Law The Battles Over The Intellectual Property Rights on COVID Vaccines

Unsure vaccine waiver will help, some leaders urge for more exports
NICOLE WINFIELD and JAMEY KEATEN, Associated Press​

GENEVA (AP) — European leaders voiced increasing skepticism Friday that a U.S. proposal to lift patent protections on COVID-19 vaccines would solve the problem of getting shots into the arms of people in poorer countries, with some instead calling for more exports of the doses already being produced.

While activists and humanitarian groups have cheered the Biden administration’s decision and urged others to follow suit, European Union leaders are hammering home the message that any benefit from a temporary waiver of intellectual property protections would be long in coming. Instead, they’ve taken the U.S., in particular, to task for not sharing more vaccines with the rest of the world.

“You can give the intellectual property to laboratories that do not know how to produce it. They won’t produce it tomorrow,” said French President Emmanuel Macron at a summit in Portugal, even though he has also said he would agree to waive the protections.

EU officials insist rewriting rules in the World Trade Organization could take months or even a year, and say they’ve found few examples — if any — that intellectual property issues are what’s holding up the rollout of vaccines.

Supporters of a patent waiver have argued it would allow more factories around the world to produce the shots, increasing the supply, especially in poorer countries. The decision ultimately is up to the 164-member WTO, and if just one country votes against a waiver, the idea will fail.

Macron said the key issues are really donations and exports — an argument also made by the pharmaceutical industry — and he said the United States should do more on that front.

The U.S. does not have an export ban on vaccines nor does it prohibit the export of ingredients for the shots. But the federal government controls hundreds of millions of doses manufactured in the country under the terms of its contracts with drug makers, and is first in line for some raw materials produced by U.S. suppliers.

The U.S. has sent Canada and Mexico about 4 million doses from its stockpile of vaccines from AstraZeneca — which hasn’t yet applied for authorization in the U.S. — and it plans to begin exporting as many as 60 million doses in coming months. Last week, the U.S. also redirected some raw materials used for AstraZeneca to India as part of its relief efforts for the hard-hit country.

Macron boasted, however, that almost half of the doses produced on in the European Union — or about 200 million — have been allowed to be exported.

“We are the most generous in the world of developed nations,” he said.

White House press secretary Jen Psaki told reporters Friday that the U.S. is going to “work with international partners, with the pharmaceutical companies to up the supply, to get as much supply out to the global community as possible.”

WTO Director-General Ngozi Okonjo-Iweala echoed some of the sentiments expressed by European leaders at a virtual conference Friday, noting that lifting patent protections could help expand fair access to vaccines but might not be the most “critical issue” in expanding vaccine production.

Other key steps include reducing restrictions on the export both of vaccines and the ingredients needed to make them, sharing the know-how behind the shots, training manufacturing personnel and increasing manufacturing capacity globally.

Meanwhile, Germany, a research powerhouse with strong biotech and pharmaceutical sectors, spoke out against waiving the protections — and also urged more exports.

“The main issue is not the question of patents. The main issue is the question of production capacity,” German Health Minister Jens Spahn said, noting that producing vaccines like one developed by German firm BioNTech — and manufactured with Pfizer —is very complicated.

Instead, he stressed that developed countries whose vaccination campaigns are going well should export more shots.

“We’ll be exporting a lot more,” he said. “I can only welcome if the United States change their policy and make vaccination doses available for other countries.”

Fatima Hassan, a human rights lawyer and director of the Health Justice Initiative in South Africa, welcomed the Biden administration’s announcement but said it’s “eight months too late.”

“We can’t basically wait for months for this waiver to be finalized,” she said. Hassan said the countries that have “overordered” vaccines are “ironically blocking the waiver and the ability of people in low income parts of the world to access the vaccines.”
https://www.krqe.com/health/wto-chief-vaccine-waiver-helpful-not-key-for-virus-fight/
 
Seems like a dumb idea. It's not like you're going to give these non-vaccine producing labs the rights and they're immediately going to jump into effective production.

