The document discusses biobusiness and biosafety, providing definitions and opportunities for biotechnology in developing countries. It examines the market for biobusiness, key opportunity areas, and factors for successful bioenterprise innovation including focusing on high-value opportunities, recognizing that innovation need not have long life cycles, and emphasizing people over technologies. The document also outlines biosafety levels and concepts from containment to facility design to protect laboratory workers and the environment.

1. Bio-Business and Biosafety, Biotechnology for
developing countries, and relevance of IPR in
biotechnology
Promila Sheoran
PhD Biotechnology
GJU S&T Hisar

2. Biobusiness
Definition
Commercial activity based on an understanding of life
sciences and life science processes:
Biomedical (including healthcare, pharmaceuticals,
medical devices, diagnostics, etc)
Agri-veterinary and Food
Environmental/Industrial
Related Areas (bioinformatics/computational biology,
bioengineering, nanobiotechnology, etc)

3. Market
BioBusiness already constitutes over 25% of global GDP
and employs some 40% of the world’s labor force:
Accounts for nearly US$12 trillion (2005)
Employment figures skewed by > 50% engaged in
subsistence level farming and low wage food
processing in developing countries (including China
and India)

4. Some Key BioBusiness Opportunity Areas With
Health and Development Implications
Biomedical BioBusiness
Healthcare
Pharmaceuticals
Biomedical biotechnology
Herbal and traditional medicine
Medical devices
Diagnostics
Agri-Veterinary and Food BioBusiness
Agriculture
Fisheries and aquaculture
Animal husbandry
Biopharming
Pets and recreational animals
Forestry and lumber
Agri-biotechnology
Food processing
Environmental and Industrial BioBusiness
Management of biodiversity
Environmental bioremediation
Waste management
Environmental biotechnology
Marine biotechnology
Industrial biotechnology: bioenergy, new
biomaterials, etc
Other BioBusiness Related Activities
Bio-IT and the application of ICT in the life
sciences
Bioengineering
Nanotechnologies as applied to life sciences
Life science and biotechnology education
Life science and biotech R&D
Life science and biotech contract services
Source: Shahi, 2002

5. Some Global Opportunities and Challenges with
Potential BioBusiness Implications
• Globalization - and the rapidly growing global economy (and growing inequity between
“haves” and “have nots”)
• Healthcare and Biomedical Sciences - Advances in healthcare and the biomedical
sciences, the genomics revolution and the move toward personalized medicine (and
the need to manage the cost of healthcare as populations age)
• Feeding the World – increased interest in more nutritious and less chemically tainted
foods (and the need to feed more people in the face of ever diminishing arable land)
• Renewables and Sustainability - Increasing demand for renewables and more
sustainable production technologies – biofuels, new biomaterials (and solving the
problems of global warming, environmental contamination and waste management)
• Responding to Threats – responding to natural and human generated threats to
economic development and stability (from pandemics, to natural disasters, to concerns
about bioterrorism)

6. The BioBusiness Innovation Landscape
Recommended Approach:
Focus on “Summit” opportunities – putting people,
technologies and resources together to capture the value
proposition
Summit Opportunities: Technology and knowledge intensive, few
competitors, high barriers to entry; high margins with well-
developed business case, “new” economy principles apply. High
BioEnterprise interest

7. Analysis: Successful BioBusiness Innovation
Critical Success Factors (given good infrastructure, facilities,
policies, etc):
 Smart People
 Smart Ideas
 Smart Money (immaterial if public or private sector driven:
Silicon Valley model – driven by private money; European model
– driven by public money)
 Smart Alliances and Partnerships (throughout the world)

8. Understanding Innovation…
It is pretty simple:
You do some stuff. Most fails. Some works.
You do more of what works.
If it works big, others quickly copy it. Then you do something else.
The trick is the doing something else.
Thomas Peters

9. Technology Adoption Challenges
Can we afford it? How will we
recover our costs?
Can it pay for itself? Is it
reimbursable? Show me the money.
We need to have this reviewed.
This is cool. I want it – does not
matter how much it costs
We'll be the first institution in the
region that has it. Makes us look
good. Let's get it!

