Tag Archives: exceptional circumstances

Exceptional Circumstances in Bayh-Dole, 10

We have been circling around the central problem of “exceptional circumstances” in Bayh-Dole. The law works to allow organizations to make decisions about patent monopolies that preempt other statutes–ones that “require a disposition of rights inconsistent” with Bayh-Dole’s arbitrary preemption … Continue reading

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Bayh-Dole preempts NIH policy on improper financial gain

Here’s a passage from the NIH Grants Policy Statement (Part I, Chapter 4): NIH grants are subject to requirements intended to ensure that recipient organizations handle their Federal awards responsibly. Recipients are required to adopt and enforce policies that minimize … Continue reading

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Exceptional Circumstances in Bayh-Dole, 9

We are working through the idea of exceptional circumstances in Bayh-Dole. There’s a problem here that lies at the root of the federal policy. Bayh-Dole states an arbitrary default–if a federal contractor acquires a patentable invention made in a project … Continue reading

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Exceptional Circumstances in Bayh-Dole, 8

We  have looked at the NIH’s views on exceptional circumstances. We started with Dr. Thomas’s 2008 talk, with a discussion about how his talk fundamentally misrepresented Bayh-Dole. We then checked out the PHS Technology Transfer Manual’s statements of policy and … Continue reading

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Exceptional Circumstances in Bayh-Dole, 7

The 2013 version of the PHS Technology Transfer Manual 607.1 on exceptional circumstances lists a set of questions that ought to be considered by those in an NIH institute or center (IC) in preparing a determination of exceptional circumstances. These … Continue reading

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Exceptional Circumstances in Bayh-Dole, 6

You may think it’s mean of me to pick on Dr. Thomas for a talk that’s a decade old, and presented before the Stanford v Roche case was decided. If so, then you might want to consider the Public Health … Continue reading

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Exceptional Circumstances in Bayh-Dole, 5

Despite the recognition that there are all sorts of federal research programs primarily directed at nonprofit-hosted research that would benefit from a determination that Bayh-Dole’s default provisions do not do a good job of promoting Bayh-Dole’s stated policy and objectives, … Continue reading

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Exceptional Circumstances in Bayh-Dole, 4

In more plain language, even with regard to outcomes, Bayh-Dole is crappy public policy. At best, Bayh-Dole has enabled a betting parlor managed by nonprofits for the future value of patent rights, especially those patents directed at controlling the “market” … Continue reading

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Exceptional Circumstances in Bayh-Dole, 3

“Exceptional” circumstances are not stated by Bayh-Dole to be rare or unusual ones–they could be common. Exceptional circumstances are those circumstances in which Bayh-Dole’s arbitrary default at 35 USC 202(a) is not the best thing for promoting the policy and … Continue reading

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Exceptional Circumstances in Bayh-Dole, 2

Here’s the slide from Dr. Thomas that starts our descent into darkness. Part of the slide contents is accurate. Part is slipped. Let’s take up the slipped. First, Bayh-Dole does not say the federal government “retains patent rights” when the … Continue reading

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