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

BIOTECHNOLOGY INDUSTRY ORGANIZATION 1

Biotech Policy: The Need for Historical Context and Perspective

Adrianne Massey, PhDManaging 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 TechnologyCell / Tissue Culture TechnologyCloning TechnologyBioprocessing TechnologyGenetic Engineering TechnologyProtein Engineering TechnologyBiosensor Technology

Biotechnology ▪ A Set of Technologies



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


Genetically Modified Organism (GMO):An organism with genetic material thatwas modified intentionally by humansGenetically Engineered Organism:An organism with genetic material thatwas modified intentionally by humans 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

TomatoCucumber


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 plantsin 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 patents1971 – 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 CaliforniaUniversity of GeorgiaKansas State UniversityColorado State UniversityOklahoma State UniversitySouth Dakota State UniversityNorth 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 Callingfor Regulatory Reform


Impacts of RegulationOn 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 acidsSoybean – Increased lysine 5 timesGrains – Increased amount and availability of iron & vitamins Fruits and Vegetables – Delayed softeningSoybean – 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 Innovationvs.

Risks/Costs of No Technological Innovation


Thank You!

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

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