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Global Access Licensing Framework & University Statement of Principles
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Transcript of Global Access Licensing Framework & University Statement of Principles
Global Access Licensing Framework & University
Statement of Principles
Global Access Licensing Framework & University
Statement of Principles
Sarah Sorscher
UAEM National Conference,
New Haven, Fall 2009
Sarah Sorscher
UAEM National Conference,
New Haven, Fall 2009
Equal Access LicenseEqual Access License
Low-cost availability of essential medicines in developing countries Use of university patents for neglected disease research This session: low-cost availability of essential medicines
Low-cost availability of essential medicines in developing countries Use of university patents for neglected disease research This session: low-cost availability of essential medicines
How it WorksHow it Works
University Licenses patents Reserves rights to sub-license to generic
producers in developing countries Licensee grants back rights on
improvements University can also sub-license these
improvements to generic producers in developing countries
University Licenses patents Reserves rights to sub-license to generic
producers in developing countries Licensee grants back rights on
improvements University can also sub-license these
improvements to generic producers in developing countries
Canudine
“OMS”
Canudine
““The The GALF”GALF”
1. Access to medicines and health-related technologies for all is the primary purpose of technology transfer
of health-related innovations. 2. Technology transfer should protect
access to the final end product needed by patients (e.g., formulated pills or vaccines).
1. Access to medicines and health-related technologies for all is the primary purpose of technology transfer
of health-related innovations. 2. Technology transfer should protect
access to the final end product needed by patients (e.g., formulated pills or vaccines).
3. Generic provision is the best way to ensure access in resource-limited countries for products that also have markets in developed countries.
3. Generic provision is the best way to ensure access in resource-limited countries for products that also have markets in developed countries.
Impact of Generic Competition: Uganda
4. Proactive licensing provisions are essential to ensure that follow-on patents and data exclusivity cannot be used to block generic production. Other barriers may need to be addressed for the licensing of biologics.
4. Proactive licensing provisions are essential to ensure that follow-on patents and data exclusivity cannot be used to block generic production. Other barriers may need to be addressed for the licensing of biologics.
4. University licensing should be systematic in its approach, sufficiently transparent to verify its effectiveness, and based on explicit metrics that measure the success of technology transfer by its impact on access and continued innovation.
4. University licensing should be systematic in its approach, sufficiently transparent to verify its effectiveness, and based on explicit metrics that measure the success of technology transfer by its impact on access and continued innovation.
“Our intellectual property should not become a barrier to essential health-related technologies needed by patients in developing countries.”
In cases where universities can fully preclude intellectual property barriers to generic provision by not patenting in developing countries, or by filing and abandoning patents, we will pursue these strategies.
We will work together to develop and apply meaningful metrics to evaluate the success of our efforts to facilitate global access and support continued innovation with particular relevance to global health.
“We will…revisit these principles on a biennial basis, to ensure that they reflect currently-understood best practices.”
Gaps and AmbiguitiesGaps and Ambiguities
Does not cover “reach-through” to other intellectual property incorporated into the end product.
Is ambiguous about generic production in manufacturing countries
Does not cover “reach-through” to other intellectual property incorporated into the end product.
Is ambiguous about generic production in manufacturing countries
Gaps and AmbiguitiesGaps and Ambiguities
No enforcement mechanism No enforcement mechanism
Where Do We Go From HereWhere Do We Go From Here
Detailed Analysis Approach your home institution Keep pushing
Detailed Analysis Approach your home institution Keep pushing
Thank YouThank You