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Transcript of Carol mimura open society july 31, 2010, copy
IP Strategies, Humanitarian Contract Clauses &
Business Models to Address Unmet Needs
July 31, 2010Open Society Symposium
Carol Mimura, Ph.D.Assistant Vice Chancellor, IPIRAUniversity of California, Berkeleyhttp://ipira.berkeley.edu
University Mission and Social CompactTeaching, Research, Dissemination of Information, Public service
University of California’s (UC’s) economic impact is huge:
7% of all R&D activity in CA takes place at UC campuses* 1.3% of the growth in CA Gross St. Product* is due to productivity gains
resulting from the research activities of the University of CA >$5B in federal funding (10 campuses) 4 invention disclosures per calendar day
As a research university we have a duty to ensure that basic research that has a practical application is
transmitted and deployed to benefit society
*2003 data from California’s Future: It Starts Here (2004) IBF consulting group
Tremendous Needs, Tremendous DisparitiesJP greatest life exp. 81 World population of 6.5 Billion Botswana lowest 35 ~1B in wealthiest World life expectancy: 65 2.4B live in low income
countriesItaly 20% age 65+*, In Haiti 4%* 3.1B in middle income
*Population Reference Bureau
Socially Responsible Licensing Program, SRLP
IP management strategy Special attention to DC unmet needs
-Neglected disease conditions-Neglected populations
Contract clauses: access & affordabilityGood stewardship of IP rights
9 Points to Consider in University Licensing
Point 9: “Consider inclusion of provisions in contracts that address unmet needs, such as those of neglected
patient populations or geographic areas, giving particular attention to improved therapeutics, diagnostics, and agricultural technologies for the developing world”
Aspirational: working out clauses, seeking solutions, experimenting
SRLP Examples at BerkeleyDiagnostics - portable, hand-held
• Dengue (Sustainable Sciences Institute) • HIV (P-o-C early) (Silicon Biodevices )
Therapeutics• Malaria ACTs, (iOWH, Amyris Biotechnologies, sanofi-aventis)• anti-viral (Samoa)• TB (CA biotechnology company)• oncology (pharma)
Vaccines• STD (pharma)
SRLP Examples at Berkeley - continuedAgricultural Biotechnology
• Plant disease resistance (Two Blades)pesticide-free crops• Super sorghum (Africa Harvest)
Public Health • sanitation, water purity (Aquaya Inst.)
Consumer Electronics & information
technology (Nokia)
University Research Results are Far from Being a Commercial Product
Commercial investment by others is required to bring basic research results to the point of practical application
Development
Discovery
Translation
Deployment
Technology transfer: the road to commercializatonof university IP is typically a series of separate steps
Often involving multiple parties
>10 years, >$1B
The Translational Research Gap is Both Wide and Deep
Bench to bedside
Licensees invest enormous sums in risky R&D, manufacturing, regulatory approvals
For profit market, For profit licensees
Bottom line: IP licensing gives industry an incentive to invest
Bench to clinic
Health Innovation Requires Many Actors, Many Inputs
Low Cost Artemisinin Combination Therapy$42.6M Bill & Melinda Gates Foundation
3-way collaboration agreement + 2 license agreements
$8M to Berkeley
BASIC RESEARCH
$12M to Amyris
BiotechnologiesAPPLIED
RESEARCH
MFG, REGULATORY,
DISTRIBUTION
$22.6M to iOWH
Pharma (sanofi-
aventis)
3- way research
Collaboration
Agreement
License #1 Berkeley to
Amyris. Developed world.
All FOUs. No profit for
malaria drug. Profit for flavors &
fragrances
License #2 Berkeley to iOWH.
Malaria FOU. Developing World.
Sell drug at cost
The Fundamental Problem
For neglected disease, neglected populationsTension, balance • profit motive, market forces(incl. price elast., related supply & demand) • societal needs that are not market drivenSRLP “access & afford” • Price -market economy factor
• Contracts - non-market economy needs
Commercial Incentives
Social Welfare
Finding the Exquisite Balance
IP licensing is but one aspect
SRLP challenge
Retain commercial incentives
Outside of “market economy” countries
Commercial Incentives
Social Welfare
AccessAffordability
ProfitShareholders
“Bento Box” Solution Humanitarian clauses + IP Strategies + Business Models
Contract Levers IP strategy
A
B
C
Business Model
1
2
3
X
Y
Z
Contract Lever IP Strategy Business Model Parties (govt, univ, industry) status (licensee, sub, collaborator)
Nonassert ion Dua l co mm ercia lizat ion
Licensed territory Patent/no p atent and whe re
For -, no n- prof it ent ity
Human itar ian Fie ld-of-use
Open license PDP, co llaborat ion, Timing, co-dev, co-mkt
Exclus ive, co-, no n-exclus ive
Open so urce Fund ing , se lf, so urces OP M
Roya lty-free in DW Roya lty bear ing, non- Roy. shar ing , -non
Research C omm ons Alliance, sponsorsh ip
Pr ice restr ictions -targ et -tiere d (conv ers ion opt ion)
Patent Poo l
Incent ives Timing (PRV) End user go vt, ind ivid, HMOs
Human itar ian re servat ion of rights
Monet ize Corpora te re spons ibility
Mandat ory sub licens ing Soc ia l impact Monet ary ROI Non-monetary ROI
Ownersh ip So le, joint Shor t te rm, long ter m ROI
No particular order, no associations horizontally
Permutations, Combinations (mix, match to create incentives, alignment)
University Contracts: License, Research, Collaboration Agreements, Foundation Awards
