Public Private Partnerships Public Private Partnerships That Promote Global HealthThat Promote Global Health

AUTM 2009 Annual MeetingAUTM 2009 Annual MeetingFebruary 13, 2009February 13, 2009

Eric GiegerichIndustry Relations Manager

Office of Intellectual Property & Industry Research Alliances (IPIRA)

University of California, Berkeley

Berkeley Principles for Socially Responsible IP Management

Principles:– Berkeley TT reflects Berkeley campus culture -- strong record of public

service and reputation for affordability of and public access to tools.

– Berkeley strives to use university resources for public benefit and to effect lasting societal change.

– Berkeley views helping the developing world as a moral imperative. Countries with resources should help those that are resource poor.

– Berkeley recognizes that most TT occurs in traditional ways --(teaching, internships, graduates, consulting, informing, visiting fellows, IABs).

– Berkeley is not harmed by Socially Responsible IP Management.• Reputational gains from good will Gift funding• Keep eye on retained commercial rights.

Practices• Highlight societal benefit as an explicit motivation.

• Stimulate business & societal change by reducing TT barriers.

• Give away technologies for humanitarian use in disadvantaged populations. • Make IP Accessible and Affordable for Humanitarian Use.• Retain commercial rights, or offer commercial rights under separate terms.

• Engender new contract and business models to develop and deploy technologies for charitable use.

• Leverage resources by attracting additional collaborations, research funding, donations, in-kind contributions.

Model Clauses and Guidance:

http://otl.berkeley.edu/show_news_flashes.php?

This is one approach on a full spectrum of IP management strategies

Berkeley Principles for Socially Responsible IP Management

Example 1 – Aquaya Institute

with a Social Impact Goal: • Make clean drinking water accessible • At little or no cost • In countries with poor drinking water and

poor public infrastructure• By developing a new class of household

consumer products for disinfecting water(using surface-bound cationic antimicrobial compounds)

Two Collaborative Research Agreements

• Berkeley Contributes:– Research expertise, collaboration in antimicrobial filters,

chemistry– Lab access to Visiting Industrial Fellow (VIF) from

Aquaya• Aquaya Contributes:

– Expertise in developing and delivering clean drinking water innovations in developing countries

– Visiting Industrial Fellow (VIF) in Berkeley’s lab– International partner network.

• Joint Contribution: – Research in safe water treatments and sanitation – Market and user adoption studies.

• Deployment Focus: – Aquaya’s partner network provides a channel in the

developing world for technology transfer. – Market, user adoption helps deployment.

Example 1 – Aquaya Institute

Example 1 – Aquaya Institute

Agreement Features:• Charitable Purpose in recital• Economically Disadvantaged Countries list in Appendix• IP Licensing – Charitable Use clause

Further Considerations• Research continues – no IP outcome yet• Keep eye on retained commercial rights• In the works…working toward same terms for a Berkeley

Water Center industry affiliate program

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

Biotechnologies

Applied

Research

Regulatory,

Distribution

$22.6M to iOWH

3 - way research

Collaboration

Agreement

License #1 Berkeley to Amyris. Developed world. No profit for malaria drug. Profit for flavors & fragrances

License #2 Berkeley to iOWH. Sell drug at cost in developing world.

Example 2 – Amyris - iOWH

LEVERAGING PHILANTHROPY

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

$8M to Berkeley

BASIC RESEARCH

$12M to Amyris

BiotechnologiesTRANSLATIONAL

RESEARCH

CLINICAL &

REGULATORY AFF.

$22.6M to iOWH

(sub to Sanofi-Aventis)

Instead of a “relay race” a single donor makes one grant to fund basic research, translational research, & clinical/regulatory activities

• No uncertainty in finding the next partner • No uncertainty in future contract terms• No gaps between stages (time, expertise, additional transactions)

Example 2 – Amyris - iOWH

BASIC RESEARCHTRANSLATIONAL

RESEARCH

CLINICAL &

REGULATORY AFF.

• This model provides seamless transitions, accelerates and streamlines translational research, commercialization, & economic development • The model exemplifies “bench to bedside” translational research.• A model to bootstrap start-ups with philanthropic donations• Resulted in equipment & material donations, additional public fundingGates hopes this structure will serve as a model for other U’s

Current Status • Berkeley research completed December, 2007

• Beat all milestone by 6 months• Sanofi-Aventis expects to have an artemisinin combination therapy on the market in 2010

• 6 years after – a 2-fold compression of bench to bedside• At the end of the day, an affordable malaria drug

Example 2 – Amyris - iOWH

• Master Agreement across campus• Focused on EE, CE, CS • Initially a typical agreement, but…• Lead professor has history in

technology for social change, healthcare applications

• BigIT has a Corporate Responsibility Program

• Berkeley actively introduced Socially Responsible IP Management terms early in discussion

Example 3 – Big IT Company

Background

Big IT

A. From Nonprofit to For Profit sponsor – How can the same entity hold both

humanitarian use NERFs and commercial rights?

B. Commercial Sale is main purpose. Charitable Use is just one purpose.

C. From Bio to IT sector– From long to short time-to-market– Broader IP focus than patents– Many IP rights go into a product, only

one of which may be Berkeley’s

Three Conceptual Hurdles

Example 3 – Big IT Company Big IT

Focus on Opportunity, Not Penalty

Example 3 – Big IT Company

A. From Nonprofit to For Profit sponsor

1. BigIT will manage Humanitarian Use Rights under its Corporate Responsibility program. 

2. BigIT will offer Humanitarian Products in EDCs at

the EDC Rate—ie., for free, below market rate, or at cost, but not at market rate according to generally accepted accounting practice (“GAAP”) -- IP provisions and fees for commercial use outside EDCs.

3. Humanitarian Use Rights are convertible to a paid license (a “Conversion”), if BigIT offers Humanitarian Products commercially, or outside EDC, or if EDC graduates.

Big IT

B. Both Charitable and Commercial Purposes• Initially: Humanitarian use rights intended to induce investment

and create markets for populations where no market incentive exists.

• BigIT said, “There are probably no markets in the world in which BigIT has no market reasons to enter.”

• Our rewrite: to induce investment and create markets for populations where

1.) it is presumed BigIT does not expect to make a near term profit under GAAP.

– There is a Conversion term for when BigIT makes a profit.

2.) strong social impact potential for EDCs3.) Corporate Responsibility can leverage investment

from business units

Example 3 – Big IT Company Big IT

• Humanitarian Product is any product incorporating one or more IP rights licensed under Humanitarian Use terms.

• Humanitarian Products, offered alone or coupled with other products and services, will be offered altogether at an EDC Rate. – Addresses anti-competitive practices– If services are core to their business, it’s a good thing

• IP is Patents and Copyrights -- everything else is offered in Reports with full use rights

Example 3 – Big IT Company

C. From Bio to IT

Big IT

Summary

• Berkeley has clear Principles and Model Clauses for Socially Responsible IP Management

• Berkeley employs Principles and Model Clauses in sponsored research and licensing – This is one approach on a full spectrum of IP

management strategies• Berkeley employs Principles across sectors—

health, water, IT, energy, agriculture, food• Berkeley continues experimenting with new forms

– industry affiliates, technology access programs, sponsored research…

Eric GiegerichIndustry Relations ManagerOffice of Intellectual Property & Industry Research Alliances (IPIRA)

egiegerich@berkeley.edu510-642-5850http://ipira.berkeley.edu/