Exceptional Circumstances in Bayh-Dole, 1

In 2008, Dr. Jeffrey W. Thomas, then a senior advisor to the Technology Transfer Center at the National Cancer Institute, gave a talk on Bayh-Dole’s exceptional circumstances. The slide deck is still up at a federal laboratory consortium web site. The talk comes three years before the Stanford v Roche decision, so it’s a given that it will be wrong about some things, but it is useful (especially since it is still up on the web) as another insight into NIH thinking about Bayh-Dole.

The purpose of Thomas’s talk is to discuss NIH’s protocols for invoking “exceptional circumstances” under Bayh-Dole. The “exceptional circumstances” provision is one of the chinks in the claim that Bayh-Dole establishes a “uniform” treatment of inventions by federal agencies. In that regard, Thomas’s talk will be most informative.

Thomas starts his talk with the popular faux version Bayh-Dole Act and some fake history. Stanford v Roche won’t excuse the fake history. Let’s examine the faux and the fake first, and then look at how Thomas shows how the NIH exploits the faux and fake to preserve a patent monopoly pipeline from public funding laundered through university patent brokers for the benefit of private pharma. Continue reading

Posted in Bayh-Dole | Tagged , , , | Leave a comment

AAU, APLU, and others aim to “bolster” federal technology transfer, 7

Frankly, I am weary of working through the HEAs’ nonsense advice to NIST. I expect you are too. Bullshit is so much more difficult to pin down than carefully reasoned discussion. It’s worth respecting carefully reasoned discussion, even if one takes issue with it, if the discussion operates on a willingness to get at the truth of things. Debate can strengthen alternative approaches to research-related innovation. But if folks are just bullshitting for political advantage, then they don’t care about the truth of things, about actual practice–they care about bluffing to whatever they see as their political goals. They might even be successful with their bluffing, but that doesn’t mean they are not prigs. And their bluffing makes it all the more difficult to have a reasoned discussion on matters of public policy.

If all you need to know is that the HEAs are engaged in political bluffery and write bullshit about Bayh-Dole and technology transfer sentence after sentence, then save your time. Go do something with your family.

The HEAs respond to NIST’s request for ideas to improve federal technology transfer with a stump speech about university technology transfer. The HEAs don’t bother even to separate out federally supported work from the rest of their member universities’ activities. Then, after crowing about how great they have been doing and how Bayh-Dole is working as intended and must not be changed, the HEAs bitch and moan about just about everything else–the patent system doesn’t provide them with absolute power to beat down everyone, there’s not enough of other people’s money available to finance their expensive, complicated, and ineffectual system. This is supposed to be helpful advice for the feds regarding federal technology transfer programs?

Someone at NIST will read the HEA missive, I’m sure, and I send them a dose of empathy. Let’s finish up. Continue reading

Posted in Bayh-Dole, Bozonet, Technology Transfer | Tagged , , , , , , | Leave a comment

AAU, APLU, and others aim to “bolster” federal technology transfer, 6

We are working through the advice that AAU, APLU, and other “higher education associations” have provided to NIST on how to improve federal laboratory technology transfer. Do you expect that these associations thoroughly vetted their draft response with all their members? Is it even a good assumption that the senior leadership of all these universities are behind this effort to help NIST? The HEAs’ position is that the way to improve federal laboratory technology transfer efforts is to ponder deeply the complaints that the HEAs have with regard to their own members’ technology transfer efforts–which of course are working out just as Bayh-Dole intends, except for the lack of a clear mission, an uncertain relationship to the public interest, problems with the patent system, the tax code, administrative overhead, confusion about software, and, oh, this:

No funding was provided for patent costs or other costs associated with the operation of university technology transfer offices established to implement Bayh-Dole…

Gracious me. Someone doesn’t understand Bayh-Dole. Bayh-Dole’s requirements are easy to comply with and easily may be accommodated with a tiny part of the administrative indirect cost payment that comes with each federal grant. Bayh-Dole implementation does not require the establishment of technology transfer offices and does not require universities to incur patent costs. Whatever university administrators decide to spend because of Bayh-Dole is because of their own choices–if not their cluelessness about Bayh-Dole and their cluelessness about how research technology comes to be used.  Continue reading

