership that could be extended to life forms
• Idea of profit making by exploiting any common heritage of
civilization or culture is unacceptable to lots of people and
communities

23. Contd…
• Hence, there is an urgent need for developing countries
like India to define clear policies for IPR in case of
scientific and technological innovations.
• World Intellectual Property Organization (WIPO) is now
developing guidelines to protect traditional and
indigenous knowledge systems.

24. Trait-Genetic Use Restriction Technology
(T-GURT)
• New trait-genetic use restriction technology (T-GURT) is
being employed as a part of biotechnology by means of
terminator and traitor genes.
• It restricts unauthorized copying of patents and monopoly
in the international marketing

26. Contd…
• But farmers cannot save seeds of their crops at the end of
the crop season
• It may therefore pose a potential threat to our food security
• (CGIAR) has decided not to incorporate T-GURT in
forthcoming plant breeding programs of international
institutions

27. Indian Proprietary Agricultural Technology Profile
• ICAR is the IP leader with over 60 granted patents in the field
of plant and animals sciences, including biotechnology, diary
technology, animal disease diagnostics, and therapeutics,
engineering and post harvest processing, and environmental
science
• Other patentees in agriculture include universities, IITs, and
other research organizations like CSIR, DRDO etc.

28. Contd…
• A few patents have been granted to individual inventors for
inventions such as: An improved agriculture harrow disk,
Tractor mounted multipurpose deep trencher, a
preparation for enhancing yield in agriculture and
horticulture, a composition for enhancing nitrogen fixation
in legumes etc.

29. Contd…
• According to the Indian Patent Act 1970 and subsequent
amendments, patents could be applied mainly for
agricultural tools and machinery or the processes for the
development of agricultural chemicals
• Any new plant variety, arising out of an innovative use of
conventional techniques or modern biotechnological
methods, is not patentable subject matter.

30. Contd…
• Since 2005 inventions related to agrochemicals as
products could be patented according to the Patent
(Amendments) Act, 2005

31. Convention on Biological Diversity (CBD), 1993
• A multinational treaty which expressly provided for the rights
of indigenous communities (Article 8 (i) of the CBD), and the
International Undertaking on Plant Genetic Resources (IUPGR)
has provided defined farmers’ rights (CBD 1994, FAO 1983)
inter alia affirm that “the past, present and future
contributions of farmers in conserving, improving and making
available the genetic resources is the basis of farmer’s rights”.

32. CBD contd…
• The Convention has three main goals:
– conservation of biological diversity (or biodiversity);
– sustainable use of its components; and
– fair and equitable sharing of benefits arising from
genetic resources.

33. CBD contd…
• The Convention was opened for signature at the Earth
Summit in Rio de Janeiro on 5 June 1992 and entered into
force on 29 December 1993
• The year 2010 was the International Year of Biodiversity
• Importantly, the Convention is legally binding; countries that
join it ('Parties') are obliged to implement its provisions.
• The convention sets out a philosophy of sustainable use of
natural resources.

34. Cartagena Protocol on Biosafety
• Supplementary agreement adopted by CBD on
29 January 2000
• The protocol became international law in September 2003
and has since been ratified by more than 100 countries
excluding USA.
• India has acceded to the Biosafety Protocol on 17th January
2003.

35. Scope of Cartagena Protocol
• The Protocol seeks to protect from the potential
risks posed by Living Modified Organisms (LMOs)
resulting from modern biotechnology intended for
direct use for food, feed or processing.
• It incorporates procedure for import of LMOs with
respect to Food, Feed and Product.

36. Risk Management
• Risk management measures include food labeling,
conditions on marketing approvals, post marketing
monitoring and development of methods to detect or
identify foods derived from modern biotechnology.

37. Salient features of the protocol
i) Precautionary principle: similar to the idea of ‘safety first’
ii) Advance Informed Agreement (AIA)
iii) Traceability: Importer of LMOs should be able to trace back
the original exporter
iv) Liability and Redress: what would happen if the trans-
boundary movement of living modified organisms (LMOs)
has caused damage.

38. Contd…
v) Biosafety Clearing-House (BCH): to facilitate
the exchange of information on living modified
organisms and to assist countries in the
implementation of the Protocol.

39. Nagoya Protocol
• Supplementary agreement to the CBD
• Adopted at the 2010, 10th Conference of Parties (COP) to the
CBD on 29th October in Nagoya, Japan and enter into force
on 12 October 2014
• It has been ratified by 53 states and the European Union
• On 22 December 2010, the UN declared the period from
2011 to 2020 as the UN-Decade on Biodiversity

40. Contd…
• It provides a transparent legal framework for the effective
implementation of one of the three objectives of the CBD:
the fair and equitable sharing of benefits arising out of the
utilization of genetic resources thereby contributing to the
conservation and sustainable use of biodiversity.

