by Dennis Crouch
The Biden Administration is seeking comment on its proposed framework for how how agencies should evaluate exercising “march-in rights” over federally funded inventions. For those familiar with march-in rights, this guidance has been a long time coming. While these powers have technically existed for years under the Bayh-Dole Act, the lack of clear procedures around their use has rendered them largely theoretical. This proposal could change that.
The Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights outlines key questions and factors agencies should weigh when deciding if march-in is warranted. It details how to gather pertinent facts, evaluate if statutory march-in criteria are met, consider alternatives, and assess potential impacts on U.S. competitiveness. The guidance also uses a number of examples that include health technologies, transportation, and manufacturing to demonstrate analysis across different sectors and contexts.
The Bayh-Dole Act gives universities and other recipients of federal research funding the right to patent inventions arising from that taxpayer-supported work. However, Bayh-Dole also includes “march-in” provisions to ensure public benefit from these publicly financed innovations. Specifically, the law states that if a university or its exclusive licensee is not taking timely, effective steps to achieve “practical application” of a federally funded invention or otherwise make it reasonably available to the public, the funding agency can “march in” and compel additional licensing.
While march-in likely still won’t become common under this proposal, the potential of losing patent rights could impact businesses relying on licensed academic research. The guidance prioritizes continued innovation — asking if march-in would “deter prospective licensees from future collaborations.” However, folded into the analysis is also concern over public return on taxpayer investment, including whether contractors make inventions “available to the public on reasonable terms.”
A key question is whether march-in rights should be exercised in to ensure reasonable pricing and therefore increase availability of drugs and treatments developed using federal funding. The framework proposes that agencies could march-in if a drug is only available to a “narrow set of consumers” due to pricing. Opponents counter that march-in rights were never intended to regulate prices. Innovators see all this as problematic and are warning that subjective determinations of “reasonable pricing” could chill private investment — and especially chill collaboration with universities or others receiving federal funding.
The comment period on this proposed regulation closes February 6th.
March in rights? The government can simply order a drug (we order you to infringe patent x) from manufacture Y and then ‘sell’ or give it away for ‘free’ if it wants. Patent X, if falling under Bayh-Dole would result in zero damages at claims court.
The real issue here is what NIH has done (perverted) with Bayh-Dole – with big pharma paying royalties to NIH inventors such as Fauci for drugs/technology/etc they regulate. So in that case ‘march in’ would be what? Make infringing drug x and pay our NIH staff inventors less? It’s quite the medical industrial complex the NIH/NSF/DARPA grant/patent/regulate/test/approve/license (kick back) highly conflicted little universe they have create. Covid/mRNA/testing/approvals/etc sure opened some eyes much wider to the kleptocracy.
^^^ even the mere appearance of this should bolster my “Everything into the Sunshine” proposition.
But Greg “I-Use-My-Real-Name-Except-When-I-Don’t” DeLassus is more concerned about obscure pre-AIA 102 wrinkles (as opposed to championing this clarity-in-sunlight-because-“Equity” drive from a Big Pharma related avenue).
Go figure.
Oh, please. This is an end-run on the APA. You want rules, you go via notice-and-comment rulemaking, not via “guidance”.
More importantly, (a) march-in-rights under Bayh-Dole were not meant to be used to try to control drug prices, and (b) if turnip-brain goes ahead with this, the only thing he’ll succeed in doing is undermining the Bayh-Dole scheme, thus reducing the development of drugs that originate in university research.
“ More importantly, (a) march-in-rights under Bayh-Dole were not meant to be used to try to control drug prices”
Are you sure about that? “Price control” is a broad term.
According to the drafters of the law – it wasn’t meant for price controls.
Excerpt from an Aug. 2016 congressional research report:
“Birch Bayh and Robert Dole, as they were then, responded with an editorial published in the Washington Post less than a month later. The editorial states in part:
Bayh-Dole did not intend that government set prices on resulting products.”
Seems to be pretty certain then.
I’ll say it again: “price control” is a broad term. It encompasses more than “setting prices.” I know this nuance will be difficult for you.
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January 10, 2024 at 10:10 am
Instead of being merely snide, maybe be explicit with A difference (nuanced or otherwise) to move the conversation forward?