10. BioPartnering: Capturing the Value Proposition
Professional Services
Legal /IPR, Media,
Recruitment etc
Regulatory Bodies
Development Agencies
Academic
Researchers
Finance
Entrepreneurs
Industry
Work for win-win Encourage public-private partnership
Bet on people Make smart investments
Source: Shahi, BioBusiness in Asia…
(Pearson Prentice Hall, 2004)

11. Some Priority Areas for Cooperation and
Collaboration: Government-Academia-Industry
 Meeting National/Regional/International Economic/Technology
Developmental Priorities
 Contract Research Initiatives
 Facilitating Commercialization of Publicly-funded R&D and Managing IP
 Bioethics
 Regulatory
 Public Health
 Biosecurity
 Incentivizing BioInnovation and BioEntrepreneurship
 Raising Funding and Investment for Biotech – including Cultivating Public
Markets for Biotech Stocks, and the development of a viable VC industry
 Public Education/Communication and the Training of Life Science Personnel

12. Making Things Happen in Bio-Business
1. Identify “Summit” opportunities
2. Recognize that Bio-Business innovation need not always be “long life
cycle”
3. Life science/biotech/Bio-IT investment need not be high risk – if you
know what you are doing
4. More developed countries do not have a monopoly on good science
and technology – innovative concepts can be found everywhere
5. Protect IP assets. Recognize that IP is not just patents – knowhow,
knowwhy and knowwho can be just as important
6. Bet on people not only on technologies - committed and capable
innovators/entrepreneurs will always find a way to win

13. Biosafety
•The maintenance of safe conditions in biological research to
prevent harm to workers, non-laboratory organisms or the
environment.
•Biosafety in Research Universities means promoting safe
laboratory practices, and procedures; proper use of
containment equipment and facilities; provides advice on
laboratory design and risk assesment of experiments involving
infectious agents, rDNA in-vitro and in-vivo.

14. History and Neccesity Of Biosafety
History:
•On 18 april 1955 the first biological safety conferrence took place at
Camp Detrick in Fredrick, Maryland in presence of fourteen
representatives from three Principal Laboratories of U.S Army.
•Biosafety, chemical, radiological & industrial safety issues were
discussed.
•Later in the United States, the Centers for Disease Control (CDC)
specified 4 different levels of biocontainment which ranges from
Biosafety level 1 (BSL-1) to Biosafety level 4 (BSL-4).
Neccesity:
•In order to avoid infection/biohazard to the laboratory personnel &
the environment biosafety levels are very important.

15. Biohazard Symbol
• Charles Baldwin at National
Cancer Institute at NIH.
• Symbol to be “memorable but
meaningless” so it could be
learned.
• Blaze orange – most visible
under harsh conditions

16. Biosafety Issues
• Laboratory Safety
• Bloodborne pathogens (BBP)
• Recombinant DNA (rDNA)
• Biological waste disposal
• Infectious substance and
diagnostic specimen shipping
• Respiratory Protection
• Bioterrorism and Select agents
• Mold and indoor air quality
• Occupational safety and health in the use of
research animals
• Biohazards used in animal models

17. Biohazardous Materials
• Viruses
• Bacteria
• Fungi
• Chlamydiae/Rickettsiae
• Prions
• Recombinant DNA
• Transgenic Plants, Animals and Insects

18. Biosafety In Microbiological
and Biomedical Laboratories
“BMBL” (acronym)
CDC/NIH Publication
Safety “Guidelines”
Regulations of Institution receives
NIH funding
Clinical & Research Lab.
Lab. Animal Facilities
Biosafety Concepts

19. Biosafety Concepts from the BMBL
Principles of Biosafety
• Practice and Procedures
– Standard Practices
– Special Practices & Considerations
• Safety Equipment
• Facility Design and Construction
• Increasing levels of protection

20. Principles of Biosafety
Biosafety Levels 1-4 (BSL)
• Increasing levels of employee and environmental
protection
• Guidelines for working safely in research & medical
laboratory facilities
Animal Biosafety Levels 1- 4 (ABSL)
• Laboratory animal facilities
• Animal models that support research
• Guidelines for working safely in animal research facilities