41. Scope of Nagoya Protocol
• The Nagoya Protocol applies to genetic resources that are
covered by the CBD, and to the benefits arising from their
utilization.
• It also covers traditional knowledge (TK) associated with
genetic resources that are covered by the CBD and the
benefits arising from its utilization.

42. International Treaty on Plant Genetic Resources
for Food and Agriculture (ITPGRFA)
• Popularly known as the International Seed Treaty, it is a
comprehensive international agreement in harmony with
the Convention on Biological Diversity, which aims at
guaranteeing food security through the conservation,
exchange and sustainable use of the world's plant genetic
resources for food and agriculture (PGRFA), as well as the
fair and equitable benefit sharing arising from its use.

43. Contd…
• The treaty has implemented a Multilateral System (MLS)
of access and benefit sharing, among those 64 countries
that ratify the treaty, of some of the most important food
and forage crops essential for food security and
interdependence.

44. Contd…
• Basic function is to promote the full implementation of the
Treaty, including the provision of policy guidance on the
implementation of the Treaty
• Governing Body elects its Chairperson and Vice-
Chairpersons, in conformity with its Rules of Procedure.
They are collectively referred to as "the Bureau"

45. ITPGRFA sessions
First Session
Second Session
Third Session
Fourth Session
Fifth Session
In Madrid in June 2006
In Rome in Oct/Nov 2007
In Tunis in June 2009
In Bali, Indonesia in March 2011
In Muscat, Oman in September
2013.

46. National Biodiversity Authority (NBA)
• NBA is a statutory autonomous body under the MoEF, Govt
of India established in 2003 to implement the provisions
under the National Biological Diversity Act, 2002, after India
signed CBD in 1992
• In 2012, NBA organized the first ever National Biodiversity
Congress (NBC) at Thiruvananthapuram, Kerala.
• NBA with its headquarters in Chennai, Tamil Nadu, delivers
its mandate through a structure that comprises of the
Authority, Secretariat, SBBs, BMCs and Expert Committees.

47. Status of India’s Biodiversity
Accounts for 7-8 per cent of the recorded species of
the world
One of the 17-mega biodiversity countries
46,000 species of plants and 81,000 species of
animals have been recorded
Acknowledged centre of crop diversity
Harbors many wild relatives and breeds of
domesticated animals and fish
Millions of microbial diversity, insects and other
species.

48. Implementation Structures of Biodiversity Act, 2002
• A three tiered structure has been established under the Act:
– At the local level  Biodiversity Management Committees
(BMCs)
– At the state level  State Biodiversity Boards (SBBs)
– At the national level  National Biodiversity Authority (NBA)
• Each of these structure are required to be connected for
decision making processes on various issues, including on issues
of access and benefit sharing (ABS).

49. Current Status of Biotechnology Research
• Genetic modification technology in agriculture first appeared
in the mid 1990s in the US
• Cultivation of genetically modified plants worldwide also
increased in 2013
• 79 % of world production of soybean is achieved with GM
soy and this figure is 32 % in the case of maize

50. Contd…
• With the adoption of Bt cotton, India’s GM crop production
almost tripled from 500,000 hectares in 2004 to 1.3 million
hectares in 2005
• India has the largest biotechnology research program in the
developing world, with 14 public-sector laboratories carrying
out research on GM cabbage, cauliflower, chickpeas, citrus,
eggplants, mung beans, melon, mustard, potatoes, rice,
tomatoes and cotton, among many other crops

51. Contd…
• Just four varieties of GM crops – soybean, maize, cotton and
canola (rapeseed) – occupy 99 per cent of commercial
plantings.
• The most widely used GM technologies involve herbicide
tolerance (HT) applied in soybean and canola, and insect
resistance, based on genes isolated from Bacillus
thuringiensis (Bt), applied in maize and cotton

52. Upcoming biotech innovations
• GENE SCISSORS Imagine being able to ‘cut-and-paste’
any genetic sequence at will, even in
living organisms.

53. • SMART SHOES
What if you could tell your phone your
next destination and let your shoes
lead the way?

54. • HEALING NANOGELS
Forget bandages and silicon
dressings: nanogels might be the
future of wound healings

55. • POLYMER TOOTH SPRAY
A Taiwanese company called Tooth film
Biofilm Innovation has developed a breath
freshener from chitosan, which is extracted
from the exoskeleton of crustaceans

56. THANK U!!!