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TWN Info Service on Health Issues (Aug20/03)
7 August 2020
Third World Network


Dear friends and colleagues,

We are pleased to share with you Article #4 of the TWN series of short reports on Intellectual Property and COVID-19 Vaccines.

In this article, the case of Vanderbilt University in Tennessee, USA that is noted for its biomedicial research is a story of the privatization of decades of publicly-funded antibody research, “particularly depressing spectacle in the face of global misery caused by COVID-19″.

Antibodies from Vanderbilt, potential COVID-19 treatments whose discovery was paid for by the public, have been turned into private property as the University and its partner, the drug giant AstraZeneca, position themselves to reap profits from the sale of expensive monoclonal antibody drugs (MABS).

The author concludes: “Which of the many COVID-19 MAB drugs under development proves to be most effective remains to be seen. Each company advancing its own candidate(s) without direct comparison at early stages is the present, inefficient, approach. If the Vanderbilt antibodies emerge from presently ongoing trials as being particularly effective, the course of action that the University has taken in licensing them exclusively to AstraZeneca will likely result in more expensive treatments and, quite possibly, lower availability.”

The full article is below.

With best wishes,
Third World Network


Pandemic Profiteers? Publicly-funded Vanderbilt University aims to make
the COVID-19 disaster its financial windfall

By Edward Hammond

Vanderbilt University is in hot pursuit of pandemic profits. Antibodies from Vanderbilt, potential COVID-19 treatments whose discovery was paid for by the public, have been turned into private property as the University and its partner, the drug giant AstraZeneca, position themselves to reap profits from the sale of expensive monoclonal antibody (MAB) drugs.

The privatization of decades of publicly-funded antibody research is a particularly depressing spectacle in the face of global misery caused by COVID-19. In the face of the disaster, many might think that non-profit researchers who depend on public grants for financial support would be eager for their discoveries to be put to maximum social benefit. After all, if the researchers’ COVID-19 work, as well as the development of their lab’s capabilities, has been paid for with a reliable stream of public money that dates back for decades, shouldn’t a lab’s discoveries be available to the public at a minimal price?

No superior testament to the societal value of public funding for biomedical research could exist than for the benefits of research richly funded by the public to be equitably delivered to all people at a time of global crisis.

Unfortunately, such thinking does not prevail at Vanderbilt, a private, nonprofit university in Nashville, Tennessee (US) that is noted for its biomedical research.

Vanderbilt’s institutional goals, at least as far as its COVID-19 antibodies are concerned, appear to be maximizing its own profits. Taking a highly proprietary approach to its COVID-19 treatment ideas, Vanderbilt is rushing to lay proprietary claims. In one notably callous publication, it even publicly congratulated itself at the frenetic pace of its COVID-19 patent applications, licenses to which the University is peddling to pharmaceutical companies.

Vanderbilt’s Vaccine Center and a spigot of public dollars

With decades of funding from the US National Institutes of Health and Department of Defense, the Vanderbilt Vaccine Research Center has developed expertise in quickly isolating potentially useful antibodies in samples taken from infectious disease victims. This speciality is useful in developing vaccines but also in diagnostic tests and as monoclonal antibody drugs, which is where Vanderbilt’s COVID-19 antibodies appear to be primarily being used.(1)

MABs can be used to treat cases of COVID-19 infection, and even as a sort of short term vaccine (e.g. for healthcare workers). MABs are likely to be the first drugs that come on the market that are specifically designed to treat COVID-19.

Vanderbilt’s Vaccine Research Center, and its leadership, have relied on a decades of public money(2) to develop the Center’s antibody isolation capabilities. Going back to the 1990s, it received over US $100,000 a year from the US health ministry to isolate respiratory syncytial virus (RSV) antibodies. This was cranked up to US $400,000 a year in the early 2000s and then supplemented by another annual US $400,000 to work on fast ways to sort and exploit immune cells. In the early 2000s, an additional US $150-200,000 a year came in to specifically look at vaccinia virus antibodies.

In 2004, the US taxpayers gave Vanderbilt US $500,000 to install specialized cell sorting and processing equipment. At the same time, the Center’s vaccinia antibody funding was bumped up to between US $300,000 and $450,000 per year. Also in 2004, a new project on rotavirus antibodies came online. That one was worth US $377,000 a year. In 2005 a new project on metapneumovirus (MPV) came in with additional funding averaging another US $325,000 a year.

While the vaccinia project ended – temporarily – with a US $285,000 grant in 2006, Vanderbilt’s Vaccine Research Center marched through the mid-2000s collecting government checks to support its facilities and for the previously mentioned RSV, MPV, and rotavirus research.

An AIDS antibody project attracted funding beginning in 2008 with a US $620,000 annual grant, later upped to US $882,000, and the Vaccine Research Center entered the 2010s with RSV, HIV, and rotavirus antibody public funding from the US health ministry.