Give more resources to those who already know how to produce the vaccine and increase vaccine sharing. India was very generous with sharing vaccines when they were doing well. Now that they need help, the world says "best of luck with that".
 
It would seem the reason this vaccination got out so quickly, was a huge pot of gold at the end of the rainbow.
if you take away that pot of gold, good luck getting them do that again, if needed.

Also, the race between the companies to be first. That competition is what drove the incredible development pace.

It’s unreal how people don’t understand this concept.

How many of these companies tried and failed? There were quite a few globally. No one is compensating them...

When there’s a reward at the finish line, the cream of the crop will rise to the top. Take that away and we’d be lucky to see a vaccine in another couple of years... if ever.
 
EU Tepid on Biden Call to Waive Intellectual Property Rights for Covid-19 Vaccines
Bloc says exporting more doses would aid struggling nations faster

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European Union leaders pushed back against President Biden’s call to waive intellectual property rights for Covid-19 vaccines, saying exporting more shots would be a faster way to help poor countries struggling to contain the virus.

The EU is ready to discuss the U.S. stance, which the Biden administration voiced earlier this week, when there is a concrete proposal, European Council President Charles Michel said at a summit in Portugal on Saturday.

“We don’t think in the short term that it’s the magic bullet,” Mr. Michel said of the proposal to lift patent protections, which could enable companies in developing countries and others to manufacture their own versions of Covid-19 vaccines.

German Chancellor Angela Merkel also rejected the idea of waiving Covid vaccine patents. She said a waiver wouldn’t make more vaccine doses available and countries should protect “the power of innovation” and patent protections. Germany is home to BioNTech SE, which co-developed a vaccine with Pfizer Inc., and CureVac NV, which is running clinical trials for a Covid vaccine.

The Biden administration’s embrace of the waiver sent the EU scrambling to explain its plans to help poor countries when the U.S. and Europe are quickly vaccinating their populations. The more the virus spreads, the more likely it is to mutate into a vaccine-resistant strain.

To help countries like India facing a surge in infections and deaths, richer countries should concentrate on increasing vaccine production around the world in facilities already making the vaccine, EU leaders said. Rich countries should also export more vaccine doses, Ms. Merkel and other EU leaders said.

The EU has exported more than 200 million vaccine doses, the same amount that has have been delivered to Europeans, EU Commission President Ursula von der Leyen said this week. The U.S. government has used the Defense Production Act to force private companies to first honor contracts with the government before they meet orders from other companies or countries. The U.S. has stockpiled millions of doses of the AstraZeneca vaccine even though the shot isn’t approved for use in the country. On April 26, the Biden administration said it would share as many as 60 million AstraZeneca doses with the rest of the world.

Late last year, India and South Africa proposed waiving patents for Covid-19 vaccines, treatments and diagnostics. More than 100 countries have supported the proposal, with the U.S. joining the chorus this week.

Even with the U.S. support, challenges remain before the patent waiver could significantly increase vaccine production. It might take several months to define the details of any plan, with potential sticking points including how drugmakers would transfer technical know-how to manufacturers without vaccine expertise. Six months could pass before plants produce their first doses of a vaccine, according to some public health experts.

Production could also be hampered by the need to fund new machinery and adapt the production process, according to some Covid vaccine manufacturers that have opposed the waiver idea.

https://www.wsj.com/articles/eu-tep...erty-rights-for-covid-19-vaccines-11620495143
 
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For a third consecutive day, the number of new coronavirus cases in India has topped 400,000. India, South Africa and the World Health Organization are now calling on the World Trade Organization to waive the patents to vaccines to allow wider access to produce them. Pharmaceutical companies and some health officials oppose the idea, however President Biden and the majority of Democrats support it. NBC’s Joshua Johnson spoke with Congresswoman Jan Schakowsky (D-IL) about why she believes it’s the right course of action.
 
The proper way: training a local partner how to make the stuff and provide them the means to do so.

