Background Information about the Policy for NIDDK-Industry-Grantee Clinical Network Collaborations
NIDDK funds research through grants, contracts, and cooperative agreements through what is commonly called the “extramural” research program. NIDDK together with its extramural grantee networks (funded through NIDDK U01 grants and cooperative agreements) routinely collaborate with industry to conduct clinical trials that utilize one or more investigational agents which are proprietary to a pharmaceutical and/or a biotech company (hereinafter, “Collaborator”). The terms and conditions under which these collaborative clinical trials are conducted are memorialized in agreements. These are signed with one or multiple industry partners for the clinical co-development of agents in Phase I–III clinical trials and define certain obligations for the government, its extramural networks, and the Collaborator. Agreements are either one of the following two types:
- Cooperative Research and Development Agreement (CRADA) – a statutorily authorized mechanism created under the Federal Technology Transfer Act of 1986 and permits the NIDDK to receive funds from the Collaborator for the study
- Clinical Trials Agreement (CTA) – an NIDDK-initiated mechanism for the clinical co-development of an agent and does not permit NIDDK to receive funds from the Collaborator
One critical obligation covered by the CRADA or CTA is intellectual property rights for inventions conceived or reduced to practice during the conduct of a collaborative clinical trial. Because Collaborators donate their proprietary agents for the conduct of the clinical trial, they often require, at minimum, a license to any new inventions discovered during the course of the collaborative clinical trial that utilizes their agent. For extramural studies, the NIDDK requires, under the terms and conditions of its funding agreement with each institution in the network (the network sites or “Institution”) to comply with its Extramural Intellectual Property Licensing Policy, defined below. In this way the NIDDK provides assurances to its Collaborator that the Collaborator will have access to new inventions discovered under the collaborative research project and memorializes such assurance in the CRADA or the CTA. This enables the NIDDK to engage in public-private partnerships with industry to test and co-develop agents so it can fulfill its mission to advance scientific discoveries to improve public health.
Rights Related to Intellectual Property and Grantee Inventions
Under the Bayh-Dole Act (see 35 U.S.C. 201 et seq.) and 37 Code of Federal Regulations Part 401, Institutions have the right to elect title to any invention they discover in the performance of a study under NIDDK sponsorship, provided that neither the NIDDK nor the Collaborator shares ownership of the invention by virtue of co-inventorship. The NIDDK Intellectual Property License for Grantee Inventions requires the network’s institutions to grant Collaborators a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all inventions for research purposes only; and a time-limited first option to negotiate an exclusive, world-wide royalty-bearing license for all commercial purposes, including the right to grant sub-licenses, to all inventions on terms to be negotiated in good faith by Collaborator and the Institution. The Collaborator has to notify the Institution, in writing, of its interest in obtaining an exclusive license to any Institution invention within six (6) months of Collaborator's receipt of notice of such invention.
NIDDK Intellectual Property Policy for U01 Grantees
In addition to complying with the NIH Intellectual Property Policy located at http://grants.nih.gov/grants/intell-property.htm, Institution agrees to promptly notify the NIDDK and the commercial Collaborator, if appropriate, in writing of any inventions, discoveries or innovations made by the Institution's investigator or any other employees or agents of Institution, whether patentable or not, which are conceived and/or first actually reduced to practice in the performance of this study using the commercial Collaborator's Agent (hereinafter "Institution Inventions"). Institution agrees to notify NIDDK and Collaborator in writing upon the filing of any patent applications related to the research with the Agent.
Institution agrees to grant to Collaborator:
- a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all Institution Inventions for research purposes only; and
- a time-limited first option to negotiate an exclusive, or co-exclusive, if applicable, world-wide royalty-bearing license for all commercial purposes, including the right to grant sub-licenses, to all Institution Inventions on terms to be negotiated in good faith by Collaborator and Institution. Collaborator shall notify Institution, in writing, of its interest in obtaining an exclusive license to any Institution Invention within six (6) months of Collaborator's receipt of written notice of such Institution Invention(s). In the event that Collaborator fails to so notify Institution, or elects not to obtain an exclusive license, then Collaborator's option shall expire with respect to that Institution Invention, and Institution will be free to dispose of its interests in such Institution Invention in accordance with Institution's policies. If Institution and Collaborator fail to reach agreement within ninety (90) days, (or such additional period as Collaborator and Institution may agree) on the terms for an exclusive or co-exclusive license for a particular Institution Invention, then for a period of six (6) months thereafter Institution shall not offer to license the Institution Invention to any third party on materially better terms than those last offered to Collaborator without first offering such terms to Collaborator, in which case Collaborator shall have a period of thirty (30) days in which to accept or reject the offer.
Institution agrees that notwithstanding anything herein to the contrary, any inventions, discoveries or innovations, whether patentable or not, which are not Subject Inventions as defined in 35 U.S.C. § 201(e)*,arising out of any unauthorized use of the Collaborator's Agent and/or any modifications to the Agent, shall be the property of the Collaborator (hereinafter "Collaborator Inventions"). Institution will promptly notify the NIDDK and Collaborator in writing of any such Collaborator Inventions and, at Collaborator's request and expense, Institution will request permission from the NIDDK/NIH*, if necessary, to cause to be assigned to Collaborator all right, title and interest in and to any such Collaborator Inventions and provide Collaborator with reasonable assistance to obtain patents (including causing the execution of any invention assignment or other documents). Institution may also be conducting other more basic research using the Agent under the authority of a separate Material Transfer Agreement (MTA), or other such agreement with the NIDDK or Collaborator. Inventions arising thereunder shall be subject to the terms of the separate MTA, and not to this clause.