The Pool for Open Innovation against Neglected Tropical Diseases (“The Pool”) seeks to make the patents and, at the discretion of a pool contributor, know-how of companies and organizations more widely available for the development of therapeutics for neglected tropical diseases (“NTDs”). The Pool contributors recognize that there are no or few commercial returns for therapeutics for NTDs but the social returns will be enormous. Therefore, the main objective of the Pool is to incentivize research into NTDs by making patents and know-how ("IP") more widely available, on terms that facilitate the development of new therapeutics, and to make the process efficient and effective.
There are two core principles that outline the scope of The Pool. Licenses for patents and know-how will be:
- Limited to therapeutics to treat the sixteen Neglected Tropical Diseases in humans (Defined by the U.S. Food and Drug Administration)
- Royalty free for sales in the world’s Least Developed Countries (“LDCs”)(Defined by the United Nations)
In addition, the following principles govern the more detailed workings of The Pool.
- Licensing policies and additional terms are expected to facilitate and encourage development, commercialization, and access of therapeutics to treat NTDs.
- Pool contributors must be willing to grant to qualified participants with a concrete proposal at a minimum, a non-exclusive worldwide license to research, develop, manufacture, and export therapeutics for NTDs for sales into LDCs under the patents that pool contributors chose to contribute (subject to the other limitations of the Pool); provided that the therapeutic is not otherwise being developed (or actively being considered for development) or commercialized for the NTD by or through the Pool contributor. Licenses to patents to manufacture, import, use, offer for sale, and sell therapeutics on an exclusive or non-exclusive basis outside of the LDCs will be negotiated on a case-by-case basis with the IP holder.
- Pool contributors may reserve the right to negotiate royalty rates beyond LDCs on a case-by-case basis. The royalty rates should take into account the contribution of the IP holder to the project and ensure rates that facilitate access of the therapeutic to the poor.
- License agreements should, however, include a non-enforcement clause prohibiting the licensee from using any IP generated through use of licensed IP to inhibit any Pool contributor's use of its own IP placed in the Pool.
- Pool contributors will retain the ownership rights to their original IP. Licenses will be granted directly by the company or organization that owns the IP, although BVGH may play a facilitating role in the process.
- Ownership follows inventorship. Pool contributors may not deny a licensee the opportunity to seek patents on any product or technology developed using patents under the scope of the license granted. Licensees are encouraged; however, to share any newly created IP with the Pool where this would further the development of therapeutics for NTDs, provided the licensee is not actively developing (or considering developing) or commercializing the therapeutic for the NTD. Pool contributors may not expect any reach-through rights.
- Reimbursement for the financial rewards that a U.S. FDA Priority Review Voucher or any other incentive would bring the licensee should also not be expected.
- Contribution of know-how is voluntary. Pool contributors have a choice as to whether, and on what terms, they will provide know-how to specific enquiries regarding possible use of technologies that might be of value to an NTD research or development project. Consideration of such requests shall be based on:
The relevance of the know-how to the problem to be solved
The cost to the Pool contributor and the available resources of the Pool contributor
The plan and proposal of the requestor demonstrating that they can make use of the
know-how - Where know-how is made available, Pool contributors may require licensees to respect the confidentiality of the know-how and limit its use to NTD-related projects.
- Pool contributors shall disclose to BIO Ventures for Global Health (BVGH), in writing, those patents and patent applications that they are willing to contribute to the Pool. Pool contributors understand and acknowledge that BVGH may publish such patents and patent applications for public inspection.
- The Pool will have de minimis standards, whereby any Pool contributors agree to all the principles in this paper.
- Entities wishing to contribute to the Pool may contact BVGH.
The Pool contributors are contributing to the Pool because they wish to use their assets to improve the health of the poor around the world through the development of new therapeutics for diseases with little or no commercial market. Therefore, requests for additional assistance from the contributors to the Pool will be considered in good faith by the Pool contributors. Requests for intellectual property that are outside of what has already been contributed to the Pool will be considered on a case-by-case basis.
BIO Ventures for Global Health (BVGH) serves as the non-profit administrator of the Pool. BVGH’s responsibility is to assist in the smooth running of the Pool and to conduct extensive outreach to potential contributors and licensees of the Pool so that all assets are being used as much as possible in the development of new therapeutics for NTDs.