BioNTech plans to expand mRNA vaccine production into Africa


BioNTech announced this week that it plans to establish mRNA vaccine production facilities in Africa, according to the Financial Times.

Why it matters: The blockbuster success of mRNA vaccines for the COVID-19 pandemic could give a boost to efforts to use the adaptable technology to tackle cancers, malaria and other intractable illnesses, as Axios has previously reported.

  • Africa has long been neglected by pharmaceutical companies, and establishing mRNA production capabilities could greatly improve the continent's prospects of combatting diseases — COVID-19 and beyond.
Context: The announcement — made jointly between BioNTech co-founder and chief executive Uğur Şahin and European Commission President Ursula von der Leyen — comes as countries in Africa have struggled to keep pace with wealthier nations in vaccinating their citizens against COVID-19.

  • The total number of COVID-19 vaccinations completed in Africa — about 39 million — accounts for just over 2% of global vaccinations, according to FT.
  • Additionally, Africa imports more than 99% of the vaccines it uses.
Details: Though still in its early stages, experts are optimistic that vaccines and therapies based on mRNA hold promise to combat infections from viruses like HIV and influenza that other vaccines have struggled to quash, according to Axios' Alison Snyder.

  • BioNTech's push to establish capacity in Africa for the early, highly technical stages of mRNA manufacturing could take about four years to complete, according to Şahin.
  • In the short term, BioNTech is planning to train a partner in Africa to "fill and finish" vaccine doses in approximately 12 months, allowing the continent to import large quantities of vaccines more efficiently, Şahin says.
What they're saying: "From the technology side, there is no reason why [vaccine production in Africa] should not be possible," Şahin told FT. “We are joining forces in a way that everyone brings in the best competences they have.”

https://www.axios.com/biontech-mrna-africa-manufacturing-a5343a1d-ba9f-4ff1-aed5-d72d74497701.html
 
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Africa seeks EU help on global vaccine-waiver
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African countries are seeking EU help on waiving vaccine patents to combat the pandemic at an upcoming meeting in Rwanda.

"The AU reiterated its support for the Trips Waiver and urged the EU to engage constructively towards conclusion of a targeted and time-limited Trips Waiver which is critical to a WTO [World Health Organisation] response to the Covid-19 pandemic," the African Union (AU) is keen to say in a joint communiqué after European and African foreign ministers meet in Kigali on 25 October, according to a draft, dated 13 October, seen by EUobserver.

Trips stands for "trade-related aspects of intellectual-property rights".

A WTO ministerial meeting in November is to decide whether to waive these for vaccines, tests, and other Covid-related medical devices so long as the pandemic lasts.

Fewer than 5 percent of people in Africa have been fully vaccinated, compared to over 70 percent in wealthy EU states.

And the imbalance posed a global danger, because novel Covid variants more easily emerged in low-vaccine regions.

But the EU Commission supported "compulsory licencing" instead of a WTO waiver, Antonio Fernandez-Martos, an EU trade official, told MPs in Brussels on Thursday (14 October).

"This is what can actually deliver increased manufacturing," he said.

Belgium, Denmark, Finland, Germany, Ireland, and the Netherlands were also trying to scupper the WTO-waiver move, according to the Geneva-based medical charity Médecins sans frontières (MSF).

"Even though France, Greece, Italy, and Spain have already come out in support of the waiver, another handful of governments in the EU with strong ties to pharmaceutical corporations is choosing to put shareholder interests over the lives of people across the globe," MSF said this week.

The AU's appeal was in the draft Kigali declaration in square brackets, meaning it might well be cut from the text.

Meanwhile, the EU wanted to say merely the WTO should do its best to help "including through trade-related aspects of intellectual property".

https://euobserver.com/world/153237
 
Moderna to build $500m vaccine manufacturing facility in Africa
By Darcy Jimenez | 07 Oct 2021​

Moderna plans to invest $500m to build a state-of-the-art mRNA facility in Africa, capable of producing up to 500 million doses of vaccines in the continent each year.

