Influenza Technologies Available for Product Development

Topics on this Page

• Overview
• HHS research has yielded technologies that hold great promise in combating influenza
• HHS actively seeks partners to develop and commercialize technologies
• The expectation of public-health benefit drives HHS licensing policy

Overview

To improve public health worldwide, the U.S. Department of Health and Human Services (HHS) grants licenses to organizations around the world to commercialize intellectual property invented by research scientists at HHS. This portfolio of patent applications, issued patents and unique biological materials includes technologies for influenza vaccines and diagnostics, all of which are available to qualified organizations, both commercial and non-profit.

To facilitate the development of new technologies world-wide, including in developing countries where there is no patent protection; HHS will license unique biological materials relevant to these technologies to organizations in such countries for the development of influenza vaccines and diagnostics. HHS can grant any qualified organization a research use license on a non-exclusive basis. HHS will not require royalties on products donated or sold at cost to public institutions for use in developing countries. License terms will be commensurate with the commitment of organizations to bring technologies to market through development on a country-by-country or regional basis.

The filing of these patent applications is consistent with the HHS policy to develop tools and technologies that facilitate the translation of research advances into medical products for the benefit of public health. This strategy has been utilized successfully by HHS to transfer technologies for vaccine development to countries such as Brazil, China, and Egypt. The patents are incentives for organizations to incur the cost and risk of investing in research advances to develop products and to bring them to market. At this early stage of development, no one knows which, if any, of these or other multiple technologies will bring the world closer to new safe and effective vaccines or diagnostics for seasonal or pandemic influenza.

HHS research has yielded technologies that hold great promise in combating influenza

Over the last several years, the efforts of HHS researchers have resulted in a number of inventions, represented within 14 U.S. patent applications and associated foreign applications (“Patent Families”), and one set of issued patents for technologies related to influenza vaccines and diagnostics. For example, four HHS/National Institutes of Health (NIH) patent families describe recombinant constructs with influenza gene inserts modified in a specific way. Developers could use these influenza-vaccine candidates alone, as a combination product, as part of a vaccine regimen, or in diagnostic applications for multiple influenza strains, including seasonal influenza strains (H1N1 and H3N2) and strains with pandemic potential (H5N1).

Five HHS/NIH patent families and one HHS Food and Drug Administration (FDA) patent family relate to other approaches to the development of influenza vaccines and diagnostics, including peptides and conjugate vaccines. One of these technologies uses tiled microarrays that contain large numbers of influenza-virus nucleic acid probes to detect and identify known and unknown subtypes of influenza viruses for types A, B, and C.

In addition, researchers for the HHS the Centers for Disease Control and Prevention (CDC) are inventors on five patent families, two of which HHS solely owns, and three of which HHS co-owns with universities. Three of these patent families are for diagnostics. The other two include a recombinant-vaccine construct with inserts of influenza genes, and a new form of recombinant influenza M2 protein.

All of these pending HHS/NIH and HHS/FDA patent applications, as well as the HHS/CDC solely owned patent families, are available for licensing by enterprises around the world.

None of the patent families would restrict the use of or claim wild-type influenza viruses.

HHS actively seeks partners to develop and commercialize technologies

All of the HHS/NIH and HHS/FDA patent families noted above are pending judgment by patent authorities, as early-stage filings in the United States, as international applications with the ability to file at a later time in specific countries, or as applications filed in individual countries or regions including the United States, Canada, the People’s Republic of China, India, South Korea, Singapore and Europe. These countries reflect the location of most organizations that have previously licensed or have expressed an interest in licensing vaccine technologies for product development from the HHS. The HHS/NIH and HHS/FDA would consider filing in other countries, if an organization in that country desires patent protection and a license as an incentive to bring a product to market there.

The HHS/CDC patent families, solely owned by HHS, are also available for licensing. The recombinant M2 technology is patented in the United States, New Zealand, Australia and some European countries, and is pending in Canada. The second technology is a diagnostic, and is pending patent approval in the United States, Europe, Canada, Singapore, Hong Kong, and Indonesia.

HHS advertises technologies available for licensing on web sites, public notices, or through direct contact with potential licensees. Through HHS technology-transfer efforts related to various discoveries of interest to developing countries, licensing professionals maintain contact with potential partners around the world.

The expectation of public-health benefit drives HHS licensing policy

HHS licenses its technologies to improve public health around the world. Furthermore, HHS is committed to an international strategic licensing strategy similar to what it has successfully utilized to transfer technologies for use in the development of vaccines against dengue, typhoid, bacterial meningitis, rotavirus and varicella-zoster to institutions in Brazil, China, Egypt, India, México, Nigeria, South Africa, and South Korea. HHS utilizes this same strategy for influenza technologies.

The technology described in these patent families could prove useful in lessening the global burden of seasonal influenza, as well as in improving the preparedness of nations against influenza strains with pandemic potential, such as H5N1 and others. Unlike traditional, seasonal vaccines against influenza, these recombinant technologies require extensive testing to show they are effective before obtaining regulatory approval and making them available to the public. Private-sector investment and expertise are critical to achieve this result. New technologies such as these could improve protection from influenza or reduce the amount of time required to produce large quantities of vaccine. The immediate challenge is to facilitate their development into products that improve public health throughout the world.

For further information about licensing these technologies, please contact the HHS/NIH Office of Technology Transfer www.ott.nih.gov (HHS/NIH and HHS/FDA inventions), or the HHS/CDC Technology-Transfer Office www.cdc.gov/od/science/techTran.