Drug Manufacturing and Formulation Services for Neurotherapeutics

REQUEST FOR COMMMENTS ON THE PROPOSED USE OF A DETERMINATION OF EXCEPTIONAL CIRCUMSTANCES (DEC) for the Drug Development Services for the NIH Blueprint Neurotherapeutics Network (BPN) SUMMARY: On behalf of the NIH Blueprint for Neuroscience Research, 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 the drug development services under the Blueprint Neurotherapeutics Network (BPN). BACKGROUND: To address the paucity of effective treatments for disorders of the nervous system, fifteen NIH Institutes and Centers have joined together to establish the Blueprint Neurotherapeutics Network (BPN). The BPN offers neuroscience researchers (Project Contributors) with promising bioactive compounds access to a full range of contracted, industry-style drug development services and expertise, including medicinal chemistry, pharmacology and toxicology, GMP manufacture and formulation, and Phase I clinical trial infrastructure. The goal of the BPN is to enable academic scientists, non-profit organizations, and small biotechnology companies to "de-risk" their neurotherapeutics projects to the point where they can attract private sector investment for commercial development. Work undertaken by BPN contractors is expected to generate new inventions. Under the Bayh-Dole Act, Government contractors generally retain the right to elect title to inventions made as a result of work performed under the contract (Subject Inventions). One of the goals of the Bayh-Dole Act is to incentivize the commercialization of Government-supported Subject Inventions. However, responses to an NINDS-issued Request for Information, as well as the experience of a number of NIH drug discovery and development programs, suggest that a standard approach to intellectual property would actually impede the goals of both BPN and Bayh-Dole. Many potential Project Contributors from academic institutions and small companies have informed the NIH that they will not participate in the BPN if there is a risk that Government contractors will obtain rights to Subject Inventions relating to Material and/or Technology that they provide as starting materials for their projects. These researchers have argued that contractor control of these patent rights would effectively prevent them from licensing products that emerge from the BPN for further development and commercialization. The Bayh-Dole Act does allow for a Determination of Exceptional Circumstances (DEC), which directs ownership of inventions made by the funding recipient to the Government or other party of the Government's choosing. The NIH has determined that exceptional circumstances exist, as described above, and that BPN contractors' and subcontractor's rights (at all tiers) in Subject Inventions should be limited accordingly. The NIH does not anticipate that this will create an undue burden on contractors, as the majority of potential contractors identified through market research are contract research organizations (CROs) that frequently provide similar drug development services for the commercial sector. These potential contractors have indicated that their business model is to provide drug discovery and development services for a fee, with no claim on any resulting Subject Inventions. PROPOSED IP STRATEGY: For the Blueprint Neurotherapeutics Network, 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: Class 1: Subject Inventions that require the use of, improve upon, or incorporate any material/technology provided by the Project Contributor, and Subject Inventions that are methods of manufacturing or synthesis of a Project Contributor's Material. If the Project 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). Class 2: Subject Inventions that do not fall into Class 1 above. Contractor retains full rights to any Class 2 inventions. RESPONSES: The NINDS invites comments on this strategy and use of a DEC for the Blueprint Neurotherapeutics Network. Alternative strategies that will support the mission of 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 Laurie Leonard, Contracting Officer at the following email address: leonardl@mail.nih.gov by 4:00 PM Local Time on April 16, 2013. Electronic submissions will be accepted only.