1. GENE EDITING: Regulatory & IP Considerations
Cassie J. Edgar
Chief IP & Regulatory Officer
Genus plc
IowaBIO Innovation Workshop
November 2017

2. Overview Why talk about IP & Regulatory? Four Key Takeaways
All organisms are not treated the same
Regulatory Framework is a global puzzle
Know your tennis balls
IP strategy needs to be evergreen
Why talk about IP & Regulatory?
Four Key Takeaways

3. Why talk about IP & Regulatory for gene editing?
Appropriate IP & Regulatory counsel is critical IP & Regulatory decisions deeply embedded from initiation through post-launch phases
Intellectual Property
Freedom to operate
Patents vs. trade secrets
Contract considerations for biological materials
Patent exhaustion, IP enforcement
Regulatory: Local, National, Global
Agency relationships and understanding requirements
Regulatory Data Package & Approvals
Stewardship
Compliance
Business Development
Startups
Funding: Seed, Series A, B, IPO
Collaborations, JVs, M&A
Product Development
Project and Portfolio Management
Risk assessment and mitigation
Launch and post-launch planning

4. Four Key Takeaways All organisms are not treated the same
Regulatory Framework is a global puzzle
Know your tennis balls
IP strategy needs to be evergreen
Four Key Takeaways

5. All organisms are not treated the same
Coordinated Framework for Biotechnology
USDA
Scope: Plants and seeds, animal biologics, meat & poultry
Gene editing: Authority to regulate GE plants that are or have the potential to be “plant pests” as defined and detailed in 7 CFR 340
Plant Protection Act (PPA) 7 U.S.C. §§ 7701 et seq.
FDA
Food & Feed, human biologics, drugs, GE animals, medical devices
Gene editing: human applications, voluntary consultation if novel protein in plants, GE animals regulated as animal drugs
Federal Food Drug & Cosmetic Act (FFDCA) 21 U.S.C. §§ 301 et seq.
EPA
Plant pesticides, herbicides, chemicals, microbials, GE mosquitos
Gene editing: GE mosquitos if they are “pesticides”
FIFRA : 7 21 U.S.C. §§ 301 et seq.
National Environmental Protection Act (NEPA)
42 U.S.C. §§ 4321 et. seq.

6. Overview: GE Food Regulatory Requirements
Examples
With GE organisms intended for human consumption, there are a variety of approvals required:
Data requirements differ per country: there is no global harmonized regulatory system
Data requirements differ for cultivation and food/feed approvals
Labeling
Changes in labeling requirements and public desire for transparency will likely also result in labeling distinction of final food products
Cultivation/Production
Approval to grow
Food/Feed
Approval for consumption
Permits/
Shipment
Examples: For interstate and international movement

7. Regulatory framework for gene editing is global puzzle
Engagement with emerging global regulatory framework is necessary for commodity products
Countries are still figuring out when and how to regulate gene edited products
Engagement in dialogue is critical
Recent jurisdictions of focus: Canada, Mexico, China, Korea, Japan, EU
With public, government, industry groups, and regulators

8. Methods of playing the game
Know your tennis balls
IP analysis and strategy begins with answering this question:
“What are you trying to accomplish”
News on interference proceedings or patent claims or “who owns the patents” must be analyzed in the proper context of that question
Consider offense and defense
Tennis Balls
Green tennis balls
Keeping score
Ball
holders
Methods of playing the game
Footballs

9. IP Strategy needs to be evergreen
Appropriate IP & Regulatory counsel is critical
IP & Regulatory decisions need to be refreshed throughout product lifecycle
On any given Tuesday, the world can change…
Intellectual Property
Freedom to operate
Patents vs. trade secrets
Contract considerations for biological materials
Patent exhaustion, IP enforcement
Regulatory: Local, National, Global
Agency relationships and understanding requirements
Regulatory Data Package & Approvals
Stewardship
Compliance
Business Development
Startups
Funding: Seed, Series A, B, IPO
Collaborations, JVs, M&A
Product Development
Project and Portfolio Management
Risk assessment and mitigation
Launch and post-launch planning
Regulatory & IP law changes on a more rapid cadence than product development timelines for gene edited products…

10. Thank you!
IP & Regulatory legal partnership with the business is critical to advancing innovation
Four Key Takeaways
for regulatory & IP
in gene editing
All organisms are not treated the same
Regulatory Framework is a global puzzle
Know your tennis balls
IP strategy needs to be evergreen
Questions?
Cassie Edgar