By Yuka Hayashi and Jared S. Hopkins
WASHINGTON -- The U.S. said Wednesday it would support the
temporary waiver of intellectual property provisions to allow
developing nations to produce Covid-19 vaccines created by
pharmaceutical companies, citing an urgent need to stem the
Overriding objections from the pharmaceutical industry, U.S.
Trade Representative Katherine Tai said the U.S. would support a
proposal working its way through the World Trade Organization. Such
a policy would waive the IP rights of vaccine makers to potentially
enable companies in developing countries and others to manufacture
their own versions of Covid-19 vaccines.
"The Administration believes strongly in intellectual property
protections, but in service of ending this pandemic, supports the
waiver of those protections for Covid-19 vaccines," Ms. Tai said in
Countries suffering from an explosion in new cases -- including
India and South Africa -- have pushed for the waiver. In India, it
was reported recently that less than 2% of the population had been
vaccinated, and new Covid-19 cases are at record highs globally, as
the pandemic rages unchecked in many poor and middle-income
Pharmaceutical companies, however, oppose it, saying the waiver
won't provide the short-term results proponents think it will,
partly because of the challenge of setting up complex new
production facilities to manufacture the vaccines.
Ms. Tai also warned that the talks at the WTO to approve a
waiver policy will take time, given the consensus-based nature of
the group, but that the U.S. will actively participate in
The Pharmaceutical Research and Manufacturers of America, the
drug industry's main D.C.-based lobbying and trade group, said the
Biden administration's decision will weaken already-strained supply
chains and spur counterfeit vaccines.
"This decision does nothing to address the real challenges to
getting more shots in arms, including last-mile distribution and
limited availability of raw materials," PhRMA said in a
Pfizer Inc., which partnered with BioNTech SE to develop a
Covid-19 vaccine, declined to comment. Representatives for Moderna,
AstraZeneca and Johnson & Johnson didn't immediately respond to
requests for comment.
Lifting patent restrictions means that rival companies would be
able to manufacture vaccines using public patents without risk of
legal challenges by Covid-19 vaccine makers, said Zachary
Silbersher, a patent lawyer at Markman Advisors, LLC.
However, manufacturing the Covid-19 vaccines is a complex
scientific process that involves securing hard-to-find raw
materials and scaling them in a way that has never been done
before, according to industry experts. Factories must be built or
retrofitted with special, expensive equipment, and employees must
have the manufacturing know-how.
"I can't imagine that waiving patent rights is all of a sudden
going to create competitors overnight," Mr. Silbersher said. "Even
if you're armed with the patents, that doesn't mean you have all
the information to make these vaccines. There's a gap, and that gap
could be significant."
In an interview Tuesday, Pfizer Chief Executive Albert Bourla
said that sharing patents doesn't make sense because doing so
wouldn't lead to increased production of vaccine doses.
"It is so wrong," Mr. Bourla said of forcing the patent sharing.
He said the limited supply of Covid-19 vaccines stems from how
before the pandemic, there weren't any approved products using the
new gene-based mRNA technology in the Pfizer-BioNTech vaccine.
Pfizer, he said, has been ramping up its manufacturing
capabilities to close that production gap for more than a year.
Dictating the sharing of patents would discourage biotech companies
from developing products for the next pandemic, he said.
Moderna last year said it wouldn't enforce patents related to
its experimental Covid-19 vaccine while the pandemic continues and
is willing to license the patents to others after the pandemic.
The U.S., the European Union and other wealthy nations were
among the countries that opposed the original waiver proposal
offered by South Africa and India in October, saying IP protection
provides an important incentive for innovation.
In her statement, Ms. Tai said the support for the IP waiver is
just one part of Washington's effort to get vaccines around the
"As our vaccine supply for the American people is secured, the
Administration will continue to ramp up its efforts -- working with
the private sector and all possible partners -- to expand vaccine
manufacturing and distribution," she said. "It will also work to
increase the raw materials needed to produce those vaccines."
Tedros Adhanom Ghebreyesus, director-general of the World Health
Organization, hailed the U.S. action as a "monumental moment in the
fight against COVID-19".
In its statement Wednesday, PhRMA said that Covid-19 vaccine
production was already ramping up and companies were exporting more
"Biopharmaceutical manufacturers are fully committed to
providing global access to Covid-19 vaccines, and they are
collaborating at a scale that was previously unimaginable."
The surprise move by the Biden administration came as the
flare-up of the pandemic in India underscores the risks that the
virus and emerging variants pose for the world.
Governments and other health experts have called for sharing
patent rights to help spur additional production of vaccines around
the world, particularly in developing nations where few people have
received shots. The U.S. and other nations have by contrast
progressed to vaccinate almost a majority of their populations.
The White House on Tuesday unveiled a goal for 70% of the U.S.
adult population to have one vaccine shot and 160 million U.S.
adults to be fully vaccinated by July 4.
The Biden administration has come under intense pressure to take
steps to ease the global vaccine shortage in recent weeks.
The current WTO agreement -- the Agreement on Trade-Related
Aspects of Intellectual Property Rights, or TRIPS -- was introduced
in 1995 upon the birth of the WTO itself, providing patent
protection to technological innovations, including drugs and
Support by the U.S. for the temporary waiver doesn't mean it
will be approved at the WTO, an organization that makes decisions
on consensus among members. The European Union, the U.K.,
Switzerland, Japan and Brazil are among the countries that opposed
the original proposal offered by South Africa and India in
"The thing that has holding things back in this case is not
intellectual property. It's not like there's some idle vaccine
factory, with regulatory approval, that makes magically safe
vaccines," Bill Gates, whose charitable foundation has made
significant contributions to global vaccine efforts, said on Sky
News last month.
Ngozi Okonjo-Iweala, who became the WTO's director-general in
March after serving as the head of Gavi, an international vaccine
group, had proposed a "third way" to improve access to vaccines
before her appointment. Her proposal focused on technology transfer
and licensing of manufacturing without requiring an IP waiver.
"Ngozi is following a dual track. She says, 'Lets talk about
TRIPS waiver,' which is so contentious that it's not going to be
resolved quickly, but at the same time, 'Lets make sure there is
more production in developing countries,'" said Alan Wolff, a U.S.
trade lawyer who finished his term as deputy director-general of
WTO last month.
The continuing debate echoes the fight over AIDS/HIV medication
in the late 1990s and the early 2000s that raised a question about
the role of intellectual property rights during a deadly public
Amid the criticism that the IP protection rule made the
medicines already readily available in wealthy nations
prohibitively expensive for poorer countries experiencing terrible
outcomes, WTO members made changes to the TRIPS agreement. The move
also encouraged pharmaceutical companies to voluntarily ease
conditions of licensing agreements, resulting in significant
declines in drug prices.
Write to Yuka Hayashi at firstname.lastname@example.org and Jared S.
Hopkins at email@example.com
(END) Dow Jones Newswires
May 05, 2021 20:22 ET (00:22 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.