Posted in Bayh-Dole, Bozonet | Tagged , , , | Leave a comment

AAU, APLU, and others aim to “bolster” federal technology transfer, 5

Higher education associations, led by AAU and APLU, give advice to NIST about ways to bolster federal technology transfer by telling NIST about non-federal university technology transfer. The HEAs have insisted that Bayh-Dole has been working as intended, which we may take to mean that the HEAs are pleased with most inventions faltering behind university patent paywalls, sky high prices for those few university inventions that become successful prescription drugs, and metrics on patents, startups, and jobs creation that are presented to look impressive but on closer inspection are unvalidated, paltry, and not specific to federally supported inventions. But it’s all good if one is bluffing for political ends. No one should expect the truth, even from HEAs.

The AAU and APLU convened working groups to study university technology transfer. They found, after extensive study, that university technology transfer should serve the public interest. We were astounded. But there was more–the AAU and APLU went on to offer suggestions to their university members:

The two associations urged university leaders to embrace the role of university technology transfer in promoting innovation and economic prosperity. These recommendations included: . . .

Wait for it…

  1. write better mission statements
  2. restrict university licensing inventions to patent trolls
  3. create new metrics that focus on economic and societal impact

Well now, that’s work well done. A new mission statement will help bolster those flagging, under funded, but wildly successful university licensing operations. Bayh-Dole should be “tweaked” to require better TLO mission statements. NIST should make sure all federal laboratories have a clear mission statement that embraces promoting innovation and prosperity. That should do it. We are all set. Continue reading

Posted in Bayh-Dole, Bozonet | Tagged , , , , | Leave a comment

AAU, APLU, and others aim to “bolster” federal technology transfer, 4

We are dealing with the bombast that AAU and other “higher education associations” put forward as advice to NIST with regard to how the federal government might better manage its own technology transfer. Instead, the HEAs seek to improve their members’ own technology transfer. The HEAs adopt the fine bureaucratic strategy of insisting they are doing everything well and Bayh-Dole is working as intended while complaining that they don’t have enough money, that the requirements are too demanding, that patent law is a problem, and that the tax code lacks the proper incentives. That is, the university approach to patent monopolies on publicly supported research is not working, but it is not the fault of the HEA members, even though they have adopted a historically failed approach, spent wickedly on it, and ignore all the key requirements of Bayh-Dole while they are at it.

Let’s continue. The HEAs are going to argue for new metrics to account for what universities do in technology transfer, since the metrics that the universities have put out during the Bayh-Dole era apparently are inadequate. But first the HEAs insist on using those old metrics.

The HEAs claim in their advice to NIST that universities received 6,452 US patents in 2016. A PTO search for utility and plant patents assigned to universities shows 10,978 US patents. But only 3,264 recite government funding. The HEA patent figures aren’t even close, and why do the HEAs cite all university patenting when the issue at hand isn’t all university patenting, but rather federal technology transfer–the inventions owned by the federal government, or made at federal labs?

Lost in all of this is the observation that universities get nearly 2/3 of their research funding from the federal government, but only about 1/3 of their patents include a federal funding notice. Isn’t that an amazing result? The HEAs want NIST to look at all university patenting, but not at the oddity that the non-federal funded research is twice as productive in producing patents as is the federally funded research. Now producing patents is itself not a good measure of anything related to technology transfer, innovation, or public benefit–but it does suggest that there are university practices at work that favor dealing with inventions that don’t involve federal funding. Continue reading

Posted in Bayh-Dole, Bozonet, Policy, Technology Transfer | Tagged , , , , , , , , | Leave a comment

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. Continue reading

Posted in Bayh-Dole, History | Tagged , , , , , | Leave a comment

AAU, APLU, and others aim to “bolster” federal technology transfer, 3

A set of higher education associations–front groups for a bunch of research universities–has published their advice in response to NIST’s call for ways to improve federal technology transfer. AAU, APLU, AAMC, COGR, and ACE all signed on to the statement that we have the opportunity to review.

Here’s the gist of NIST’s call:

NIST requests information from the public regarding the current state of Federal technology transfer and the public’s ability to engage with Federal laboratories and access federally funded R&D through collaborations, licensing, and other mechanisms.

