Managing the First Genetically Engineered Events to Go Off Patent
Panel
Jarrett Abramson Senior Intellectual Property Counsel at International Maize and Wheat Improvement Center (CIMMYT) CGIAR Consortium Jim Schweigert President Gro Alliance
Stacey Stater Associate General Counsel, Regulatory Law & Policy Monsanto Company Shane Anderson – Co-moderator Partner Faegre Baker Daniels Craig Komanecki – Co-moderator Partner Faegre Baker Daniels
Jim Schweigert President Gro Alliance
The Market for Post-Patent Traits
Is it Real or is it Hype?
Basic Trait Licensing Model
Cost Ratio Outline Item Weight Genetic Royalty 1 Seed Production Costs 1-2 Sales, Admin, Distribution, etc 1-3 Trait Royalty 1-7
Monthly Dec CBOT 2004-2016
Major Corn and Soybean Production Areas
The Market Could be Huge Then, Right?
Well…Maybe, but Challenges Still Exist
• Intergressing traits into genetics is difficult and expensive
• Not all inbreds perform well with certain traits • Yield Drag / Poor Pollinator, etc. • Change in Maturity
• Not all hybrid combinations work well with certain traits • Same challenges as above Plus Issues with Expression in Final
Product (hybrids) • Even an issue for commercialization for major companies and
has been an issue with trait launches from multiple trait providers (both inbred and hybrid performance)
Seed Production In One Slide
Challenges…(Cont.)
• The Trait May be Off Patent, but the Genetics May Still be Protected
• Cost advantage would exist (no trait royalty) • Company may still need to license in genetics, but may not
have the rights to conduct breeding (many genetic licenses limited crossing ability)
• Genetics That are No Longer Protected are Not New • By the time protection has expired, genetics are not usually
competitive • If the Genetics and Traits are Not Protected, Farmers
May Save the Seed • (primarily a self-pollinated crop concern)
Current Marketing of Post-Patent Traits
• Activity in the following areas - soybeans • North Dakota • Nebraska • Missouri • Arkansas • others?
• Who Might Sell Them • Interest ranges from Universities, to Independent
Companies, to Mulit-Nationals
What’s the Future Hold?
• Post-Patent Traits will enter the US market in areas of lower productivity
• Will primarily be introduced in two ways • Small companies and universities in small
amounts • As an element of a stacked product by
multi-nationals
• Market share of these products will be small as stand alone products, but could be larger as part of a stacked strategy
Stacey Stater Associate General Counsel, Regulatory Law & Policy Monsanto Company
15
GMOs: The most thoroughly reviewed food product in the world United States: Gold Standard
Monsanto: Safety = #1 Priority
Globally: > 30 government bodies’ globally review and approve GMOs. GMOs have been grown or imported by >70 countries since 1996
Published May 2016: National Academy of Sciences Report on GE
Crops “No substantiated evidence of a difference in risks to human health between current commercially available genetically engineered (GE) crops and conventionally bred crops, nor did it find conclusive cause-and-effect evidence of environmental problems from the GE crops.”
2015 ISAAA Report 20th Anniversary of the Commercialization of Biotech Crops
The International Service for the Acquisition of Agri-biotech Applications (ISAAA) published its annual report on the Global Status of Commercialized Biotech/GM Crops. The report documents key milestones in the worldwide adoption of GM crops and the benefits documented by both developing and industrialized countries.
Ag Biotech Driven by Lengthy Product Development Cycle and Large Investment Process
Year -2 -1 0 2 4 6 7 1 3 5 8 Discovery
Gene/Trait Identification Phase I
Proof of Concept
Phase II Early Development
Phase IV Regulatory Submission
• High throughput screening
• Model crop testing
• Gene optimization
• Crop transformation
• Trait development
• Pre-regulatory data
• Large scale transformation
• Trait integration • Field testing • Regulatory data
generation
• Regulatory submission • Seed bulk-up • Pre-marketing*
$2-5M (5%)
$5-10M (25%)
$10-15M (50%)
$15-30M (75%)
$20-40M (90%)
On Average: Time to market: 10-12 years Total expense: >$100M
Spen
ding
(P
roba
bilit
y of
Suc
cess
in %
)
•Numbers (time duration, spending, and probability of success) are all estimates. The actual for individual projects could vary.