Development,Translation
Deployment, Commercialization
Discovery, Innovation
University SRLPs only ONE part of a multi-part solution
Diminishing Role
University Contracts
Development,Translation
Deployment, Commercialization
Discovery, Innovation
•Public health & global health organizations• Health infrastructure
in Developing Countries (DCs)
• DC manufacturing, trade relationships
• Public policy & international policy
• International law & treaties
• Poverty, sanitation, environment
Downstream solutions by others are necessary
Diminishing Role
University is one contributor among many
Government
IndustryFoundations
Academia,ResearchInstitutes
InternationalRelief Agencies
NGOs
InternationalFinancial Institutions
Int’l HealthOrganizations
LESSONS LEARNED:One Size Does Not Fit All
Must preserve incentives
Must preserve Options• Filing outside of US, JP, EPO, CA, AU
- in-country presence- long term view
• Not obtaining IP rights- commons can destroy traits- invent around
• Compulsory licensing - last resort
No dismantling of the system, just adjustments
SRLP: Patterns, Models Traditional, linear (handoff)
A B
University Corporate Licensee
Federal funding
Discovery
VALU
E
IP rightslicensing
R&Dregulatory
deployment
SRLP: Patterns, Models• Traditional, linear handoff• Push me - Pull you
A B
University Corporate Licensee
Federal funding
Discovery, IP rights, licensing, R&D, clinical, regulatory, commercialization
Traditional, Linear License
• Value Proposition• Poor, Push Me - Pull You• No profit incentive DCs
• Royalty free in EDCs- Provide at cost or free• Royalty bearing • Third party challenge• Enforcement
A B
University Corporate Licensee
Federal funding Expensive R&DRegulatory risks
Discovery R&D Clinical Regulatory Deploy$1B and 12+ years
Reward
Risk
Hand-Off
License + Research Collaboration: Partnering• Non linear• Overlapping & loopbacks• Value Proposition better• Compressed timeline• Shared funding • Gap funding• Shared tools, expertise, data• Lower risk, more mature• Feedback: adjustments
– Scale -up considerations– Proprietary components
A B
University Corporate Licensee
Shared fundingTools, data
Expensive R&DRegulatory risks
Discovery, Translation, Commercialization
R:R balance better. Both parties perform in parallel, not just in sequence, innovation acceleration, extend Univ. role further into value chainGoal alignment: translational research, improvements
RewardRisk
Partnering: PDPs Play a Central RoleProduct Development Partnerships (PDPs) nonprofits, funded by foundations, othersPartner up & down the value chain & leverage mutual resources, capabilities, Operate in crucial, middle area; Add value, decrease risk, increase uptake under SRL
termsA to C unlikely (too risky); B to C likely (nonprofits have de-risked)
Research
VALU
E
IP rightslicensing
R&DClinical
regulatorydeployment
A C
Discovery Development Translation
B Commer. uptakeSpecial terms
Multiple Licensees: NonProfit, ForProfit & Hybrid
Still no profit incentive DCs for both • Value proposition good • Different incentivesFor-profit• Profit goal• Dual commercialization plan• Dual market (short term, nonprofit)• Corporate Social Responsibility• Bootstrap philanthropyNon-profit: • Funding from Charitable orgs• Shared grants• Charitable aims as goal for NP• Partnering Ultimate Goal: DERISK for FOR PROFITsublicensee
A
B
University
Licensee is NonProfitLT is Dev Countries FOU is humanitarian
Expensive R&DRegulatory risksLong term prospects
C
Licensee is ForProfitLT Developed worldFOU is market driven(+humanitarian)
Reward Risk
For Each Scenario Align Goals,Incentives for Each Participant
Must be able to answerWhat’s in it for Me? (“WIIFM”)
For each party to:Invest in rare, neglected, tropical diseaseSell, distribute at costInvest in DC manufacturingImprove DC health delivery systemsPrepare next generation of SR global citizens
A+B+C(A+B)+DA+CB+C(C+D) A laterJoint VentureStrategic AlliancePPP, PDP Acquisition
“WIIFM” for Industry• More than ever before!• FDA priority review voucher ($50M - $300M)*• Assistance in navigating drug regulatory systems in NG-
endemic countries • In-country market presence (will scale, create customers)• Social ROI - goodwill• Employee retention, satisfaction• Partnering opportunities (pipelines from PDPs and PPPs)
*Food, Drug and Cosmetic Act section 524, 21 U.S.C. Section 360n (2008)
WIIFM: Universities, Research InstitutesFulfill social mission, achieve societal impact, global scaleAlign moral imperative to help with University mission
– Teaching, research, public service– TT and IP management for public benefit– Prepare the next generation
Diversify funding sources - government, foundations, FPs, NPs, PDPs
- traverse valley of deathCollaborations, involvement further into the translational
research space (accelerate innovation)Influence public policy, research paradigms address grand
challenges & industry-university relationsReputational gains, gifts, goodwill, donations
WIIFM for Government• Global linkages• G. Health linked to poverty• Obama Global Health Initiative• U.N. Millennium Development
Goals• Global economic development
goals inextricably linked to global: health, food security, energy risks, the environmental, political stability
• Investments create markets, wealth, goodwill
Resources:
Socially Responsible Licensing at Berkeley
Humanitarian Use Clauses in Contracts
http://ipira.berkeley.edu then “Socially Responsible IP management”