You may not know the term Technology Transfer, but it refers to NIH’s standard process of transferring medical knowledge from NIH laboratories to other organizations for the purpose of developing that knowledge into outputs like medical products to enhance public health. Routinely, NIH intramural scientists disclose their discoveries to NIH technology transfer specialists who decide if patenting is appropriate and can work to seek appropriate development and commercialization partners and licensees.
NIH is now exploring how it might leverage such partnerships to further enhance health in a new, proposed policy within NIH’s Intramural Research Program. The policy would require organizations partnering with NIH through a patent licensing agreement that succeed in bringing certain products toward market to submit a plan outlining steps they intend to take to promote patient access to those products. In this context, patient access is defined broadly to include product affordability, availability, acceptability, and sustainability.
Through Request for Information (RFI) on Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning, you can provide feedback on a draft policy and accompanying draft license agreement language that incorporates patient access in the commercialization process for NIH-owned inventions. While this is a proposal that, if implemented, would affect the NIH Intramural Research Program, NIH is seeking comments and input from our many communities on how to achieve its policy goals most effectively.
The new policy would apply to patent licenses for the commercialization of drugs, biologics, vaccines, or devices. NIH would employ a tiered approach, where licenses granted for late-stage inventions that are closer to market launch would include more specific, tailored access-oriented provisions, while licenses granted for early-stage inventions would be more flexible to reflect the higher uncertainty associated with technologies that lead to drugs, biologics, vaccines, or devices.
NIH recognizes that the policy needs to be reasonable, i.e., not seek to force licensees into access obligations that obstruct commercial development or damage the viability and sustainability of a product in the market.
The RFI linked above details the proposed policy’s scope and requirements, components of access plans, and assessment methods. Considering those elements, you are asked to weigh in on specific issues like promoting meaningful access approaches; promoting transparency in the biomedical research enterprise and return on investment; providing flexibility while achieving clear policy objectives; helping licensees achieve access goals; establishing licensee obligations depending on the stage of technology development; and assessing policy impact.
All interested individuals and communities are welcome to respond—patients and patient advocates, small business firms, technology transfer and licensing professionals, investigators, public health organizations, investors, industry partners, healthcare providers, universities, research institutions, and other members of the public.
The comment period ends on July 22, 2024.
Comments are voluntary and may be submitted anonymously. Take care not to include any personally identifiable information nor any proprietary, classified, confidential, or sensitive information. NIH may post responses online without redaction.
Direct questions to Abby Rives at SciencePolicy@od.nih.gov. Learn about technology transfer at NIAID by exploring our Technology Transfer and Intellectual Property Office page.