The biotech is yet to select a country and site for the factory, but says it is expected to include drug substance manufacturing for its Covid-19 and other mRNA vaccines, with the opportunity for bottling and packaging capabilities on-site.

The announcement comes amid a fierce patent waiver debate between pharma companies, governments, and charities. The World Health Organization (WHO) and rights groups like Amnesty have said vaccine makers should share doses and technology with low-income countries, which have received disproportionately low supplies of Covid-19 vaccines compared to wealthier nations.

The world’s leading Covid-19 jab manufacturers, including Moderna, have so far refused to transfer their vaccine know-how into WHO’s Covid-19 technology access pool – and are staunchly opposed to a patent waiver that would allow vaccine makers in poorer countries to domestically produce approved Covid-19 jabs.

The pharma industry has argued that waiving intellectual property rights would remove the incentive for drugmakers to innovate. Some companies have also insisted that the technology needed to produce their vaccines is too complex to simply transfer over to other manufacturers.

Commenting on the proposed facility, Moderna CEO Stephane Bancel said the company is “determined to extend Moderna’s societal impact” through its investment in the African vaccine manufacturing plant.

“While we are still working to increase capacity in our current network to deliver vaccines for the ongoing pandemic in 2022, we believe it is important to invest in the future,” he added.

“We expect to manufacture our Covid-19 vaccine as well as additional products within our mRNA vaccine portfolio at this facility.”

https://www.pharmaceutical-technology.com/news/moderna-build-vaccine-manufacturing-facility-africa/
 
Medical Aid Groups Welcome Plans by Moderna to Build Plant in Africa
By Victoria Amunga | October 12, 2021​

Medical aid groups are welcoming plans by U.S. drug maker Moderna to build a plant for manufacturing vaccines in Africa. The groups say the plant, the first from a company making a COVID-19 vaccine, will help in fighting vaccine inequality.

African countries are facing a shortfall of nearly 500 million COVID-19 vaccines according to the World Health Organization.

The shortage has left most countries unable to vaccinate even the most vulnerable 10 percent of their populations.

Last week, U.S. drug maker Moderna announced plans to build a plant on the African continent. Its statement is raising hope Africa will have a sufficient supply of COVID-19 vaccines in the future.

Medical aid groups say although the plan will boost Africa’s vaccine manufacturing capacity, the continent still needs an immediate solution to shortages. Dr. Githinji Gitahi is the chief executive officer at Amref Health Africa.

"As significant as it is because of the high financial commitment of 500 million dollars, there are several other factors to consider," said Gitahi. "One, that factory will not be a solution to the current challenge of vaccine access in Africa. If the factory is going to be ready in 2-4 years Africa wants to vaccinate at least 70% of its population by the end of June next year. Therefore, Africa still demands the most important step in redistribution of doses earmarked for rich countries to come into Africa."

Although Moderna has yet to say where it will build the factory, at least 10 countries, among them Kenya, Morocco, South Africa and Senegal, have expressed an interest in hosting the facility.

Dr. Willis Akhwale, the chairman of Kenya's vaccination task force, says Moderna will need to look at the project as a partnership with the host country.

"If Moderna is coming to open, they should come with an open mind that they are bringing technological transfer, not just setting up a factory," said Akhwale. "Therefore, they need to transfer that technology to the host country. The other thing is capacity building of the local people beyond just the COVID-19 vaccine towards the whole human vaccine manufacturing.”

The Africa Centers for Disease Control and Prevention welcomes the idea of manufacturing the COVID-19 vaccine on the continent.

Dr. Bernhards Ogutu, chief research officer at the center's office in Kenya, says although the process is likely to take a long time, it's a promising sign for making health care more available in Africa.

"If we really want health care affordable and accessible to all, then we must start doing a lot of production of health commodities in the region," he said.

