Bayh-Dole’s preemption of public purposes to re-establish a patent monopoly pipeline

I wrote a Twitter thread in retweeting this observation.

Don’t forget about Bayh-Dole, passed in the 80s, which enabled the #NIH to use our tax dollars to fund drug research at institutions & businesses; allow them to patent those discoveries & then grant exclusive licenses to drug companies. Until then, they were in the public domain.

Of course, Bayh-Dole did not enable NIH to fund drug research at institutions and businesses–it had been doing that for years already. And same for patenting–at least for nonprofits, the NIH had restarted the Institution Patent Agreement program in 1968. The IPA program allowed nonprofits to patent discoveries and grant exclusive licenses to drug companies. But yes, otherwise, inventions in federally supported research addressing matters of public health were to be made available to all. The IPA master agreement even has an elaborate apparatus that makes it appear that non-exclusive licensing would be the primary method of nonprofit invention deployment, but when the IPA program was reviewed, almost all the nonprofit deals were exclusive. The non-exclusive licensing apparatus was just for show.

What leverage did the pharmas have over the NIH that led the NIH to create a patent monopoly pipeline from federally supported research to pharma companies? What would motivate the NIH to go against the public policy of the executive branch and the Public Health Service to deliver patent monopolies into private hands? Dunno. Maybe it was just an Iago-like distaste for things being valued for being the right thing to do.

Anyway, here’s the thread, with some minor edits to fill out lines.

NIH lawyer Latker wanted a patent monopoly pipeline. Got his opportunity with the Harbridge House report in 1968 to restart the IPA program. Eventually over 70 nonprofits joined the IPA program and the program expanded to include NSF.

The IPA program got shut down in 1978 when Latker tried to make it government wide, apparently to try to capture biomedical research outside of NIH/NSF that wasn’t so readily piped to pharma. Biomedical research at the DOE, for instance, or in the DoD.

Legislators challenged how the IPA program operated and looked at its practices. They determined the IPA program was ineffective, did sweetheart deals with pharma, and ran against public policy.

Latker then drafted Bayh-Dole to replace the IPA program and put the patent pipeline on a statutory basis out of reach of federal agency objectives. That’s the implication of calling Bayh-Dole a “uniform” policy–they mean “arbitrarily in favor of private patent monopolies.”

Bayh-Dole’s core deal is that any federal contractor who gains ownership of an invention made in a project receiving federal support can preempt any public objective to exploit a patent monopoly.

Exploiting a patent monopoly for maximal profit becomes *the* public purpose not only for the invention but for the publicly funded project that produced the invention.

Think of it as a parallel to Milton Friedman’s argument that the public purpose of a corporation is to make money for its shareholders. Just substitute “patent on an invention made in a project intended to serve the public interest.”

The Kennedy executive branch patent policy of 1963 formalized a flexible approach to federally supported inventions that was responsive to public purposes.

The Kennedy policy identified one condition where contractors should own, four conditions in which the government should own, and anything else was to be handled by upfront agency specification or an after-invention determinations if a contractor wanted to retain ownership.

The Kennedy policy provided that contractors should own when they have an established non-government market position. Makes sense. At the time of Bayh-Dole, big companies did not need Bayh-Dole–except in one area . . .  pharma.

The Kennedy policy required govt ownership of inventions when the federally supported research “directly concerns the public health.”

And federal government ownership meant that most inventions should be “dedicated” to the public or made available through non-exclusive, royalty-free licenses (to control quality, or to deal with foreign imports undermining domestic businesses).

Put another way–the *premise* for federal funding of research in areas directly concerned with public health–like medicinal chemistry–is to make the results generally available for any and all practice. Not merely to “announce” results and withhold the right to practice by obtaining patents.

The NIH IPA program and then Bayh-Dole, which was also drafted at the NIH, are about repudiating the justification for providing federal money to support medicinal chemistry research. Bayh-Dole allows “contractors” to preempt that justification and substitute “making money by exploiting patent monopolies as the patent system intends.”

But all this is nonsense. Clever nonsense but still nonsense. The patent system places invention ownership with inventors. Bayh-Dole is written to make it appear institutions have control. (So they can hand inventions to companies).

