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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.

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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.”

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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.

An earlier version of this story stated that no company has tried to develop Moderna’s Covid-19 vaccine since the Massachusetts-based company vowed not to enforce its related patents for the duration of the pandemic. It’s not publicly known whether that’s the case.

  • Even IF “needy” countries could actually produce the vaccines properly and without contamination etc: what Biden is proposing would cause an immense and debilitating rat-race for supplies – ingredients and containers alike – that would grind actual vaccine production to a dead-stop. It would be the very worst and most counter-productive move. What must happen instead is full supply support for the companies making the vaccines in the safe havens where they operate under strict quality controls. And richer nations can fund the purchase and distribution to the needy nations – in order to end this pandemic.

  • The notion that the “needy” / “poor” countries can actually manufacture completely new-technology vaccines correctly and safely is a pipe-dream. These countries are poor because of a whole lot of issues, such as safety, hygiene, and also corruption, power-struggles (wars, in some), discrimination between religions, tribes, genders, etc. Giving those governments the formula (that they likely can not properly process) leads to augmentation of their problems, as distribution / use of the products would more than likely not be fair. It is far more logical that nations without such (humanitarian / hygienic / scientific) issues do the manufacturing – and either provide the vaccines or set up a low-cost deal with all other nations chipping in to help the rest of the world. That would be the most logical action in a pandemic, on this Planet where far too many are not treated equally and fairly by their own governments.
    BTW : Pfizer/BioNTech and AstraZeneca/Oxford have promptly in the past days applied for FULL patents (not just Emergency Use Authorization) for their vaccines. Smart move, with millions vaccinated with their vaccines there are now more than enough data to prove the efficacy and safety. They’ve earned it.

  • Biden administration has been pressured by the Indian American CEOs of Microsoft, Google, etc. to give up the patents for Indian companies.
    __________________________________________________________________

    As Nan stated: “India and Africa are making the noise about patents to distract the world of how incompetent their government is in dealing with Covid…
    There are more anaphylaxis reactions to mRNA vaccine, and poor countries can’t afford Epinephrine as emergency treatment.” Lower quality production will lead to unsafe products. Even Emergent Co. got millions of doses ruined.

    Furthermore, as noted by Stephen, this move by the admin will also lead to “ship Western technology to China so they can steal it.” Who knows what they will use the mRNA technology for in their P4 labs?

  • You didn’t build that. Here we go again. Government taking credit and ownership of private IP and doing whatever it feels like with the fruits of private labor. Here’s an idea. If Sleepy wants to provide a company’s IP to the world for free, negotiate compensation with the company with some of the trillions he’s spending to pay people not to work while millions of jobs can’t be filled in the US. Crazy times when we give away IP and pay people not to work. Atlas Shrugged?

    • Its almost like were not all in this together. Not like the US government funded the initial research into mRNA or SARS vaxes or anything like that. Truly the only ones benefiting should be Moderna and Pfizer in this situation because they developed this vax all on their own with zero help.

    • Correction, Taylor : Moderna got USD 1 billion from Operation Warpspeed (its Chief, Moncef Slaoui, coming freshly off the Moderna board clearly being – let’s say – “biased”. This vaccine is Moderna’s very first and only product). Sharp contrast with Pfizer/BioNTech that did all the R&D on its own experienced dime, without any support from US coffers. Logically they now charge a bit more for their superb vaccine.

  • Look at who these lazy reporters quote in this opinion piece. ANY public health advocates? ANY third world advocates? ANY of the two dozen countries able and ready to produce non-mRAN vaccines? Nah. Doesn’t fit the Big Pharma narrative. STAT is betraying its journalistic duties with propaganda pieces like this. Very disappointing. But I guess, Big Pharma provides the ad revenues, so… #BeLikeNYT

    • They should make the high tech remove all their censors and hand over their company to be regulated by the government, before asking Pharma to hand over their hardwork and remove patents. WHO should buy from Pharma and distribute to countries. Biden has no business getting involved in private business.

  • It seems Angela Markle was able to comprehends what some senile Democratic politicians failed to comprehend. The problem is not the patents but the capacity to create a high standard vaccine. Especially in poor countries that can’t afford massive investment in the cooler or expertise to create a high quality vaccine.

    The Democrats who like to join the van even if it leads to mass murder (technically defective vaccine made from some countries without expertise can end up killing someone), together with India and South Africa needs to shut up. There are more anaphylaxis reactions to mRNA than the DNA vaccine, and poor countries can’t afford Epinephrine as emergency treatment.