Instead of providing anything of substance that might contribute to a discussion of federal lab and agency technology transfer, the AAU, APLU, and other HEAsses instead submit a tome about themselves and claims they make for and about their university members. It’s like they can’t read. No matter, we have worked through their statement of “priorities.” Now let’s work through the details of what these HEAs think is important for federal lab technology transfer.

In the first two parts of this article, we looked at the the HEAs’ statement of “priorities.” Now let’s deal with their discussion. We will quote bits and comment.

The HEAs assert that Bayh-Dole is working “as intended.” This is all very well, but the primary statute dealing with federal laboratory technology transfer is Stevenson-Wydler, which Bayh-Dole acknowledges takes precedence. Of course, Stevenson-Wydler has been amended to point back to Bayh-Dole at various points, so it’s all a fine bit of spaghetti code. Wouldn’t it be great if attorneys had to learn a structured programming language before they could practice law?

The HEAs assert that Bayh-Dole is working. Surely it’s not “working as the law provides” since universities don’t comply, federal agencies don’t enforce, and federal agencies don’t act on the rights reserved for them. Surely it’s not working “as intended by Congress” because no one bothers to comply with what Congress set out as Bayh-Dole’s policy at 35 USC 200–that is, unless Congress intended for everyone to give the law lip service and then do WTF they wanted, deceive about impacts, and generally screw things up. Thus, it would be nice to get clear from the HEAs just what they think the intention for Bayh-Dole is, and who it is who has that intention, since clearly it’s not the express statement of Bayh-Dole’s policy and objectives. Continue reading

Posted in Bayh-Dole, Bozonet | Tagged , , , , | Leave a comment

AAU, APLU, and others aim to “bolster” federal technology transfer, 2

We are working through advice offered to NIST by various higher education associations on how to improve federal technology transfer by funding without oversight the “technology transfer” programs of non-federal institutions. If the gist is all you  need, then don’t bother reading further. Perhaps giving more and more money to university administrators for consistently failed programs is better than spending that money on research or something. Perhaps there’s a public policy debate there.

In the meantime, we are working through the list of priorities from the HEAs (AAU, APLU, AAMC, COGR, ACE), and we are in the middle of the potpourri priority (4) in which everything that’s wrong with the failed model of university administrations dealing patent monopolies stems from failings of the patent system, which is not sufficiently “robust.” If software cannot be “patented,” so the HEA argument goes, then how can it possibly be excluded from use so that speculators on monopoly positions will be attracted to spend money to try to profit from that patent monopoly by making commercial products? The HEAs continue:

and inconsistency in the government’s approach to rights in software,

We can’t have open source, apparently. The HEAs evidence no clue with regard to software. Perhaps that is because the university folks behind the HEA’s position here also don’t have a clue. I ought to know. I’ve done a heck of a lot of software deals for research universities, from open source to venture-backed startups, with all sorts of things in between.

Software is one area in which patents are pretty much useless for university-based research enterprise other than to disrupt collective development and to make people find ways to design around you. Pretty much the only thing one uses software patents for is to attract investment capital to a startup, and the investment capital willing to accept that a startup has an invention under license from a university is a pretty low-IQ investment firm. It is no wonder that most university licensing offices have no success patenting software. Oh, well, my licensing group did have success–we were always relieved when there wasn’t any federal money involved and didn’t have to deal with the Bayh-Dole advocates and their fixation on patent monopolies. As one software developer has advised with regard to patents in software, “Don’t be an asshole.” But AAU and the other HEAs want to be that asshole and want the federal government to help them to be better, more bolstered, robust assholes. HEAsses! Neat. Continue reading

Posted in Bayh-Dole, Bozonet, Metrics, Open Source, Technology Transfer | Tagged , , , , , , , | Leave a comment

AAU, APLU, and others aim to “bolster” federal technology transfer, 1

AAU has tweeted out its happiness with advice it and other “higher education associations” (APLU, AAMC, COGR, and ACE) have given in response to NIST’s call for public comment on ways to improve federal “technology transfer.” AAU tweets that “Bayh-Dole is working as intended.” It is unfortunate that we don’t know who did the intending that the AAU reports. Maybe that would help to explain the silliness that follows.

We will work through the HEAs’ priorities, note that their exercise is unresponsive to NIST’s call, and then examine their discussion in some detail. If you want to skip all that, the gist is that these HEAs want is more money and less accountability for the administration of technology licensing programs that have failed to produce.

