#bayh-dole | Explore Tumblr Posts and Blogs

mostlysignssomeportents · 6 months

Text

Uncle Sam paid to develop a cancer drug and now one guy will get to charge whatever he wants for it

Today (Oct 19), I'm in Charleston, WV to give the 41st annual McCreight Lecture in the Humanities. Tomorrow (Oct 20), I'm at Charleston's Taylor Books from 12h-14h.

The argument for pharma patents: making new medicines is expensive, and medicines are how we save ourselves from cancer and other diseases. Therefore, we will award government-backed monopolies – patents – to pharma companies so they will have an incentive to invest their shareholders' capital in research.

There's plenty wrong with this argument. For one thing, pharma companies use their monopoly winnings to sell drugs, not invent drugs. For every dollar pharma spends on research, it spends three dollars on marketing:

https://www.bu.edu/sph/files/2015/05/Pharmaceutical-Marketing-and-Research-Spending-APHA-21-Oct-01.pdf

And that "R&D" isn't what you're thinking of, either. Most R&D spending goes to "evergreening" – coming up with minor variations on existing drugs in a bid to extend those patents for years or decades:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3680578/

Evergreening got a lot of attention recently when John Green rained down righteous fire upon Johnson & Johnson for their sneaky tricks to prevent poor people from accessing affordable TB meds, prompting this excellent explainer from the Arm and A Leg Podcast:

https://armandalegshow.com/episode/john-green-part-1/

Another thing those monopoly profits are useful for: "pay for delay," where pharma companies bribe generic manufacturers not to make cheap versions of drugs whose patents have expired. Sure, it's illegal, but that doesn't stop 'em:

https://www.ftc.gov/news-events/topics/competition-enforcement/pay-delay

But it's their money, right? If they want to spend it on bribes or evergreening or marketing, at least some of that money is going into drugs that'll keep you and the people you love from enduring unimaginable pain or dying slowly and hard. Surely that warrants a patent.

Let's say it does. But what about when a pharma company gets a patent on a life-saving drug that the public paid to develop, test and refine? Publicly funded work is presumptively in the public domain, from NASA R&D to the photos that park rangers shoot of our national parks. The public pays to produce this work, so it should belong to the public, right?

That was the deal – until Congress passed the Bayh-Dole Act in 1980. Under Bayh-Dole, government-funded inventions are given away – to for-profit corporations, who get to charge us whatever they want to access the things we paid to make. The basis for this is a racist hoax called "The Tragedy Of the Commons," written by the eugenicist white supremacist Garrett Hardin and published by Science in 1968:

https://memex.craphound.com/2019/10/01/the-tragedy-of-the-commons-how-ecofascism-was-smuggled-into-mainstream-thought/

Hardin invented an imaginary history in which "commons" – things owned and shared by a community – are inevitably overrun by selfish assholes, a fact that prompts nice people to also overrun these commons, so as to get some value out of them before they are gobbled up by people who read Garrett Hardin essays.

Hardin asserted this as a historical fact, but he cited no instances in which it happened. But when the Nobel-winning Elinor Ostrom actually went and looked at how commons are managed, she found that they are robust and stable over long time periods, and are a supremely efficient way of managing resources:

https://pluralistic.net/2023/05/04/analytical-democratic-theory/#epistocratic-delusions

The reason Hardin invented an imaginary history of tragic commons was to justify enclosure: moving things that the public owned and used freely into private ownership. Or, to put it more bluntly, Hardin invented a pseudoscientific justification for giving away parks, roads and schools to rich people and letting them charge us to use them.

To arrive at this fantasy, Hardin deployed one of the most important analytical tools of modern economics: introspection. As Ely Devons put it: "If economists wished to study the horse, they wouldn’t go and look at horses. They’d sit in their studies and say to themselves, ‘What would I do if I were a horse?’"

https://pluralistic.net/2022/10/27/economism/#what-would-i-do-if-i-were-a-horse

Hardin's hoax swept from the fringes to the center and became received wisdom – so much so that by 1980, Senators Birch Bayh and Bob Dole were able to pass a law that gave away publicly funded medicine to private firms, because otherwise these inventions would be "overgrazed" by greedy people, denying the public access to livesaving drugs.

On September 21, the NIH quietly published an announcement of one of these pharmaceutical transfers, buried in a list of 31 patent assignments in the Federal Register:

https://public-inspection.federalregister.gov/2023-20487.pdf

The transfer in question is a patent for using T-cell receptors (TCRs) to treat solid tumors from HPV, one of the only patents for treating solid tumors with TCRs. The beneficiary of this transfer is Scarlet TCR, a Delaware company with no website or SEC filings and ownership shrouded in mystery:

https://www.bizapedia.com/de/scarlet-tcr-inc.html

One person who pays attention to this sort of thing is James Love, co-founder of Knowledge Ecology International, a nonprofit that has worked for decades for access to medicines. Love sleuthed out at least one person behind Scarlet TCR: Christian Hinrichs, a researcher at Rutgers who used to work at the NIH's National Cancer Institute:

https://www.nih.gov/research-training/lasker-clinical-research-scholars/tenured-former-scholars

Love presumes Hinrichs is the owner of Scarlet TCR, but neither the NIH nor Scarlet TCR nor Hinrichs will confirm it. Hinrichs was one of the publicly-funded researchers who worked on the new TCR therapy, for which he received a salary.

This new drug was paid for out of the public purse. The basic R&D – salaries for Hinrichs and his collaborators, as well as funding for their facilities – came out of NIH grants. So did the funding for the initial Phase I trial, and the ongoing large Phase II trial.

As David Dayen writes in The American Prospect, the proposed patent transfer will make Hinrichs a very wealthy man (Love calls it "generational wealth"):

https://prospect.org/health/2023-10-18-nih-how-to-become-billionaire-program/

This wealth will come by charging us – the public – to access a drug that we paid to produce. The public took all the risks to develop this drug, and Hinrichs stands to become a billionaire by reaping the rewards – rewards that will come by extracting fortunes from terrified people who don't want to die from tumors that are eating them alive.

