Regulation and intellectual property of agricultural biotechnologies: Perspectives from the private sector

BIOTECHNOLOGY INDUSTRY ORGANIZATION 1
Biotech Policy: The Need for
Historical Context and Perspective
Adrianne Massey, PhD
Managing Director, Science and Regulatory Affairs
Biotechnology Innovation Organization

Trade association
950 members in 30 nations
– Companies – most are small, “platform” technology
– Academic research institutions/universities
– State-level economic development
Many different economic sectors: health, ag, food
processing, manufacturing, energy, environment…
Use biotechnologies to
– Conduct research
– Make products
– Improve processes

Monoclonal Antibody Technology
Cell/Tissue Culture Technology
Cloning Technology
Bioprocessing Technology
Genetic Engineering Technology
Protein Engineering Technology
Biosensor Technology
Biotechnology ▪ A Set of Technologies

Genetically Modified Organism (GMO):
An organism with genetic material that
was modified intentionally by humans

Genetically Modified Organism (GMO):
Genetically Engineered Organism:
using recombinant DNA (rDNA) techniques
• 1983 – first rDNA plant created
• 1995 – first commercial release
• 1996 – wide-scale commercial
release

“…We have recently advanced our
knowledge of genetics to the point
where we can manipulate life in a
way never intended by nature.
We must now proceed with utmost
caution in the application of this
new found ability.”

“…We have recently advanced our
knowledge of genetics to the point
where we can manipulate life in a
way never intended by nature.
We must now proceed with utmost
caution in the application of this
new found ability.”
1906, critic of the plant breeder,
Luther Burbank

Genetic modification of food is not new.
- All crops we grow
- All animals we raise for food
- All microbes used in food processing
are “GMO’s”

Non-GMO Fruits = Fruits from Wild Plants
Banana
Maize
Tomato
Cucumber

Genetic modification of food crops
stopped being “natural” centuries
before genetic engineering
- Certain varieties of all major crops came
from “unnatural” breeding and have been
in the food supply for many decades.

“Unnatural” Breeding
Plants that do not interbreed successfully
in nature (infertile offspring)
1792 – Plant breeders cross plants
in two different plant species and obtain
fertile seeds (interspecific hybridization)
1906 – Plant breeders cross plants
in two different genera (intergeneric hybrid)

Selective Breeding Across Genera
Bread wheat has been
crossed with at least
eleven different
species in six
different genera.
(No GE wheat has been
commercialized.)

Policy Ignores Plant Breeding History
Ignoring these facts:
• Genetic modification of food is not new.
• Genetic modification of food stopped being
“natural” a long time ago.
Problems with legal definitions of GMOs
- Scope captures unintended products
- Regulatory uncertainty
- Risk or lack of risk is not a factor

Policy Ignores History of Agriculture
If genetic engineering did not exist, these
problems/issues would still exist:
• “Superweeds” – weeds resistant to herbicides
• Insects resistant to Bt (Bacillus thuringiensis)
• Genes moving across taxonomic Families, Orders,
Classes and even Kingdoms
• Gene flow from crops to wild relatives & crops
• Unknown/unexpected allergens
• Farmers not replanting saved seeds
• Patents on plants and seeds

U.S. Law – Plant Intellectual Property
1930 – Plant Patent Act (patent)
1970 – Plant Variety Protection Act (certificate)
1985 - General U.S. Patent Law also applies
to plants (utility patent - broader)
1931 – 1983: >6,100 plant patents
1971 – 1983: >950 PVP certificates

Plant Intellectual Property Protection
Fill in the blank
____________ has filed a number of lawsuits
against U.S. farmers and agricultural retailers.

Plant Intellectual Property Protection
University of California
University of Georgia
Kansas State University
Colorado State University
Oklahoma State University
South Dakota State University
North Dakota State University
____________ has filed a number of lawsuits
against farmers and ag retailers.
All were successful.

U.S. System for Crop Improvement
Private company Improved crop $$$
Gov’t $$$ Public sector Improved crop

Government resources have decreased
Gov’t $ Public sector Improved crop $$
University of California: 10-30 new varieties/yr

University of California – 2007 Snapshot
Non-GE Plant Varieties with Active IP Protection
• Grains 448
• Fruits 101
• Flowers 95
• Vegetables 60
Revenue: 2 strawberry varieties>$3 million/yr

Policy Ignores History of Agriculture
If genetic engineering did not exist, the
regulatory system would look very different.

U.S. Agriculture in 1970
>90% of the soybean and maize acreage is
planted in herbicide tolerant varieties
Breeders continue to
• incorporate disease and insect resistance
genes into crops whenever possible
• improve certain processing traits
• improve nutritional value of grains
• meet consumer demands, [e.g.,
fresh produce year-round]

U.S. Regulatory System – 1970
All new plant varieties are tested by the
developer to ensure it is equal to or better
than existing varieties for the new trait
All new plant varieties are subject to
post-market regulatory oversight.
If there is/might be a problem, U.S. regulators
have very broad authority to act.

U.S. Regulatory System – GE Crops
Pre-market regulatory approval has been
added to post-market oversight
Pre-market approval is the norm for new
• Pharmaceuticals
• Pesticides
• Chemicals

U.S. Regulatory System – GE Crops
Pre-Market Regulatory Approval Systems
• Requirements continually increase,
independent of increased risk or
instances of harm.
• As requirements increase, developer’s
costs increase and that cost increase
has impacts.

Regulation: A Primer by Dudley and Brito
Health and Environment
Regulations
USA
Executive Orders Calling
for Regulatory Reform

Impacts of Regulation
On Products Developed

U.S. Field Trials of GE Plants
Fruits/Vegs Commodity
1992 41% 56%
2002 18% 80%

U.S. - Requests for Commercial Approvals
Type of Traits
Product Quality Agronomic
93 – 96 43% 56%
97 – 99 24% 73%
00 – 04 5% 93%

What Could Have Been in GE Crops
Potato – Amaranth gene protein – Most essential amino acids
Soybean – Increased lysine 5 times
Grains – Increased amount and availability of iron & vitamins
Fruits and Vegetables – Delayed softening
Soybean – Designer fatty acid profiles (increase
monounsaturated; eliminate trans fatty acids; omega 3’s)
Fruits/grain – Nutraceuticals found in vegetables – lycopene,
glucosinolates, lutein, isoflavonoids, saponins,
Peanuts, etc.- No allergenicity
…………………………………

Impacts of Regulation:
Who Develops Products

U.S. System for GE Crop Improvement
Private company Improved crop $$$$
Large enough market to return costs
- Large volume commodity
- Large scale problem

Gov’t $$ Public sector Improved crop
Small, local problems
Small volume crops
Public sector in U.S. rarely, if ever, uses GE
to improve crops due to regulatory costs.

Final Thoughts
Risks/Costs of Technological Innovation
vs.
Risks/Costs of No Technological Innovation

Thank You!

Regulation and intellectual property of agricultural biotechnologies: Perspectives from the private sector

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Viewers also liked

Viewers also liked (14)

Similar to Regulation and intellectual property of agricultural biotechnologies: Perspectives from the private sector

Similar to Regulation and intellectual property of agricultural biotechnologies: Perspectives from the private sector (20)

More from ExternalEvents

More from ExternalEvents (20)

Recently uploaded

Recently uploaded (20)

Regulation and intellectual property of agricultural biotechnologies: Perspectives from the private sector