Law The Battles Over The Intellectual Property Rights on COVID Vaccines

[method115]

I could have swore I read the opposite. I think I just misread the article. Good to hear they aren't trying to be involved in killing more people for big pharma.

 

[skysolo]

"Backing" and actually doing anything are two separate things.

 

[Stokanator]

Smart move, next time there’s a pandemic pharmaceutical companies will care less about making a vaccine since they’re not gonna get paid for it! Capitalism is the only reason this vaccine was fast tracked!

 

[Rational Poster]

Please. Like the deals that will be made won't benefit the pharmecuetical companies even more.

This was always going to be the public play. They may be evil, but they sure as shit ain't stupid. They are 3 steps ahead at all times and this is completely strategic on behalf of all parties involved.

Then why have they been distributing the vaccine at cost and why is it free for everyone?

 

[fedoriswar37]

Lol Sounds like lip service, looks like lip service . Likely lip service.

 

[forum poster]

Nice

 

[Ophydian]

Smart move, next time there’s a pandemic pharmaceutical companies will care less about making a vaccine since they’re not gonna get paid for it! Capitalism is the only reason this vaccine was fast tracked!

I’m not sure you are aware but Moderna had been working on the COVID vaccine for 8 years and it was in stage two trial in 2019. That isn’t fast tracked.

 

[fedoriswar37]

I’m not sure you are aware but Moderna had been working on the COVID vaccine for 8 years and it was in stage two trial in 2019. That isn’t fast tracked.

Lol its literally in there name. It's what they do

 

[Fluffernutter]

As the Executive Order been signed yet?

 

[Stokanator]

I’m not sure you are aware but Moderna had been working on the COVID vaccine for 8 years and it was in stage two trial in 2019. That isn’t fast tracked.

So all the talk from every single news agency about a push to create this vaccine in a “record pace” was all absolute garbage and this strand of COVID has been around for 8 years but only became a pandemic 14 month ago? Yeah that sounds right!?!?


Here is the information that highlighted every single important miles stone with the vaccine with nothing listed before January 2020

https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19

another one

https://news.ncsu.edu/2020/12/vaccine-manufacturing-q-and-a/

 

[Arkain2K]

Unsurprisingly, vaccine companies are pushing back as their stocks tanked.

 

[Arkain2K]

E.U is sorta on board, without Germany, the only E.U members who actually produced a functional vaccine in the BioNTech-Pfizer partnership.

 

[Damien Karras]

Smart move, next time there’s a pandemic pharmaceutical companies will care less about making a vaccine since they’re not gonna get paid for it! Capitalism is the only reason this vaccine was fast tracked!

I believe in the free market to solve this problem and so I actually agree with you. Although, it's not as if Pfizer, Moderna, and AstraZeneca haven't had their cut, but this news undercuts their anticipated profits. That said, Pfizer far exceeded their quarterly projections.

 

[Arkain2K]

Just in case anyone here are behind on the news, this is the real reason why India have a shortage, despite having the licenses to produce AstraZeneca, Johnson & Johnson, and Novavax locally, and it has nothing to do with patents.

Waving IP will do absolutely nothing in increasing their maxed-out capacity, since their government refused to invest in their own manufacturer when it mattered.

India vaccine shortage will last months because government failed to prepare for second wave
By Shweta Sharma | Mon, 3 May, 2021

Adar Poonawalla has said that production of Covid-19 vaccines for India will increase from July 2021 to about 100 million doses a month
​

The chief executive of India’s largest vaccine manufacturer has said the country will face a shortage until at least July because of the Modi government’s failure to prepare for the current second wave of the Covid-19 pandemic.

Despite its huge manufacturing capacity, India is facing a shortage of vaccines which has come in for criticism all the more as the country is simultaneously ravaged by a devastating Covid outbreak. The country has reported more than 300,000 cases a day for 10 days running, and is now the only country in the world to record more than 400,000 cases in a single day.

Adar Poonawalla, the chief executive of the Serum Institute of India (SII) which is manufacturing the Covid-19 vaccine developed by Astra Zeneca and the University of Oxford, told the FT they would increase the production of vaccines from the current rate of about 60 to 70 million doses a month to about 100 million by July.

SII, the world’s largest vaccine producer, was struggling to keep up with the domestic requirements for vaccines even before India opened its vaccination drive to all adults from 1 May, with widespread reports of vaccine centres running out long before the end of the day.