The transfer of this patent is indefensible. The government isn't even waiting until the Phase II trials are complete to hand over our commonly owned science.

But there's still time. The NIH is about to get a new director, Monica Bertagnolli – Hinrichs's former boss – who will need to go before the Senate Health, Education, Labor and Pensions Committee for confirmation. Love is hoping that the confirmation hearing will present an opportunity to question Bertagnolli about the transfer – specifically, why the drug isn't being nonexclusively licensed to lots of drug companies who will have to compete to sell the cheapest possible version.

If you'd like an essay-formatted version of this post to read or share, here's a link to it on pluralistic.net, my surveillance-free, ad-free, tracker-free blog:

https://pluralistic.net/2023/10/19/solid-tumors/#t-cell-receptors

My next novel is The Lost Cause, a hopeful novel of the climate emergency. Amazon won't sell the audiobook, so I made my own and I'm pre-selling it on Kickstarter!

547 notes · View notes

megachirottera · 1 year

Text

Conflitti di interessi: la collusione segreta di Pfizer con il NIH

Ora non ci sono dubbi. Burocrati non eletti gestiscono l’intero complesso sanitario senza alcun controllo. Praticamente ci stanno dicendo di sederci… Source: March 21, 2023; Analysis by Dr. Joseph Mercola [>Fact Checked<] (more…) “”

View On WordPress

23 notes · View notes

queenofzan · 4 months

Text

in fact, just in case my hour and a half of research can help someone else, here's the comment I posted under a cut!

I made sure that I addressed the stuff I felt able to address that they specifically asked about, ie

NIST is specifically interested in receiving input from the public pertaining to the following questions: (1) After reading through the framework and example scenarios, if needed, how could the guidance about when an agency might want to exercise march-in and the factors that an agency might consider be made clearer? (2) The framework contains many terms which have specific meanings under Bayh-Dole or in technology development and commercialization. Are the definitions provided at the beginning of the framework easy to understand? Do they aid in your ability to interpret the framework? (3) How could the framework be improved to be easier to follow and comprehend? (4) Does this framework sufficiently address concerns about public utilization of products developed from subject inventions, taking into account the fact that encouraging development and commercialization is a central objective of the Bayh-Dole Act? (5) The framework is not meant to apply to just one type of technology or product or to subject inventions at a specific stage of development. Does the framework ask questions and capture scenarios applicable across all technology sectors and different stages of development? How could any gaps in technology sectors or stages of development be better addressed?

This framework first came to my attention through the lens of pharmaceutical patents, with this framework being touted as a way to seize patents from companies that are engaging in price gouging or holding onto patents for drugs that they are not producing. The benefits of exercising march-in rights on pharmaceutical patents to increase public safety and ensure that the huge amount of money the American taxpayers have sunk into pharmaceutical research is repaid in some measure are obvious. Public health and safety should not and can not practically be in the hands of private companies who have demonstrated more care for profits than for easing human suffering and saving lives; it is absurd that, for example, diabetics like my uncle should have paid taxes their whole lives, huge proportions of which went to drug research, and now find themselves unable to afford the insulin they need to continue living. I am frankly astonished, as someone younger than the Bayh-Dole Act, to find that the federal government has possessed the right to march-in for my entire life and failed to exercise it for the good of the American people. If a more specific framework to guide agencies in when it is appropriate to march-in would help them actually exercise this right, we should by all means adopt it.

Having read through the framework several times, I find it is clear and detailed enough that I think I know how I would proceed if I worked at an agency and found myself considering whether to march-in. There are enough details and clarifications as to what kind of additional research or fact-finding should be done that the process seems, if not straight-forward, manageable. I especially appreciate the specific instances noting when it would be appropriate to consult with counsel or subject matter experts as to whether or not Bayh-Dole applies.

As a layman previously unfamiliar with Bayh-Dole, the definitions provided at the beginning of the framework were very helpful! I went back to consult them several times to ensure I knew exactly what was being talked about; they definitely aided my ability to interpret the framework. Additionally, when I found I had questions (such as what constituted a subject invention), there was usually further explication of the term within the framework when it became relevant.

I especially appreciate the further elaboration on whether or not Bayh-Dole criteria apply to pricing concerns. Previous decisions by the NIH, such as In the Case of NORVIR and In the Case of Xatalan seem to imply that disproportionately high costs do not unreasonably limit public availability of a subject invention. While there is still some room for disagreement under this framework, the extensive clarification of how and when Criterion 1 would apply to a commercialized product is both helpful and reassuring. Unfortunately, the high cost of some common subject inventions is a very pertinent factor in whether or not the public is meaningfully able to use those inventions, and I appreciate that being explicitly acknowledged by these guidelines.

As I said at the beginning of my comment, I came across this framework in the context of pharmaceutical patents. I did find that colored my perception of this framework. However, the examples in particular helped highlight areas other than drug patents which might qualify as subject inventions under Bayh-Dole. I do believe the guidelines as written clearly apply to other areas and industries as well, and are not overly specific to any one industry.

This last bit is beyond the scope of this framework--or indeed of Bayh-Dole itself, as far as I understand--but I found myself thinking about it while considering this framework. As a seamstress, I am frequently running up against the problem of previously-common textiles growing increasingly difficult to source, and supplies I consider everyday necessities no longer being manufactured. I would argue it's in the public interest to have access to quality textiles regardless of how profitable they may or may not be, at least as a cultural connection to the rich history of textile manufacture, but even I wouldn't put it in the same category as vaccines or novel water filtration methods. Still, considering I am aware of at least one developed vaccine being shelved more or less indefinitely due to lack of demand, the parallel to my own industry-specific production woes struck me.