By September, an estimated 5.2 billion COVID vaccine doses had been administered globally but only 2 percent of those were in Africa. African medical groups say they hope that the manufacturing of such vaccines on the continent will prevent such unequal distribution in the future.

https://www.voanews.com/a/medical-a...moderna-to-build-plant-in-africa/6267639.html
 
Moderna announced last October that they wouldn't enforce their COVID vaccine patents during the duration of the pandemic, which is propably the reason why South Africa will try to copy their mRNA vaccine rather than Pfizer-BioNTech's.

South Africa will try to replicate Moderna's mRNA vaccine, with backing from the WHO

By LORI HINNANT, MARIA CHENG and ANDREW MELDRUM | October 24, 2021

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A sign hangs at an Afrigen Biologics and Vaccines facility in Cape Town, South Africa, Tuesday, Oct. 19, 2021. A team of Afrigen scientists is assembling the equipment needed to reverse engineer Moderna's coronavirus vaccine

CAPE TOWN, South Africa (AP) — In a pair of Cape Town warehouses converted into a maze of airlocked sterile rooms, young scientists are assembling and calibrating the equipment needed to reverse engineer a coronavirus vaccine that has yet to reach South Africa and most of the world’s poorest people.

The energy in the gleaming labs matches the urgency of their mission to narrow vaccine disparities. By working to replicate Moderna’s COVID-19 shot, the scientists are effectively making an end run around an industry that has vastly prioritized rich countries over poor in both sales and manufacturing.

And they are doing it with unusual backing from the World Health Organization, which is coordinating a vaccine research, training and production hub in South Africa along with a related supply chain for critical raw materials. It’s a last-resort effort to make doses for people going without, and the intellectual property implications are still murky.

“We are doing this for Africa at this moment, and that drives us,” said Emile Hendricks, a 22-year-old biotechnologist for Afrigen Biologics and Vaccines, the company trying to reproduce the Moderna shot. “We can no longer rely on these big superpowers to come in and save us.”

Some experts see reverse engineering — recreating vaccines from fragments of publicly available information — as one of the few remaining ways to redress the power imbalances of the pandemic. Only 0.7% of vaccines have gone to low-income countries so far, while nearly half have gone to wealthy countries, according to an analysis by the People’s Vaccine Alliance.

That WHO, which relies upon the goodwill of wealthy countries and the pharmaceutical industry for its continued existence, is leading the attempt to reproduce a proprietary vaccine demonstrates the depths of the supply disparities.

The U.N.-backed effort to even out global vaccine distribution, known as COVAX, has failed to alleviate dire shortages in poor countries. Donated doses are coming in at a fraction of what is needed to fill the gap. Meanwhile, pressure for drug companies to share, including Biden administration demands on Moderna, has led nowhere.

Until now, WHO has never directly taken part in replicating a novel vaccine for current global use over the objections of the original developers. The Cape Town hub is intended to expand access to the novel messenger RNA technology that Moderna, as well as Pfizer and German partner BioNTech, used in their vaccines.

“This is the first time we’re doing it to this level, because of the urgency and also because of the novelty of this technology,” said Martin Friede, a WHO vaccine research coordinator who is helping direct the hub.

Dr. Tom Frieden, the former head of the U.S. Centers for Disease Control and Prevention, has described the world as “being held hostage” by Moderna and Pfizer, whose vaccines are considered the most effective against COVID-19. The novel mRNA process uses the genetic code for the spike protein of the coronavirus and is thought to trigger a better immune response than traditional vaccines.

Moderna has pledged to build a vaccine factory in Africa at some point in the future. But after pleading with drugmakers to share their recipes, raw materials and technological know-how, some poorer countries are done waiting.

Afrigen Managing Director Petro Terblanche said the Cape Town company is aiming to have a version of the Moderna vaccine ready for testing in people within a year and scaled up for commercial production not long after.

“We have a lot of competition coming from Big Pharma. They don’t want to see us succeed,” Terblanche said. “They are already starting to say that we don’t have the capability to do this. We are going to show them.”

If the team in South Africa succeeds in making a version of Moderna’s vaccine, the information will be publicly released for use by others, Terblanche said. Such sharing is closer to an approach U.S. President Joe Biden championed in the spring and the pharmaceutical industry strongly opposes.