21. Biosafety Concepts
The BMBL
(1) Standard Laboratory Practices
• Most important concept / Strict adherence
• Aware of potential hazard
• Trained & proficient in techniques
• Supervisors responsible for:
– Appropriate Laboratory facilities
– Personnel & Training
• Special practices & precautions
– Occupational Health Programs

22. Biosafety Issues
The BMBL
(2) Safety Equipment
• Primary Containment Barrier
• Minimize exposure to hazard
– Prevent contact / Contain aerosols
• Engineering controls/ equipment
• Personal Protective Equipment (PPE)
– Gloves, gowns, Respirator, Face shield, Booties
• Biological Safety Cabinets
• Covered or ventilated animal cage systems

23. Biosafety Concepts
The BMBL
(3) Facility Design and Construction
• Secondary Barrier/ Engineering
controls
• Contributes to worker protection
• Protects outside the laboratory
– Environment & Neighborhood
• Ex. Building & Lab design, Ventilation,
Autoclaves, Cage wash facilities, etc.

24. Laboratory Design
“Warehouse Type Lab”

25. Types Of Biosafety Levels
There are 4 types of biosafety levels according to the risk
factors involved depending on the nature of pathogen
being handled.

26. BSL 1 (Basic teaching, Research)
 This level is suitable for work involving well characterized agents
not known to cause disease to healthy adult human & it gives
minimal protection to the operating person.
 Work is done on open benches or simple cabinet without laminar
air flow or with horizontal laminar (class 1) may be used.
 Access limited when work in progress.
Cont..

27.  Basic precaution is taken such as wearing gloves, protective
eyewear, sink for washing hands, etc.
 The lab is not necessarily saparated from the building.
 No eating, drinking, applying cosmetics, mouth pipetting.
 Openable windows must have screen.
 Regular disinfection/decontamination must be done atleast
once per day.

28. Risk Group 1 Agents
• E.coli K-12
• Transgenic Plants
• Plasmids
• Fungi
• Mold
• Yeast

29. BSL 2 (Primary health services, diagnostic
service, research)
 BSL 2 is same as like BSL 1 but few modifications are made since
this level includes risk factors more than BSL1.
 Agents associated with human disease.
 Effective treatment and preventive measures are available.
 Biohazard sign must be at entrance.
Cont..

30. Restricted access, control of waste disposal, protective
clothing, no food & drinking.
 Class 1 cabinets (horizontal laminar) are used.
 Written report for spills, accidents , medical evaluation.
 Biosafety cabinets should be decontaminated regularly.
 First aid, medications on accidental cases is must.
 Expose to mucous membranes must be avoided.

31. Risk Group 2 Agents
• Human or Primate Cells
• Herpes Simplex Virus
• Replication Incompetent
Attenuated Human
Immunodeficiency Virus
• Patient specimens

32. A standard lab
Working on influenza virus in
safety cabinet
Class 1 cabinetBiohazard sign

33.  BSL 3 (Special diagnostic service, reasearch)
This level is applicable to clinical, diagnostic,
teaching, research, or production facilities in
which work is done with indigenous or exotic
agents which may cause serious or potentially
lethal disease after inhalation.
 It includes various bacteria, parasites and
viruses that can cause severe to fatal disease in
humans but for which treatments exist.
Cont..

34.  Vertical laminar flow hood with front protection.
 Strict access control to lab.
 Two sets of self closing doors.
 Protective clothing, gloves face shield mask, goggles, closed
shoes, automatic or elbow taps on sink.
 Windows closed and sealed.
 Negative pressure in labs, directional airflow & air not re-
circulated, proper decontamination of wastes before
disposing.
 In case of spillage trained staff deals with it.
 Common example of pathogens: Yersinia pestis,
Mycobacterium tuberculosis, etc

35. BSL-3

36.  BSL 4 (Dangerous pathogen units)
This level is required for work with
dangerous and exotic agents that pose a
high individual risk of aerosol-transmitted
laboratory infections, agents which cause
severe to fatal disease in humans for which
vaccines or other treatments are not
available.
Lab is separate.
Totally enclosed system.
A completely sealed cabinet (class 3) with
glove pockets to allow manipulation of
cultures.
Biohazard hood(glove box)