By 2010, the six-year old cell sorting machine installed in 2004 was considered outdated, so the US health ministry paid another US $500,000 for a new “Becton Dickinson custom multilaser LSRII flow cytometer”.

The AIDS antibody work eventually ended, but it was quickly replaced by other public funds. A grant worth over US $300,000 a year on dengue antibodies came in 2011 and, in the same year, on the heels of the 2009/2010 H1N1 influenza pandemic, Vanderbilt struck gold with nearly US $1.1 million per year to isolate influenza (and vaccinia) antibodies. In 2012, this was bumped up to US $1.7 million. A separate new project also on influenza added US $400,000 more.

In 2013 and 2014, an additional over US $200,000 a year came to isolate rift valley fever virus antibodies. Icing on cake was a separate public grant to pay US $100-200,000 a year for Phd students to work at the Center, and another grant to pay administrative expenses related to Vanderbilt’s coordination with other labs.

2016 was an even better year for public money. The Center first brought in a US $2.4 million annual grant for “structure based design of antibodies and vaccines.” Then came US $700,000 to isolate chikungunya virus antibodies and, with the Ebola outbreak in West Africa, more money to look for filovirus antibodies.

In 2017, a new US $2.6 million for influenza antibodies came along (reduced to US $1.3m in 2018) as well as additional funding to coordinate with other labs funded by the US biodefense program.

By the late 2010s, Vanderbilt’s center soldiered on with public funds to study zika, influenza, and chikungunya antibodies, along with core support for its facilities and coordination with other biodefense researchers. All of these grants, and the ones before, are public money given to Vanderbilt in order for it to develop its abilities to isolate and characterize infectious disease antibodies.

And that’s just the health ministry funding. In ways that are much harder to document, the US Department of Defense has also supported the Vaccine Research Center, particularly DARPA, the US Defense Advanced Research Projects Agency.

Along Comes COVID-19

The most important US defense ministry grant to Vanderbilt, for this COVID-19 story, came in January 2018, when DARPA signed a five year agreement with Vanderbilt that is “worth up to $28 million.” The rather ambitious goal of the project, called the “Pandemic Protection Platform program” (3) is “to develop protective antibody treatments that can be rushed to healthcare providers around the world within 60 days after the outbreak of viral disease.”

When COVID-19 came a little over two years later, Vanderbilt’s number was up. The emerging COVID-19 pandemic was precisely the scenario that DARPA was paying Vanderbilt to prepare for.

Vanderbilt did indeed rush to healthcare providers in early 2020, but it was not bringing antibody treatments. Rather, Vanderbilt was in a hurry to get tissue samples of COVID-19 victims, both because of the public health emergency and because it wanted to patent antibodies isolated from the samples before other research groups did.

One healthcare provider Vanderbilt tapped was the University of Nebraska, where a publicly funded national hospital quarantine ward,(4) specializing in treatment of unusual viruses, was among the first US hospitals to treat COVID-19 patients in February 2020. The first COVID-19 patient samples that Nebraska sent under a material transfer agreement (MTA) to anyone else was on 2 March. That shipment was to Vanderbilt.(5)(6) The Vanderbilt – Nebraska MTA specifically states that Vanderbilt work with the samples is under the DARPA Pandemic Protection Platform program.(7)

Once Vanderbilt acquired the samples from Nebraska and other healthcare providers, it used its skills and equipment – the fruit of decades of heavy public investment – to look for SARS-CoV-2 antibodies. Unsurprisingly, Vanderbilt did isolate antibodies that it and others believe may be effective in treating the pandemic disease.

Did Vanderbilt then rush to healthcare providers, or public agencies, around the world with those publicly-funded potential treatments, as Vanderbilt described the DARPA program? Did it offer the antibodies to the US government, which paid for their discovery, both directly and through decades of investment in developing Vanderbilt’s capabilities? Did Vanderbilt analyze how its publicly-funded antibodies might be produced through a public effort, to avoid high prices and intellectual property problems?

None of those possibilities seems to have been the case.

What Vanderbilt did do was to rush to file patent applications. A University article unashamedly crows about the “record breaking” speed with which Vanderbilt has been laying claim to antibodies and other COVID-related discoveries, proudly noting “the filing of 11 patent applications in record time.” (8) Success, for Vanderbilt, seems to be defined as rapid privatization of publicly funded discoveries that might help stop the pandemic.

Patent applications filed, Vanderbilt began peddling its antibodies to pharmaceutical multinationals and diagnostics companies. It found success. In April Vanderbilt quickly signed an evaluation deal and then, in June, an exclusive license for six antibodies to AstraZeneca, which will develop two of them as the company’s lead MAB cocktail drug.

