what can we learn from open source and open standards

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What Can we Learn from Open Source and Open Standards? September 1, 2015 Andrew Updegrove Gesmer Updegrove LLP [email protected]

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Page 1: What Can We Learn from Open Source and Open Standards

What Can we Learn from Open Source and Open Standards?

September 1, 2015

Andrew UpdegroveGesmer Updegrove LLP

[email protected]

Page 2: What Can We Learn from Open Source and Open Standards

What does Traditional Pharma Look Like?

All R&D costs borne by one companyAll risk borne by one companyAll patent rights held as long as

possible by one company

Page 3: What Can We Learn from Open Source and Open Standards

What do Traditional Pharma Results look like?Limited number of new drugs per yearLimited number of diseases/conditions

addressedDelayed sharing of research and resultsOngoing consolidation due to costsLimited distributionMarketing is profits-driven (regardless of

efficacy)

Page 4: What Can We Learn from Open Source and Open Standards

What do Open Standards and Open Source Look like?

Very broad, global collaborationVoluntary participationVoluntary sharing of burdensVoluntary sharing of valuable

intellectual propertyVoluntary uptake of deliverables

Page 5: What Can We Learn from Open Source and Open Standards

What do Open Source and Open Standards Results Look Like?Thousands of new efforts launched every yearUbiquitous global adoptionLowest cost implementationSpringboard for new businessesProliferation of platforms for innovationImmediate, or rapid disclosure of results

Page 6: What Can We Learn from Open Source and Open Standards

Why does this happen?

Page 7: What Can We Learn from Open Source and Open Standards

Because the participants trust the system and believe

in the rewards

Page 8: What Can We Learn from Open Source and Open Standards

Rewards CredibilityOpen Standards and Open Source

Build EcosystemsDiverse examples of the economic

benefits of network effects (railways, telecommunications, Internet, Wi-Fi, etc.)

Networks are much easier to create collaboratively than proprietarily

Lower strategic risk, more predictability

Page 9: What Can We Learn from Open Source and Open Standards

Level Playing FieldsRules ensure that all have an equal

opportunity to benefitIn open standards, it’s open admissions,

strict IPR policies, and RAND implementation

In open source, it’s open participation and licensing rules that assure equal ability to implement

In open standards, it’s consensus rulesIn open source, it’s meritocracy

Page 10: What Can We Learn from Open Source and Open Standards

Intellectual PropertyEach approach has found a way to deal

with intellectual property that is acceptable to the IP ownerIn standards, “Necessary Claims” will be

available to all on RAND terms, and indirect benefits exceed direct benefits to IP owners

In open source, IP owners have ample opportunity to monetize IP, dramatically lower R&D, and dramatically lower strategic risk

Page 11: What Can We Learn from Open Source and Open Standards

Common Goals

Everyone benefits from the same successIn open standards, the wider the uptake,

the wider the marketplace and the more certain the rewards

In open source, the more successful the project, the more prestige for the developers, and the more customers for the sponsors

Page 12: What Can We Learn from Open Source and Open Standards

What are the Lessons for Us?Success depends on:

Appropriateness of domain (not every development type needs broad collaboration)

Credibility of outcomes (will network effects, or similar drivers result)

Governance systems that ensure a level playing field

IPR rules that are acceptable and effective to the industry in question

Willingness of target participants to embrace approach

Page 13: What Can We Learn from Open Source and Open Standards

Key Lessons

All domains are different – while the high level principles must be applied, each domain will require a unique implementation of the open model

The art in designing an open model is to make it want to default to success

In order to default to success, all key stakeholder groups must be identified and provided with an often unique valuable proposition

The model must lead naturally to rapid implementation by the same participants

Page 14: What Can We Learn from Open Source and Open Standards

R&D Through Availability in the FieldWho are the stakeholders in the

resulting network effect ecosystem?Government health agenciesFoundationsResearch LabsProduction facilitiesTest vendorsDistributorsNGOs active in the fieldOthers?

Page 15: What Can We Learn from Open Source and Open Standards

How to Address the Clinical Gap?Form a non-profit investment fund

Applies a triage approach to funding, from infectious diseases (I) to high-profit margin drugs (III) and funds all types

No royalties on I, modest on II, and industry-standard royalties on III

All royalties are reinvestedExclusive licenses scale by tier as well (0 for

I, 2 years for III, five years for III); generic thereafter

Page 16: What Can We Learn from Open Source and Open Standards

Fund Governance and Funding

Balanced board of directors that includes representatives of all stakeholders, but controlled by non-commercial Directors

Advisory Boards from certain classes of stakeholders (Pharma, Government, Foundation, Manufacturers)

Initially funded by government, Foundations and Pharmas (who thereby become eligible to become licensees)

Also accepts “targeted” funding for specific projects in any tier

Page 17: What Can We Learn from Open Source and Open Standards
Page 18: What Can We Learn from Open Source and Open Standards

Questions?