•* Pre-Marketing includes education and technical communications on products
Phase III Advanced Development
Commercial Sales/Planting
9 10
18
Current U.S. Regulatory Context The Coordinated Framework
Shipping Field testing Plant Inc. Protectants (PIPs) - Permits - Field Testing - Notifications - Food Safety Tolerances
PIP Registrations Determination of Food and Feed Herbicide non-regulated status safety consultation Registrations
Three regulatory agencies have oversight for plant biotechnology products under existing legislation
USDA FDA EPA
All Plants Food, Feed, Pharma ‘Pesticidal’ substances
Plant Protection Act Food Drug Cosmetic Act
National Environmental Policy
Act (NEPA)
FIFRA Food Drug Cosmetic Act
precommercial commercial
Sources: ISAAA, Biotechnology Industry Organization, USDA Foreign Agriculture Service, Africa Biosafety Network of Expertise (ABNE).
Product Life Cycle Stewardship
Stewardship for the product life cycle focuses on:
The commitment to food, feed and environmental safety Full compliance with applicable regulatory
requirements Continual active engagement with the
stakeholders to evaluate and promote appropriate stewardship approaches Maximizing access to the technology and its
benefits
Stewardship Activities are Organized in Categories by Phase of Life Cycle
Chemistry Activities Diagnostic Methods Incident Management Launch Preparation Commercial
Sustainability Product
Discontinuation
Discovery/Early
Development Confined Field Activities Regulatory Activities External Contracts Seed Management Communication
Management
Excellence Through Stewardship Mission
ETS promotes the responsible management of plant biotechnology by developing and encouraging implementation of product stewardship practices which: support compliance with regulatory requirements achieve and maintain plant product integrity assist in preventing of trade disruptions promote shared experience and best practices that
foster knowledge transfer across the industry and value chain
drive continuous improvement of stewardship practices as technologies and products advance
excellencethroughstewardship.org
Seed Innovation & Intellectual Property Rights
Genetics Breeding Technologies Biotech Traits Seed Treatments Brands
Post Patent Access to Traits in the US The AgAccord
Applies to the event (trait) after patent expires. > US cultivation and export market import authorizations only
Need for continued regulatory support and stewardship of events. Trade must be maintained. > Proprietary Regulatory Property (PRP)
AgAccord is private contractual solution; provides transparency and predictable framework to access Generic Events. Ability to share costs associated with maintaining global authorizations.
Two agreements: > Generic Event Marketability and Access Agreement (GEMAA) > Data Use and Compensation Agreement (DUCA) > www.agaccord.org
Jarrett Abramson Senior Intellectual Property Counsel at International Maize and Wheat Improvement Center (CIMMYT) CGIAR Consortium
2016 Food & Agriculture National Conference
Managing the First Genetically Engineered Events to Go Off Patent
A Look Outside the United States
by
Jarett Abramson Senior Counsel
Centro Internacional de Mejoramiento de Maiz y Trigo
Global GM crops grown by country Country Area (Millions of
Hectares) % of global GM hectares
Crops
1 United States 73.10 40.3% Maize, Soy, Cotton, Canola, Sugar Beet, Alfalfa, Papaya, Squash, Potato
2 Brazil 42.20 23.3% Maize, Soy, Cotton
3 Argentina 24.30 13.4% Maize, Soy, Cotton
4 Canada 11.60 6.4% Maize, Soy, Canola, SB
5 India 11.60 6.4% Cotton
6 China 3.90 2.1% Cotton, Papaya
7 Paraguay 3.90 2.1% Maize, Soy, Cotton
8 Pakistan 2.85 1.6% Cotton
9 South Africa 2.70 1.5% Maize, Soy, Cotton
10 Uruguay 1.64 0.9% Maize, Soy
GM traits as percent of total GM area
• 57% of the world’s GM crops are herbicide-tolerant • 15% of the world’s GM crops are for insect
resistance • 28% are stacked with both herbicide tolerance and
insect resistance • Remainder is virus tolerance, drought tolerance,
disease resistance
Differing Views of Crops
The Real Challenge for Public, Open Source GMOs
• The greatest impediment to saving seeds once the patent on the trait expires is not the technology developers, it is the regulatory systems in other countries.
• Many of the key US ag export markets approve a trait for a limited number of years. Once that approval expires, the trait developer must go through the regulatory approval process all over again – which means spending money to do more research and submit data to the regulators.