37. Positive pressure personnel suite.
 Life support system.
Multiple showers at entry & exit
Vaccum room, ultra violet room.
Special waste disposal.
Double ended autoclave through wall.
Supervised by qualified scientists who are trained and
experienced in working with these agents.
Positive pressure suits

38. Biosafety Level 4
• Lassa Fever Virus
• Ebola Hemmorrhagic Fever
Virus
• Marburg Virus
• Herpes B Virus

39. General Good Lab Technique
• Hygienic Practices
– No Smoking, Eating, Applying cosmetics, lip balm, contacts
– Wash hands after procedures
– Decontaminate lab bench before and after work

40. General Operational Practices
• Proper attire
– Minimum – lab coat, safety glasses, gloves
• Plan your work
– Know in advance what you are working with
– Read available resources (MSDS)

41. Biotechnology for developing countries
The challenge according to FAO
• To feed a population of 9 billion persons by 2050,
without allowing for additional imports of food,
continents have to increase their food production
roughly:
– Africa 300%
– Latin America 80%
– Asia 70%
– Even the US has to increase food production by 30% just
to supply food for the projected population of 348 million
person

42. “New” constraints
• Erosion, water and irrigation problems
• Climate change => Global warming?
• Soil fertility
• Urbanization and land being retired from production
• Consumer concerns about intensive agriculture: Organic,
Fair Trade
• Competition from biofuels production
• Social, philosophical, ethical and religious concerns over
the food production system
• Concerns over globalization and corporate control of
agriculture
• …

43. The Green Revolution
• Transformation of agriculture during 1940s-1970s that
lead to significant increases in yields
• Firmly based on:
– Agricultural production needs to keep pace with
population growth
– Agricultural sciences philosophy of maximizing
production per unit of land
– Plant breeding developments of the late 19th early 20th
centuries
• Initially focused on a few crops (Wheat, rice, maize) but
has been expanded

44. Norman Bourlag: Father of the Green
Revolution
• Developed the wheat program that later became CIMMYT in 1963
– Shuttle breeding
– Incorporate short-stature genes into wheat
– Increased yield and rust resistance in wheat
• Mexico:
– 1948 self sufficient wheat producer
– 1965 Net exporter
• Won Nobel Peace Prize in 1970 and World Food
Prize
• Genesis of the Consultative Group of International
Agricultural Research ( CGIAR)

45. How was the Green Revolution possible? An
agronomist perspective on a technological
triumph as an engineering feat…
• Incorporation of a dwarfing genes from natural populations into
wheat and rice
• In maize: more vertical orientation of leaves, reduces self-shading
while allowing planting of narrower rows and thus increases in
densities
• Plants bred to dedicate a larger share of photosynthesis efforts to
grain rather than to stems and leaves
– Harvest index of older varieties was 20% whereas HYV around 50-
55%
• Relatively insensitive to day length – can be planted in a
wider range of latitudes
• Increased responsiveness to fertilizer and water

46. Green Revolution: Successes
• Significant increases in yields and production
– From 1950 to 1992, the world’s grain output rose from 692
million tons produced on 1.70 billion acres of cropland to 1.9
billion tons on 1.73 billion acres
– India: food production increased from 50 to 205 million tons
during the last 5 decades
– But, barely happened in Sub-Saharan Africa
• Economic output per hectare increases significantly
• 30% increase in cereal and calorie availability per person
• Poverty reductions—some studies show this is attributed to GR
raising farmers incomes

47. Green Revolution: Social and Economic Criticisms
• Does not address underlying social, cultural, ethnical and
institutional constraints that create vulnerability and thus affect
livelihoods
– Is hunger and food insecurity a question of production or unequal
distribution of resources?
• Increased mechanization affected rural labor employment
• Debt effects and credit institutions necessary
• Technology not scale neutral
– Uneven adoption as larger/wealthier farmers adopted first capturing
larger share of benefits
• Landowner/Landholder displacement
• Dependence on pesticides and fertilizers

48. Green Revolution: Environmental/Ecological
Criticisms
• Loss of agricultural biodiversity, not so clear effect on wild
biodiversity
– Focus on few crops => monocultures
• Increased uses of pesticides and the pesticide treadmill
• Increased use of fertilizers
• Irrigation
– Negative impacts of salinization, damage to soils, and
lowering of water tables
– Need to build dams and irrigation systems

