rebecca goulding alt ip

Alternative Licensing Solutions for Global AccessOpen Science Summit:

Theme 5: The Role of UniversitiesRebecca Goulding, PhD

ISIS, Sauder School of Business, UBCIntellectual Property and Policy Research Group, UBC

[email protected]

mailto:[email protected]

Outline• The Problem• Gaps in the Neglected Disease Drug Pipeline:

Intellectual Property Barriers and Solutions• Alternative Licensing Options

– Open Source Licensing – Patent Pools Licensing – Global Access Licensing– Other options

• What should/can Universities do?

The Problem

Pre- Discovery clinical Clinical Trials Delivery

1. Discovery Gap

2. Research and Development (R&D) Gap

3. Delivery Gap

Neglected Diseases (ND) Pipeline Gaps

1 2 2 3


1. Discovery Gap- profit-based choices

- lack of early research funding/government focus

- lack of access to IP (patents and know-how), blocking patents, patent thickets

ND Pipeline Gaps

1 2 2 3

Modified from Pecoul, 2004 PLoS Med

QuickTime™ and a decompressor

are needed to see this picture.

1. Discovery Gap Solutions- New collaboration/IP models:

Open Access/Source, Pre-competitive, Patent pools

- New funding models

Government, private, prizes, public decisions about spending (CIRN), Open Science Fund?
















2. Research and Development (R&D) Gap - profit-based choices/lack of funding

- appropriate formulations not developed

- lack of access to IP (patents and know-how), blocking patents, patent thickets

ND Pipeline Gaps

1 2 2 3

The R&D gap

Trouiller et al., Lancet 2002

0%

2%

4%

6%

8%

10%

12%

14%

Cardiovascular Cancer HIV/AIDS Tuberculosis Malaria Tropical diseasesCardio Cancer HIV TB Malaria Tropical

diseasesProportion of DALYSProportion of new drugs - 1975-1999

2. R&D Gap Solutions- New innovation/collaboration/IP models

Open Source/Patent Pools?

Product Development Partnerships

- Regulatory incentives (FDA Vouchers)

- New funding models (Health Impact Fund, FRIND)


3. Delivery Gap - registration problems

- lack of production

- drugs unaffordable (patent monopolies)

- poor drug design

ND Pipeline Gaps

1 2 2 3

3. Delivery Gap Solutions- Make cheaper, design better drugs

Patent pools for generic HIV drugs (UNITAID)

Fund HIV ARV Purchasing Orgs

Compulsory licensing

- Innovative distribution systems, improve infrastructure, training,



Patent

Patent Definition

(a) A patent is a grant of a right to exclude others from using an invention for a set period of time - need to enforce patent.

(b) For a patent to be granted, the claims involved must be: novel, non-obvious, and useful or industrially applicable.

License Strategies

• A Patent only grants a party the right to exclude (or prevent) others from using the invention.

• "Exclusive" licenses are those that allow only one licensee for the designated IP

• A "non-exclusive" license is simply a license that is made available by the patent holder, or licensor, to more than one party.

Open Source

• OS = Intellectual Property (IP) + Distinctive License (IP = some form of defensive proprietary right)

• Aim is to – foster collaboration and innovation– increase scientific openness and

transparency– increase access

viral open license

- use

- modify

- redistribute open license

open license



Open Source-like Initiatives ©?

• Open Source-like/Open Access © license examples– Tropical Disease Initiative– Open Source Drug Discovery– Sage Bionetworks/Commons







QuickTime™ and a decompressorare needed to see this picture.

Open Source Patent Licensing

• OS biotech/pharma patent license examples– Equitable Access License (Universities Allied

for Essential Medicines)– BiOS/Cambia– BioBricks Foundation

QuickTime™ and a decompressorare needed to see this picture.QuickTime™ and a

decompressorare needed to see this picture.QuickTime™ and a

decompressorare needed to see this picture.

Open Source Patent Licensing

• Questions– OS infection of other licenses?– What kind of license? Viral?– When can one fork?– Type of product development (drug vs.

diagnostic) - matters for incentives

Open Source Patent Strategy

• Pros and Cons for Universities– Attractiveness to potential licensees (e.g. industry)?– Depends on technology and stage of development:

•Drugs vs Diagnostics vs Research Tools+ Future access to improvements (vs. research

exemption clause)+ Build collaborative science and innovation

network?

Patent Pools

one standard

non-exclusive

license

When two or more patent holders license their IP rights to one another or to a specifically created admin entity, or to a third party.













Early patent pools





Patent Pools

• “legitimate” Patent Pools: 1st gen: WWI Strategic Goals Public

Policy2nd gen: Consumer electronics

1990s/2000s3rd gen: Humanitarian Goals?

