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Author Archives: Gerald Barnett
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
Posted in Bayh-Dole, Bozonet
Tagged Bayh-Dole, Bristol-Myers, drugs, medicinal chemistry
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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
Posted in Bayh-Dole, Policy
Tagged Bayh-Dole, exceptional circumstances, Xtandi
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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
Posted in Bayh-Dole
Tagged 35 USC 200, Bayh-Dole, covenant, march-in, policy, price, utilization
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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
Posted in Innovation, Technology Transfer
Tagged development, research monopoly
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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
Posted in Innovation, Sponsored Research
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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
Posted in Bayh-Dole, Sponsored Research
Tagged Bayh-Dole, march-in
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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
Posted in Bayh-Dole, Policy, Social Science
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Bayh-Dole and the Keys to the Gates of Heaven, Part 1
Overcoming a usual narrative is takes tremendous work. There are many arguments against doing so: the received view is true; working against best practices can create liability or distrust; challenging the status quo can hurt one’s career; refusing to accept the … Continue reading
Posted in Bayh-Dole, Bozonet, Social Science
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Behind the Usual Narrative, Part V
Universities Help to Make the Problem Universities created the federal contracting mess for basic research by insisting that the federal government not concentrate contracting authority in a single agency set up specifically for providing grants under the most liberal patent … Continue reading
Posted in Bayh-Dole, History, Policy, Sponsored Research
Tagged Bush, IPA, Latker, uniform patent policy
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Ordinary and subject patent monopolies
Here’s a diagram that might help discussions of patent rights made with federal funding. A general monopoly A operates without any constraints of law, and in particular without regard for anti-trust law. Thus, such a monopolist may exercise ranging power, … Continue reading