The country of over 1.3 billion people the world’s biggest vaccination drive in January 2021, but so far only 1.5 per cent of its population is fully vaccinated and only 10 per cent have received their first jab. The expansion of the vaccination drive to all adults needs 1.6 billion doses.

The shortage meant that only six states were able to expand their rollouts fully on 1 May, with several including Maharashtra and Delhi delaying the move until more vaccine stocks arrived.

The virulence of the second wave in India has also spiralled into an economic crisis, with more states going under lockdown posing a threat to the country’s growth that had only just started picking up in recent months. Experts believe that boosting the vaccination drive could offer the Indian economy a chance to bounce back.

Mr Poonawalla, who was facing severe criticism, recently left for London to join his wife and children following what he called the threats from politicians and “powerful men” demanding quick delivery of the Covid-19 vaccine, reported The Times.

He told the Financial Times that his company’s image was maligned by the Indian government over the shortage and price of vaccines while saying it is the government that is responsible for that and not the company.

Mr Poonawalla said SII was unable to ramp up production because “there were no orders” from the government, saying that he had been “victimised very fairly and wrongly” for what amounted to the Modi administration’s failure to prepare in January while case numbers were still low.

“Everybody really felt that India had started to turn the tide on the pandemic,” he said.

India ordered 21 million doses from the Serum Institute of India but did not indicate when it would buy more. The government abruptly added an order for 110 million doses in March when there was a sudden spike in cases, and in April offered SII a loan to boast production once case numbers were into the hundreds of thousands daily.

SII’s jabs have accounted for nearly 90 per cent of doses administered in the country, while homegrown vaccine maker Bharat Biotech accounts for the rest.

The Indian government had allocated £3.41bn in its national budget in January 2021 for the Covid-19 vaccination programme.

https://in.news.yahoo.com/news/india-vaccine-shortage-last-months-093702897.html

 

[Chest Rockwell]

Then why have they been distributing the vaccine at cost and why is it free for everyone?

Lolol. Because world governments literally paid for the R&D and then prepaid for their doses. Free for everyone. That's hilarious.

 

[Rational Poster]

Lolol. Because world governments literally paid for the R&D and then prepaid for their doses. Free for everyone. That's hilarious.

Is R&D normally free?

 

[Gandhi]

This smells like wrong headed malarkey. Someone needs to explain how waiving IP is going to fix India’s supply chain. I am all for throwing the kitchen sink in resources in getting this stuff to everyone, but we need to do it without the unintended consequences. If we want the IP waived then pay for it to be waived.

 

[Curmudgeon]

And now it's here.

It sure is.

 

[Arkain2K]

Waiver of patent rights on Covid-19 vaccines, in near term, may be more symbolic than substantive
By Damian Garde , Helen Branswell , and Matthew Herper | May 6, 2021

The U.S.’s stunning endorsement of a proposal to waive Covid-19 vaccine patents has won plaudits for President Biden and roiled the global pharmaceutical industry. But, at least in the short term, it’s likely to be more of a symbolic milestone than a turning point in the pandemic.

For months, proponents of the proposal have argued that the need to waive intellectual property protections was urgent given the growth of Covid cases in low- and middle-income countries, which have been largely left without the huge shipments of vaccine already purchased by wealthy countries. But patents alone don’t magically produce vaccines.

Experts suggested the earliest the world could expect to see additional capacity flowing from the waiver — if it’s approved at the World Trade Organization — would be in 2022.

Prashant Yadav, a supply chain expert and senior fellow at the Center for Global Development, said the biggest barrier to increasing the global vaccine supply is a lack of raw materials and facilities that manufacture the billions of doses the world needs. Temporarily suspending some intellectual property, as the U.S. proposes to do, would have little effect on those problems, he said.

“My take is: By itself, it will not get us much benefit in increased manufacturing capacity,” Yadav said. “But as part of a larger package, it can.”

That larger package would include wealthy nations like the U.S. mounting an Operation Warp Speed-style effort to invest in manufacturing in low-income countries, he said, using their vast financial resources to actually produce vaccine doses rather than solely targeting patents.

Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown Law, said the waiver is necessary but hardly sufficient. It will likely take months of international infighting before the proposal would take effect, he said, months during which would-be manufacturers would not have the right to start producing vaccines.

“We’re not talking about any immediate help for India or Latin America or other countries going through an enormous spread of the virus,” Gostin said. “While they’re going to be negotiating the text, the virus will be mutating.”

