International Patent Filing: The University Perspective Technology Transfer Tactics August 5, 2010

Overview Emory Statistics General Patent Filing Overview Licensee Issues Nationalization and Regionalization Examples and Strategies Conclusion 10/24/20152Gateway to Discovery, Innovation, and Products

Overview of Filing Practices About 200 ID’s per year File about provisional patent applications per year Focused in healthcare 10/24/20153Gateway to Discovery, Innovation, and Products

Overview of Filing Practices International Filings 10/24/20154Gateway to Discovery, Innovation, and Products

Overview of Filing Practices International Filings – past EPO 10/24/20155Gateway to Discovery, Innovation, and Products

Initial Filing Decisions For Emory Focused in technology areas with long ramp up times – Ready for filing vs must publish – Almost all provisional applications When publication imminent – – Do you need European rights?? Keep grace periods in mind – Canadian Example Publication Diagnostic test (unlikely to enter foreign) Canadian company interested – 1 year general grace period 10/24/20156Gateway to Discovery, Innovation, and Products

Initial Filing Decisions For Emory Does international filing make sense? – Emory ex-US filed technologies – overall income >$720M (>$190M without royalty sale) ( ) – Other, non-ex-US filed revenue ~$20M – Example – Largest royalty stream - >60% from ex-US sales since /24/20157Gateway to Discovery, Innovation, and Products

Conversion Decisions PCT vs US only – Historical filing strategies – PCT and US – PCT only – US only – Technology Type – Device – Software – Pharma » Therapeutics » Diagnostics 10/24/20158Gateway to Discovery, Innovation, and Products

Speed of Prosecution PCT filing delays prosecution USPTO examination tracks – Accelerated Examination Claim limits and ESD – Patent Prosecution Highway programs If favorable examination in “office of first filing”, get claims accelerated in other PTOs – Currently: Australia, Canada, Denmark, EPO, Japan, Korea, Singapore – Triple Tier Examination Proposal Fast track (no ESD), regular, slow track 10/24/20159Gateway to Discovery, Innovation, and Products

Technology Timing How long does it take to get to “Proof of Principle” Prototyping - <1 year Drug Discovery 10Gateway to Discovery, Innovation, and Products

Licensing Issues Timing of License – Technology type and effect on licensing – 2009 Cancer Institute Study 50% of licenses executed in 3 years from first filing and >90% by 8 years Emory – ~45% by 3 years, ~90% by 8 years Later deals in pharma – potential higher royalties, better up fronts Support longer development times 10/24/201511Gateway to Discovery, Innovation, and Products

Licensee Needs What purpose does patent serve? – For litigation, where are potential infringers? Market size Manufacturers (without US import) Competitors – For ‘value add’, is there high perceived value in industry? 10/24/201512Gateway to Discovery, Innovation, and Products

Licensee Issues What do licensees expect – Technology type decisions Will the license get done? How will it affect the deal terms? – Cost-benefit analysis International filing costs: EPO alone >20K, overall >100K to be expected Expect at least 20-40K before reimbursement - will you increase deal value by that? 10/24/201513Gateway to Discovery, Innovation, and Products

Nationalization Decisions Licensed vs unlicensed case Examples – 75-80% nationalization decisions – unlicensed Examples – Inflammatory disorders – ex-US; – Quantum dot coating – US only Strategies for cost reduction Keep your eye on the ball!! 10/24/201514Gateway to Discovery, Innovation, and Products

Nationalization Decisions Special problems with start ups – Largely immune to costs – Floating debt – Want broad filings to ‘increase value’ Strategies for cost reduction – Budget, budget, budget – Watch the bottom line – Do not lose control 10/24/201515Gateway to Discovery, Innovation, and Products

Validation Decisions Licensed vs Unlicensed – Where does one typically validate – Why do you care where a licensee validates – Validating on your own dime “Sunk Cost” issue Will you enforce? Costs – Translations – London Agreement – What are the claims?? Example of claim limitations 10/24/201516Gateway to Discovery, Innovation, and Products

Strategies Keep goal in mind – – Don’t undermine global opportunity, but cost-benefit differs depending on opportunity Take control!! – Get budget and watch it – Shop for alternative options – Delay high costs until license – Watch costs for risky licensees 10/24/201517Gateway to Discovery, Innovation, and Products