Wednesday, December 12, 2012

Rai & Sampat on Bayh-Dole Underreporting

I’m very interested in university patenting and licensing under the Bayh-Dole Act, so I enjoyed the new Nature Biotechnology piece by Arti Rai (Duke Law) and Bhaven Sampat (Columbia Public Health), in which they report that universities don’t meet reporting requirements when they patent the results of federally funded research.

The Bayh-Dole Act requires universities to report patent applications and "efforts at obtaining utilization" to funding agencies, and to report federal funding in patent documents using a government-interest statement. Rai and Sampat found that only 43% of academic biomedical patents issued from 1980 to 2007 contain government interest statements, even though 60% of academic biomedical research was federally funded over this period. They also report that in a database of patents reported to NIH, generally only 60-80% of patents contain government-interest statements (even though 100% should). And they found eight FDA-approved drugs that failed to acknowledge their government funding in associated patents.

Rai and Sampat conclude that reporting on patents is improving but still incomplete, and they note this “does not bode well for reporting on actual utilization.” What are the consequences of this? The authors note that underreporting creates uncertainty about government march-in rights (although these rights are not actually exercised) and makes assessing the success of commercialization efforts difficult. But their most pointed criticism is not of universities, but of government agencies for keeping data that is reported under Bayh-Dole “shrouded in secrecy”—for example, by not allowing access to the iEdison database that contains information provided by grantees to the 29 funding agencies.

This piece is worth reading for anyone interested in Bayh-Dole patenting—especially because it is only four pages, far shorter than the average needlessly wordy law review article!

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