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