49. Biotechnology as a tool
What is biotechnology?
• Manipulation of living organisms for a useful purpose
• Definition that covers a broad range of techniques
– Traditional: Plant breeding, tissue culture, micropropagation
– Modern: Marker assisted selection, Genetic Modifications
and Genomics
• Only GM products are currently regulated for
biosafety

50. GM Biotechnology – What is its status?

51. A reality check?

52. Implications for developing country agriculture
• Majority expansion is in four crops and two traits (insect
protection and herbicide tolerance) produced by industrialized
countries for its agriculture
• Diffusion to developing has been a (fortunate) development
• Challenge now is meeting explicit needs of
– Developing countries
– Smallholder / resource poor farmers
– Crop / traits

53. R&D and innovation for and by developing
countries
• Crops and traits of interest/value have been produced
• Capacity to develop GM crops and other biotechnologies
– Advanced => China, Brazil, Mexico, India, Argentina
– Medium- Advanced => Philippines, Thailand, Indonesia
• Next Harvest documented 270 technologies in 16
developing countries

54. Why GM biotech?
• Embodied technologies
• Address specific productivity constraints not easily
addressed by conventional means
• Can be deployed in low resource use production systems
• Flexible – fit with other production systems
– GM and Integrated Pest Management
– GM and organic production methods (!!!)
• Impacts can be non-pecuniary, indirect, and scale neutral
• Scalable

55. How does a producer benefit? Insect resistance
traits
The case of Bt cotton

56. Bt maize in the Philippines
• Growing Bt maize significantly increases profits and yields
• Significant insecticide use reductions
• Adopters tend to be
– Cultivate larger areas
– Use hired labor
– More educated
– have more positive perceptions of current and future status

57. Bt maize in Honduras
•Excellent target pest control
•Bt yield advantage 893-1136 Kg ha -1 yield (24-33%)
•Bt maize yields preferred even by risk averse producers
•100% higher seed cost than conventional hybrid
•Institutional issues important

58. Black Sigatoka Resistant Bananas in
Uganda
•Consider irreversible and reversible cost and benefits
by using the Real Option model
•One year delay, forego potential annual (social)
benefits of +/- US$200 million
•A GM banana with tangible benefits to consumers
increases their acceptance for 58% of the population

59. Productivity: Evidence for Bt Cotton Gains
Bt cotton in:
• United States: yield effect 0 – 15%
• China: yield effect 10%
• South Africa: yield effect 20%-40%
• India: yield effect 60 – 80 %
In every country have reduction in chemical usage

60. The Impact of Bt Cotton in India
• Bt cotton is used to provide resistance to the American
bollworm (Helicoverpa armigera).
• The technology was developed by Monsanto and was
introduced in collaboration with the Maharashtra Hybrid
Seed Company (Mahyco).
• Field trials with these Bt hybrids have been carried out since
1997 and, for the 2002/03 growing season, the technology
was commercially approved by the Indian authorities.

61. Results
• Bt hybrids were sprayed three times less often against
bollworms than the conventional hybrids.
• On average, insecticide amounts on Bt cotton plots were
reduced by almost 70%, which is consistent with studies from
other countries.
• At average pesticide amounts of 1.6 kg/ha (active ingredients)
on the conventional trial plots, crop damage in 2001/02 was
about 60%. Bt does not completely eliminate pest-related yield
losses.

62. Results II
• Average yields of Bt hybrids exceeded those of non-Bt
counterparts and local checks by 80% and 87%, respectively.
• 2001/02 was a season with high bollworm pressure in India,
so that average yield effects will be somewhat lower in years
with less pest problems.

63. Concluding comments
• Biotechnology and Genetically Modified Crops are still only
technologies
• Similarities and differences with other technologies
• Actual and potential benefits from GM technology
adoption…important tool to consider. Cannot disregard
• Developments in the public sector in developing countries
• Additional crops/traits of interest whose limitations can
probably be only addressed through biotechnology means,
will be available if we manage to resolve institutional and
regulatory issues.