But I know you–you aren’t content with the bland conclusion that faceless bureaucrats who won’t even put their names to a string of unfounded assertions have produced another foul document asking for more money for administrators to use with less oversight. You want to see how bad it really is, and thus you read on.

Here are the “priorities” that AAU and other HEAs recommend for NIST. Let’s consider.

(1) No changes to the Bayh-Dole Act are necessary. The statute should be considered a set of core principles that must be protected.

In other words, there should be no innovative change to a law concerning the use of inventions. Yes, that’s very bureaucratic. Furthermore, there should be no change to a law regarding federal licensing of inventions owned by the federal government that merely provides that the government may license such inventions non-exclusively, co-exclusively, or exclusively to the point of assignment. So the federal government can do most anything–but how does preserving such authorization (35 USC 207, 209) help the government understand what it should do? Again, it’s very bureaucratic to say nothing should change in a part of a law that doesn’t have much of anything to do with federal technology transfer other than say “do anything you want.”

While we are at it, what are the core principles of Bayh-Dole? Let’s put them in pragmatic style:

  • University administrators may preempt both federal and faculty public purposes
  • Keep reports of utilization a federal secret
  • Federal agencies need not enforce the standard patent rights clause
  • Federal agencies need not act on rights reserved for the federal government
  • Third parties have no right to appeal actions by universities or inaction by agencies

Continue reading

Posted in Bayh-Dole, Bozonet, Metrics, Policy | Tagged , , , , , | Leave a comment

Bayh-Dole Basics, 7: Disclosure comments, 4

Though it’s rather useless to do so, let’s consider then the steps required by a Bayh-Dole compliant disclosure. I say it’s useless because no one complies with Bayh-Dole and federal agencies don’t care. The law doesn’t operate but enables something else to operate. It’s like using the rule of law to avoid the rule of law. If you follow this recursion, then you see the cleverness of Bayh-Dole. It’s the flip of “copyleft.” Rather than use copyright to require others to “share alike,” Bayh-Dole posits using patents to “defect on the commons that justifies the use of public resources” to justify the use of public resources. “We must prevent stuff that is publicly funded because it should be public to become public because if it became public then the public would not benefit from it not becoming public.”

Let’s put it in terms you may recognize: the public won’t benefit from publicly funded research unless that research is secured as patent monopolies and conveyed to single companies for their exclusive use, because no company will develop any such invention without a patent monopoly and freedom to exploit that monopoly–and that, my friends, is the only path to public benefit arising from publicly funded research. Any enforcement of Bayh-Dole would sour the whole enterprise and drive away these companies that are essential to the public benefit that may arise from publicly supported research.

Or, in its politically effective form: “what is available to all will be used by none.” Absurd? Yes, of course. Crazy? Yes, beyond simple lunacy. Inspired? Yes, but only if you are a BDCBF Bayh-Dole advocate.

Steps in Disclosure

It is important, then, that folks get the disclosure right. Bayh-Dole’s standard patent rights clause (at (f)(2)) requires contractors to require their technical employees to make a written agreement that includes a promise to disclose inventions to the contractor so the contractor can comply with the disclosure requirement. The disclosure must identify the funding agreement and the inventors, as well as any statutory bar to patenting. But the core of the disclosure is that:

It shall be sufficiently complete in technical detail to convey a clear understanding to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological or electrical characteristics of the invention.

In other words, the disclosure is essentially the text needed for the specification part of a patent application–the part that teaches one with ordinary skill in art how to practice the invention. Put another way: before a contractor must disclose a subject invention, the contractor must

  • determine that the invention is or may be patentable,
  • obtain information on possible patent bars,
  • acquire ownership of the invention,
  • determine that the invention was made under a federal contract,
  • obtain a sufficient description of the invention that it could use the description to prepare a patent application, and
  • convey this description to its patent administrators.

This ought to look like a weird list. How can anyone determine that an invention may be patentable without having a full disclosure of the invention and information regarding patent bars? But none of these things are required until a contractor owns an invention made under a federal funding agreement–including, even, determining whether the invention was made under a federal contract. Continue reading

Posted in Bayh-Dole | Tagged , , | Leave a comment