ip management strategies to maximize research impact ...citris-uc.org/files/carol...

62
IP Management Strategies to Maximize Research Impact Collaboration & to Maximize Research Impact, Collaboration & Translation September 22, 2008 Carol Mimura, Ph.D. Assistant Vice Chancellor for Intellectual Property and Industry Research Alliances (IPIRA) Ui it f C lif i B kl University of California, Berkeley

Upload: others

Post on 27-May-2020

6 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

IP Management Strategies to Maximize Research Impact Collaboration &to Maximize Research Impact, Collaboration &

Translation

September 22, 2008

Carol Mimura, Ph.D.Assistant Vice Chancellor forIntellectual Property and Industry Research Alliances (IPIRA)U i it f C lif i B k lUniversity of California, Berkeley

Page 2: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

University Mission and Social Compact

Teaching, research, dissemination of informationpublic service

California’s Future: It Starts HereUC’s Contributions to Economic Growth, Health & CultureIn 2002:In 2002:

7% of all R&D activity in CA takes place at UC campuses1.3% of the growth in CA Gross St. Product is due to productivity gains resulting from the research activities ofproductivity gains resulting from the research activities of the University of CAThree invention disclosures per calendar day

As a university we have a duty to ensure that basic research that has a practical application is

transmitted and deployed to benefit society

Page 3: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

IP M t t B k lIP Management at Berkeley

Page 4: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

IPIRA acknowledges the importance of Industry-University collaboration as an innovation accelerator

Economic Development

that fuels economic development

University Industryy

Page 5: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

…and to acknowledge that Industry-University Partnerships, which lie at the intersection of science,

Science &Engineering

business and law, engender research & innovation

Business Law

Page 6: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Industry-University relationships have been instrumental in the development of the biotech & high tech industries, two of the

Science &

p gCalifornia’s important economic drivers. Those sectors continue to support industry/university research collaboration and innovation.

Engineering

University EconomicDevelopment

InformationTechnology gyBiotechnology

Energy Biosciences

Business LawIndustryBusiness y

Page 7: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Interconnected Overlapping Triads

Government

Interconnected, Overlapping Triads

Law Firms Seed Capital

Industry UniversityVenture Industry y

Capital

Page 8: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Logo reflects theVitality and Interconnectivity of the Industry-University interfaceVitality and Interconnectivity of the Industry-University interface

Relationships are Key

We MUST WORK TOGETHERincluding PPPs and PDPs to bridge translational research gaps

Page 9: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

IPIRA Consists of Two Peer Divisions under Common Management

Industry Alliances Offi

Office of Technology Li iOffice

IAOLicensing

OTL

Page 10: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Relationships Are Key

Our Network is Our StrengthOur Network is Our Strength

Page 11: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Research at BerkeleBerkeley

Industry Alliances Office Office of Technology LicensingIP LICENSING

Funding & Collaboration PULL PUSH

IAOgy g

OTL

Private Sector ate SectoResearch and

Commercialization

Corporate Sponsored Research Agreements, Collaboration Agreements Incoming MTAs

Patent and Copyright Licenses, Outgoing MTAs, SRA Support StartupsAgreements, Incoming MTAs,

Industry Affiliates Programs (Consortia)

SRA Support, Startups

Page 12: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Self-perpetuating cycle that stimulates innovation and reduces the emphasis on IP marketingand reduces the emphasis on IP marketing

Corporate sponsorCorporate sponsor funds desired research

and is the ready licensee

Innovation and

Funding, materials

PULL PUSHand

New IPmaterials, collaboration

Industry Alliances Office of Technology IPIRA

yOfficeIAO

gyLicensing

OTLBerkeleyResearch

Page 13: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Berkeley’s Approach in IPIRA

What is technology transfer?