#don't just copy my comment obviously #but even in an elevated register my comment might be. a little more understandable than the legalese

4 notes · View notes

meret118 · 5 months

Text

When Joe Biden was elected president, Medicare was barred by law from negotiating the prices it paid for the drugs it purchased with taxpayer dollars. For a generation, presidential candidates of both parties had pledged to kill the “noninterference clause” that was the price Big Pharma extracted in 2003 from President George W. Bush to extend Medicare coverage to drugs (“Medicare Part D”). Last year, Biden finally got rid of the noninterference clause as part of the Inflation Reduction Act, and in October, the Health and Human Services Department announced that negotiations had begun on prices for 10 drugs that represent about 20 percent of all drugs covered under Medicare Part D. Changing the law to allow Medicare to negotiate drug prices was, as Biden would say, a Big Fucking Deal. If you’re one of those people who tells pollsters that Biden has done a poor job managing the economy, Medicare price negotiation is one of the better examples that prove you wrong.

. . .

On Thursday, the Biden administration announced that a review initiated last March by the Departments of Health and Human Services and Commerce concluded that, contrary to a rule proposed by the Trump administration but never finalized by the Biden administration, “price can be a factor in determining that a drug or other taxpayer-funded invention is not accessible to the public.” (Italics mine.) According to Politico, the Biden administration isn’t targeting any particular drug, and it isn’t expected to; so far, the policy seems intended mainly to put drug companies on notice that if they price drugs derived from federal research too prohibitively, they’ll risk the feds finally imposing the punishment Bayh and Dole authorized 43 years ago.

-----

Biden is the best president we've had in longer than I've been alive, and I'm over 50! I'm so fucking sick of people who claim to be liberals constantly putting him down, and saying they won't vote for him. I'm not happy with everything he's done either. The way to make things even better is to vote for the progressive candidate in the primaries, and then vote for Biden and any Democratic candidate in the general election.

If you're a liberal and don't vote in the general election or vote third party, you are worse than a republican, because you know how horrible republican policies are, and are still helping them win!

#Biden

4 notes · View notes

wumblr · 2 years

Text

It’s possible that UniEnergy stayed within the bounds of its agreement with the government, thanks to the vagueness of a 42-year-old law, the Bayh-Dole Act, which governs how technology licenses are managed. With new rules announced last year, the Biden administration is clamping down on what it calls loopholes in that law, and has signaled it wants to bring clean energy manufacturing jobs back home. “Should I fire more of them so that I can build a production line that already exists in China?” [CEO Rick Winter] asked. The decision to move all manufacturing to China strained the technology license’s condition that products be “manufactured substantially in the United States.”

oh this is going to happen over and over isn't it. it is so obvious they care more about manufacturing in the US than meeting any climate mitigation goals. not that the battery worked, but that... proves the point worse, doesn't it. they would rather manufacture a nonfunctioning battery in the US and leave tons of toxic waste lying around than actually do anything

thanks, bluewave!

17 notes · View notes

umanta · 1 year

Text

reading articles about the bayh dole act makes me want to kill someone.

the writer of the article usually

ITS TRAGIC ITS A TRAAGEDY I CRIED JUST READING THE WIKIPEDIA PAGE

#this is baout patent law

2 notes · View notes

biotech-news-feed · 4 months

Link

US patent law that – proponents argue – incentivized development of the mRNA vaccine tech used to fight COVID-19, continues to foster collaboration between academia and biopharma. The Bayh-Dole Act – which was enacted in 1980 – gave universities, no #BioTech #science

#Blockchain #Crypto

0 notes

avtechnologysworld · 4 months

Text

Scope of Work in Government Contracts: Compliance and Best Practices

The scope of work plays a vital role in any government contract, as it establishes the boundaries and expectations of the project. Clearly defining the scope of work upfront helps ensure all parties understand their responsibilities and have realistic expectations of the project outcomes and deliverables. However, developing an effective scope of work requires meticulous planning and consideration of compliance and best practice standards. This blog post will discuss key aspects of scope of work in government contracts, with a focus on compliance and recommended practices. The first key area we will examine is scope development through the use of X Draw tools.

Scope Development through X Draw Tools

When initially developing the scope of work for a government contract, it is important to gather all relevant information to clearly define the project requirements and boundaries. One best practice is to utilize visual mapping or diagramming tools, such as X Draw, to organize key aspects of the scope. X Draw tools allow parties to create visual representations of scope elements, key deliverables, dependencies, timelines, and other factors. This provides a clear overview of the scope that facilitates discussion and ensures all parties have a shared understanding from the start.

Some key elements that should be mapped out using tools like X Draw include:

Project Objectives and Goals: Clearly define the intended outcomes and purpose of the project.

Key Deliverables: Outline the tangible goods or services that must be provided. Include details on specifications, acceptance criteria, and due dates.

Tasks and Activities: Break down all work required into discrete, measurable tasks with start and end dates. Define logical dependencies and sequences.

Risks and Assumptions: Identify potential risks or uncertain factors. Note key assumptions being relied upon.

Acceptance Criteria: Determine clear standards for accepting deliverables and determining satisfactory completion.

Resources and Staffing: Note all material, equipment, facilities, personnel needed. Define required roles and responsibilities.

Clearly visualizing all scope aspects upfront through tools like X Draw helps identify gaps or areas of uncertainty early. It serves as a documented basis for ongoing scope management.

Scope Regulations and Compliance Standards

When developing scopes of work for government contracts, it is crucial to ensure compliance with all applicable regulations and standards. This protects both the government agency and the contracting company. Some key compliance factors to keep in mind include:

Scope Definitiveness - Per the Federal Acquisition Regulation (FAR), scopes for fixed-price contracts must be "definite and certain." No ambiguous language or gaps can exist.

Performance-Based Language - FAR guidelines require scope statements for service contracts use clear, specific, and measurable performance standards defining required outcomes, not vague descriptions of work.

Intellectual Property - All IP ownership terms must comply with relevant statutes like the Bayh-Dole and Stevenson-Wydler Acts. Scope must delineate IP treatment for contract deliverables clearly.