64. Intellectual Property Rights
•Patents
•Industrial designs
•Trade and service marks
•Copy rights
•Geographical indications or appellations of origins
•Layout designs (of integrated circuits).
•Neighbouring rights.
•Undisclosed INFORMATIONS (trade secrets).
•Anticompetitive practices in contractual licenses.
•Protection of inventions in biotechnology (plants).

65. IPR
•A legal concept: Copyright, trademarks and geographic
indications, patents, trade secrets, plant variety protection
•A social construct that defines “intangible” borders (as
opposed to tangible, real property borders)
•A business asset that can be valued and traded
•An instrument to achieve humanitarian objectives
•A policy tool to foster investments in innovation

66. FOR MOST PRODUCTS EVERY FORM OF
INTELLECTUAL PROPERTY RIGHTS CAN BE
OBTAINED
CAMERA
“PATENT”  For every individual improved mechanism
“DESIGN”  For outer shape & Contour / Configuration
“TRADE MARK” Brand name or Logo for goods denoted as ®
“Copy right” For Instruction / manual booklet denoted as ©

67. Major cases of IPR in Biotechnology
1. The IP situation with golden rice
2. Diamond v. Chakrabarty Patent Infringement
3. India-US Basmati Rice Dispute
4. Novartis patent case: cancer drug Glivec

68. 1.The IP situation with golden rice
• ~70 patents and patent applications might be applicable to
golden rice when all patents issued in or applied for in all
countries were considered.
•A dozen material transfer agreements were also identified, 1 of
which needed a license.
•The published analysis, and legal opinion, concluded that, in
practice, only a few patents were applicable in developing
countries.

69. Resolving the IP constraints with golden rice
1. Assembly of IP and tangible property rights:
- within a few months, in licensing, for humanitarian use,
led by Zeneca (Adrian Dubock), of key IP components
(Bayer AG, Monsanto, Novartis AG, Orynova BV, Zeneca
Mogen BV, others)
2. Out-licensing, by Syngenta, via the inventors, the bundled IP to
public sector institutions in developing countries:
- Bangladesh India, Indonesia, Philippines, Vietnam and
many more
- Policy support from Syngenta’s chairman, Heinz Imhof

70. Principal terms of the humanitarian license
• For use by resource-poor farmers
(< US$10,000/year from farming)
• Use of public varieties
• No technology fee
• Farmers are allowed to reuse harvested seeds
• No release in countries lacking biosafety regulations
• Export to licensees for research and use is permitted
• Improvements:
– Humanitarian use allowed (Syngenta already licensed many
improvements)
– Commercial rights to improvements are granted back to
Syngenta

71. 2. Diamond v. Chakrabarty Patent Infringement
 The case was heard in the United Sates Supreme Court in
1980.
 It entailed the patentability of genetically modified
organisms.
 Genetic engineer ,Ananda Mohan Chakrabarty developed a
bacterium called Pseudomonas putida.
 This was while working with General Electric.
 The bacterium can break down crude oil which made it
suitable for treating future oil spills.

72. Chakrabarty
• He was an investor of the bacterium by the General Electric.
• This was when the company applied for patent.
• The patent examiner rejected the application.
• This was because living things were not being patentable
subject matters at the time.
• The examiner quoted Section 101 of the Title 35 U.S.C.

73. Case
 Board of Patent Appeals and Interferences upheld its
initial decision.
 The United States Court of Customs and patent did not.
 It overturned this case in favor of Chakrabarty.
 Aegued that all micro-organisms are living things does not
have legal significance.
 Sidney A. Diamond who was the Patents and Trademarks’
commissioner made an appeal to Supreme Court.
 This case was deliberated on 17th March 1980.

74. Court’s Decision
 A decision was made on 16th June 1980 and on 31st March
1981.
 This was USPTO granted patent which was to Chakrabarty’s
favor.
 The court noted that a live micro-organism made by human
under Title 35 U.S.C, 101.
 The micro-organism of the respondent constituted of a
composition of matter.
 The decision was written by Warren E. Burger, the Chief
Justice.
 Others who joined him were Potter Stewart, William
Rehnquist, John Paul Stevens and Harry Blackmun.

