Category Archives: Policy

Bayh-Dole march-in won’t change drug prices but other things might–2

Now let’s look at alternatives to Bayh-Dole’s march-in procedures to address competition, public access, and prevention of unreasonable use, including price gouging. We will consider two within Bayh-Dole and two outside Bayh-Dole. The Bayh-Dole alternatives are: use the government license … Continue reading

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Bayh-Dole march-in won’t change drug prices but other things might–1

Folks think that somehow Bayh-Dole permits government take over of pharma patents and by doing this, somehow, the price of drugs will necessarily–magically–go down. Let’s work through this idea. Set aside for a moment that many drugs don’t do much … Continue reading

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War and Publification of Medicine Development, 3

Think of it this way, at least simplistically. You are patent counsel for the NIH in 1968. You have no control over how the NIH allocates funding, and the NIH chooses to fund lots of research and declines to fund … Continue reading

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War and Publification of Medicine Development, 2

The “war on disease” usage asserts a primary federal government role in directing the research and development of disease-directed therapies. The “war” usage asserts that the “market” for treating disease with new therapies–inventive therapies–is a governmental market, and that patents … Continue reading

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War and Publification of Medicine Development, 1

In 1944, President Roosevelt asked Vannevar Bush to respond to four questions (or, perhaps it was Vannevar Bush who arranged for President Roosevelt to ask him four questions). These questions formed the foundation for his report Science the Endless Frontier. … Continue reading

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A non-compliant Bayh-Dole written agreement at Yale-5

We are working through Yale’s “Patent Policy Acknowledgement & Agreement.” We have been looking at Paragraph 6 of the Yale patent policy to try to make sense of what inventions Yale really does assert an interest in. Paragraph 6 demands … Continue reading

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A non-compliant Bayh-Dole written agreement at Yale-4

We are working through Yale’s “Patent Policy Acknowledgement & Agreement.” Most recently we borked about employment and faculty freedom. Now let’s look at how the agreement deals with consulting. It tries to worry the problem of conflicting obligations–Yale doesn’t want … Continue reading

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A non-compliant Bayh-Dole written agreement at Yale-3

We are working through Yale’s “Patent Policy Acknowledgement & Agreement.” The agreement requires personnel signing it to “abide” by Yale’s patent policy, as if that patent policy does not apply but for this agreement. That’s a bit odd. Even odder, … Continue reading

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A non-compliant Bayh-Dole written agreement at Yale-2

Now let’s look at a “Patent Policy Acknowledgement & Agreement” from Yale University. Here it is: Yale’s web site asserts that this agreement is required “for grant and patent compliance.” That’s a strange combination–grant and patent. One might think grant … Continue reading

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A non-compliant Bayh-Dole written agreement at Yale-1

Bayh-Dole’s standard patent rights clause introduces a requirement not in Bayh-Dole. 37 CFR 401.14(f)(2) requires contractors to require their employees, other than clerical and non-technical employees, to make a written agreement to protect the government’s interest in subject inventions: The … Continue reading

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