Category Archives: Bayh-Dole

Inventors would own more, were it not for noncompliant Bayh-Dole practice

Posted on March 10, 2023 by Gerald Barnett

I saw this tweet this morning: I agree Inventors should own more, but institutions were/are the heart of Bayh-Dole that (arguably) enables IP-driven startups… this is bc many/most PI inventions would go into a black hole without tech transfer officer … Continue reading →

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Why not let’s try, Frank?

Posted on March 9, 2023 by Gerald Barnett

Frank Cullen, writing at the “Council for Innovation Promotion” has posted a hand-wringing response to a letter from members of Congress to the Secretary of Health and Human Services requesting that the government use Bayh-Dole’s march-in provisions to address price … Continue reading →

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March-in rights, Xtandi, and Bayh-Dole’s patent rights clause

Posted on March 3, 2023 by Gerald Barnett

Senator Bernie Sanders just tweeted about Xtandi, asking patients taking Xtandi to share their stories. The prostate cancer drug Xtandi was invented by taxpayer-funded scientists at UCLA, but now costs Americans nearly $190,000 — or up to six times the … Continue reading →

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NIAID Breezily Repudiates Supreme Court Ruling

Posted on February 22, 2023 by Gerald Barnett

Perhaps you wanted a short version. NIAID puts this in guidance to inventors regarding inventions made in NIH-funded work: Under the Bayh-Dole Act, your institution as the grant recipient owns rights to the NIH-funded invention and has the right and … Continue reading →

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NIAID botches Bayh-Dole

Posted on February 22, 2023 by Gerald Barnett

This will be a bit of a long ride. Buckle up. In 2011, the US Supreme Court ruled in Stanford v Roche that the Bayh-Dole Act does not vest title to inventions made in federally supported work with the nonprofit … Continue reading →

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The Bayh-Dole Public Bargain, 2

Posted on January 20, 2023 by Gerald Barnett

Baked into Bayh-Dole is the policy expectation that a holder of a patent on a subject invention will offer products based on that invention as if there were competition, even if a patent is used to suppress that competition. In … Continue reading →

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The Bayh-Dole Public Bargain, 1

Posted on January 19, 2023 by Gerald Barnett

Bayh-Dole is directed at federal agencies contracting for research or development with small businesses and nonprofits. The law requires agencies to use a default patent rights clause in every funding agreement unless an agency can justify a different clause. The … Continue reading →

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An Open Letter to Senator Warren Regarding Xtandi

Posted on January 16, 2023 by Gerald Barnett

Dear Senator Warren: You have called repeatedly for the federal government to use regulatory tools available to it to address the high prices charged for drugs. Your attention to this matter is much appreciated! I write with specific reference to … Continue reading →

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Smells Like Bayh-Dole Spirit

Posted on January 9, 2023 by Gerald Barnett

Bayh-Dole has two main concerns: contractor patent rights (35 USC 202-204) and federal agency disposition of patents (35 USC 207-209). These two sets of provisions work together in odd but let’s say intended ways. For instance, 35 USC 207(a)(2) authorizes … Continue reading →

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The Bluntly Essence of Bayh-Dole’s Contracting Provisions

Posted on January 8, 2023 by Gerald Barnett

Let’s be super bluntly. The essence of Bayh-Dole’s contracting provisions is: Make new product available promptly, and at a competitive price. That’s it. That’s what all the apparatus and fuss is about, and what federal agencies refuse to recognize or … Continue reading →

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