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Author Archives: Gerald Barnett
Bayh-Dole Basics, 8: Reasonable Terms Comments-5
We are working through the prior federal regulations in an effort to understand the “reasonable terms” requirement in Bayh-Dole’s 35 USC 203(a)(1) march-in condition. In the Kennedy executive branch patent policy, contractors had two primary routes to retain ownership of … Continue reading
Bayh-Dole Basics, 8: Reasonable Terms Comments-4
We are working through the details of prior treatments of what becomes “reasonable terms” in Bayh-Dole’s definition of “practical application.” This definition in turn becomes the threshold for federal agency march-in under 35 USC 203(a)(1)–the first of the four march-in … Continue reading
Bayh-Dole Basics, 8: Reasonable Terms Comments-3
We are working through the NIH’s Institutional Patent Agreement master template to establish the context for Bayh-Dole’s use of “reasonable terms” in its definition of practical application, which in turn establishes the march-in threshold for 35 USC 203(a)(1), one of … Continue reading
Bayh-Dole Basics, 8: Reasonable Terms Comments-2
Now we get to government rights under march in. Here we have complications. In 1968, Norman Latker, NIH’s patent counsel, revived the Institutional Patent Agreement program, under which the NIH (and later the NSF) contracted with nonprofits so that a … Continue reading
Posted in Uncategorized
Tagged Bayh-Dole, development, exclusive license, IPA, Latker, march-in, master agreement
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Bayh-Dole Basics, 8: Reasonable Terms Comments-1
This will be longish. It’s a document of the details. In a world where people spout TL;DR for most any issue of substance, and want a sound bite to gulp instead, this ain’t it. Perhaps we can get all brief … Continue reading
Posted in Bayh-Dole, History
Tagged Bayh-Dole, Kennedy patent policy, march-in
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Bayh-Dole Basics, 8: Reasonable Terms
[Short: There are two “reasonable” terms in Bayh-Dole. The first has to do with reasonable terms on offer to the public. These terms, including price, are the terms a reasonable person would expect if there were competition, even if a … Continue reading
Posted in Agreements, Bayh-Dole
Tagged Bayh-Dole, march-in, practical application, reasonable terms
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Patents, Medicines, Public Funding–2
We have distinguished four sorts of medical interventions–prevention, cure, facilitation, and alleviation. We have also argued that from a public health point of view, prevention and cure are tops, and facilitation and alleviation are great when they support prevention and … Continue reading
Posted in Innovation
Tagged acute, alleviator, chronic, cure, drug, facilitator, prevention, prices
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Patents, Medicines, Public Funding–1
Let’s look at four areas of health “technology”: preventions, cures, facilitators, and alleviators. A prevention does just that–prevents an adverse health condition. A vaccine, for instance, prevents a disease (for many, and sometimes with adverse reactions, even deaths). Or, regular … Continue reading
Posted in Innovation, Policy
Tagged alleviator, CF, cure, facilitator, prevention
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Bayh-Dole is thin soup when it comes to federal innovation policy
NIST wants march-in for Bayh-Dole’s section 203(a)(2) and (3) to be for “national emergencies” only. Section (a)(2) concerns health or safety needs that are not “reasonably satisfied.” Section (a)(3) concerns regulatory requirements that are not “reasonably satisfied.” But the *price* … Continue reading
More bad Bayh-Dole advice in the wild
Here are “three important questions answered” by a company specializing in Bayh-Dole compliance. (I’m sorry, Nikki. Have your people up their game.) 1) If you report an invention after the 60-day deadline, can the Government take title? Yes, the Government … Continue reading
Posted in Bayh-Dole, Bozonet
Tagged Bayh-Dole, compliance, disclosure, subject invention
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