    What needs to be done is those countries that are rich like India and Africa (with all it natural resources) get rids of the corruption in their government and force their government to improve the health system in those countries. India is more concern about investing in space and nuclear technology than in its health care system.

    The rest of the world who manufacture vaccine should probably do those things 24/7 and donate what they can to the poorer countries, of which India is not a poor countries. India needs to pay for the vaccine.

    UN including WHO should probably cut more waste and put those saving into a pool of money to buy vaccine for the poor countries.

    Private people should be allowed to donate money for the purchase of vaccine and medicines for poorer countries.

    India and Africa are making the noise about patents to distract the world of how incompetent their government is in dealing with Covid. Look at some small countries in Asia, they are doing well.

    I am not sure why Biden is not donating vaccine to poorer countries. This is more important than waiving patent IP which can take years to have effect.

    It is ironic that UK is the head of the Commonwealth yet it turn down India when India appeal for vaccine. It does shows that when bad times comes, UK will abandon those other countries in the Commonwealth. Time to dissolve the Commonwealth and everyone join the UN. At least even if it is corrupt and ineffective, WHO still moves to help other countries.

    Last, Tedros not deserved a second term for acting late when WHO already has the information as early as Dec of 2019.

    • Completely wrong. There are more than two dozen countries with facilities ready – RIGHT NOW – to make non-mRNA vaccines. Look it up.

    • The UK may be manufacturing a COVID vaccine (AstraZeneca) but not at great volume, certainly not at a volume sufficient to make much difference to India. And remmeber, not only has AstraZeneca pledged to make the vaccine for no profit, but also has exported the knowhow to any country that chooses to make it. This the Serum Industry of India is making AstraZeneca vaccine. This is true in many countries across the world – Mexico, Brazil among others. The UK model was to develop a vaccine (research in Oxford funded by government), team up with a pharmaceutical company to make at no profit, and to export the ability to make the vaccine not export UK manufactured vaccine.

  • “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.”
    The SKy is Falling, the Sky is Falling!
    With the tens of millions Big Pharma rains on Congress? Hundreds of millions? This is pure fantasy. STAT – with these pronouncements – is participating in the Big Pharma full court press to protect their 95% profit margins. Disgusting.

  • Excellent article- many of the so called experts are still living in the 1990s and think vaccines are no different than small molecule HIV drugs- waiver the patent and declare victory. They could not be more wrong…

    The reason so much investment is in biologic drugs (antibodies, vaccines, cell and gene therapies) is precisely because they cannot be easily copied

    There is absolutely no way that the tech transfer can be enforced by the government- The US govt would have to grab Moderna and Pfizer’s employees and send them overseas and force them to spill their trade secrets… I do not see how that happens…

    Any expert advocating immediate tech transfer needs to explain how they would actually accomplish it- in a plausible legal way- not the intellectual lazy: “the government must Force company A to do XYZ by whatever means necessary…”

    • Spot on. A patent is a contract that a government provides that guarantees an inventor the right to exclude others from duplicating his/her invention (composition of matter, process, design) in exchange for disclosing how to produce the invention. While the patent has to include an accurate and complete description of the ‘best way’ at the time the patent was filed, it can also (and often does) provide accurate and complete inferior ways to achieve the final result. This ‘hide in plain sight’ strategy can cost infringers much time and money to navigate. The knowhow generated in the original R&D venture ( which offer requires many years) is the key to streamlining the duplicating the invention. That’s why many companies take licenses, not necessarily because they fear being sued for infringement. I fear that we will begin to see more pharma patents with hundreds of examples that lead to inferior products. There are also many instances where the raw material is specified, but the result is dependent upon the brand or manufacturer. All C10 fatty acids are alike, but some manufacturers C10 fatty acids are purer than others.

  • What problem are we solving? If it’s maximum number of shots in arm over minimum time, this is not the solution.
    Last night, when I heard the anthrax/Bayer/Cipro story intro to Maddow’s A block, I thought she would explain how this situation is NOT analogous. Must say I was shocked to hear what followed: IP waivers, raw materials, equipment, tech transfer, validation, training.
    Any physical organic chemist or operations management expert can tell you that the only way to increase Output is to address the rate determining step.
    If additional facilities are needed, I can guarantee that each of the current producers can get an additional facility online quicker than another entity being coached through the process. To me, this sounds more like a JOBS act for whichever countries become the beneficiaries.

  • Thank you so much for enlightening concerned people who know not so much, such as myself. There are many who are not well-informed!

    • Don’t count this as Enlightenment. This is pure propaganda from Big Pharma.

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