Intellectual Property and Resource Sharing

Inventions and data arising from research using annotated biospecimens may have commercial value. As researchers and industry sponsors have sharply increased their demand for properly prepared and clinically annotated biospecimens, some institutions have begun to assert control over biospecimens, associated data, and research findings. The current variability in intellectual property (IP) policies at institutions hosting research and biospecimen resources may ultimately lead to problems in biospecimen and data access, timely and open publication, sharing of research findings, and establishment of new biospecimen resources. Sharing of research data obtained through use of biospecimens and associated research materials (e.g., derivatives) is essential for the advancement of science. Accordingly, research data and tools generated through the use of biospecimens should be shared in a timely manner and, to the greatest extent possible, in a manner consistent with applicable NIH sharing policies.

C.5.1. Material Transfer Agreements

An agreement (e.g., MTA or contract) with terms consistent, as applicable, with the NIH Research Tools Policy, the NIH Data Sharing Policy, and other applicable NIH sharing policies should be used for the transfer of materials among academic, nonprofit, and/or industrial organizations (see Appendix 4 for a sample MTA). Clinical protocols are not designed to document material transfers and are usually inappropriate for this purpose. Examples of agreements that capture the basic principles of the NIH policies above are the NIH Simple Letter of Agreement and the Uniform Biological Material Transfer Agreement [119]. However, these agreements are insufficient for the transfer of human specimens without appropriate modification. Desirable terms in an MTA for the transfer of biospecimens include the following:

Clear descriptions of the biospecimens and/or unmodified functional derivatives thereof (e.g., DNA and RNA) and identification of the institutions involved;
Clear identification of the human subjects status of the biospecimens and associated obligations;
Specific assurance that the biospecimen source site obtained appropriate informed consent and IRB approval;
Agreement to abide by appropriate laws, rules, and regulations associated with human subjects research and private information;
Acknowledgement of the recipient’s right, or lack thereof, to further distribute the biospecimens;
Assurances of the end user’s academic freedom and the right to publish research results will not be hindered by the biospecimen resource; IP terms consistent with, as applicable and permissible, the basic principles of the NIH Research Tools Policy and other applicable NIH sharing policies, such as no reach-through by the biospecimen resource to end users’ IP and the sharing of research resources and data by the end-user with the research community;
Description of any expectations regarding the dissemination of research data; and
Conditions, or limitations, on commercial use, if any.

The following Web pages are relevant to this issue:

C.5.2. Inventorship

Generally, biospecimen resource staff, as custodians of biospecimens, will not be considered a priori inventors under patent law for inventions made using materials distributed by the biospecimen resource. In general, one whose sole contribution to an invention consists of the routine collection, handling, storage, and disbursement of biospecimens might not rise to the level of “inventor.” Inventorship is determined by patent law and is considered on a case-by-case basis by legal personnel.

C.5.3. IP Rights

Generally, biospecimen resources have no inherent rights to future IP of end-users, such as reach-through rights to inventions made by investigators using samples obtained from the biospecimen resource.

C.5.4. Licensing

When IP resulting from biospecimen research is exclusively licensed, a research use license should be retained that allows nonprofit and Government research use and ensures access to resources and data for research and educational purposes.

C.5.5. Data and Resource Sharing

Through MTAs or other appropriate documents, research data and research resources obtained using biospecimens should be made available to the research community to the greatest extent possible, consistent with, as applicable, the NIH Data Sharing Policy [68], the NIH Genomic Data Sharing Policy [69], other applicable NIH sharing policies, [68] and the NIH Research Tools Policy [114]. Consistent with the applicable NIH policies, completed data sets and resources should be released in a timely fashion; i.e., no later than acceptance for publication of the main findings from the final data set. To promote future biomedical research, data and resources developed with biospecimens would be retained only as long as necessary for legitimate and imminent research purposes. Information that is identifiable or linked to a specific individual should be shared under an agreement with appropriate privacy safeguards and adherence to applicable legal requirements. A reasonable delay to ensure an investigator’s publication priority or to secure IP protection is acceptable. See Section C.6. Conflicts of Interest

A financial COI exists, according to Public Health Service (PHS) regulations, when a designated institutional official(s) reasonably determines that an extramural Investigator’s significant financial interest could directly and significantly affect the design, conduct, or reporting of PHS-funded research (42 CFR Part 50, Subpart F and 45 CFR 94). An Investigator is defined by these regulations as the principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded by PHS or proposed for such funding Generally, it is the awardee institution that is responsible for maintaining compliance with the requirements of the regulations, identifying and managing Investigator Financial Conflicts of Interest and reporting them to the PHS-awarding component. Investigators disclose their Significant Financial Interests, as defined in 42 CFR § 50.603 and 45 CFR § 94.3, to their institutions. Significant Financial Interests include those of an investigator’s spouse and dependent children. Extramural investigators conducting biospecimen research activities supported by PHS grants, cooperative agreements, or research contracts are subject to the requirements of these regulations (see the NIH Office of Extramural Research [120] Web site for more information on COIs). Federal employees are subject to different regulations related to COI, as described in 18 USC 208, the Standards of Ethical Conduct for Employees of the Executive Branch, and agency-specific regulations (see the NIH Conflict of Interest [121] Web site for more information related to federal employees).