Commercial production is the point at which intellectual property could become an issue. Moderna has said it would not pursue legal action against a company for infringing on its vaccine rights, but neither has it offered to help companies that have volunteered to make its mRNA shot.

Chairman Noubar Afeyan said Moderna determined it would be better to expand production itself than to share technology and plans to deliver billions of additional doses next year.

“Within the next six to nine months, the most reliable way to make high-quality vaccines and in an efficient way is going to be if we make them,” Afeyan said.

Zoltan Kis, an expert in messenger RNA vaccines at Britain’s University of Sheffield, said reproducing Moderna’s vaccine is “doable” but the task would be far easier if the company shared its expertise. Kis estimated the process involves fewer than a dozen major steps. But certain procedures are tricky, such as sealing the fragile messenger RNA in lipid nanoparticles, he said.

“It’s like a very complicated cooking recipe,” he said. “Having the recipe would be very, very helpful, and it would also help if someone could show you how to do it.”

A U.N.-backed public health organization still hopes to persuade Moderna that its approach to providing vaccines for poorer countries misses the mark. Formed in 2010, the Medicines Patent Pool initially focused on convincing pharmaceutical companies to share patents for AIDS drugs.

“It’s not about outsiders helping Africa,” Executive Director Charles Gore said of the South Africa vaccine hub. “Africa wants to be empowered, and that’s what this is about.”

It will eventually fall to Gore to try to resolve the intellectual property question. Work to recreate Moderna’s COVID-19 vaccine is protected as research, so a potential dispute would surround steps to sell a replicated version commercially, he said.

“It’s about persuading Moderna to work with us rather than using other methods,” Gore said.

He said the Medicines Patent Pool repeatedly tried but failed to convince Pfizer and BioNTech to even discuss sharing their formulas.

Back in Cape Town, the promise of using mRNA technology against other diseases motivates the young scientists.

“The excitement is around learning how we harness mRNA technology to develop a COVID-19 vaccine,” Caryn Fenner, Afrigen’s technical director, said. But more important, Fenner said, “is not only using the mRNA platform for COVID, but for beyond COVID.”

https://apnews.com/article/coronavi...-town-health-48046e5255cc3e4fa27455fc12ab5e52
 
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BioNTech to work with Senegal and Rwanda to make mRNA vaccines
By CARLEY PETESCH | October 26, 2021

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DAKAR, Senegal (AP) — Senegal and Rwanda have signed an agreement with German company BioNTech for the construction of its first start-to-finish factories to make messenger RNA vaccines in Africa.

BioNTech, which developed the Pfizer-BioNTech COVID-19 vaccine, said Tuesday that construction will start in mid-2022. It is working with the Institut Pasteur in Dakar, Senegal’s capital, and the Rwandan government, a statement said.

“State-of-the-art facilities like this will be life-savers and game-changers for Africa and could lead to millions of cutting-edge vaccines being made for Africans, by Africans in Africa,” said Matshidiso Moeti, the World Health Organization’s Regional Director for Africa. “This is also crucial for transferring knowledge and know-how, bringing in new jobs and skills and ultimately strengthening Africa’s health security.”

Ugur Sahin, the co-founder and CEO of BioNTech, said its goal is “to develop vaccines in the African Union and to establish sustainable vaccine production capabilities to jointly improve medical care in Africa.”

BioNTech had already agreed in August to work with Rwanda and Senegal to establish facilities in Africa capable of end-to-end manufacturing of mRNA-based vaccines, under license.

The novel mRNA process uses the genetic code for the spike protein of the coronavirus and is thought to trigger a better immune response than traditional vaccines. Scientists hope the technology, which is easier to scale up than traditional vaccine methods, might ultimately be used to make vaccines against other diseases, including malaria.

BioNTech said the facility in Africa will eventually produce about 50 million doses of the vaccine per year, with the capacity to increase.