The patent system does not require inventors to use the patent system. Bayh-Dole makes it appear that inventors can be forced to file patent applications. Actually, Bayh-Dole *doesn’t* do this, but no one complies with Bayh-Dole!

And Bayh-Dole adds an elaborate apparatus to patents on subject inventions, apparently to adapt the patent system for proper use with the results of publicly funded research–an invention working requirement, a competition requirement, and special requirements for nonprofits.

If the patent system were suited to publicly supported research, there would be no need for these add-ons, which have been federal policy since the Kennedy patent policy in 1963. But here’s the cleverness:

The public protections apparatus has never been used. No march-ins to address nonuse or unreasonable use–ever. The public protections are not complied with, go unenforced, or can be waived, and are.

So Bayh-Dole is a law that makes it look like the patent system should be shaped to address publicly funded research, but in practice the purpose is to move patent monopolies to private hands for whatever exploit.

Drug prices are a symptom of this policy. A broader public domain in medicinal chemistry would limit the scope of subsequent patenting, opening up more classes of compounds for independent development

Faculty inventors and nonprofits could choose to dedicate inventions to the public domain as standards, as collaborative contributions, without the threat of non-compliance or federal agency patent paywalls.

Development of new classes of drugs and variations of formulations and delivery methods could happen outside of patent monopoly pharma–in competition with it.

We might expect by having alternatives in treatment development we would also have alternatives in the treatments themselves. And that might lead to treatments available at much lower costs. At least that’s an idea worth considering.

Bayh-Dole is designed to prevent such things from happening. A patent in medicinal chemistry takes in hundreds to thousands of compounds along with whole classes of methods, all treated as “equivalents” of the best mode of practicing the invention.

A company holding a monopoly on those claims may pick one or two compounds to develop–and suppresses the hundreds to thousands of others. Bayh-Dole enables that suppression.

It’s not just the “Xtandi” or “Emtriva” that’s “patented”–it is all the “equivalent” compounds and classes of compounds and methods of delivery… Bayh-Dole requires licensing for competition, but again no one enforces that–

Because the motivation behind Bayh-Dole–as expressed every day by its advocates–is to allow owners of inventions made in publicly funded work to exploit patent monopolies however they want, regardless of the public purposes that justified funding the research.

Public purposes are just fluffy thinking that prevents the public from objecting to the allocation of federal money as a subsidy for pharma industry profits. So are Bayh-Dole’s public protections.

The IPA program normalized the avoidance of public purposes in federally supported medicinal chemistry research. Bayh-Dole made that avoidance statutory.

And Bayh-Dole made that avoidance government-wide, applicable to all areas of government subvention or procurement. Any federal contractor can preempt any public purpose by acquiring ownership of a patentable invention made in government supported projects.

While this has been great for big pharma, and for the speculative biotech industry that sells up to pharma or wants to be pharma–for everything else, it’s a disaster, except for patent speculators.

Do you see the software industry out hooting the virtues of Bayh-Dole? Or the nanotech industry? Or how about the cell phone industry? No, crickets everywhere else.

Bayh-Dole works against standards, interoperability, cumulative technology, cross-licensing, public domain, commons, rapid uptake for uses internal to companies, competitive development.

Bayh-Dole works against federal contracting, too: for multidisciplinary projects, for projects funded in parallel, for multi-institutional projects, for consortia, for development of a product desired by a federal agency using multiple contractors. All of this Bayh-Dole trashes.

Any single contractor obtaining ownership of an invention made in any such effort can defect on the public, shared objectives and exploit patents for its maximal benefit. And that’s the dominant university technology transfer operating model.

Extract inventions from public purposes–regardless of what agencies want or what faculty in proposing the research want–and offer them to patent speculators or to pharma. Only stipulation is that the university gets to participate in the upside of exploiting the monopoly.

At best Bayh-Dole’s operation can be justified as “even from sucky things like this good stuff still happens, though rarely.” That’s what it means when AUTM or AAU or APLU claims that what’s happening is all the result of Bayh-Dole.

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