Tag Archives: Bayh-Dole

Royalty sharing as federally mandated divisiveness

Posted on November 8, 2016 by Gerald Barnett

Here’s a sliver of divisiveness in Bayh-Dole (35 USC 202(c)(7)). In the case of a nonprofit organization, …. (B) a requirement that the contractor share royalties with the inventor On the face of it, this seems to be a happy requirement. … Continue reading →

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

Posted on October 31, 2016 by Gerald Barnett

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

Posted on October 30, 2016 by Gerald Barnett

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

Posted on October 29, 2016 by Gerald Barnett

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

Posted on October 29, 2016 by Gerald Barnett

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

Posted on October 26, 2016 by Gerald Barnett

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 served up by the Catholic University of America’s general counsel

Posted on October 12, 2016 by Gerald Barnett

Here’s a bit from the office of general counsel at Catholic University of America. See how many things this statement of Bayh-Dole gets wrong in only four sentences. I’ll give you a few minutes. The Bayh-Dole Act of 1980 (Patent … Continue reading →

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Five Audit Issues for University Compliance with Bayh-Dole

Posted on October 10, 2016 by Gerald Barnett

While most discussions about Bayh-Dole compliance focus on the time periods for reporting inventions, filing patent applications, and giving notice of election to retain title, the compliance issues that matter are often overlooked. The top five involve ownership, money, and … Continue reading →

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Does Bayh-Dole Require Reasonable Pricing?

Posted on October 2, 2016 by Gerald Barnett

[Revised and extended for clarity] Short answer: no, but well, sort of, er, actually–yes! but not what you might expect. In 2005, Norman J. Latker, the key draftsman of both the Institutional Patent Agreement and Bayh-Dole published a critique, along with … Continue reading →

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The Effect of Bayh-Dole on University Therapeutics

Posted on October 1, 2016 by Gerald Barnett

Yesterday Kelly Sexton tweeted out the following claim: It would be great to think that the Bayh-Dole Act has resulted in a bunch of new therapeutics reaching the public. And perhaps that’s the case. And it might even be simpler … Continue reading →

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