[ As vaccination rates increase in the U.S., developing nations
— which have sought the patent waiver for months — are facing
massive coronavirus outbreaks. ] [[link removed]]

BIDEN TO SUPPORT WAIVING PATENTS FOR COVID-19 VACCINES  
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Daniel Marans and Sara Boboltz
May 5, 2021
Huff Post
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_ As vaccination rates increase in the U.S., developing nations —
which have sought the patent waiver for months — are facing massive
coronavirus outbreaks. _

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The Biden administration plans to support a temporary waiver on
patents and other intellectual property rules preventing developing
countries from mass-producing generic COVID-19 vaccines, United States
Trade Representative Katherine Tai announced on Wednesday.
 

U.S. Trade Representative Katherine Tai announced the Biden
administration’s support for the waiver on Wednesday.
A group of developing countries led by India and South Africa was
pushing for the move, which comes as a relief for global public health
advocates.

“The Administration believes strongly in intellectual property
protections, but in the service of ending this pandemic, supports the
waiver of these protections for COVID-19 vaccines,” Tai said in a
statement_. _ 

The United States does not have the power to unilaterally enact the
patent waiver, nor did Tai commit to the version of the waiver
currently drafted by India and South Africa. Instead, she pointed to
the need for further negotiations. 

But Tai’s remarks signal the end of American leadership of a bloc
composed primarily of wealthy nations that has prevented the World
Trade Organization from reaching the unanimous consensus needed to
even begin negotiations over the terms of a waiver. 

Because the U.S. — which is home to some of the world’s most
lucrative pharmaceutical companies — has historically been a major
obstacle to patent liberalization, American support for the waiver is
widely viewed as a sign that it will eventually be adopted. 

It is an outcome that the pharmaceutical industry has fought hard to
prevent, deploying more than 100 lobbyists
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in the first few months of 2021 to pressure lawmakers. Shares of
Pfizer, BioNTech, Novavax and Moderna fell
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Tai’s announcement.

The Pharmaceutical Research and Manufacturers of America, the
country’s largest pharmaceutical trade organization, issued a
scathing statement claiming that the waiver would do more harm than
good. 

“In the midst of a deadly pandemic, the Biden Administration has
taken an unprecedented step that will undermine our global response to
the pandemic and compromise safety,” PhRMA president and CEO Steve
Ubl said. A patent waiver, Ubl argued, “flies in the face of
President Biden’s stated policy of building up American
infrastructure and creating jobs.”

But public health experts say that failure to prioritize vaccinations
for populations around the world as fast as possible will end up
hurting Americans, dragging the pandemic on and creating opportunities
for new variants to arise. When the coronavirus spreads unchecked, it
can mutate, leading to variants that could be more resistant to
already-developed vaccines, requiring even more global resources to
end the pandemic. 

For-profit drug makers deployed a variety of talking points against
the waiver. They argued that it could lead to faulty drug production,
allow China or Russia to steal valuable intellectual property, or
disincentivize further development of treatments related to COVID-19.
Yet many proponents of the waiver argue that the huge sums of public
money pumped into the pharmaceutical industry to develop COVID-19
treatments and vaccines weakens companies’ arguments about
intellectual property. 

The pharmaceutical industry has claimed that the current dearth of
vaccine supplies is due to a lack of raw materials and industrial
capacity in developing countries, rather than the lack of legal
freedom to use and replicate patented technologies.

Tai addressed the high demand for raw materials, saying that the
administration would work to alleviate supply shortages where they
crop up. Coronavirus vaccines can require more than 200 individual
materials sourced from a variety of countries, and there is currently
very little transparency in the supply chain.

Public health advocates noted that several pharmaceutical companies
have also already partnered with drug makers in developing nations to
manufacture smaller batches of vaccines, and companies in countries
like Bangladesh
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said they are ready to mass produce the shots the moment a waiver
takes effect.

While there is already a global initiative funded by the U.S. and
other high-income countries that aims to bring vaccines to low-income
countries (COVAX), experts say it does not have enough resources to
completely solve the problem of vaccine inequity. 