Most common definition of TT is not consistent with our approachpp

Our approach is expansive

TT is an ongoing relationship continuum, not a single transaction

•many years, many points of contact

•building a pyramid, contributing

diff t t f idifferent sectors of a pie

Relationship model: collaborations, partnerships are key

Our networks are our strength

Page 14: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Consistent with UC Goals,Immediate Past UC President Robert Dynes: RD & D

R h D l t d DELIVERYResearch, Development and DELIVERY

UC $3B federal funding, $8.5 total research funding7% of R&D in the State of California7% of R&D in the State of California3 invention disclosures per day

IMPACT as goal of TT program at BerkeleyIMPACT as goal of TT program at BerkeleyIP management approach favors all forms of dissemination

Page 15: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

TT Success Under the Relationship & Social Impact Model

• Success in TT consists of rights transfer and knowledge transfer in both directions to enable innovation acceleration, deployment, uptake, , p y , p ,translation

• Maximization of research IMPACT is the goal is the primary factor inMaximization of research IMPACT is the goal is the primary factor in gauging TT success

• Revenue generation being secondary to that• Revenue generation being secondary to that

Page 16: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Most TT occurs in traditional ways: teaching, graduates, consulting, informing

With ownership comes responsibility

Good stewards of IP think of broad implications when they make University property proprietary

and don’t impede public access to vital technologies for research, for cures

Technology transfer at Berkeley is reflective of the culture at Berkeley

Berkeley has a strong record of public service (and B-school law-school)Berkeley has a strong record of public service (and B school, law school), established reputation for public access to tools (BSD, opensource licensing)

Page 17: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

All Under the “Umbrella” of the Corporate Relationship

Industry Alliances OfficeIAO

Office of Technology LicensingOTLIAO OTL

Page 18: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

TT is a relationship continuum, not a single transaction The Relationship Model Bears FruitThe Relationship Model Bears Fruit

When institutions value the corporate relationship more than any single transaction, utilize their networks to advantage, and value research support as highly as license revenue, the overall dynamic changes

• Break through cultural and negotiation barriers

• Attracts funding, promotes collaboration

• Establishes a high comfort level for consummating transactions or g ggiving gifts

Page 19: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

The Relationship Model Bears FruitThe Relationship Model Bears Fruit

Corporate Sponsored Research funding nearly tripled

Gift Funding increased both from private and foundation sources

Foundation funding increased

Greater number and types of PPPs, PDPsy

Page 20: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

New Definition of Success in IPIRA Makes all approaches equally viable effectiveMakes all approaches equally viable, effective

If success is measured only by numbers of patents, patent royalties and fees you bring in licensing practices will reflect that

• Nonremunerative transactions & free licenses less desirable

• Services will have a lower priority

• Schizophrenia (service or business?)

• Misaligned expectations

Page 21: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

If: Social impact, translational efficiency, innovation acceleration global outreach, uptake, collaboration, sharing, gifts, reputational gains, affiliation, PDPs, PPPs

Including: speed of, efficiency of, efficacy of above

Then: No single model for transacting TT is dominant. Industry-specific needs can be addressed. Full spectrum of IP management strategies is available to deploy innovation for maximal societal impact

“Alternatives” to traditional TT are equally viable:patent pooling, public domain, open source, royalty free licensing, commons, not patenting or not patenting in certain geographiesp g g g p

Page 22: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Expanded Definition of TT Success Expanded Menu of Choices for Different Industry

The traditional “biotech” TT model:

Sectors

Emphasis on IP protection, long R&D time lines, exclusive licensing, and running royalties, milestone payments, multiple payments

Informed past TT metrics, reports: Statistics informed practice

“Biotech” TT model is but one approach among manyNon-royalty bearing licenses: not counted (under-), disincentive, deemed less

important, low priority

• Information Technology (IT) industry, chemical, oil & gas different needsgy ( ) y, , g

• Freedom to operate in research agreements (NERF, nonassert): short R&D timelines, incremental improvements, no running royalties, nominal fees

Page 23: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Metrics for Measuring Impact

Social impact, translational efficiency, innovation acceleration, global outreach, uptake, collaboration, sharing gifts reputational gains affiliation PDPs PPPssharing, gifts, reputational gains, affiliation, PDPs, PPPsIncluding: speed of, efficiency of, efficacy of above

Double Bottom-Line AccountingDouble Bottom-Line Accounting

Financial Social ImpactTraditional metrics:# of licenses# of patents

Neglected or tropical disease research funded, lives saved, medical costs

d d ftp

# license revenue# start-upEquity options

reduced, software distributed under BSD, research tools shared, collaboration enabledEquity, options collaboration enabled, knowledge and expertise transferred…

