Repeal of Bayh-Dole

There are lots of calls to repeal Bayh-Dole. That would be a good thing to do. Bayh-Dole has been a failure, just like the NIH’s IPA program on which it was based, which was shut down in 1978 as ineffective (it was) and contrary to public policy (also was). Bayh-Dole has been even worse than the IPA program. It has been so bad that universities and federal agencies and “advocates” for the law won’t even report metrics relevant to the law. Instead they report fake metrics, such as unvalidated economic model output treated as fact. And while they are at it, they take the upper end of the range estimated by the model, and treat that as fact. And also instead, in their reports of “success,” they bundle in all university licensing rather than just the licensing specific to Bayh-Dole (less than half the activity, though federal funding is more than half of university research funding–funny that).

Also instead, they switch to talking about products based on “public-private partnerships” rather than on investments in developing inventions made in work supported by federal funds, that would not have been made but for the availability of a patent monopoly. And they never talk about the inventions that have been suppressed, never licensed, or licensed to speculators for schemes that never worked out, or licensed and turned into products but sold at monopoly–gouging–prices, in which those universities involved are complicit because, hey, they have signed up for a share of the income (even though that share is often less than 2%).

Oddly, all the talk about Bayh-Dole has to do with biotech and proprietary drugs. No one talks about engineering or nanotechnology or software and how university patents are so very necessary in these fields. Generally, patents aren’t necessary for new technology adoption in these fields, but Bayh-Dole saddles university research with patents anyway. No one talks about the awful record that small companies have with turning NSF-funded SBIR grant work into new products. It’s easier to get more SBIR grants, apparently, than it is to produce an actual product, patent or not.

We could also talk about how Bayh-Dole practice–every university aiming to own everything that smells remotely like an invention–destroys cumulative technology development, pre-commercial collaboration, the formation of commons and standards. It’s all the worse when a federal grants program spreads work on a given area around to a number of universities–then each university holds its little gobbets of patented invention and anyone trying to use anything ends up running afoul of ten or twenty or fifty universities holding patents that block research, use, or development. The best alternative is to ignore university research altogether, design around it, exclude it from standards, disrupt it, infringe and then claim the patents are invalid, and otherwise actively work to make that university research meaningless. If your company is not going to get the exclusive patent license on offer, does not need to develop a commercial product, then you work around the university invention rather than adopt it. You aim to make the university patents worthless. That’s the necessary outcome of current university Bayh-Dole practice.

So before we get going, let it sink in really well that Bayh-Dole is a failure. What you see out there is a lot of fake history, fake metrics, and fake accounts of the law, both as it is written and what it is intended to do. Get your mind around the enormity of the scam, how long it has been allowed to persist, and who has enabled that persistence.

Repeal won’t be easy. First, there has to be congressional will to repeal. There will be a whole lot of squealing by university administrators and their patent law firms. These ticks have hit an artery and are not going to release their bite just because someone holds a match to their butts. And keep in mind that pharma spends a heck of a lot of money lobbying congress. There are a bunch of compromised people there. Do you expect them to defect on their patrons? Well, perhaps they would, if you offered them something. But offering them the chance to “do the right thing” is pretty low on their list, don’t you think?

And even if there’s a repeal, there’s got to be a plan to (i) repair the damage, if that’s possible, and (ii) put something in place that prevents the NIH, especially, from simply reverting to its old workarounds, like the IPA program, and (iii) something in place that does a better job dealing with inventions in advancing the frontiers of science, and (iv) something that does a better job rallying resources to develop medical interventions–better than the gawd-awful worst approach of Bayh-Dole practice and better than the takes ten years and a billion dollars of the pharma industries approach.

And even then, the pharma sweet spot is a drug that makes an acute condition chronic, delays disease progression for a few months until a body can’t take the toxicity, or mitigates symptoms usually about twice as much as a placebo. Think of it, for $10,000 a year you can reduce migraine events from 8 to 4. But for almost nothing you could take a sugar pill and reduce your migraine events from 8 to 6. And perhaps if someone bothered to find out why you were having migraines, you could reduce those events to zero. But that would be an awful result for a pharma company making millions pitching 4 is better than 8. And it is! And worth millions! And a cure apparently *isn’t*. That’s just one more way “commercialization” of medicine sucks. So, public health research policy should aim to do way better than pharma, focusing on prevention and cures, and for everything else developing it way faster and way less expensively.

Repeal, then, if we could get it to happen, leaves us with a lot of work to do. It would be an interesting discussion, but it would be politicized from the get-go, and what are the odds that anything meaningful would emerge? Even Vannevar Bush, who had some of the best insight and experience of the last 100 years saw his proposal co-opted by politics and turned into one more porkfest of government funding.

Bayh-Dole is a fail. The text of the law is a fail. The practices established under the law are a fail. The achievement of practical application is a fail. The people attracted to Bayh-Dole practice are largely a fail. The fake history constructed around Bayh-Dole is a fail.

Repeal. But it won’t be easy, and we need to repair and replace.

What to do then, while we work on repeal?

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