From Lab to Commercialization: NIH Licenses Offer Another Path

Patently BIOtech

(Original post at BIOtechNow)

If a biomedical breakthrough occurs within a federal lab, chances are your company can license use of the technology from the National Institutes of Health’s Office of Technology Transfer (OTT).

Every year, literally hundreds of biomedical breakthroughs take place in federal labs, and OTT handles licensing of such technologies for all labs within the Health and Human Services Department. NIH promotes licensing and use of these developments to create practical applications.

While NIH works to make the licensing process easy, it also seeks the development of as many products as possible that have the potential to improve public health. For that reason, it rarely grants exclusive-use licenses. In fact, the more licensees the better, in its view.

“This allows more than one company to develop products using a particular technology, products which may ultimately compete with each other in the marketplace,” OTT points out in its licensing documentation. “NIH recognizes that companies typically need an exclusive market position to offset the risk, time and expense of developing biomedical diagnostic or therapeutic products; however, companies do not necessarily need to achieve that position by exclusively licensing a government technology used to develop that product.”

The OTT website provides extensive lists and details of the technologies available for licensing. Toward its goal of improving public health, the agency breaks out licensing opportunities for neglected diseases and rare diseases in their own sections on the site. In addition to explaining the different types of licenses and research opportunities available, the site also provides examples of the forms and documents needed to apply for licenses.

NIH developments have played a role in many successful biomedical products. Determining the value of the government’s technology transfer work is tricky, the agency concedes. Typically, success is measured in patents approved and royalties received by the government.

“This approach does not depict the full scope of activities and may, in fact, distort the importance of ensuring that novel biomedical inventions are commercialized,” the agency notes in the preface to NIH Technologies in the Development of Healthcare Products, an online collection of case studies that showcase the impact of tech transfer.

Ultimately, the report notes, the most crucial factor is “the extent to which technologies developed in NIH laboratories and transferred to commercial partners are meeting the NIH mission of improving the public health.”

Based on that mission, the licensing process focuses on ensuring that licensed technology results in the creation of actual products. When applying for a license, a company must submit a business development plan, which OTT then uses to create performance benchmarks. OTT monitors each licensee’s performance and adjusts benchmarks as needed to ensure commercial development of government-derived inventions.

The Office of Transfer Technology will have a booth providing information about its programs at the upcoming BIO International Convention.

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