Restricted Activities - The scope cannot include any inherently governmental functions, personal services, construction, or other activities prohibited by law or regulation.

Changes and Modifications - The contract terms must establish a formal process complying with FAR for any scope changes, consistent with statutory requirements for contract modifications.

Access to Facilities - If contractor access to government facilities will be needed, appropriate security clearance and suitability standards must be addressed in the scope.

Adhering to regulatory compliance standards protects the integrity and legality of the scope and ultimately the contract as a whole. Failing to meet compliance could result in protests, disputes or contract termination down the line.

Clear Statement of Requirements

At the core of any effective scope of work is a clear, unambiguous statement of requirements. This establishes precisely what the contractor is expected to deliver under the contract. Some essential elements of a well-written statement of requirements include:

Task Descriptions: Provide concrete, specific descriptions of the work, goods or services required for deliverables and milestones. Clearly distinguish discrete tasks.

Specifications: Include measurable technical requirements, performance standards, quality levels, and any applicable specifications like codes or regulations.

Acceptance Criteria: Define how deliverable completion and quality will be evaluated, approved and accepted. Quantitative metrics are best.

Schedule: Provide complete schedule details including deliverable and milestone due dates, completion windows, and any schedule constraints.

Locations: Note any specific locations or sites where work will occur or deliverables need to be provided if applicable.

Reporting: Requirements for status reports, completion reports or other documentation need to be defined.

Change Management: Processes by which changes can be requested and approved must be established.

The statement of requirements lays the groundwork for proper performance, acceptance procedures, and change management. It ensures a shared understanding from the contract signing.

Conclusion

Defining a clear, compliant scope of work is central to developing successful government contracts. Following best practices like visual mapping tools, adhering to regulatory standards, and crafting a distinct statement of requirements establishes a solid foundation. Doing so protects all parties and sets the stage for meeting project objectives on schedule and within budget. Careful planning and scope development delivers value by ensuring contract expectations are realistic and outcomes are achievable as written.

0 notes

xtruss · 4 months

Text

US Senator Elizabeth Warren (D-MA) speaks during a hearing by the Senate Finance Committee on the proposed budget request for 2024, on Capitol Hill in Washington, DC, March 16, 2023. Andrew Caballero-Reynolds/AFP/Getty

Elizabeth Warren: America—It's Time to Tell the Government We're Sick of Big Pharma's Racket —Opinion

— December 14, 2023 | Newsweek

For years, cancer patients and advocates pleaded with the government to use a tool that has been around for decades: the Bayh-Dole Act. Using "march in" rights granted by this law, the government could re-license patents for inventions that benefited from taxpayer dollars if those inventions aren't made available to the public on "reasonable terms." Cancer patients have rightly argued that demanding $190,000 a year for a life-saving drug is not "reasonable."

The government should've used its march in rights long ago, but pharmaceutical companies have lobbied to exclude a drug's price from the determination of what's "reasonable." They argue that evidence from legal scholars and others to the contrary should just be ignored.

In March, the government rejected a march-in petition for Xtandi, but said that things were about to change. It announced plans to develop a framework that would finally—finally—implement the march-in provision of the Bayh-Dole Act and consider price as a factor.

In releasing the draft framework, the Biden-Harris administration was unambiguous: price can be considered in the government's decision to march-in on a drug. That curbs the ability of pharmaceutical companies to jack up the price of drugs taxpayers helped pay to develop.

The battle isn't over. The march in guidance isn't finalized, and it should be strengthened to make clear that a drug's price is unreasonable if Americans are forced to pay more for drugs they paid to develop. Big Pharma will also do everything in its power to prevent this plan from going into effect. But we can fight back.

Here's what comes next: /the march in framework will be open for public comment until February 6. That means Big Pharma will have until February 6 to ferociously lobby our government and scare Americans into thinking that actions to lower drug prices will destroy innovation, take drugs out of circulation, and generally cause the earth to stop rotating on its axis. In that same time, I will fight to ensure the administration strengthens and finalizes this framework so Americans can have a little more breathing room when it comes to their health care costs—and I'll bring along as many people in Congress as possible.

But the real fight will play out with all of you. If Americans weigh in at Regulations.gov, then all the lobbying from Big Pharma won't make a dent. This is the moment to tell our government that we're sick of Big Pharma picking up drugs that we paid to develop and then charging Americans significantly more for those drugs than they charge patients abroad.

For everyone who is battling cancer or another disease, this is the moment. For everyone who knows someone who needs access to a high-priced drug that your tax dollars helped develop, this is the moment. And for everyone who is just plain sick of Big Pharma ripping off our nation, this is the moment. We can speak up online and participate in the public comment process to tell our federal government that Big Pharma has had its day and its gargantuan profits, and now it's time to make government work for the American people. This is a righteous fight.

— Elizabeth Warren is a United States Senator from Massachussetts.

#Opinion #Elizabeth Warren #Elizabeth Warren | United States Senator | Massachussetts #Big Pharma #US 🇺🇸 | US News #Newsweek

0 notes

nedsecondline · 5 months

Text

Hiltzik: The U.S. finally moves to stop drug profiteering - Los Angeles Times

…The significance of Biden’s move can’t be overstated, for it signals that drugmakers that abuse their patent rights by profiteering may lose their patents altogether. You can expect Big Pharma to pay attention to this threat. Bayh-Dole empowered private companies to commercialize inventions that grew out of federally funded research, but it reserved certain rights for the government to protect…

View On WordPress

0 notes

investmentdigest24hrs · 5 months

Text

Biden administration sets policy to seize patents of government-funded drugs to slash prices

In a further attempt to lower exorbitant medicine prices and encourage greater pharmaceutical competition, the Biden administration on Thursday said it might take the patents of some pricey pharmaceuticals away from manufacturers. The Biden administration’s decision stems from a provision within the Bayh-Dole Act, which grants the government the right to take control of patents for inventions…