Page 24: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Metrics

Challenges: Quantitation (reputation)CommensurationBase-lineDifferent portals (% of gift funding)St ffi i f t tStaffing, infrastructure

Examples:

UC Berkeley's Economic Impact and Social Benefitshttp://www.berkeley.edu/econimpact/http://www.berkeley.edu/econimpact/

Better World Projecthttp://www betterworldproject net/index cfmhttp://www.betterworldproject.net/index.cfm

Page 25: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

A Full Spectrum of IP Management Models to Achieve Impact, Access, Uptake & Disseminationp

Gift Nonexcl.,IP-moot

SRA Exclusive,IP-centric

Industry ConsortiaDefault is nonexclusive

IP-neutral

Increasing emphasis on IP and deliverables

Decreasing indirect cost rates reflecting decreasing rights

IP expectedWork planDeliverables

Intermediate overheadMembership agreement

No contractNo deliverables

Budget

Page 26: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Applying new metrics the goal of Impact can be achieved in many waysProcess: management to achieve translation of research resultsProcess: management to achieve translation of research results

SRAExclusive,IP centric

IndustryAffiliate

Programs

Open Collaboration

Open SourcePatent PoolsIP Commons

Public DomainIP-moot

Decreasing emphasis on IP deliverables ownership

IP-centric Programs IP Commons

Decreasing emphasis on IP, deliverables, ownership

Continuum of management tools to ensure access, dissemination g ,

Innovation acceleration RELATIONSHIP LIFECYCLEA given activity is not at the expense of anotherA given activity is not at the expense of anotherDifferent approaches for different purpose & nuances within categories400+ agreements / year

Page 27: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration
Page 28: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration
Page 29: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

The IT Perspective

Information Technology is:Not biotech, not pharma

Incremental improvementsShort R&D timeframesNo running royalties

Freedom to operateFreedom to operateNonexclusive (often NERF) licenseNOT exclusive, royalty bearing, high risk, high investment

Publication and public domain fineWe hear you:y

HP’s Global Collaborative Research (HP Open Innovation)Intel Lablet at Berkeley Open Collaboration

Page 30: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Intel Open Collaboration Agreement

Intel lablet in Berkeley (U WA, CMU, Cambridge*)Off-campus (adjacent)Hi hl l ti h bl k titiHighly speculative research, blue-sky, noncompetitiveIP not expected to arise

Publish early and oftenPublish early and oftenCan file patents but all nonexclusive licenses First 7 years, noneOther companies can participate none to dateOther companies can participate, none to date

Innovation accelerator: encourages collaborationReduces barriers in areas where IP perceived to be aphindrance to collaboration

Access to Intel equipment, chips, personnelAccess talent, cutting edge researchR&D outsourcing: Tennenhouse DARPA

Page 31: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

U.C. Berkeley’s Socially Responsible Licensing Program (SRLP)

One of several IP rights management strategies in IPIRA

St i t i i th i t f h i ll i thStrives to maximize the impact of our research, especially in the developing world http:ipira.berkeley.edu

C b i t B k l f hCan bring resources to Berkeley for research Typically agree to forgo or reduce future IP license revenue

Can include not patenting and/or selectively by geographyCan include not patenting and/or selectively by geography

Faculty service, societal benefit

Broader base of foundations and agencies as a funding resource

Page 32: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Goals of the Socially Responsible Licensing Program in IPIRA

Ensure widespread availabiity of technology & healthcare in the developing worlddeveloping worldAttribution Revenue sharing Affordable pricingAffordable pricing Reservations of rightsExpeditious sharing of research materialsExpeditious publication of scientific results in accessible journalsIP management that provides commercial incentives, yet benefits the poor

Page 33: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Why?

Help for the developing world is a moral imperative. Countries with resources should help those that are resource poor.

