Licensing

GLOBAL ACCESS LICENSING FRAMEWORK

Every university-developed technology with potential for further development into a drug, vaccine, or medical diagnostic should be licensed with a concrete and transparent strategy to make affordable versions available in resource-limited countries for medical care. Licenses are complex and each will be unique. Universities should therefore implement Global Access Policies that adhere to the following six principles:

       Goals

1. Access to medicines and health-related technologies for all is the primary purpose of technology transfer of health-related innovations. This includes protecting access to the final end product needed by patients (e.g. formulated pills or vaccines).
2. Technology transfer should preserve future innovation by ensuring that intellectual property does not act as a barrier to further research.
    
   Strategies
3. Generic competition is the most efficient method of facilitating affordable access to medicines in resource-limited countries. Legal barriers to generic production of these products for use in resource-limited countries should therefore be removed. In the cases of biologic compounds or other drugs where generic provision is forecast to be technically or economically infeasible, “at-cost” or other provisioning requirements should be used as a supplement to generic provisioning terms but should never replace those terms.
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.
5. University technology transfer programs should facilitate future innovation by patenting only when truly necessary to promote commercialization, utilizing non-exclusive licensing, creating streamlined processes for materials transfer, and reserving broad rights to use licensed technology in future research.
6. A global access licensing policy 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.

NOTE: For more detailed background and citations explaining these principles, please download the linked Word or PDF document below.

A summary of selected case studies and proposals by Yale, Berkeley, and Washington Universities. 

This document contains some recent media attention, identifying university impact on ensuring global access. It promotes the need and significant contribution university research makes to the drug development pipeline. 

A review of the access gap and its principal causes. A survey of current strategies to combat the access gap. The current structure of university research and technology commercialization efforts. Patenting and regulatory practices. Use of licensing agreements to promote access. Model licensing provisions, the EAL. Recommendations for encouraging uptake and implementation of the EAL.

A glossary of terms used in licensing for equitable access and neglected disease research.

A little background on: Patents * Licensing new inventions * What is the EAL? * How do patents affect the pricing of drugs in the developing world? * Where do universities fit into the picture?

What: An approximately three year old program to: • Promote widespread availability of technology and healthcare, including in the developing world • Share revenue and/or other benefits with those who collaborate with U.C. Berkeley researchers • Give proper attribution to a research source or collaborator • Maximize the societal benefit of technologies developed at U.C. Berkeley • Stimulate additional investment by others to achieve these goals