Vanderbilt also licensed antibodies to Leinco Technologies, a maker of test kits and test kit ingredients. Finally, in a bit of self-dealing that is common at US research universities, it licensed other antibodies to a company named IDBiologics. It turns out that IDBiologics is a project of none other than James Crowe, the Director of the Vanderbilt Center for Vaccine Research.(9)

The terms of Vanderbilt’s licenses are confidential, but the University has said nothing to suggest that the deals were executed with anything less than Vanderbilt’s best efforts to maximize its financial benefits.

AstraZeneca and the Pandemic Protection Platform program

AstraZeneca too is part of the DARPA Pandemic Protection Platform, and the UK-based company has also benefitted from US public research money in relation to the COVID-19 MABs and their development.

Details about DARPA funding, however, are notoriously difficult to pin down and AstraZeneca has not publicly elaborated on its arrangements with the US defence agency. The Pandemic Protection Platform was initiated in 2018 and included AstraZeneca. The Platform was a five- year project, suggesting it will remain active at least until 2023. But despite having licensed the MABs from Vanderbilt, AstraZeneca now refers to its participation in the Pandemic Protection Platform in equivocal, past tense terms.

At the very least, AstraZeneca’s statements downplay the public investment. In relation to COVID-19 MABs generally, the company says that it is “using proprietary antibody discovery technology that was previously developed under an agreement with the US Defense Advanced Research Projects Agency (DARPA) as part of the Pandemic Preparedness Platform programme”. This may refer to a “technology investment agreement”, whose partial text is publicly available, that AstraZeneca entered into with DARPA in 2018,(10) though that agreement is only part of the story.

To launch trials of the Vanderbilt antibodies, AsrtaZeneca has received US $23.7 million from DARPA and BARDA, the US biodefence agency.(11) AstraZeneca does not itself appear to have made any announcement of this public support. But probably not coincidentally, Vanderbilt issued a press release announcing its antibody licenses to AstraZeneca on the same day that BARDA posted information on its website announcing the US $23.7m grant. Like AstraZeneca, Vanderbilt made no explicit reference to new funding from DARPA/BARDA to test the MABs when it announced their license agreement.

The timing would suggest that the two events – the grant and the license – are linked, and that either Vanderbilt or, more likely, AstraZeneca made signing the MAB deal contingent on still more money coming from the US government.

Auguring toward inefficiency and more expensive drugs

Vanderbilt’s MABs are shaping up to be a case of private hijacking of publicly funded research. And while AstraZeneca has not announced pricing for its candidate, MABs are a notoriously expensive type of drug and AstraZeneca has made no public commitments about prices (assuming the antibodies survive clinical trials). AstraZeneca has also exclusively licensed six antibodies from Vanderbilt yet is only developing two of them, opening questions about the others. Will they be fully evaluated? Is AstraZeneca trying to “catch and kill” the antibodies?

If Vanderbilt’s license to AstraZeneca has any special provisions for the public interest, or to ensure affordability and stimulate production at sufficient scale, the University has not mentioned them. If Vanderbilt officials have suffered any pangs of conscience about their rush to privatize COVID discoveries, they have not expressed as much either. To the contrary, Vanderbilt has released self-congratulatory press items about the speed and breadth of its COVID-19 intellectual property claims, (12) as if attacking the public interest was somehow laudable.

Plainly, Vanderbilt’s profit seeking and lower drug prices stand in direct opposition. The University has already been paid by the government. As the patent rights holder it might have leveraged its power in the public interest, but it does not appear to have done so. It instead appears as if the University counts collecting profits for itself as being equally or more virtuous than using its position to work for affordable delivery of publicly funded drug discoveries to COVID-19 victims.

The US government too has potential leverage over the Vanderbilt MABs due to the funding that it has provided both Vanderbilt and AstraZeneca. AstraZeneca’s technology investment agreement with DARPA (and perhaps other agreements) contains government “march in rights”, (13) and DARPA’s contracts with Vanderbilt may well also contain them. This leverage might be used in the public interest, however, the entwining of government and industrial interests in the US have made it quite rare for the US government to assert its interests in pharmaceutical inventions. With the nationalistic approach to COVID-19 taken by the Trump administration, in the unlikely event that US were to exert its patent powers at all, at present any such action would likely be for the benefit of the United States.

With billions of dollars of government investment – globally – flowing into COVID-19 vaccines and therapies, what might have instead happened with Vanderbilt’s antibodies is disheartening to contemplate. Rather than a license that places production and pricing decisions exclusively in AstraZeneca’s hands, making the antibodies and the cell culture inputs necessary to produce them available on a non-exclusive basis to many manufacturers would not cost the public significantly more than what it is already paying. After all, the US is already paying for testing and development – so why not make the benefits of that investment more broadly available? And if the antibodies are effective, this would stimulate lower cost production in more countries.