The opportunity cost of giving away University-generated therapies, etc. for free in the developing world is low compared to the societal benefit

The university is not harmed because the goal is consistent with our definition of TT success of maximizing “impact”

Success is measured by new metrics: lives saved, social impact, research funding

Consistent with our culture, professionally rewarding

Can stimulate business & societal change

R i l iReputational gains

Page 34: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

ExamplesInnovations Licensed

and/or Funded Under SRLPand/or Funded Under SRLPDiagnostic: Hand-held, MEMS device Denge Fever, Nicaragua

Sustainable Sciences Institute (nonprofit). Eva Harris: Royalty free sales for l SSI i fit i t i t i A hi t las long as SSI remains a nonprofit in certain countries. Achieves our mutual

goal of bringing low-cost diagnostic to developing world. Wanted patents…

Therapeutic: Antiviral compound from native plante apeut c t a co pou d o at e p a tCommonwealth of Samoa research collab. & revenue sharingJay Keasling: Compound from Mamala tree bark. Possible HIV drug. Attribution to Samoa naming plasmids, etc. Access to native trees, local experts facilitation of exports Revenue sharing if a drug is commercializedexperts, facilitation of exports. Revenue sharing if a drug is commercialized

Agriculture: Plant disease resistanceAg-biotech company license No-cost sublicenses in AfricaAg biotech company license. No cost sublicenses in Africa

Vaccine: TB vaccine researchIf vaccine is invented with company funding at Berkeley, vaccine distribution p y g y,will be royalty-free in defined countries

Page 35: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Examples, continued

Hunger: bioEnhanced SorghumAfrica Harvest consortium funded by Gates Foundation Advance commitment toAfrica Harvest consortium funded by Gates Foundation. Advance commitment to

allow royalty free sales in Africa. More nutritious and more digestible sorghum

Sanitation: Water purity and testingSanitation: Water purity and testingAquaya Institute: global access strategy

And several research agreements from federal and foundation sourcesAnd several research agreements from federal and foundation sources

Advance commitment from Berkeley to grant royalty-free licenses and/or requirement to provide licensed products for free or at cost for humanitarian usep p

Page 36: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

PDP: Malaria Drug Development Partnershipa t e s p

• Malaria afflicts up to 500M per year, kills 1-3M. Tropical disease, under resourced - profit margins low.

• Berkeley (Jay Keasling) has patented technology that allows terpene synthesis genes to engineered in E. coli and yeast. Overproduce artemisinin for ACT.

• Reduce reliance on natural product (extracted from wormwood)Reduce reliance on natural product (extracted from wormwood)

• Berkeley’s start-up Co., Amyris Biotechnologies, Inc. refine and scale up

The Instit te for One World Health (iOWH) is the orld’s first nonprofit pharmace tical• The Institute for One World Health (iOWH) is the world’s first nonprofit pharmaceutical company and has expertise in clinical trials, FDA regulatory approvals. Mission: cure infectious diseases in developing world

Gates Foundation Berkeley iOWH Amyris have a mutual goal of making the existing• Gates Foundation, Berkeley, iOWH, Amyris have a mutual goal of making the existing malaria drug affordable ($2.40 per dose to ~24 cents).

• Neither Berkeley, iOWH, Amyris alone can see the project through to completion, Bill & Melinda Gates Foundation will fund if pricing and access goals are assuredMelinda Gates Foundation will fund if pricing and access goals are assured

Page 37: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Low Cost Artemisinin Combination Therapy$42.6M Bill & Melinda Gates Foundation

3-way collaboration agreement 2 license agreements3-way collaboration agreement, 2 license agreements

$22.6M to iOWHPharma (Sanofi-

$12M to Amyris Biotechnologies REGULATORY,

Pharma (SanofiAventis)

$8M to Berkeley APPLIEDRESEARCH

DISTRIBUTION

BASIC RESEARCH

3- way research Collaboration

License #1 Berkeley to Amyris. Developed

License #2 Berkeley to iOWH. Sell drug at cost Collaboration

Agreementworld. No profit for malaria drug. Profit for flavors & fragrances

gin developing world

Page 38: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

A Single Grant to Expedite Translational Research and Clinical/Regulatory Approvals

$12M to Amyris Biotechnologies

$22.6M to iOWH(Sanofi-Aventis)$8M to Berkeley

UniversityBASIC RESEARCH

Biotechnology Co.A li d RESEARCH

Pharmaceutical Co.