Off-patent GMO: What happens now?
• Regulatory Status in Non-High Income Economies – No AgAccord/Generic Event Marketability and Access
Agreement OUS – Each country sets forth its own equivalent National
Biotechnology Development Policy – Member countries are required to designate competent
authorities and National Focal Points (Liaison officers) to deal with national GMO matters and liaise with the International Secretariat of Convention on Biological Diversity
– Countries follow the Cartagena Protocol on Biosafety
National Biotechnology Development Policy
• Generally the Policy should be thought of as a prohibition of anyone dealing with a GMO (e.g. for research, manufacture, production, commercial release and import) unless licensed by the National Biosafety Authority for contained use or intentional release into the environment
Requirements For Submission of Dossier
• Regulation and Stewardship – Research - contained use, confined use – Introduction into the environment – Placing on the market – Import, transit, export
National Biosafety Authorities • The mandate of NBA is to exercise supervision and control over the
development, transfer, handling and use of genetically modified organisms (GMOs) with a view to ensuring and assuring safety of human and animal health and provision of an adequate level of protection of the environment – NBA provides approval or denial for the development, transfer, handling and
use of genetically modified organisms • Co-ordinate, monitor and assess activities relating to the
development, safe transfer, handling and use of genetically modified organisms in order to ensure that such activities do not have adverse effect on human health and the environment
• Co-ordinate research and surveys in matters relating to the safe development, transfer, handling and use of genetically modified organisms, and to collect, collate and disseminate information about the findings of such research, investigation or survey
• Identify national requirements for manpower development and capacity building in biosafety
CBD and Cartagena Protocol
• The Cartagena Protocol regulates “transboundary movement, transit [movement through countries other than the country of initial export and final import], handling and use of living modified organisms (LMO) that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.”
• The Protocol addresses two general categories of LMOs: – those intended for release into the environment (e.g., seeds for
cultivation and animals for breeding); and – those intended for use in food or feed, or for processing (e.g.,
bulk commodities, such as corn, cotton, and soy).
Risk Assessment
• Objective: “To identify and evaluate the potential adverse effects of GMO to human health, animal and environment”
• General principles:
– Scientifically sound and transparent manner – Lack of scientific knowledge or consensus does not imply
a particular level of risk – Risk of GMO must be considered in the context of non-
GMO
Case Study - WEMA • Designed to bring drought-tolerant and insect-protected
maize using conventional breeding, marker-assisted breeding, and biotechnology, with a goal to make these varieties available royalty-free to smallholder farmers in Sub-Saharan Africa through African seed companies.
• Donated Traits – Mon810 – Mon87460
WEMA Cont.
• Integrated Pest Management (IPM) practices and to develop and implement Insect Resistance Management (IRM).
• Filed first application form for environmental release for Bt Maize. – General Information – Information on the Genetically Modified Organism – Characteristics of genetic modification – Recipient Organism Or Parental Organisms – Donor organism (s) – Intended Use and Receiving Environment – Environmental Safety Assessment
WEMA Cont.
• Received conditional release of insect resistant Bt maize in Kenya by Kenya’s National Biosafety Authority.
• Future Steps: – Conduct an Environmental Impact Assessment (EIA) prior
to the National Performance Trials (NPTs) and an Environmental Social Impact Assessment (ESIA) of the NPT sites;
– Submission of a product stewardship management plan and a monitoring roadmap; and
– Conduct a compositional analysis of the Bt maize grain, in accordance with CODEX Alimentarius Plant Guideline, during the NPTs.
WEMA cont. • Future Steps for Licensing
– Excellence Through Stewardship Protocols in Place Management accountability Addressing applicable regulatory requirements Ensuring further development and implementation of a product-specific
IRM plan Implementing market deployment and IRM awareness strategy
• Farmers • Retailers • Growers
Implementing compliance programs Implementing resistance monitoring Handling reports of potential resistance Records and documentation
Thank you for your interest!
Panel
Jarrett Abramson Senior Intellectual Property Counsel at International Maize and Wheat Improvement Center (CIMMYT) CGIAR Consortium Jim Schweigert President Gro Alliance
Stacey Stater Associate General Counsel, Regulatory Law & Policy Monsanto Company Shane Anderson – Co-moderator Partner Faegre Baker Daniels Craig Komanecki – Co-moderator Partner Faegre Baker Daniels