View On WordPress

0 notes

thxnews · 9 months

Text

New Executive Order Boosts US Jobs and Domestic Manufacturing

Summary

President Biden issued an Executive Order aimed at bolstering domestic manufacturing and promoting American jobs through enhanced research and development (R&D) efforts. The order highlights the critical role of the United States' innovation ecosystem, including world-class universities, Federal laboratories, and technology incubators, which are supported by Federal investment. By prioritizing R&D funding across sectors, the Administration seeks to accelerate the transition of new discoveries from laboratories to the marketplace. The policy mandates that technologies and products developed with U.S. Government support should be manufactured domestically whenever feasible and in compliance with applicable laws. This initiative aims to bolster the country's economic competitiveness, domestic manufacturing capacity, and national security. Additionally, it seeks to strengthen global critical supply chains, support net-zero emissions by 2050, and foster joint R&D efforts with partners and allies. The order calls for coordination and consultation among various agencies to implement these objectives. Agency heads are encouraged to consider domestic manufacturing in R&D funding agreements and develop technology R&D roadmaps with a focus on supporting U.S. manufacturing. Small businesses are encouraged to participate in innovation and research solicitations, with streamlined access to funding opportunities. To facilitate reporting and tracking of inventions developed through federally funded R&D, agencies must implement standardized and streamlined reporting requirements, ensuring transparency and visibility to taxpayers on Federal R&D funding's utilization. Critical and emerging technologies are prioritized for domestic manufacturing, with potential exceptions evaluated based on economic and national security considerations. Agencies must also improve the waiver process under the Bayh-Dole Act, which allows exceptions to domestic manufacturing requirements when warranted by certain circumstances. The order includes provisions for annual reporting on its implementation's effectiveness and encourages agencies to seek alternative benefits from waiver applicants to ensure the United States' economic interests are protected. It emphasizes the importance of protecting sensitive information while providing sufficient transparency to the public. Overall, the Executive Order on Federal Research and Development reinforces the U.S. commitment to nurturing innovation, supporting domestic manufacturing, and bolstering the country's position as a global leader in technology and sustainability.