Which of the many COVID-19 MAB drugs under development proves to be most effective remains to be seen. Each company advancing its own candidate(s) without direct comparison at early stages is the present, inefficient, approach. If the Vanderbilt antibodies emerge from presently ongoing trials as being particularly effective, the course of action that the University has taken in licensing them exclusively to AstraZeneca will likely result in more expensive treatments and, quite possibly, lower availability.

For previous IP and COVID-19 Vaccines Series postings please see: https://twn.my/title2/briefing_papers/covid19_vaccines_series.htm


l. Monoclonal antibodies (MABs) that directly target COVID-19 are akin to a refinement of convalescent plasma therapy, the treatment wherein a recovered patient’s blood plasma is transfused to a current victim in the hopes that antibodies from the recovered person will help the current victim fight off the disease. In the case of MAB drugs, rather than the un-targeted approach of transferring whole plasma, which has thousands of components, a single antibody is produced (in steel or plastic containers by biotech means) and administered as a drug. The single antibody, which is sometimes used with one or more others in a MAB “cocktail”, has been selected as being one that is (hopefully) especially effective against the disease. These single antibodies, cocktails, and ways to formulate and administer them are typically covered by patents and other intellectual property (e.g. manufacturing trade secrets).
2. All of the funding figures in this section are drawn from a multiyear search for grants with James Crowe (Director of the Vaccine Research Center) as an investigator on NIH Reporter, the US National Institutes of Health funding reporting system, available at https://projectreporter.nih.gov/reporter.cfm
3. Confusingly, there are at least three different names used for this program. Vanderbilt refers to it as the “Pandemic Protection Platform”, whereas AstraZeneca calls it the “Pandemic Preparedness Platform”. DARPA itself refers to the effort as the “Pandemic Prevention Platform”.
4. See: https://www.unmc.edu/healthsecurity/education/capabilities/index.html
5. University of Nebraska MTA with Vanderbilt University, 2 March 2020. Variously noted with document numbers “MTS3255” and “MTA20247T”. Obtained under the Nebraska Public Records Law.
6. Four days later, on March 6th, Nebraska transferred COVID-19 patient samples to Mt. Sinai School of Medicine in New York, another university playing at the game of turning the pandemic into a commercial success. Notably, that MTA too establishes that Mt. Sinai’s collection of samples was under DARPA funding, through a program called “ECHO” (Epigenetic Characterization and Observation).
7. The author has sought additional early material transfer agreements for SARS-CoV-2 viruses and encountered stiff resistance from US public universities that want to keep their transfers of the virus a secret. The major US coronavirus research center at the University of North Carolina at Chapel Hill has denied access to all of its SARS-CoV-2 MTAs in their entirety, arguing that every bit of every MTA it has signed for COVID materials must be secret from the public because of the potential commercial value of research in progress. The University of Georgia answered a request for its SARS-CoV-2 MTAs by claiming that it is unable to find its own CoV-2 MTAs without manually reviewing every MTA executed across the entire university, including by unrelated programs like plant breeding and soil science, for the entire relevant time period. This grossly exaggerated and unnecessary review, Georgia insists, will require many hours of professional staff time, and those many hours must be paid for by the freedom of information requester. Of course, in reality, the University does not need to review MTAs from research that has nothing to do with COVID, but by insisting on the elaborate and overcomplicated procedure, it uses exorbitant fees as a way to stop transparency.
8. Vanderbilt Center for Technology Transfer & Commercialization 2020. Center for Technology Transfer & Commercialization breaks records in rapid facilitation of COVID-19 related agreements (press release). 9 July.
URL: https://news.vanderbilt.edu/2020/07/09/center-for-technology-transfer-commercialization-breaks-records-in-rapid-facilitation-of-covid-19-related-agreements/
9. See http://idbiologics.com/?page_id=385
10. Though marked “Proprietary & Confidential”, this contract can be downloaded from AstraZeneca’s website at: https://www.astrazeneca.com/content/dam/az/Government%20Contract
%20T%26Cs/Flowdown%20Requirements%20for%20Subcontracts.pdf

11. BARDA 2020. BARDA, DARPA, and AstraZeneca Collaborate to Develop a Novel COVID-19 Therapeutic (press release). 9 June. https://www.medicalcountermeasures.gov/newsroom/2020/astrazeneca/
12. Vanderbilt Center for Technology Transfer & Commercialization 2020.
13. The Bayh-Dole Act of 1980 awards title to inventions made with US federal government support allowing patent claims over inventions by recipients of public funding. It also provides federal agencies with “march-in rights” that allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants.” If the patent owner refuses to do so, the government may grant the license itself. This is a form of compulsory licensing, a feature of patent law.

 


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