Working through an old misrepresentation of Bayh-Dole, 3

I have previously pointed out the University of Rochester’s strange policy statement with regard to commercialization. This is part of Rochester’s new and stinky. There’s a statement that pops up on the Rochester site that it will be down for a policy update on February 27, so maybe things will change. In the meantime, let’s have a visit. Here’s Section 6.2 of Rochester’s IP Policy (my bold):

Whenever possible, the University endeavors to make its creative works and inventions available on a non-exclusive basis; however, in many cases an exclusive license may be necessary to make it economically feasible for an enterprise to undertake commercial development and production.

The two highlighted phrases are incompatible. If it is possible to make stuff available non-exclusively, and the university then does so, then it cannot also be necessary to offer exclusive licenses. Or, if it is necessary to offer exclusive licenses for commercial development, then “whenever possible” means merely “whenever there’s no takers for exclusive licenses.” But even that is a problem. How will anyone know there’s no takers for an exclusive license? Yes, that’s right–when the patent expires and there’s no monopoly available to offer. Continue reading

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Working through an old misrepresentation of Bayh-Dole, 2

We have dived into an old, stinky document once on-line at the University of Rochester that misrepresents Bayh-Dole requirements. The document has since come down, but its shadow remains over Rochester invention policy and practice. Thus, it is worth reading the old and stinkies to gain a sense of perspective on the new and still stinkies.

While we are at it, Rochester misrepresented (and still does) the scope of Bayh-Dole’s claim on inventions:

creation of inventions from federally sponsored grants

Bayh-Dole makes a different claim. Bayh-Dole defines “funding agreement” to include any agreement “for the performance of . . . work funded in whole or in part by the Federal Government.” (I left out the “experimental, developmental, or research” adjectives before “work” so the grammar becomes clear–the noun is work, not “research” or some such thing. The “in part” makes it clear that the “work” involved may not be funded entirely by a federal grant. Parts of the “work” may not be supported with federal funds. Doesn’t matter. What matters is a clear understanding of the “work.” We could capitalize it–Work–it should always be a defined term. One of the greatest failings in Bayh-Dole practice is inattention to the definition of the Work. The definition includes federal objectives in providing funding, specifications of the work, statements made in proposals submitted through organizations and companies, statements made by those organizations and companies with regard to their purposes and practices. If someone wants a narrower definition of Work, they have to be clear about it, express, even to the point of stating what the Work does not include–and they must do this defining as part of their proposal, before any federal award is made.

Inventions that might come within scope of Bayh-Dole, when owned by a contractor, are not just those that were made “from” a federal grant. The inventions that come within scope are any made in the performance of the indicated Work, regardless of whether the inventive activity was paid for with federal funds or with other funds or with no funds at all. All that matters is that some part of the Work received federal funds. Some part of the Work was pitched as worthy of public support. That means, necessarily, that the public (sometimes via Bayh-Dole) should have the benefit of the entirety of the Work’s outputs. As the implementing regulations for Bayh-Dole have it (37 CFR 401.1):

Separate accounting for the two funds used to support the project in this case is not a determining factor.

If separate accounting could be used, then it would be easy to shift work that appeared to be inventive off to a non-federal account and avoid federal claims on any resulting invention. That’s what University of Southern California and its inventors did in the research that led to the Mine Safety Appliances litigation–where the court made clear that USC could not extract work from its federal grant Work, do that work on the side, and then come after the federal government to pay royalties to use that side work. Continue reading

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Working through an old misrepresentation of Bayh-Dole, 1

I was doing some work to find a broken link and ended up at the web site of the University of Rochester Offices of Technology Transfer, as of July 6, 2011. Here’s a bit from their information “For Inventors: Commercialization Process”:

The University is also mandated under Federal Law to report the creation of inventions from federally sponsored grants to the Federal Government and grant the U.S. Government a royalty-free, irrevocable, worldwide license to the invention. The Invention Disclosure Form serves as a vehicle for the University to comply with these regulations.