Official Executive Order Issued By the President

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: Section 1. Policy. The United States maintains an unparalleled innovation ecosystem with world-class universities, Federal laboratories, research centers, and technology incubators, supported in part by Federal investment. Our world is healthier, smarter, more connected, and more sustainable because of Federal taxpayers’ investment in discovery and innovation that has supported the commercialization of new products and services. My Administration has prioritized support for our unique innovation ecosystem by reinvesting across sectors in research and development (R&D), demonstrations, education, and the necessary infrastructure to accelerate the transition of discoveries quickly from the lab to the marketplace. This investment is designed to produce cutting-edge technologies that support the competitiveness, domestic manufacturing capacity, and well-being of the United States economy; United States workers; our communities; and our national security. Ensuring the commercialization of federally funded inventions by United States manufacturers — while maintaining intellectual property rights — will build on the successful legacy of the United States in spurring economic growth and enhancing United States competitiveness through R&D. It will also further our joint R&D work with partners and allies to strengthen the resilience of global critical supply chains and secure America’s leadership in delivering a net-zero emissions economy by no later than 2050. Therefore, it is the policy of my Administration that when new technologies and products are developed with support from the United States Government, they will be manufactured in the United States whenever feasible and consistent with applicable law. Sec. 2. Coordination and Consultation. (a) The Assistant to the President for National Security Affairs, the Assistant to the President for Economic Policy, and the Director of the Office of Science and Technology Policy (OSTP) shall coordinate the executive branch actions necessary to implement this order through the interagency process identified in National Security Memorandum 2 of February 4, 2021 (Renewing the National Security Council System). (b) In implementing this order, the heads of executive departments and agencies (agencies) shall, as appropriate and consistent with applicable law, consult outside stakeholders — such as those in industry; academia, including Historically Black Colleges and Universities, Tribal Colleges and Universities, and other Minority Serving Institutions; non-governmental organizations; communities; labor unions; and State, local, Tribal, and territorial governments — in order to implement the policy identified in section 1 of this order. Sec. 3. Strengthening Domestic Manufacturing. (a) The Secretary of Defense, the Secretary of Agriculture, the Secretary of Commerce, the Secretary of Health and Human Services, the Secretary of Transportation, the Secretary of Energy, the Secretary of Homeland Security, the Director of the National Science Foundation, and the Administrator of the National Aeronautics and Space Administration should consider domestic manufacturing in Federal R&D funding agreement solicitations, as appropriate and consistent with applicable law. These agency heads shall also consider how their respective agencies’ R&D funding agreements support broader domestic manufacturing objectives, including the development of production facilities and capabilities broadly supportive of United States manufacturing, as appropriate and consistent with applicable law. (b) The Director of OSTP, working through the National Science and Technology Council (NSTC) and in coordination with the Director of the Office of Management and Budget’s Made in America Office (Made in America Director) and the heads of agencies identified in subsection (a) of this section, shall seek to add “domestic manufacturing” to future interagency technology R&D roadmaps, as appropriate. The Director of OSTP shall endeavor to standardize the format of domestic manufacturing considerations in technology R&D roadmaps to ensure that industry, the research community, and agencies create the conditions for new technologies to be produced in the United States once they are commercialized. (c) In collaboration with the Administrator of the Small Business Administration (SBA), the heads of agencies participating in the Small Business Innovation Research and Small Business Technology Transfer programs are encouraged to advance a coordinated interagency approach to innovation and research solicitations with the goals of reducing barriers to program participation, streamlining access to funding opportunities, and encouraging production of new technologies in the United States. The heads of these agencies are further encouraged to collaborate with the SBA to support small businesses transitioning technologies from intramural and extramural labs to commercial markets. (d) The heads of agencies that have statutory Other Transaction Authority, or that can use other business arrangements authorized by the Congress, are encouraged, when appropriate, to consider using these authorities to purchase or invest in leading-edge technologies to support their production in the United States. If these agencies use these authorities to purchase or invest in the development of new technologies, the terms of these purchases and investments should ensure that the product is substantially manufactured in the United States, as appropriate and consistent with applicable law. (e) To further support the commercialization and production in the United States of technologies developed, in part, through federally funded R&D, the heads of agencies identified in subsection (a) of this section are encouraged to establish or enhance the technology transfer and commercialization capabilities of their agencies. Sec. 4. Modernizing Reporting of Invention Utilization. (a) In an effort to streamline reporting requirements for recipients of Federal R&D funding agreements, the heads of agencies identified in section 3(a) of this order should seek to make reporting on the utilization of “subject inventions” (as defined in 35 U.S.C. 201(e)) easier and consistent across the United States Government. (b) To incentivize domestic manufacturing through the reporting of invention disclosures and the utilization of those inventions, the heads of agencies identified in section 3(a) of this order shall require recipients of Federal R&D funding agreements to track and update the awarding agency on the location in which subject inventions are manufactured. (c) The heads of agencies identified in section 3(a) of this order should require recipients of Federal R&D funding agreements to report annually to the awarding agency the names of licensees and manufacturing locations of the applicable subject inventions. (d) Within 60 days of the date of this order, the Secretary of Commerce, through the Director of the National Institute of Standards and Technology (NIST) and in consultation with the Office of Management and Budget (OMB), should develop award terms and conditions regarding the reporting requirements in subsections (a) through (c) of this section to be implemented by each awarding agency identified in section 3(a) of this order. Award terms and conditions shall ensure that the reporting of the information specified in subsections (b) and (c) of this section protects business confidential information, consistent with 35 U.S.C. 202(c)(5), while providing increased visibility to taxpayers on the use of Federal R&D funding in support of domestic manufacturing and job creation. (e) The Secretary of Commerce, through the Director of NIST and in consultation with the Interagency Working Group for Bayh-Dole, shall consider developing an action plan, including resource requirements, to transition all agencies identified in section 3(a) of this order to the iEdison reporting system to track unclassified subject inventions, patents, and related utilization reports by calendar year 2025. The Secretary of Commerce shall submit the action plan to the Director of OMB within 1 year of the date of this order. (f) Not later than 120 days after issuance of any final regulations implementing the action plan described in subsection (e) of this section, the heads of agencies identified in section 3(a) of this order shall report to the Director of OMB and the Director of OSTP on steps their respective agencies have taken to transition all unclassified reporting to iEdison by the end of calendar year 2025. These reports may include resource needs and timelines for implementation. (g) Within 180 days of the date of this order, the Secretary of Commerce, through the Director of NIST and in consultation with the Interagency Working Group for Bayh-Dole, should develop common invention utilization questions (utilization questions), allowing agencies to add agency-specific questions. (i) The utilization questions should be used by all agencies by May 1, 2024, for subject inventions that a Federal R&D funding agreement recipient has elected to retain title on or after the date of this order. (ii) The utilization questions should require information on the locations where subject inventions are produced or are used to produce a product. (iii) The Secretary of Commerce, through the Director of NIST, and the heads of other agencies should aim to minimize the reporting burden on recipients of Federal R&D funding agreements associated with the utilization questions, in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) and applicable OMB guidance. (h) Within 2 years after the date of this order and annually thereafter, the heads of agencies identified in section 3(a) of this order shall submit reports to the Made in America Director on the utilization of inventions that were developed through their previous R&D funding agreements and reported after the date of this order, including where products embodying a subject invention or produced through the use of a subject invention were manufactured. Sec. 5. Securing Critical and Emerging Technologies Through Domestic Manufacturing. (a) Within 90 days of the date of this order, the heads of agencies identified in section 3(a) of this order shall consider whether “exceptional circumstances” exist warranting a determination that a restriction of the right to retain title to any subject invention funded by their respective agencies’ R&D funding agreements will better promote the policy and objectives of the Bayh-Dole Act, as appropriate and consistent with applicable law, including 35 U.S.C. 202(a). Such consideration shall include evaluation of whether “exceptional circumstances” exist to warrant the extension of the requirement to manufacture “substantially in the United States” to recipients of Federal R&D funding agreements, to non-exclusive licensees of subject inventions, and for use or sale of subject inventions outside the United States, as appropriate and consistent with applicable law, including 35 U.S.C. 202(a). In considering the issuance of such determinations for these purposes, the heads of agencies identified in section 3(a) of this order shall: (i) consider measures for technologies important to the United States economy and national security, including critical and emerging technologies such as energy storage, quantum information science, artificial intelligence and machine learning, semiconductors and microelectronics, and advanced manufacturing; and (ii) consider narrowly tailoring terms related to enhanced United States manufacturing while encouraging technology transfer and commercialization, and allowing small businesses and nonprofit organizations to retain ownership of and commercialize their federally funded subject inventions. (b) The heads of agencies identified in section 3(a) of this order shall consider whether other measures are needed to promote domestic manufacturing of subject inventions funded by their respective agencies. Sec. 6. Implementation of this Order. (a) Within 2 years of the date of this order and annually thereafter for 5 years, the heads of agencies identified in section 3(a) of this order shall submit a report on their respective agencies’ implementation of this order to the Director of OMB and the Director of OSTP. (b) Each report shall include, to the extent possible, a review of this order’s effectiveness in using the R&D funding agreements of the agencies identified in section 3(a) of this order to support domestic manufacturing, United States industrial competitiveness, and job creation. (c) Each report shall include, to the extent possible, identification of any challenges to implementation of this order or to the effectiveness of this order in accomplishing the policy goals described in section 1 of this order, as well as recommendations to address such challenges. Sec. 7. Improving the Waiver Process. (a) Under the Bayh-Dole Act, agencies may waive the requirement that certain products embodying the subject invention or produced through the use of the subject invention be “manufactured substantially in the United States” if, as specified in 35 U.S.C. 204, “reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States” or “under the circumstances domestic manufacture is not commercially feasible.” (b) Every agency should consider developing a process by which the agency may waive the domestic manufacturing requirements for agency-funded technology or technology developed under an agency funding opportunity without a request from a recipient of a Federal R&D funding agreement. As part of its process, an agency should seek concurrence from the Made in America Director to waive the domestic manufacturing requirements, and should set forth specific factors that may support a waiver, including whether the manufacture of the technology outside the United States is in the economic or national security interest of the United States. (c) The heads of agencies identified in section 3(a) of this order shall ensure that the waiver process for their agency is rigorous, timely, transparent, and consistent, with due regard for all applicable authorities, including Executive Order 14005 of January 25, 2021 (Ensuring the Future Is Made in All of America by All of America’s Workers), and the Bayh-Dole Act’s requirement that a waiver be available when reasonable but unsuccessful efforts have been made to license to a company that could substantially manufacture in the United States, or when domestic manufacture is not commercially feasible. (d) The Secretary of Commerce, through the Director of NIST and in consultation with the Interagency Working Group for Bayh-Dole, the NSTC Lab-to-Market Subcommittee, and the Made in America Director, shall provide guidance to agencies on the factors and considerations that should be weighed in determining whether domestic manufacturing is not commercially feasible. Guidance shall be designed to help applicants understand the factors an agency will consider when evaluating a waiver application, and should ensure that a determination of the commercial feasibility of manufacturing abroad is not based on substandard or unacceptable working conditions. Within 90 days of the date of this order, the Secretary of Commerce, through the Director of NIST, shall make the guidance available for public comment. (e) Within 90 days of the date of this order, the Secretary of Commerce, through the Director of NIST and in consultation with the Interagency Working Group for Bayh-Dole, shall develop common waiver application questions for use by all agencies. (i) The common waiver application questions should include as relevant criteria, as appropriate and consistent with applicable law: (A) how the waiver will be used; (B) why it is important that the subject invention be brought to market; (C) any potential economic and national security impacts of manufacturing the subject invention abroad; (D) the benefits that will accrue to domestic manufacturing and United States jobs as a result of the subject invention being brought to market; (E) whether the applicant is proposing an exclusive or non-exclusive license; and (F) the conditions under which the subject invention would be manufactured abroad, including unionization of workplaces, health and safety standards, labor and wage laws, and environmental impacts. (ii) Given the need to maintain agency flexibility, the heads of agencies identified in section 3(a) Read the full article

