Waiver of patent rights on Covid-19 vaccines, in near term, may be more symbolic than substantive

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.

Source: STAT