Notice Number: NOT-NS-09-008
Release Date: March 27, 2009
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
The National Institute of Neurological Disorders and Stroke (NINDS) is seeking public comment on a proposed use of a Determination of Exceptional Circumstances (DEC), as provided for under the Bayh-Dole Act, for its new Medicinal Chemistry for Neurotherapeutics Program (MCNP).
The goal of the NINDS MCNP is to improve public health by stimulating the development of new drugs for neurological diseases. The NINDS has supported high-throughput screens and basic research studies that have led to the discovery of many small molecule compounds with activity in models of neurological disease. Some of these compounds might be transformed into drugs, with chemical modifications to improve their potency and pharmacological properties. However, biotechnology and pharmaceutical companies are hesitant to invest in the early development of compounds for rare diseases or new targets, given concerns about market success, budgets, and associated risks. Academic researchers who have identified a promising compound rarely have access to medicinal chemistry services. The MCNP is intended to overcome these barriers. The MCNP will provide the resources and chemistry expertise to transform small molecule compounds with evidence of bioactivity into lead compounds of sufficient potency, efficacy, and drug-likeness to begin the preclinical studies required for an investigational new drug application. Once their projects have “graduated” from the MCNP, researchers can take advantage of other NIH resources, such as the NINDS Translational Research Cooperative Program, the NIH Rapid Access to Interventional Development (RAID) Pilot Program, and funding agreements for clinical trials to advance their drug leads through preclinical and clinical testing. Researchers may also engage industry and other non-government resources for follow-up work.
The MCNP is envisioned as a collaborative effort between an NINDS-contracted medicinal chemistry service facility and academic or industry researchers with bioassays that model neurological disorders and bioactive small molecule compounds. Under the MCNP, the researchers (Contributors) will provide their compounds to the NINDS medicinal chemistry service facility (Contractors) as a starting point for chemical optimization. The Contractors will design and generate chemical analogs of these starting compounds, and the Contributors will test the chemical analogs in their disease bioassays. The results will inform the next round of analog design and development, and so on, for potentially dozens of rounds.
The design of new chemical analogs under the MCNP may generate new inventions. The Bayh-Dole Act establishes the rights and obligations of grantees and contractors to Subject Inventions—inventions that are conceived or first actually reduced to practice in the performance of work under a funding agreement by the Federal Government. One of the goals of the Bayh-Dole Act is to incentivize the commercialization of Government-supported Subject Inventions. Under the Bayh-Dole Act, Government contractors generally retain the right to elect title to inventions made by its researchers as a result of their work performed under a Government-supported agreement. A Determination of Exceptional Circumstances (DEC) to the Bayh-Dole Act directs ownership of inventions made by the funding recipient to the Government or other party. Thus, without a Determination of Exceptional Circumstances, the NINDS-contracted MCNP medicinal chemists would retain the right to elect title/ownership of inventions to all new compounds that they invent under a funding agreement from NINDS.
Responses to a NINDS-issued Request for Information (RFI) directed at potential Contributors and Contractors suggest that allowing the Contractors to retain ownership to the chemical analog patent rights would actually impede the further development and commercialization of new drugs. In order to develop good lead compounds, the MCNP must attract promising, high quality starting compounds. Potential Contributors informed the NINDS that they would participate in the MCNP only if they could be assured full ownership of patent rights to all analogs generated from their starting compounds. Most potential Contractors did not express interest in retaining ownership of Subject Inventions directed to the analogs and their methods of use. These potential Contractors indicated that their business model for these particular circumstances would be to provide specific services for a fee.
PROPOSED INTELLECTUAL PROPERTY STRATEGY: For the MCNP, the NINDS is considering a Determination of Exceptional Circumstances (DEC), as provided for under the Bayh-Dole Act. The DEC would cover two classes of Subject Inventions:
1) For Subject Inventions directed to analog compounds and their methods of use, the NINDS medicinal chemistry Contractors would be required to offer the first right of assignment to the Contributor. If the Contributor declines offer of assignment, then NINDS may dispose of the invention rights as NINDS determines would be in the best interests of the program and public health (e.g., allow Contractor to retain invention rights).
2) For Subject Inventions directed to the methods of manufacturing the analog compounds, the Contractor would retain all rights, but the DEC may require that the Contractor grant or agree to negotiate licenses so as to enable research use and commercialization of the compounds.
Rights to all other Subject Inventions will be retained by the Contractor pursuant to the Bayh-Dole Act.
The NINDS invites comments on this strategy and use of a DEC for the MCNP. Alternative strategies that will encourage the contribution of chemical compounds to the program will be considered before a final determination is made regarding the use of a DEC.
Please submit your comments to the attention of Annette Carter, Contracting Officer at the address below by 4:00 PM Local Time on April 17, 2009.
Annette Carter, Contracting Officer
National Institutes of Health,
NINDS R&D Contracts Management Branch
6001 Executive Blvd., Suite 3287
Bethesda, MD 20892-9531
or via courier to
Rockville, MD 20852
Electronic submittal will also be accepted at firstname.lastname@example.org
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Office of Extramural
National Institutes of Health (NIH)
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Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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