#CommercializationofNewProducts #DomesticManufacturingandJobs #FederalInvestmentinDiscovery #FederalResearchandDevelopment #InnovationandEducationInfrastructure #NationalSecurityandResilience #TechnologyIncubatorsandR&D #UnitedStatesInnovationEcosystem #USCompetitivenessandEconomy #USIndustrialCompetitiveness

0 notes

queenofzan · 4 months

Text

catch me in 2023 having opinions about the under-utilized potential of the bayh-dole act of 1980

2 notes · View notes

technsavi · 1 year

Text

More DOE Bureaucracy Equals Less Innovation

“Rather than undermining the most successful technology commercialization system in the world, we should find effective ways to make more products here. Discouraging commercialization doesn’t do that.” You have to give them credit. The Department of Energy (DOE) bureaucracy doesn’t give up. For more than 40 years, they’ve been resisting the Bayh-Dole Act’s mandate cutting Washington out of…

View On WordPress

0 notes

carnalesferales · 2 years

Text

DARPA desarrolló la vacuna de ARNm a través de Moderna en 2013

Antes de los bloqueos mundiales de 2020, la Defense Advanced Research Projects Agency (DARPA) y los National Institutes of Health (NIH) estaban trabajando subrepticiamente en una nueva plataforma de vacunas de ARNm mediante una nueva empresa de biotecnología llamada Moderna. Su planificación estratégica comenzó en 2013, cuando los fondos de DARPA fueron utilizados por Moderna para inventar métodos para inducir una respuesta inmune de corta duración mediante la administración de vacunas de ARNm.

El inventor de la plataforma de ARNm, el Dr. Robert Malone, revela que “Moderna fue fundada esencialmente por DARPA. Se utilizaron millones de dólares en subvenciones de DARPA para construir el programa de vacunas, mediante patentes transferidas a Moderna. Sin embargo, Moderna se niega a revelar estas adjudicaciones DARPA en las solicitudes de patente que ha presentado para la nueva tecnología de vacunas.

DARPA está detrás del experimento de la proteína de espiga de ARNm, con ayuda de los NIH

A medida que se revela este proyecto secreto de la DARPA, queda claro que fuerzas del gobierno estadounidense estaban planeando liberar esta tecnología durante años antes de una “emergencia de salud pública”. Para lograr el cumplimiento, sólo necesitaban explotar la psicología humana, suspender el estado de derecho y amenazar los medios de vida de las personas para coaccionar a la población a participar en este experimento y alterar la fisiología natural de sus células y funciones biológicas. Un director de los NIH, el Dr. Anthony Fauci, se encargó de ello cuando pidió un cierre nacional en marzo de 2020. Para llevar a cabo el plan, Fauci pide ahora a las inyecciones obligatorias de este software de explotación genocida.

El grupo de vigilancia, Knowledge Ecology International, señala que Moderna recibió 20 millones de dólares en subvenciones de DARPA varios años antes de la “pandemia mundial”. El grupo afirma que estos fondos “probablemente” condujeron al desarrollo de esta nueva tecnología de vacunas. Esta larga operación de larga data incluye 26 patentes asignadas a “Moderna” o “ModernaTx”, así como 154 solicitudes de patentes. Un examen más detallado de estas patentes muestra que Moderna participó en el programa de DARPA Autonomous Diagnostics to Enable Prevention and Therapeutics (ADEPT). Esta financiación allanó el camino para que Moderna desarrolle programas de vacunas de ARNm contra los virus de Chikungunya y Zika, y otros patógenos respiratorios para el futuro.