Not sure that Bayh-Dole contemplated NIH staff inventors getting paid 350k bonus per year (i think it’s capped) for patented inventions that are licensed* to big pharma, and the NIH regulates big pharma.
*Sure is a clever way to add ‘extra’ (everybody in my lab shared in the discovery) inventors, license more patents than necessary**, and kickback cash directly into the pockets of your regulators.
** Do we ever see Big Pharma v. NIH where Big Pharma is challenging validity of an NIH owned patent?
“ Not sure that Bayh-Dole contemplated NIH staff inventors getting paid 350k bonus per year”
What amount did they contemplate? What would be fair to you?
From someone who seems to always think that those wanting to monetize their patents are “grifters,” your comment smacks of a level of tone-deafness that is impressive even for you.
How about an amount of ZERO, as any grift, kickback, or the like is – you know – not good?
In your opinion, how much should NIH staff inventors be paid and by what criteria should their salaries and bonuses be determined? You obviously have thought very deeply about this.
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January 11, 2024 at 9:50 am
Your question is an absolute non-sequitur to the point at hand.
It absolutely matters NOT AT ALL what my opinion is as to the determination of pay and bonuses for NIH staff inventors.
Not at all.
The clear point here is that grift should not be entertained.
As I noted – you are ALWAYS on about the ‘grift’ involved for most anyone having a patent or wanting to monetize their patent property.
It is beyond bizarre that you appear to want to turn a blind eye to the point at hand.
I understand you are here to devalue this blog and the cheapen debate. Only a federal employee could be so obtuse and oblivious to this conflict of interest and deliberate perversion of Bayh-Dole.
Mmm, I’ve considered that, but Malcolm’s cognitive dissonance is so severe that he must be actively involved in something that he detests.
Were he but a federal employee, he would not go so apoplectic.
Baloney, Dennis. This is an end-run on the APA. You want rules, you go via notice-and-comment rulemaking, not via “guidance”.
More importantly, (a) march-in-rights under Bayh-Dole were not meant to be used to try to control drug prices, and (b) if president clueless goes ahead with this, the only thing he’ll succeed in doing is undermining the Bayh-Dole scheme, thus reducing the development of drugs that originate in university research.
But I don’t expect a professor at a state university to exhibit intellectual honesty (exhibit A: all those pro-discrimination “DIE” pieces you’ve been running here, with comments turned off).
In all fairness, even though Prof. Crouch has the buck-stops-here responsibility for any and all (vapid) virtue signaling, it is more than abundant that the signaling commences explicitly without the ability for feedback by way of direct comments is the work of others who have been granted that level of authority.
As to the Federal Register notice, at this morning’s read, there have been about 28,000 comments (with almost another month to go).
Question 3 would be greatly augmented with a “everything into the sunshine” stance.
As I have (long) championed for the MESS that is the US medical system, with its varied players and HIDDEN shell games (and yes, this especially includes you, the insurance agencies), having a full ability to Follow the Money would be a FIRST step, and likely an important one that would inform ANY further contemplated steps.
Without this, this with existing influence will only game the legislation to their desired ends.
This would be a perfect time with all the plagiarism charges to file fraud and ethics complaints against the “professors” writing these DEI papers that are published on this blog. I am trying to get some of the big non-profits to take an interest in prosecuting these “professors.”
similar comments to last time…
To whom are you filing these charges, and what are their ‘standards?’
Hint: You are simply barking up the wr0ng tree to think that Academia writ large has the ethical standards that you believe to be in place.
They do not.
There be no true meritocracy there.
I can neither confirm nor deny that Prof. Gay will cover this in any of her classes in which she will STILL be being paid $900,000 a year at Harvard.
I CAN confirm that other notable Harvard ‘teachers’ recently hired include the likes of Brian Stelter and former Chicago Mayor Lori Lightfoot.
The audience is not academia. And I think you way underestimate the number of causes of action that go beyond simple ethics complaints.
“The audience is not academia.”
Great, a little step. Now, who is the audience?
“And I think you way underestimate the number of causes ”
Same two-step as last time. Instead of merely telling me that I have done so, give me a viable cause of action.