Tai, who is representing the U.S. at a WTO meeting in Geneva on
Wednesday and Thursday, emphasized that hammering out the details of a
waiver could be a long, complex process.

“We will actively participate in text-based negotiations at the
World Trade Organization (WTO) to make that happen,” she said in her
statement. “Those negotiations will take time given the
consensus-based nature of the institution and the complexity of the
issues involved.”

Still, the Biden administration’s decision marks a dramatic finale
to a months-long pressure campaign for Biden to reverse his
predecessor’s opposition to allowing talks over a waiver to begin,
and is a victory for progressive lawmakers. 

In October, India and South Africa wrote a letter
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asking that WTO member states enact a waiver on patents and other
intellectual property protections “until widespread vaccination is
in place globally.”

As vaccines have become more available in the United States and the
COVID-19 pandemic has intensified in the developing world, calls for
the temporary waiver from public health advocates and progressive
politicians across the world have intensified.

In mid-April, Sen. Bernie Sanders (I-Vt.) and nine other
senators signed a letter
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addressed to Biden calling for the waiver. Sanders applauded the
administration’s decision on Wednesday, saying that “putting
people over profits” was necessary to end the pandemic. 

And on Tuesday, Rep. Jan Schakowsky (D-Ill.) unveiled a similar
letter
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in the House with the support of a majority of the House Democratic
Caucus. The letter included the signatures of a number of moderate
Democrats from swing districts, such as Reps. Elissa Slotkin of
Michigan and Jared Golden of Maine.

In a press conference touting the letter on Tuesday, Rep. Earl
Blumenauer (D-Ore.), chairman of the House Ways and Means
Committee’s subcommittee on trade, framed the issue as a question of
self-interest in protecting Americans from additional spread of the
COVID-19 virus.

“It is beyond comprehension that we’re not doing everything we can
to make sure that we break this vicious cycle of reinfections,” he
said, before expressing confidence that Tai knew how to “thread the
needle” between the concerns of drug makers and the need to combat
the pandemic. 

Before he was elected in November, he told terminally ill activist Ady
Barkan that waiving the patent rules would be ‘the only humane
thing in the world to do.’

Even Sen. Joe Manchin (D-W.Va.), a moderate with ties to the
pharmaceutical industry, noted
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that funding from the U.S. government that helped support vaccine
research should entitle the global public to lower drug prices.

In the end, it was Biden’s own remarks that may have had the
greatest effect. Before he was elected in November, he told terminally
ill activist Ady Barkan
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waiving the patent rules would be “the only humane thing in the
world to do.”

The White House was increasingly at pains to explain the discrepancy
between Biden’s remarks then and his inaction up until now. 

“The president spoke about his support for this type of a waiver
back during the campaign,” White House press secretary Jen Psaki
said on Wednesday before Tai’s announcement. “But ... we have been
running a process in the administration that includes all stakeholders
in the administration, and he is somebody who has welcomed people of
different views.”

It is too soon to tell whether the announcement marks a new approach
to U.S. intellectual property policy more broadly. But the news comes
less than a month after the White House narrowly avoided choosing
between IP protections and its climate agenda. 

Earlier this year, a dispute between LG Chem and SK Innovation, two
South Korean battery manufacturers, boiled over when the U.S.
International Trade Commission ruled in LG Chem’s favor, deciding to
ban the other firm from importing the raw materials needed to make the
lithium-ion units that power electric vehicles.

n response to the ruling, SK Innovation said it would likely need to
shutter a $2.6 billion battery factory complex in Commerce, Georgia,
unless Biden issued a rare presidential veto of the ITC decision.
Industry analysts warned that without the factory, LG Chem could gain
a near-monopoly hold on the electric vehicle market, granting it the
ability to dictate prices. Trade hawks argued vetoing the ITC decision
risked weakening the U.S. stance on IP protections.

Hours before Biden faced a legal deadline to decide on the veto, SK
Innovation and LG Chem reached a settlement
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allowing the White House to avoid the decision altogether. 

_Alexander C. Kaufman contributed reporting._

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