Making Bayh-Dole March-in and Government License Work

There’s a lot of stirrings about using Bayh-Dole’s march-in procedure to address the high price of drugs in the United States. Under march-in, a federal agency has the right to require a federal contractor (or anyone who is an assignee or exclusive licensee–which also become contractors under the obtuse definitions of the law) to grant licenses under their patents on subject inventions–inventions the contractor has acquired, and which were made in work receiving federal funding–if the contractor has not achieved timely “practical application” of a subject invention. Bayh-Dole defines practical application as use of the invention such that the “benefits are available to the public on reasonable terms.”

The terror among the folks that exploit Bayh-Dole to speculate on the value of patents obtained on public interest inventions–patent folks at universities, especially–is that the courts, if not federal agencies all on their ownsome, might agree that “reasonable terms” does include “reasonable price.” Surely it does. Thus, pure terror. For a group that has been lying about Bayh-Dole for forty years, there’s really no where else to go–they can’t turn their lying up to 11 and make any difference. March-in can also be used if health needs are not satisfactorily met. More terror for the patent speculation crowd. This is all set out in 35 USC 203. Continue reading

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The Faculty Stack, 4: Frontiers Science and Other Science

We are working toward the faculty stack. To get there, however, we need context. We started with Vannevar Bush’s problem–how to connect federal resources to the free play of free intellects to expand the frontiers of science. The new awareness gained then could be used by skunk works teams drawn out of institutional research–industry, government–to develop and demonstrate prototypes outside what institutions would set as their objectives or would be willing to fund. An authoritative person–CEO status, such as a Director of a national research foundation with solid tech credentials–could then present the prototype for institutional use.

The new science would come from unexpected places. Computer science might inform telecommunications. Atomic physics might inform medicine. Thus, there was little purpose in identifying social or industry or military areas of need and conducting research on them. Need is nice, but it is already embedded in an institutional matrix of expectation and plausibility. Some years ago, I was contacted by a technology scout working for the military. “I’d like to come out to the university for a visit,” he said. “Sure,” I responded, “what would you like to see?” “That’s the problem,” he replied. “If I tell you what I’m interested in, then you will show me stuff that’s like what I’m already thinking about. Show me what you don’t think I’m interested in.” And that’s what I did. End of day, he goes, “Whew, that just obsolesced our research in multiple areas. We will have to start over.” Continue reading

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Another question on RE: are exclusive license and assignment the same thing?

Here’s another question on RE: “is an exclusive license of technology and an assignment the same thing?”

Answer: yes and no.

Let’s talk exclusive license and assignment of inventions rather than technology. An assignment expressly conveys title to an invention. An exclusive license, if it transfers all substantial rights in an invention, functions effectively as an assignment. Otherwise, it’s just an exclusive license. So, no and yes.

Continue reading

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The Faculty Stack, 3: Linking Federal Resources with Free Play

We are working through the idea that faculty independence is an important element in the justification to push federal funding for research activities to universities. For Vannevar Bush, the idea was that the frontiers of science were best explored by the “free play of free intellects.” Bush’s idea proved to be a difficult concept for administrators, managers, bureaucrats, and policy-makers to grasp. Bush argued that mission-directed research, important as it is, was constrained by the needs, expectations, and readiness to support of the organizations that controlled that research, whether corporations or government. While scientific frontiers might be expanded by such research, Bush argued that merely making more of such mission-directed work did not adequately get at the range of the unknown frontiers. Something else was needed–“free play of free intellects” was Bush’s attempt to capture this something else.

The idea of “play” operates in a number of ways. “Play” is inherently opposed to directed work, or at least work directed by others. Play is distinct from “work”–even though one might work–exercise, think–to play well. Play follows its own directions and pacing. Combine play and intellect and, Bush argues, you have prepared the ground for insights that expand the frontiers of science rather than plat out new townships in spaces already opened up.

The problem Bush faced was how to link of government-scale resources with this idea of “free play of free intellects.” Continue reading

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Latker Here, There, and Everywhere in Bayh-Dole

Norman J. Latker is the architect of present federal patent policy. Let’s work through his resume. It provides a remarkable tale of persistent influence leading to the unenforced, innovation-stagnating, dismal-performance (but it’s all kept secret, by law) Bayh-Dole Act.

Latker earned degrees in civil engineering and law from the University of Illinois. Worked then as a patent examiner from 1956 to 1959. Then he moved into patent work for the federal government, briefly with the Army and Air Force, before moving in 1963 to work at the NIH. He was Senior Patent and Copyright Attorney when he restarted the NIH IPA program. Latker served as the head of the Patent Branch for the Department of Health, Education, and Welfare from 1969 to 1979. He moved to the SBA from 1979-81, and then to the Department of Commerce in 1981.