BioNTech also said it is in discussions for expanding its partnership with the South African vaccine manufacturer Biovac, which is based in Cape Town. Biovac will assemble the vaccine using ingredients provided by BioNTech, a process called fill and finish. That production will begin in 2022 with a goal of reaching more than 100 million finished doses annually.

In July, Senegal had announced that the Institut Pasteur would manage a new manufacturing hub to produce vaccines including for COVID-19. The hub was estimated to cost $200 million and would be financed partly by funds from European and U.S. governments and institutions.

These vaccine manufacturing hubs in Africa will help reduce its dependence on imports, as the continent currently relies on imports for about 99% of its vaccine needs, according to the WHO. Africa and its 1.3 billion people remain the least-vaccinated region of the world against COVID-19, with just over 5% fully vaccinated, according to the Africa Centers for Disease Control and Prevention.
https://apnews.com/article/coronavi...irus-vaccine-f800599b45c433f09a03bdd625c46ddb
 
Moderna backs down in its vaccine patent fight with the National Institutes of Health
The dispute was over who deserves credit for inventing the central component of the company’s Covid vaccine.
By Rebecca Robbins and Sheryl Gay Stolberg | Dec. 17, 2021



Moderna has backed down in a bitter dispute with the government over who deserves credit for a crucial component of its coronavirus shot, in a case that has major implications for the vaccine’s future distribution and Moderna’s future profits.

Moderna has decided for now not to take the final step in securing a patent — making the payment that would allow it to be issued — because doing so “could interfere with further discussions aimed at an amicable resolution” with the National Institutes of Health, Colleen Hussey, a spokeswoman for Moderna, said on Friday.

She said the company also wanted to “avoid any distraction” to ongoing collaborations as it races to determine whether it will need to modify its shot or take other steps to fight the fast-spreading Omicron variant.

Moderna, whose vaccine grew out of a four-year partnership with the National Institutes of Health, maintains its position that its scientists alone deserve credit for the genetic sequence at the heart of the vaccine, but “acknowledges that N.I.H. feels equally strongly” that its scientists should be named as co-inventors, Ms. Hussey said.

Ms. Hussey said the company had informed the N.I.H. a week ago of its decision to back down in the dispute. The Washington Post earlier reported Moderna’s decision.

Moderna could still secure the intellectual property claims it was seeking. The company has filed an application that would allow it to do so later, Ms. Hussey said.

The company had been seeking to patent the genetic sequence that instructs the body’s cells to make a harmless version of the spike proteins that stud the coronavirus’s surface, prompting a powerful immune response.

If the N.I.H. scientists were credited on the patent, the government could, in theory, have more of a say in which companies manufacture the vaccine. The federal treasury could also bring in revenue from licensing out the patent.

Moderna had only named several of its own scientists as the co-inventors of the sequence — even though company scientists worked closely with N.I.H. researchers in the earliest days of the pandemic, racing to identify the gene for the virus’s spike protein that would offer a blueprint for designing a vaccine.

Moderna has also received $1.4 billion from the federal government to develop and test its vaccine and another $8.1 billion to provide the country with 500 million doses.

The N.I.H. has said three scientists at its Vaccine Research Center — Dr. John R. Mascola, the center’s director; Dr. Barney S. Graham, who retired this year; and Dr. Kizzmekia S. Corbett, who is now at Harvard — should be named as co-inventors on the disputed patent.

Dr. Anthony S. Fauci, who oversees the vaccine researchers as the director of the National Institute of Allergy and Infectious Diseases, declined to comment.

Zain Rizvi, the research director at the advocacy group Public Citizen, who has been researching the patent dispute, called on the Biden administration to press Moderna to share its technology with other manufacturers, and to prioritize deliveries to developing countries.

“Confronted with relentless public pressure, Moderna appears to be trying to defuse the situation,” Mr. Rizvi said. “But it still refuses to call the vaccine what it is: the N.I.H.-Moderna vaccine.”

https://www.nytimes.com/2021/12/17/us/moderna-patent-nih.html
 
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