It’s NOT that I think that such may not exist, but you have provided NO details of one that could work.
You have a sounding board and someone willing to hear you out. I just want something meaningful (believe you me, I am one that thinks Academia needs some serious ethics rules).
anon, just read the news stories about plagiarism.
It is a very similar situation. And in both cases what we have is the Woke abusing our system for their agenda.
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January 8, 2024 at 6:10 am
The existence of abuse is not being questioned.
Have read the news stories about plagiarism (and have noted that Prof. Gay maintains her $900,000 annual salary at Harvard).
The issue that I am seeking clarification on pertains to the details that would be viable.
Again, I hear you, and I am not saying that I don’t want to hear you. I am saying that I need to hear more, and more details.
Remember when right wing drooling grandpas complained incessantly about “cancel culture”?
Accountability and Cancel Culture are very different things Malcolm.
oh remember the time you got so confused you called yourself a liar?
Another post on a debunked point.
How much 0bsess10n have you displayed with this particular attempt at a falsehood, Shifty?
+1
+1
Remember when all that push back (actually from young people mainly) made it uncool to “muh cancel” all but the worse offences saving the culture a tiny bit? Pepperidge Farm remembers.
link to i.kym-cdn.com
In any event bros, I just wanted to say that I’m pis sed. I’ve been ready to get myself a stingray corvette for like 3 years now and instead of them still being like 30-45k as they were trending before the commies came to America in 2020 ish in microscopic form, now anything 2020 model or newer even used is all 60-70k (you can literally buy a new one for 69k). I don’t want to pay more than 45-48.
Who would complain about being “canceled” for $ 900,000 per year? The point of canceling is to impact the person financially.
Anyway, as Anon already pointed out, holding someone accountable for their many acts of plagiarism is a far cry from canceling someone for something they said 20 years ago as a teenager.
“Specifically, the law states that if a university or its exclusive licensee is not taking timely, effective steps to achieve “practical application” of a federally funded invention or otherwise make it reasonably available to the public, the funding agency can “march in” and compel additional licensing.“
Correction: this provision does not apply to licensees. The law is very specific in naming only “contractors or assignees.” It speaks about licensees elsewhere, but march-in on the basis of failure to achieve “practical application” (including availability to the public on reasonable terms) only applies to conduct attributable to contractors/assignees (the university in your example).
Thank you, Moscow, for the only comment on topic…..
One thought that no one has explored – could pharma seek gov’t help to march-in on the university’s IP if they are charging unreasonable royalties for their patents?
For example, in drug development, many times Universities may screen a library of compounds to see if they have certain target effects. (This is typically done under a sponsored research agreement partially funded by pharma and partially funded by an NIH grant, which implicates Bayh-Dole.) The University patents the genus structure of these new compounds. Universities do not have the infrastructure to take these “hits” and turn them into a lead molecule. So, it is at this point in development, the University tech transfer office gets involved to license the library of compounds and IP to pharma. The success rate of mining a drug from these hits is abysmally low and extremely expensive. Typically, pharma must do more synthetic chemistry on any of the hits to turn the hits into a drug, and this results in the drug not actually being found (i.e., be exemplified, we can argue at a different time if they satisfy the written description requirement).
With that backdrop, market rates for University licenses are high single-digit royalties and 6-digit milestones for this IP and a couple vials of “powders” of compounds.
Can Pharma argue that the royalty rates asked by Universities are not consistent with an entity taking reasonable efforts to achieve a practical application of the government funded IP? Could Pharma use the march-in rights to force lower transaction costs from Universities?
I would posit that both sides of these transactions and the relative levels of profits would provide the optimal possible lens to evaluate your questions.
I agree. Since the ADA, there are price controls on pharmaceutical products. The consequence is that (on one side of the transaction) profit margins of pharma are reduced. Looking at the other side of the transaction, university tech transfer offices must realize that they must charge less. Accordingly, if tech transfer office are not downwardly adjusting their licensing asks, this should be sufficient for pharma to march in and take their IP.
An interesting suggestion, but (as you point out above vis not meant for price controls), would this then too be refused as it is about price controls by way of profit margins along the spectrum?