This account of Bayh-Dole (“Federal Law”) is wrong in many ways. Rochester has in the intervening years removed this text–but it was around for a good while. Rochester’s intellectual property policy, however, still makes ugly Bayh-Dole assertions, such as

Federal research agreements generally require that universities take title to resulting inventions and discoveries, subject to certain obligations concerning exploitation in the public interest.

Which is dead wrong. Nothing in federal research agreements require universities to take title to “resulting inventions and discoveries”–even with NIST’s stupid addition of an assignment requirement in the written agreement requirement, since that assignment requirement is specific to subject inventions, which are inventions that a university has already taken title to. Alas.

It is important to look at these old, stinky documents to see how badly and for how long Bayh-Dole has been misrepresented to university faculty (and misused to deprive faculty, staff, and students of their rights to inventions, including the right to practice their inventions without university administrator permission). Let’s examine. Continue reading

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International Response to Bayh-Dole

You may have heard that Bayh-Dole is the most perfect law to stimulate technological innovation and translate publicly supported research into public benefit by passing inventions through the hands of speculative investors to be made into commercial products, using patents to exclude all others and attract the interest of the speculators, without whom no public benefit is possible. While you are astute enough to see this for the stinking pile of nonsense that it is, many of your colleagues apparently find it attractive and have rushed to adopt something similar.

But that’s not the version of Bayh-Dole they should be adopting.

Continue reading

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Faux Bayh-Dole: patent and do whatever

Sweep away the unused parts of Bayh-Dole, and it looks like this:

If a contractor acquires an invention made in work receiving federal funding, then the federal government cannot require assignment of the invention to the federal government unless the contractor does not disclose or patent the invention. 35 USC 202.

If the contractor does not acquire the invention, then Bayh-Dole does not apply and one or more other federal statutes may apply. 35 USC 210. Stanford v Roche.

The federal government may license exclusively any federally owned invention. 35 USC 207.

That’s it. Everything else is waste and distraction. We can make it even simpler–because the law clearly is much too complicated for any mere university or federal bureaucrat. Not even the NISTwits delegated to manage the implementing regulations have the capacity to comprehend the law. Scores of university lawyers tacking their ignorance onto laughable amicus briefs in the Stanford v Roche case show just how compromised–and IP incompetent–they are. Continue reading

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Bayh-Dole march-in won’t change drug prices but other things might–2

Now let’s look at alternatives to Bayh-Dole’s march-in procedures to address competition, public access, and prevention of unreasonable use, including price gouging. We will consider two within Bayh-Dole and two outside Bayh-Dole. The Bayh-Dole alternatives are: use the government license (35 USC 202(c)(4)) and enforce the nonprofit invention assignment clause (35 USC 202(c)(7)(A)).Those outside Bayh-Dole: use the broad limitation on government infringement at 28 USC 1498 and modify federal patent law at 35 USC 287(a)(2) to remove the exception that permits patent holders to have the right to a remedy for infringement of compositions of matter or processes used in medical treatments. Bayh-Dole first. If people are going to bother with such a broken, mismanaged law, uncomplied with, unenforced law as Bayh-Dole, then at least they ought to go after the parts that might have immediate effect. Continue reading

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Bayh-Dole march-in won’t change drug prices but other things might–1

Folks think that somehow Bayh-Dole permits government take over of pharma patents and by doing this, somehow, the price of drugs will necessarily–magically–go down. Let’s work through this idea.

Set aside for a moment that many drugs don’t do much more than make acute conditions chronic–they don’t cure, they don’t prevent, they treat symptoms, they delay, they have side effects that may require other drugs. In short, they are highly profitable stopgaps that delay disease so that–if there’s sufficient progress–someday one can expect to die of something else, and most every something else has its own set of delaying, mitigating drugs. Each line of drugs has its own $100K or more per year price tag. The argument is that the public demands that stopgap drugs be made much cheaper. It is a reasonable argument.