BASIC RESEARCH Applied RESEARCH REGULATORY&CLINICALS

• Instead of a “relay race” a single donor makes one grant to fund basic research translational research clinical & regulatorybasic research, translational research, clinical & regulatory activities• No uncertainty in finding the next partner • No uncertainty in future contract terms• No gaps (time, expertise, additional transactions) between stages

Page 39: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

This model: seamless transitions toaccelerate & streamline translational research,accelerate & streamline translational research, commercialization & economic development

BASIC RESEARCH APPLIED RESEARCH CLINICAL/REGULATORY

•The model exemplifies “bench to bedside” translational research.

•Gates: hopes this structure will serve as a model for other Universitiesand calls it “An extraordinary public-private partnership that combines cutting edge science with a commitment to affordability and accessibility for those people in need.”y y p p

•William Haseltine: HGS founder: “The beginning of a new paradigm that could be transformational.”

•Tony Fauci, NIAID Director, “…Collaborations, coordination, and synergies between the private and public sectors are becoming increasingly essential.”

Page 40: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Socially Responsible Licensing at Berkeleyy p g y

Humanitarian Use Clauses in Contracts

References:

www.ipira.berkeley.edu then “socially responsible IP management”

Page 41: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Socially Responsible Licensing at Berkeley: Humanitarian Use Clauses

How: Implementation of the Program. Addressing Access and AffordabilityIN A LICENSE AGREEMENT

1) Goal of inducing investment: Grant of royalty free sales in a specified licensed territory ) g y y p y– In the developing world (but royalty collected in the developed world)– Def. of developing world has varied: “least developed” list of countries defined by WHO,

predefined list of countries such as “low and middle income” list on charity sites. Static list, dynamic list.y

– Inventors must agree (informed participation)– Revoked if licensee nonprofit status is lost or converted

2) Goal of ensuring affordable access: Require the licensee to give away for free2) Goal of ensuring affordable access: Require the licensee to give away for freein the developing world or sell at cost (or offer the lowest cost granted to any customer)

- definition of “at cost”: cost of manufacture and distribution- please consider: collusion, price fixing, antitrust, anticompetitive behavior

3) Ensure access for nonprofit research: Reservation of the rights:standard shop right for ourselves and other nonprofits.

4) In future, to license a generics manufacturer if licensee doesn’t provide access (but issues of accreditation, branding, packaging, parallel importation)

Page 42: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Socially Responsible Licensing: Humanitarian Use ClausesHow: Implementation of the Program. Addressing Access and AffordabilityIN A RESEARCH AGREEMENT ( ti t IP t d l d t)IN A RESEARCH AGREEMENT (prospective terms, IP not developed yet)

a) future grant of royalty free sales in a specified territory – In the developing world (but royalty collected in the developed world)In the developing world (but royalty collected in the developed world)– To the extent we are legally able to do so– And if all future inventors agree

b) and/or share revenue (or other benefits) with a collaborator or supplier– To the extent we are legally able to do so– Administered through a nonprofit organization (laborious details)

E th t f d l f di i t d i th d t B h D l– Ensure that federal funding is not used in the program due to Bayh-Dole requirement that net profits be used “for research and educational purposes”

c) address affordable pricing:- “reasonable efforts to license resultant IP for public benefit keeping in mind

Berkeley’s and X’s mutual goals of providing low cost therapies for free, at cost, or at minimal profit in the developing world.”

d) Give attribution (when naming discoveries, identify and thank providers, experts)

Page 43: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

$500M over 10 years funded by BPFor Sponsored Research and 10 New Faculty positions

UC BerkeleyLawrence Berkeley National Laboratory

University of Illinois at Urbana ChampaignUniversity of Illinois at Urbana-Champaignwww.energybiosciencesinstitute.org

Page 44: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Genesis of the EBI

2006 Sustainable solutions must be researched NOW- biologists

BP Steve Koonin Chief Scientist (formerly Cal Tech)BP Steve Koonin Chief Scientist (formerly Cal Tech)

RFP challenge: Open + Proprietary research and NERF license

“Help us to INVENT the FUTURE”

46 applicants to 5 to 1

All of the principles and methodologies brought to bear

Page 45: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

PROPOSAL

Huge collaborative effort: Departmental Chairs, Deans, VC, ChancellorRegional agencies, g g ,State Governor, SenatorLBNL, UIUC, Office of the General Counsel