75. 3. Basmati Rice and Asia
• Rice is an important aspect of life in the Southeast and other parts
of Asia.
• For centuries, it has been the cornerstone of their food and
culture.
• Basmati has been grown in the foothills of the Himalayas for
thousands of years.
• Basmati rice is being grown in subcontinent for centuries.
• Its flavour and aroma has been developed through selective
breeding for thousands of years.
• It is common knowledge that what Champagne is to France,
Basmati is to subcontinent (Pakistan and India).

76. Basmati Rice
• Basmati means the “queen of fragrance or the perfumed
one”.
• Origin: Pakistan and India
• Indian varieties are Safidon, Haryana, Kasturi (Baran,
Rajasthan), Basmati 198, Basmati 217, Basmati 370,
Kasturi, Mahi Suganda.
• Pakistani varieties Basmati 370, Super Basmati, Pak
(Kernal) Basmati, Basmati 386, Basmati 385 and Basmati
198.

77. The Case Issue
In the late 1997, when an American company RiceTec Inc. was granted a
patent by the US patent office to call the aromatic rice grown outside India
"Basmati", India objected to it. India has been one of the major exporters of
Basmati to several countries and such a grant by the US patent office was
likely to affect its trade. Since Basmati rice is traditionally grown in India and
Pakistan, it was opined that granting patent to RiceTec violated the
Geographical Indications Act under the TRIPS agreement. A geographical
indication (sometimes abbreviated to GI) is a name or sign used on certain
products which corresponds to a specific geographical location or origin (e.g..
a town, region, or country). The use of a GI may act as a certification that the
product possesses certain qualities, or enjoys a certain reputation, due to its
geographical origin. RiceTec's usage of the name Basmati for rice which was
derived from Indian rice but not grown in India, and hence not of the same
quality as Basmati, would have lead to the violation of the concept of GI and
would have been a deception to the consumers.

78. Patent Advantage to RiceTech
• RiceTec able to not only call its aromatic rice Basmati within
the US, but also label it Basmati for its exports.
• Captures the whole US trade market.
• Exclusive use of the term “basmati”.
• Monopoly on breeding 22 farmer-bred Pakistani basmati
varieties with any other varieties in the Western Hemisphere.
• Proprietary rights on the seeds and grains from any crosses.

79. Disadvantage of Patent to India and Pakistan
• Economic loses.
• Global trade losses.
• Both countries lose their global market share.

80. Government of India Response to Patent
• Government of India under severe pressure from its exporters
and farmers logged an appeal with USPTO.
• They submitted the evidence to USPTO.
• India exports about 400,000 - 500,000 metric tons of Basmati
annually. In 1996-97, India exported approximately 523,000
tonnes of Basmati to Europe.

81. Result of patent case
• RiceTec Inc. took back 15 claims out of 20
• They also took back its claim on the name
“Basmati”.

82. 4. Novartis patent case
•Glivec is a medicine discovered and developed by Novartis for
the treatment of chronic myeloid leukemia (CML), a cancer of
white blood cells and for the treatment of a rare form of stomach
cancer called gastrointestinal stromal tumor (GIST).
•Glivec is one of the first cancer drugs that validate rational drug
design, based on an understanding of how some cancer cells
function. These molecularly targeted drugs are different because
they target abnormal proteins that are fundamental to the cancer
itself.

83. •Glivec, used in treating chronic myeloid leukemia and some
other cancers, costs a patient about $2,600 (Rs 1,30,000) a
month. Its generic version was available in India for around
$175 (Rs 8,750) per month, reported Associated Press. The
medicine is the lifeline for poor in many developing countries.
•Novartis had argued that it needed to new patent to protect
its investment in the cancer drug Glivec while activists said the
company was trying to use loopholes to make more money out
of a drug whose patent had expired.

84. •Glivec has been patented in nearly 40 countries but only faced
problems in India. The drug was given an EMR by the Indian
patent office in the year 2003, which was for the duration of 5
years. Later, Novartis sued Ranbaxy and Cipla before the High
Courts of Madras and Bombay for making the generic versions
of Glivec. Novartis has fought a legal battle in India since 2006
for a fresh patent.
•In a landmark judgement, India's Supreme Court on December
2014, rejected a patent plea by Swiss drugmaker Novartis AG
for cancer drug Glivec, boosting the case for cheaper drugs for
life-threatening diseases.

85. Thank
You