My desire for broad sunlight has less to do with abject price controls and more to do with simply highlighting WHERE the profits occur – along the entire spectrum.
My view is that IF the public is armed with this factual information, the ability to game ANY laws will be greatly reduced.
I would further posit this on a world-wide market basis (for any firms that would wish to operate in the US), as geographic gaming is certainly as aspect of disparate prices carried by US consumers.
I know there’s been a lot of interest in UFOs lately, but Martian rights seems a little extreme.
Just to be clear, “long time coming”in this instance is … 43 years and a few weeks.
Yes, that’s a long time.
December 31, 1980= 43 years plus a few weeks. I wonder at the marvel and how they separated me into another, with the knowledge collected and filed by the SSA, under the control of the OIG and all gathered information recorded by the IRS and they still got away with it.
Democracy is a funny animal. The Dems claim to help the downtrodden and the poor. And in order to pay for their programs to accomplish this, they rob the same people who they claim they are going to save. I wonder how many people they have robbed of their dreams know this.
Robin Hood they are not.
The only endearing quality the Democrats have is the knowledge Orangeman or his minions will fail this time too.
Hmmm … “march in rights” sounds like what SCOTUS did when they Mayo / Alice marched in on the patent eligibility rights the Constitution grants solely and exclusively to Congress.
Those (and I am looking at you, Greg) that wildly embrace the Sprint Left “Equity” agenda should be ALL FOR pharma prices to be strictly controlled by the Executive Branch to ensure that historically disadvantaged peoples can obtain their drugs at rock botttom prices.
The business model of other
F
A
I
L
E
D
development efforts should not be folded into any drug that has passed FDA process, and ONLY a “reasonable” (read that as SMALL percentage of ACTUAL cost) profit should be allowed.
Isn’t this the natural result that would be CONSISTENT with the principles of “Equity” (as that term is bandied about by the Sprint Left)?
Yeah . What was it your own designated expert said about you?
oh thats right. terribly sloppy reader, writer, and thinker.
and remember the time you got so confused you called yourself a liar?
and who could not forget the time you proved you can cut and paste off the internet? when you discovered wikipedia but alas it was wrong.
LMAO, FUNNY YOU ARE. INFORMATIVE TOO.
How unlike you Shifty to jump into a TOP thread and make the choices of your posts that earn me coin.
Thank$
Debunked and stale memes “own designated expert,” what I “called myself,” and “mis-framed interaction of wikipedia” (at least you are no longer attempting to claim that I was expressly wrong in my showing you multiple wikipedia references, including the original point of Alfred Nobel, he of the Nobel Prize, and the inventor of dynamite, of which in your repeated Coyote of the Coyote/Road Runner meme, continue to self-detonate).
So more appropriately, Thank$$$.
And you be you.
sorry i misspoke. your own designated expert did not say you were a terribly sloppy reader, writer, and thinker. He said you were an incredibly sloppy reader, writer, and thinker.
Imagine anon outing himsrlf yet agsin.
And for this idi@t to tell someone else they have no law license, while they too are not practicing because of constant write ups and
punishment themselves, and being called Pompous @ss in 2010, only to have his bestest buddy(ahem) get that sanction hidden because of his TN connection and their very very strong connection. Hey Pompousssy, how did the 2010 sanction get written up? I suppose who was in charge was law abiding.
sorry meant to be a reply to 1.1.2.1.3.
Thank$ again Shifty.
You keep on leaving out the context of the reason why that particular person (while still capable for being admired for most of his legal views) is holding a grudge because some irreverent pseudonym’d poster showed him up on a legal principle, and that same person simply cannot come to grips with the fact that the blogging forum does NOT carry the same ‘rules’ as a court of law.
But you be you – I enjoy making coin from your choices.
Shifty, did anon tell you that I may not be a Marylou Henner. But with my own history I do okay.
Judd Hirsch approves this comment.
according to Marylou she had sex with everybody in Taxi except danny de vito . Is there more to the story?
link to youtube.com
anon, don’t deflect. That is surely my grandmother Edna.
No deflection from me.
(love the Edna reference)
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