And sure, the argument is about an aspect of public health. But it misses the huge problem that these drugs play on a kind of mental addiction–people need them because they are made to appear better than any alternative–a placebo, say, or an older drug now off patent, or some other intervention. But they don’t stack up to cures or prevention or restorations–however these might be brought about. So set it aside for a moment that the drugs making lots of profits are not necessarily the medical interventions we actually want. They are what we want because we don’t have what we actually want, and they are set up as better than the past or placebos.

Now consider the Bayh-Dole  march-in proposal. Continue reading

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War and Publification of Medicine Development, 3

Think of it this way, at least simplistically. You are patent counsel for the NIH in 1968. You have no control over how the NIH allocates funding, and the NIH chooses to fund lots of research and declines to fund much development, unlike other federal agencies which do fund developmeny (such as the Department of Agriculture, the Department of the Interior, Atomic Energy Commission, and the military departments). If you then ignore the fact that the development of medicines has a long history of work by physicians, pharmacists, hospitals, universities, and non-profit organizations–most working without the requirement of profit-seeking or a precondition at the outset for commercial mass production–then you might create a dichotomy in which either the federal government funds development or development must be done by industry. It would be a false dichotomy, or a politically clever one, but it would ignore the broad non-commercial history of medicine development.

Pause on this dichotomy: it is a policy choice made by a patent attorney working for the NIH to use patent rights to favor industry with a particular operating model (monopoly power over medicines for commercial exploitation) over the other people and organizations with a range of substantially different operating models (such as open collaboration, local DIY production, partnership with companies providing contract services) that have produced new medicines–drugs, vaccines, and the like. Now, once you accept this policy choice to favor industry, then if industry demands patent monopolies in order to allocate funding for new possible medicines, then, obviously, the necessary thing is to enable a pipeline of patent monopolies on compounds, methods, and instruments made in federally supported work, no matter whether those patents are pushed through federal research contractors or handled directly by federal agencies. Continue reading

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War and Publification of Medicine Development, 2

The “war on disease” usage asserts a primary federal government role in directing the research and development of disease-directed therapies. The “war” usage asserts that the “market” for treating disease with new therapies–inventive therapies–is a governmental market, and that patents have no particular meaning in this market. This is especially the case given that the federal government awards patents in the first place. Why should the government give any inventor or company the right to disrupt the government’s efforts to fight anything, including disease?

It is worth here pausing to consider the broad policy implications. If the federal government announces that research concerning public health is within the government’s proper interest, and that the results of such research should be made available to the public, then the private effort to profit from the results of research in this same area–public health–are at odds with the public policy. One might say, contrary to that policy.

Consider water. Say that the federal government were to declare that clean drinking water should be made available to all, and that is a proper and vital interest of government to advance treatments to assay and treat water. The federal government declares war on unsafe water and undertakes to support, develop, and provide such new water technologies. Any advances in science and technology directed at water during this war are publified. If you are going to do research in this area, then you are necessarily part of the war effort or working to exploit and disrupt the war effort. Continue reading

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War and Publification of Medicine Development, 1

In 1944, President Roosevelt asked Vannevar Bush to respond to four questions (or, perhaps it was Vannevar Bush who arranged for President Roosevelt to ask him four questions). These questions formed the foundation for his report Science the Endless Frontier. The first question asked how the new science developed in military research during the war could be made available to the public for beneficial use. The second question was this:

With particular reference to the war of science against disease, what can be done now to organize a program for continuing in the future the work which has been done in medicine and related sciences?

Let’s consider this “war of science against disease.” On the surface, we can read it as simply a flowery metaphor for using the tools of science to understand and cure diseases. If one is into logical abstractions, then that’s probably the end of it. But “war of science against disease” signals much more than that, and it is worth considering this signalling in the context of federal research and invention policies.

Roosevelt’s premise underscores the translation of the war theme–an institutional construct designed to shift around institutional thinking–from the conflict on the battlefields of Europe, Asia, and Africa to civilian purposes:

New frontiers of the mind are before us, and if they are pioneered with the same vision, boldness, and drive with which we have waged this war we can create a fuller and more fruitful employment and a fuller and more fruitful life.

There’s a bunch happening under the surface here. Continue reading

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