• In U.S. Patent Pools need to fulfill Anti-trust/competition guidelines 1995

Patent Pools• 3rd generation of Patent Pool examples

– SARS– Golden Rice– MPEG LA Genetic diagnostic– UNITAID : 2009– GSK : 2009

The Need• Increasing need for new low cost antiretrovial

formulations - standard of care changing, resistance increasing, funding decreasing

The Problem• Lack of production of ARV fixed-dose combinations

and new formulations (e.g. pediatric)

• High costs of ARVs (that are produced) in developing countries




are needed to see this picture.Patent Pool

NTD patent pool

• GSK announced patent pool for NTD R&D in 2009

• Aim to stimulate innovation by increasing access to IP

• 800 GSK patents and pending apps for NTDs compounds

• Alnylam joined with 1500 RNAi patents 2009• Emory 2010, MIT 2010, iThemba 2010



Patent Pools• Pros and Cons for University licensing

-/+ Depends on license terms•What countries/use?•Who owns improvements?•Standard license to reduce transaction

costs? •Royalties?•Increased collaboration?

+ Pool admin finds licensee

Global Access Licensing

License with specific terms/clauses that ensure access

to drug/diagnostic etc in developing countries





University Principles on Global Access

“Nine Points To Consider…”

2008

2007

2009

Global Access

• Major Questions- Country focus (BRIC countries)- Improvements (open licensing?)- Non-assert clauses vs. grant back- How durable?

Global Access

• Pros and Cons for Universities+ Terms are negotiable/not one size fits all– Might lose access to improvements– Depending on terms, industry interest may

change

Various forms of IP and control of invention

Public Domain

OS Patent + Viral License

OS Patent Non-Viral License

Patent + Non-exclusive License

Patent + Exclusive License

Control



Access toimprovements

University Mission

Industry Interest

NGO/Activists Alumni

Journal Requirements

Funding Agency Requirements

sStudents

Researchers desire to

commercialize

Tenure Requirements

Researchers desire for openness

Thanks!

Open Source: Decision TreeNew Technology

Disseminate Keep in-house

Non-proprietary/public domain Proprietary/patent

Exclusive Non-exclusive Open Source

Academic/BSD-style license Copyleft license

Narrow copyleft obligation Broad copyleft obligation

Other Options?

• Non-exclusive licensing– Creative Commons Model Patent License– Many university technologies are already non-exclusively

licensed (e.g. research tools etc) NIH/OECD guidelines– Research tools versus chemical compounds

• Public Domain as an alternative– John Sulston’s Manchester Manifesto

How does a TTO decide?

• One size might not fit all• Specific clauses may work best• Be willing to prioritize global access, and fight

for it• Needs support of University administration

39

OS Software vs OS Genomics

• Genomics innovations are protected by patent

• Development times tend to be long with many uncertainties related to safety and efficacy

• Often, a firm’s IP is its only asset and investment vehicle during the long development phase

• Medical products heavily regulated and require large infusion of $ and structured development regime to meet regulatory, development and approval hurdles

• Software is protected by ©

• Development times are shorter

• In general, there is not a need for specialized equipment or laboratories

• Software generally has relatively short-term, intense periods of uptake

40

Case Study 1 - BiOS

• BiOS: part of CAMBIA

• Stated Objective: Ensure that “Enabling Research Tools” are and remain available

41

Case Study 2 - BioBricks™

• BioBricks™ dedicated to making the tools of synthetic biology available on an OS basis

• Aim: Safeguard against patent thickets in order to promote development of synthetic biology

42

BioBricks™ OS License (continued)

• Aim: "to ensure that BioBrick standard biological parts remain freely available to the public“ as building blocks encouraging growth of synthetic biology

• Not viral but attribution required: “If User makes available, commercializes, or otherwise distributes the Materials . . .in either their original form or a modified form, User shall attribute use of the BioBrick Agreements to the Foundation by using reasonable efforts to conspicuously include the BioBrick . . . logo in all packaging or product inserts, publications, and grant-related materials related to the Materials and modifications of the Materials”

• Obligates Users to Refrain from IP enforcement: Users of Biobrick materials must agree "not enforce proprietary rights in the Materials . . . in any manner against or otherwise adverse to the BBF or Users (including a User's manufacturers, distributors, customers, or anyone else acting under User's authority or control), materials repositories and/or materials libraries." (Section 3(a)).

• Commercialization: Possible with some limits on patent enforcement against Biobrick users

43

BiOS License (continued)

• Aim: “BiOS owns or controls the rights to certain enabling technologies and associated patents, patent applications, knowhow and materials . . . . and is willing to grant the right to use IP and Technology to any party, without discrimination as to payment of fees of any kind“ (Preamble)

• Virality: In licensing or passing on these improvements, the licensee is obligated to make them "available to others under the terms of the [PMET or HT] Agreement" and "at a price not to exceed reasonable cost of production." (PMET and HT, Section 5)

• BiOS license must dominate: a licensee that uses another third party licensed technology in making an improved product cannot accept provisions that obligate the licensee to keep the improved product proprietary. Neither may the BiOS licensee accept an obligation in a third party license to assert patent rights against another party infringing the patent rights on the derivative plus BiOS product.

• Commercialization: products created as a result of work under this license are not under the obligation to be made available to others under the terms of the Agreement, to the extent that those products cannot be characterized as enabling technologies in and of themselves

rebecca goulding alt ip

Documents

target binding pairs

osdd retains ownership

simple cc attribution

druggable disease targets

future inventions coming

tropical disease initiative

similar attempts biotechnology

os software principles