Proposal Nov. 2006, London presentation, December

Level of commitment: Bell Labs model & philosophyLevel of commitment: Bell Labs model & philosophy

Jan announced: delivering results innovation cultureJan. announced: delivering results, innovation culture

Feb. kick-off meeting. Contract November, 2007

Advisors: Academic Senate chairs, student group

Page 46: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Common Mission

D l f d d th i t lDevelop new sources of energy and reduce the environmental impact of energy consumption

Produce transportation fuels from biomassProduce transportation fuels from biomass

Economics and social issues around biofuels

Microbially enhanced oil recovery

Carbon sequestrationq

Page 47: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

U.S. Federal Government R&D HistoryHomeland Security,

Reagan “Star Wars” Program

JFK ApolloProgram

Carter EnergyCarter EnergyProgram

M. Hoeffert

Courtesy of Chris Somerville

Page 48: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Biomass as a Source for T i F lTransportation Fuels

Biomass is an excellent o ass s a e ce e tstarting material for biofuels• Plentiful• Biomass crops do not need

as much water or fertilizerWaste wood and papercould also be used to

d f lproduce fuels

Page 49: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Energy Biosciences Institute• BP funded• $500M ($50M/year for 10 ( y

years)

• ~25 lead investigatorsBroad multidisciplinary• Broad, multidisciplinary

• Bottom up• Shared space

University of California, Berkeley ●

Lawrence Berkeley Laboratory ● BP ● Shared space• Dedicated new UC

building, located on UCB

University of Illinois, Urban-Champaign

campus (Helios Energy Research Facility)

Page 50: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Broad multidisciplinary institute, shared vision alternative fuelsO t f HELIOS t LBNLOne component of HELIOS at LBNL

Open and Proprietary components both at Berkeley and at UIUCCommon goal, physically separate

BP Applications Lab: Proprietary ResearchRented at FMV$200M building, $70M from state state of California

Grants making programAnnual, Open call for proposals

Page 51: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

EBI Legal Structure

funds

BP

funds

ENERGY BIOSCIENCES INSTITUTE (EBI)

BP Subsidiary BP Subsidiary

contracts contracts

BP Proprietary Component

UC Berkeley Host Institution

t tt t

Other BP Components

subcontracts contracts

contracts subcontracts

Lawrence Berkeley N ti l L b

subcontracts contracts

contracts subcontracts

Other Entities

as appropriate

OPEN RESEARCH PROPRIETARY RESEARCH

National Lab

OPEN RESEARCH PROPRIETARY RESEARCH

University of Illinois Urbana

OPEN RESEARCH PROPRIETARY RESEARCH

ENERGY BIOS CIENCES INSTITUTE (EBI)

OPEN RESEARCH PROPRIETARY RESEARCH

Page 52: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Governance BoardUCB Vice Chancellor for ResearchLBNL Director Scientific AdvisoryUIUC Vice Chancellor for ResearchBP RepresentativesEBI Director, Assoc. Dir., Dep. Dir.

yBoard

EBI Director(UCB/LBNL)

EBI Assoc. Dir.(BP)

EBI Deputy Director(UIUC)

EBI Team- Program directors- BP investigators

Program Directors- Feedstocks- Biomass- Depolymerization

g

EBI Organization

- Depolymerization- Biofuels production- Fossil fuel bioprocessing- Socioeconomic systems Organization- Disc. dev. support centers

UCB/LBNL/UIUC Investigators

Page 53: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

GovernanceDirector (BK) Deputy Director (UIUC) Associate Director (BP)Director (BK), Deputy Director (UIUC), Associate Director (BP)

Executive committee - 7+2 primarily academic-annual call for proposalsannual call for proposals-peer review-proposed slate of project-2/3 majority vote2/3 majority vote

Governance board 4+4 equal representation-majority vote-majority vote-quorum is 5, at least one from Berkeley -approve slate as a whole, cannot cherry pick from the crop

25 laboratory heads

Page 54: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

10 New Faculty Positions

7 at Berkeley3 at University of Illinois at Urbana-Champaign

$1M in startup funds$500K in renovation costs

50% salary (100% of EBI Director)

