COI Toolkit

Recommendations, tools, and resources for the conduct and management of financial relationships between academia and industry in biomedical research




References and Resources

(1) Inventors as investigators: The ethics of patents in clinical trials, J Kimmelman, Acad Med, 2007

(2) For a good summary, see The Bayh-Dole Act: A Guide to the Law and Implementing Regulations, Council on Government Relations, 1999 (PDF)

See also

Company founders: Voices of experience, L DeFransesco, Nature Bioentrepreneur, 2004 - Interviews with nine leading scientists who founded startup companies reveal some common themes and lessons.


Patenting and Licensing of Research Inventions

Be aware of and adhere to requirements of funding agreements related to disclosure of inventions and your own institutional patent policies. Issues can arise when an investigator's role as an inventor conflicts with other institutional responsibilities. Policies differ as to whether or not holding a patent or submitting a patent application is defined as a potential conflict of interest (1).

Requirements: Under the Bayh-Dole Act (2), investigators conducting federally-sponsored research must disclose inventions resulting from that research to their institutions. Institutions own intellectual property resulting from an investigator's federally-funded research. Proper disclosure policies and procedures must be followed, and investigators must not condone or participate in moving technologies and discoveries "out the back door" to companies with which they have a relationship. This is illegal.

Co-inventors: Patent law requires disclosing collaborating inventors (including trainees) on patent applications, and there are legal criteria for who is an inventor and who is not. These criteria are different from who might be included as an author on a paper, and investigators should be aware of this distinction. Investigators should seek institutional guidance if they have questions about their institution's policies on these matters.

Institutional technology transfer offices: Inventors should cooperate with their institutional technology transfer office to help the office fully understand their invention, evaluate its scope and potential, achieve appropriate intellectual property protection, and identify appropriate licensees for the invention. Inventors should respect the decision of institutional professionals responsible for these decisions.

When holding a role in a start-up company, be guided by agreed-upon limits to the scope of the relationship. Close interaction between the inventor of the technology and the licensing company is often very beneficial because the inventor of a technology often has the most expertise to help translate that technology into a useful product. But investigators with dual roles (research faculty and company founder/consultant) face challenges of potential overlap of research interests, thereby blurring the line between institutional responsibilities and outside interests. It is appropriate (and often necessary) for an investigator to serve initially in a managerial role. Activities may include consulting, reviewing strategic plans, and discussing the company's progress. A contract should be used to define activities and method of compensation.