En respuesta a la investigación, DARPA declaró que estaba “buscando activamente las adjudicaciones de la agencia en Moderna para identificar las patentes y las patentes pendientes, en su caso, que puedan estar asociadas con el apoyo de DARPA”. En lugar de someterse a una auditoría independiente de su operación planificada de proteínas de espigas de ARNm, la DARPA está autorizada investigar su propio rastro financiero, que seguramente conduce a los experimentos secretos de ARNm realizados por sus agentes en Moderna.

Independientemente de la mayor conspiración para experimentar en poblaciones humanas, Moderna tiene la obligación legal de revelar el apoyo del gobierno federal de EE.UU. en las solicitudes de patentes en virtud de la Ley Bayh-Dole y de los reglamentos emitidos por la Oficina de Patentes y Marcas de EE.UU. DARPA admite claramente que está en el origina de este experimento global, afirmando en su página web: “La primera vacuna contra el coronavirus que comenzó a probarse en humanos provino de una inversión de DARPA en Moderna”. Aunque las invenciones de ARNm fueron concebidas durante los últimos ocho años, Moderna no revela que DARPA estuviera detrás de los proyectos desde el comienzo y ha negado que hubiera fondos federales involucrados.

Hasta 2016, el genetista Daniel Wattendorf fue director de programas en DARPA, donde inició y dirigió programas que despliegan diagnósticos, medicamentos de transferencia genética, glóbulos rojos de ingeniería y vacunas de ARN. Estuvo detrás del programa ADEPT en 2012 y avanzó en la investigación del ARNm a través de Pfizer y Moderna en 2013. Después de dirigir estos programas de vacunas de ARNm, ocupó el cargo de Director de Innovate Technology Solutions en la Fundación Bill y Melinda Gates, donde es responsable de la creación de pruebas de diagnóstico y plataformas biotecnológicas para “soluciones de salud mundiales”.

Cuando el Pentágono financia y despliega un experimento en toda la población, no es de extrañar que los Estados Unidos se vean obligados a aceptar una emergencia de salud pública indefinida en todas las comunidades simultáneamente. Estados Unidos sigue sufriendo bajo la ley marcial médica, la suspensión de las libertades civiles y la amenaza continua de la fuerza totalitaria, incluso contra los cuerpos de los trabajadores de la salud y los propios militares.

Un experimento global está convirtiendo los cuerpos de las personas en sistemas operativos, controlados por actualizaciones de vacunas de ARNm.

DARPA tiene claro que estas vacunas de ARNm no pretenden proporcionar inmunidad, sino que invocan una “inmunidad transitoria” que obliga al organismo a crear anticuerpos durante sólo unas semanas o meses. Directamente de Darpa «Pandemic Prevention Platform»: “Uno de los principales beneficios del enfoque basado sobre los ácidos nucleicos para limitar la propagación de la infección es que las construcciones genéticas introducidas en el cuerpo serían tratadas rápidamente y no se integrarían en el genoma de un individuo. Asimismo, los anticuerpos producidos en respuesta al tratamiento sólo estarían presentes en el organismo durante semanas o incluso meses. Esto es coherente con la intención de DARPA de proporcionar de forma segura una inmunidad transitoria, detener la propagación de la enfermedad creando un cortafuegos y ganar tiempo para desarrollar y desplegar respuestas médicas a largo plazo”.

Este programa de ARNm es un sistema operativo instalado en el interior de los seres humanos, un siniestro proceso de control del cuerpo que es admitido abiertamente por Moderna. Estas vacunas son un arma de control nanotecnológico que proporciona instrucciones codificadas genéticamente para volver a cablear los procesos celulares normales del receptor. Cuando se codifica una toxina específica (proteína de espiga) y se produce en el cuerpo del receptor, tu sistema inmunitario se ve obligado a responder. Sus células inmunitarias se atenúan con el tiempo y se vuelven dependientes de las instrucciones, ya que se produce un fenómeno biológico llamado cebado de patógenos o potenciación dependiente de anticuerpos.

La primera parte de este experimento de control global fue psicológica, obligando a las personas a pensar que tenían que reproducir las toxinas en sus cuerpos para demostrar que eran inmunes a algo que nunca había sido aislado o cuantificado. Se encerró a la gente y se le dijo que no podía entrar en contacto con las personas, que todo el mundo estaba enfermo y que el aire estaba contaminado mientras los sistemas médicos aislaban a la gente, suspendían el tratamiento y asesinaban a los pacientes con respiradores.

La segunda parte de este experimento de control y manipulación, en tiempo de guerra, consiste en definir el protocolo inicial de dos inyecciones, que condiciona a las personas a aceptar múltiples inyecciones para que su sistema inmunitario siga funcionando de acuerdo con la “ciencia”. La tercera parte se está introduciendo actualmente en todo el mundo, ya que se inyecta una tercera dosis de proteínas de espiga de ARNm en personas que ya son susceptibles a los patógenos virales y “necesitan una inyección de refuerzo”.

A partir de cada año, se le dirá a la gente que necesita una actualización de su sistema de “inyección de refuerzo” a medida que se anuncia una “nueva variante”. La plataforma de ARNm de armas biológicas de proteínas de espiga que se está lanzando hoy por la coacción y la fuerza fue planeada hace años por DARPA, NIH, Moderna y sus agentes en la Fundación Bill y Melinda Gates.

naturalnews

(traducción: verdadypaciencia.com)

Fuentes

SeekingAlpha.com

Brighteon.com

EverydayConcerned.net

KEIOnline.org [PDF]

Darpa.mil

NaturalNews.com

0 notes

skolr · 4 years

Text

It’s time to eliminate patents in universities

With a poor return of value, and a huge overhead for research, patents are a bad investment for the academy.

“It is true that many people in science will scoff if you try to tell them about a scientific community in which ideas are treated as gifts. This has not been their experience at all. They will tell you a story about a stolen idea. So-and-so invented the famous such and such, but the man…

View On WordPress

#Bayh-Dole #patents

1 note · View note