All appointments according to standard departmental procedures

Campus benefits from salary savings, space made available when EBI researchers move to new building, augmentation of existing programs in

i di i liemerging disciplines

Reputation in energy research

Page 55: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

BP’s call for proposals challenged academic applicants to propose a research institute

with Open and Proprietary research components

OPEN PROPRIETARY

Commercial applications labBasic, academic research

Research performed by BPemployees

Research performed by UCB,LBNL, UIUC employees

Confidential

Results belong to BP

Results all published

Results belong to UCB LBNL Results belong to BPResults belong to UCB, LBNL, and/or UIUC

Page 56: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

EBI Open and Proprietary Components Help Us To Implement a Shared Vision

Of translating basic, academic, research results from the EBI into global energy solutions

Science-to-technology transition can be expedited through innovative Public-Private Partnerships

Bench to bedside

Bench to fuel tank

University as Innovation accelerator

Bench to fuel tank

Engineering and Agricultureo input from industry provides valuable insight

bl t b l do problems to be solvedo where and how academics can help

Page 57: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

EBI IP & Contract Structure

Master Agreement & Sponsored Research AgreementMaster Agreement & Sponsored Research AgreementBetween UC Berkeley and BP

Terms and conditions flow down through subcontracts and inter-institutional agreements

LBNL UIUCUIUC

And two leases to BP from each of UC Berkeley and UIUC

Page 58: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Sponsored Research Agreements

Academic, publishable research

Work plan agreed by PI and company in advanceWork plan agreed by PI and company in advance

Corresponding budget (personnel, supplies, full indirect costs)

IP owned by the research institution

First right to negotiate an exclusive license to project IP

Licenses retain standard “reserved rights” and require diligence

Fees and royalties sometimes negotiated in advance (expressed as a range)

Background IP (BIP)

Publication preview right 30 days (+60 if patents are requested)

Research must be published, no editorial rights for Sponsor

Page 59: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

IP Ownership: Follows U.S. Patent Law

Inventions made solely by UCB, UIUC, or LBNL, personnel in their

own space

Inventions made solely by BP personnel in their own space (rented)

“Mine”

Solely owned by“Yours”

Solely owned by UCB, LBNL or

UIUCSolely owned by BP

Inventions made by at least one inventor from BP and at least one inventor from UCB/LBNL/UIUC

“Ours”

J i tl O d(due to WFO precedent

Jointly Owned( pat LBNL)

Page 60: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Licensing of EBI InventionsFor inventions that are solely owned by UCB, LBNL and/or UIUC

that are fully funded by BP

Non Exclusive E l iNon-Exclusive

We will grant to BP a Non-Exclusive, Royalty Free (NERF)

Exclusive

UCB, LBNL and UIUC agree that BP may obtain Exclusive license

commercial license in BP’s field:

1. BP will be required to diligently pursue commercialization of the licensed

BP may obtain Exclusive license rights to our sole or joint interests in EBI inventions

In the Field of Usecommercialization of the licensed invention(s)

2. Inventor institution will not be obligated to file for patents unless it has a commitment from at least one licensee

In the Field of Use

Under pre-negotiated, capped feesUp to $100,000/ year + patent costsBut Bonanza Clause if a blockbustercommitment from at least one licensee

to underwrite patent costsBut Bonanza Clause if a blockbuster

Page 61: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Research Implementation A Grants-Making Process

Master sponsored research agreement - streamlined

S ifi j t i di id l i l ti l tt

A Grants Making Process

Specific projects: individual implementing letters

47 projects f nded o t of 240 applications in first ear47 projects funded out of ~240 applications in first yearLess control than the typical corporate sponsor of research

Page 62: IP Management Strategies to Maximize Research Impact ...citris-uc.org/files/Carol Mimura_OpenInnovation_Sept24_2008.pdfIP Management Strategies to Maximize Research Impact Collaboration

Common Themes

Open innovation principles in action

NetworksNetworks

Collaboration (inflows and outflows)

Sharing (distributed innovation)

Uptake

Multiple and multifaceted approach

C ti d fl ibl t ffiCreative and flexible - staffing

To accelerate innovation and stimulate investment

To deploy rights responsibly with a goal of social impact