Monthly Archives: October 2016

3 Ways to Get at Bayh-Dole Abuses

Here are three approaches to get at abuse of Bayh-Dole by patent brokers. 1. Invoke the non-use march-in condition. 35 USC 203(a)(1) Demand federal march-in for nonuse (35 USC 203(a)(1)) for all subject inventions claimed by universities that do not meet … Continue reading

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Don’t think it will be easy to get at Bayh-Dole

Bayh-Dole was designed to create private patent monopolies for the pharmaceutical industry that operate without public oversight or accountability. Almost everything about Bayh-Dole is a corruption of prior federal and university practice. Sure, it is possible that university administrators might stand up and … Continue reading

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To fix Bayh-Dole on reasonable pricing, why not start by enforcing the law?

I spent some time working through whether Bayh-Dole requires reasonable pricing. The simple answer is “No.” Of course, the simple answer isn’t very helpful, or accurate. Bayh-Dole does not require reasonable pricing by design of those drafting the bill. The … Continue reading

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The FDA really did approve federally supported drugs before Bayh-Dole

Joe Allen, the political coordinator behind the Bayh-Dole Act, is seen by some as an expert on the law, because, well, he helped assemble the sausage. Me, I have become something of an expert on Bayh-Dole because I have had … Continue reading

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Use Bayh-Dole 35 USC 202(a)(ii) to deal with (future) drug prices

The Washington Monthly has a new article out by Alicia Mundy on high drug prices and Bayh-Dole. Mundy reports on efforts to use march-in procedures under Bayh-Dole to force lower the price of drugs that were developed with federal support. There’s substance … Continue reading

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Bazooka or Squirt Gun?: Working through 35 USC 200

Bayh-Dole gets at monopoly pricing through patent law, not licensing restrictions. Bayh-Dole is a part of federal patent law, not federal procurement regulations. This was a big change from the prior practice, including the Institutional Patent Agreement program. Unlike the … Continue reading

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Research Monopolies and Development Monopolies

Here is one thing that I don’t understand about the standard distinction between research and development and how all this fits into ideas about commercialization. Let’s say that research produces a result that is immediately useful. Isn’t the research then development? … Continue reading

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Research and Development

In 2 CFR 215 (Circular A-110), we find definitions of research and development (dd): Research and development means all research activities, both basic and applied, and all development activities that are supported at universities, colleges, and other non-profit institutions. This … Continue reading

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Bayh-Dole, the love monster of patent attorneys and speculators

Joe Allen has written a new piece warning of the dangers of trying to use Bayh-Dole march-in procedures to control drug prices. And he has a point–the Bayh-Dole march-in procedures were not designed to deal with pricing. In fact, the … Continue reading

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Bayh-Dole and the Keys to the Gates of Heaven, Part 2

There are plenty of people who have not adopted the usual narrative regarding Bayh-Dole. They may not have heard of Bayh-Dole, and they might not know much about university research, other than that there sure seems to be a lot … Continue reading

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