What did he do during this time in the federal government? Continue reading

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The faculty stack, 2: Basic Research and IP Policy

The idea I will pursue here is that university faculty represent a distinct and important kind of discoverer–researcher, investigator, noodler, gadgeteer, irrelevanteur, loon. Our search for what we cannot imagine depends in having at least some really capable folks out looking for what it is that we don’t think about, whether that’s because we once knew things that we have since forgotten, or failed to recognize the importance of the lint we carry in our collective pockets, or just didn’t know the durn thing even was a thing. In this search, being tied up in institutional–even societal–purposes is limiting. There’s still much good stuff to find of course in institutionally directed or shaped study, but the desirability of constraints limits the search. We can set up many talented people to try to improve battery technology. Companies want that. Governments want that. Social advocates want that. But that throws resources into batteries and entrenches the idea of battery over other forms of energy storage, and other forms of energy. Better batteries is a good mission, but there’s room for talented people to be off-mission–and I’d argue, it’s not just important there are some, but necessary.

As Benoît Godin has pointed out, “innovation” starts its linguistic life in Greece as a word with the meaning “opening up a new mine.” Digging where there’s nothing with the expectation that it’s worth digging because you might find something anyway. Why dig where there’s nothing when you could be a productive digger helping out in a mine where there clearly, rationally, is already something? Continue reading

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For Latker, Bayh-Dole wins a political battle over delivery of research to the public

In February 1974, Norman J. Latker, patent counsel for the NIH, gave a talk in Chicago with the title “Progress Towards a Uniform U.S. Government Patent Policy for Universities and Non-Profit Organizations.” You can find most of it at IP Mall. The talk is illuminating with regard to the motivations that led Latker to work tirelessly to create the thing we call Bayh-Dole but really is the “Latker Act.”

Latker prefaces his remarks with a disclaimer:

Today I wish to note that I am speaking for myself–on my own time, at my own expense.

That is because, apparently, Latker was speaking against the prevailing policy of the Department of Health, Education, and Welfare. That sets the tone for what follows.

Latker describes himself as an “advocate for creators,” and claims affinity with the university administrators in his audience. Latker quotes a passage from Ayn Rand’s The Foundationhead giving a fanciful account of the discover of fire, held to be a demon for his gift. Latker says, that’s were we are today. An open implication is that he feels a sympathy for the demon fire maker. Continue reading

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The faculty stack, 1: Academic Freedom and IP Policy

[The aim is to get to the next article, but I found myself writing this one first. How it goes. Purdue is the ground zero for what has become the Bayh in Bayh-Dole, so we may as well. Purdue has just changed its IP policy, and there’s something about that, too, but I have managed to avoid it, having worked through the older versions of both the academic freedom policy and IP policy.]

University policies typically contain a statement of academic freedom, often placed in a faculty handbook, which is then wrapped into the formal policies of the university. Many of these statements derive from a 1940 AAUP statement on academic freedom. Here’s the research part of that statement:

Teachers are entitled to full freedom in research and in the publication of the results, subject to the adequate performance of their other academic duties; but research for pecuniary return should be based upon an understanding with the authorities of the institution.

There are two points: full freedom for research so long as it doesn’t distract from other duties, but a university ought to regulate outside pay for research. Let’s look then at a few ways this policy crosses patent policy. Continue reading

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NIST, Bayh-Dole Policy, and Disincentives

I spent the past two weeks working on comments in response to NIST’s proposed new regulations for Bayh-Dole. I ended up with 73 pages of answers to questions and section-by-section comments, and about 60 pages of outtakes. NIST didn’t make it easy.

NIST’s restatement of Bayh-Dole’s “framework” makes material omissions that tacitly endorse a reading of Bayh-Dole that the Supreme Court rejected. NIST didn’t show markup of deletions and additions, its summary of changes omitted a number of significant changes, it used “clarify” when it meant “change entirely from the clear meaning of the law,” and it didn’t consistently mark relocated text at both the point of deletion and the point of addition.

Then there was the inattention to detail–change a definition at 37 CFR 401.14(a) but forget to change it at 401.2, too, and drop a whole section that still has pointers to it. And finally there were the big hits to public interest–a clueless effort to exclude price from the meaning of “reasonable terms,” a rewrite of the inventor patent rights clause to make it into more of an inventor submit to your employer clause because we say so provision, and an open request for someone, anyone, to tell them that the government license is a “use” license not a “practice and have practiced for any government purpose” license. Continue reading

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Unenforced, Bayh-Dole enables a federal offer to look the other way on price-gouging

The government’s failure to use its government license to practice and have practiced (=make, use, and sell) puts undue pressure on march-in to address nonuse and unreasonable use of inventions arising in work receiving federal support. NIST wants to gut both march-in and the government license. The gutting is justified as a consequence pf the difference between expenditures on research and expenditures on “development” of inventions into commercial products. That distinction is delusional.

Under Bayh-Dole, medical research is key part of any project that intends to result in medical products. Universities taking federal money state as much in their formal policies on research and technology transfer–in some, it’s even in their mission statements under the heading “economic development.” That’s the difference between the “work” that federal money supports at least part of (35 USC 201(b)) and the “work” specified in any particular proposal for federal funds. Federal agencies and universities alike argue that they intend their participation to move from research to development to commercial product. The “project” spans the entire arc. Federal funding at any point in this arc creates a federal–public–interest in the results of anything done along that arc. The federally funded part of the arc supports the entire arc; the federal funds support the entire arc by supporting any part of the arc, such as, say, a research part of the arc. Continue reading

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