Even James Love, director of the nonprofit Knowledge Ecology International and a longtime advocate of intellectual property reform, acknowledges a patent waiver would be a valuable first step, not a panacea. The fairly narrow proposal would mostly allow countries to issue compulsory licenses, essentially allowing third-party manufacturers to make and sell other companies’ patented products, while also helping free up some information about how that manufacturing is done. But that, at least, could provide a financial incentive for those third parties to invest in vaccine production.

“In our experience, when the legal barriers disappear and there’s a market, capacity increases faster than you would think,” he said.

In October, Moderna vowed not to enforce its Covid-19-related patents for the duration of the pandemic, opening the door for manufacturers that might want to copy its vaccine. But to date, it’s unclear whether anyone has, despite the vaccine’s demonstrated efficacy and the worldwide demand for doses.

That underscores the drug industry’s case that patents are just one facet of the complex process of producing vaccines.

“There are currently no generic vaccines primarily because there are hundreds of process steps involved in the manufacturing of vaccines, and thousands of check points for testing to assure the quality and consistency of manufacturing. One may transfer the IP, but the transfer of skills is not that simple,” said Norman Baylor, who formerly headed the Food and Drug Administration’s Office of Vaccines Research and Review, and who is now president of Biologics Consulting.

While there are factories around the world that can reliably produce generic Lipitor, vaccines like the ones from Pfizer and Moderna — using messenger RNA technology — require skilled expertise that even existing manufacturers are having trouble sourcing.

“In such a setting, imagining that someone will have staff who can create a new site or refurbish or reconfigure an existing site to make mRNA [vaccine] is highly, highly unlikely,” Yadav said.

There are already huge constraints on some of the raw materials and equipment used to make vaccines. Pfizer, for instance, had to appeal to the Biden administration to use the Defense Production Act to help it cut the line for in-demand materials necessary for manufacturing.

Rajeev Venkayya, head of Takeda Vaccines — which is not producing its own Covid vaccine but is helping to make vaccine for Novavax — said supply shortages are impacting not just Covid vaccine production but the manufacture of other vaccines and biological products as well.

“This is an industry-wide … looming crisis that will not at all be solved by more tech transfers,” Venkayya said.

He suggested many of the people advocating for this move are viewing the issue through the prism of drug development, where lifting intellectual property restrictions can lead to an influx of successful generic manufacturing.

“I think in this area there is an unrecognized gap in understanding of the complexities of vaccine manufacturing by many of the ‘experts’ that are discussing it,” said Venkayya, who stressed that while he believes they have good intentions, “nearly all of the people who are providing views on the value of removing patent protections have zero experience in vaccine development and manufacturing.”

As Michelle McMurry-Heath, CEO of the trade group BIO, put it in a statement, “handing needy countries a recipe book without the ingredients, safeguards, and sizable workforce needed will not help people waiting for the vaccine.”

Conversely, the drug industry claims that waiving patents, even temporarily, risks irreparable damage to the system of incentives that made the rapid development of Covid-19 vaccines possible. Stephen Ubl, CEO of the powerful lobbying group PhRMA, said in a statement that the idea “flies in the face of President Biden’s stated policy of building up American infrastructure and creating jobs by handing over American innovations to countries looking to undermine our leadership in biomedical discovery.”

Umer Raffat, an equities analyst who tracks pharmaceuticals at Evercore ISI, thinks the risks to the drug industry might be overstated. It’s highly doubtful a patent waiver would set a precedent beyond vaccines, Raffat wrote in a note to investors, and the scarcity of raw materials combined with complexity of modern pharmaceutical manufacturing makes it unlikely that any third party could meaningfully compete with a multinational drug company.

But the decision could nonetheless be a sea change for the way governments think about intellectual property — a hole in the IP dam that unleashes a tidal wave.

Love, of Knowledge Ecology, said that the decision shifts the discussion around pandemic vaccines from countries believing there is nothing that can be done to a new position: “What do we need to do?” Said Love: “If you really think this is a big emergency, ‘what do we need to do’ should be the question, not just saying we can’t do anything.”

That could, in turn, have long-term impacts on how countries view pharmaceutical intellectual property — and how much protection drug makers are provided on their own patents.

https://www.statnews.com/2021/05/06...r-term-may-be-more-symbolic-than-substantive/

 

[terrapin]

So many of the vaccines R&D was funded by the government anyways the companies shouldn’t be profiting off it too much to begin with

this.

the longer we wait and let poor countries go unvaccinated the more likely it is that the virus mutates into other forms that the present vaccines do not work against.

profit motive is absurd and immoral in this case.