Pressure Mounts to Lift Patent Protections on Coronavirus Vaccines

https://www.nytimes.com/2021/05/03/us/politics/biden-coronavirus-vaccine-patents.html

Version 0 of 1.

WASHINGTON — President Biden, faced with surging Covid-19 crises in India and South America, is under intensifying pressure from the international community and his party’s left flank to commit to increasing the vaccine supply by loosening patent and intellectual property protections on coronavirus vaccines.

Pharmaceutical and biotech companies, also feeling pressure, sought on Monday to head off such a move, which could cut into future profits and jeopardize their business model. Pfizer and Moderna, two major vaccine makers, each announced steps to increase the supply of vaccine around the world.

The issue is coming to a head as the World Trade Organization’s General Council, one of its highest decision-making bodies, meets Wednesday and Thursday. India and South Africa are pressing for the body to waive an international intellectual property agreement that protects pharmaceutical trade secrets. The United States, Britain and the European Union so far have blocked the plan.

Inside the White House, health advisers to the president admit they are divided. Some say that Mr. Biden has a moral imperative to act, and that it is bad politics for the president to side with pharmaceutical executives. Others say spilling closely guarded but highly complex trade secrets into the open would do nothing to expand the global supply of vaccines.

Having the recipe for a vaccine does not mean a drugmaker could produce it, certainly not quickly, and opponents argue that such a move would harm innovation and entrepreneurship — and damage America’s pharmaceutical industry. Instead, they say, Mr. Biden can address global needs in other ways, like pressing companies that hold patents to donate vast quantities of vaccine or sell it at cost.

“For the industry, this would be a terrible, terrible precedent,” said Geoffrey Porges, an analyst for the investment bank SVB Leerink. “It would be intensively counterproductive, in the extreme, because what it would say to the industry is: ‘Don’t work on anything that we really care about, because if you do, we’re just going to take it away from you.’”

Dr. Anthony S. Fauci, Mr. Biden’s chief medical adviser for the pandemic, said in an interview Monday that the drugmakers themselves must act, either by greatly expanding their manufacturing capacity to supply other nations at “an extremely diminished price” or by transferring their technology to let the developing world make cheap copies. He said he was agnostic on a waiver.

“I always respect the needs of the companies to protect their interests to keep them in business, but we can’t do it completely at the expense of not allowing vaccine that’s lifesaving to get to the people that need it,” Dr. Fauci said, adding, “You can’t have people throughout the world dying because they don’t have access to a product that rich people have access to.”

For Mr. Biden, the debate over the waiver is both a political and a practical problem. As a presidential candidate, he promised the liberal health activist Ady Barkan, who has amyotrophic lateral sclerosis, or A.L.S., that he would “absolutely positively” commit to sharing technology and access to a coronavirus vaccine if the United States developed one first. Activists plan to remind Mr. Biden of that promise during a rally scheduled for Wednesday on the National Mall.

“He’s not being bold on this,” said Gregg Gonsalves, a Yale epidemiologist who fought similar battles during the AIDS crisis of the 1980s and 1990s, and is expected to speak at the rally. “They said this during the AIDS epidemic, too. All the same excuses are coming up from 20 years ago.”

The proposal by India and South Africa would exempt World Trade Organization member countries from enforcing some patents, trade secrets or pharmaceutical monopolies under the body’s agreement on trade-related intellectual property rights, known as TRIPS. The idea would be to allow drug companies in other countries to make or import cheap generic copies.

Proponents say the waiver would free innovators in other countries to pursue their own coronavirus vaccines, without fear of patent infringement lawsuits. They also note that the proposed waiver goes beyond vaccines, and would encompass intellectual property for therapeutics and medical supplies as well.

“Many people are saying, ‘Won’t they need the secret recipe?’ That’s not necessarily the case,” said Tahir Amin, a founder of the Initiative for Medicines, Access & Knowledge, a nonprofit dedicated to eliminating health inequities. “There are companies that feel they can go it alone, provided they don’t have to look over their shoulder and feel like they are going to take someone’s intellectual property.”

The pharmaceutical industry counters that rolling back intellectual property protections would not help ramp up vaccine production. It says that other issues are serving as barriers to getting shots into arms around the world, including access to raw materials and on-the-ground distribution challenges.

And just as important as having the rights to make a vaccine is having the technical know-how, which would have to be supplied by vaccine developers like Pfizer-BioNTech and Moderna — a process known as technology transfer.

Sharon Castillo, a Pfizer spokeswoman, said the company’s vaccine requires 280 components from 86 suppliers in 19 countries; it also needs highly specialized equipment and personnel, and complex and time-intensive technology transfers between partners and global supply and manufacturing networks, she said.

“We just think it’s unrealistic to think that a waiver will facilitate ramping up so quickly as to address the supply issue,” she said.

On Monday, Pfizer’s chief executive, Albert Bourla, said on LinkedIn that his company would immediately donate more than $70 million worth of medicines to India and is also trying to fast-track the vaccine approval process in India. The company also posted on Twitter promising “the largest humanitarian relief effort in our company’s history to help the people of India.”

Moderna, which developed its vaccine with funding from American taxpayers, has already said it would not “enforce our Covid-19 related patents against those making vaccines intended to combat the pandemic.” But activists have been calling not just for the waiver, but for companies to share expertise in setting up and running vaccine factories — and for Mr. Biden to lean on them to do it.

Last month, more than 170 former heads of state and Nobel laureates, including Gordon Brown, the former prime minister of Britain; Ellen Johnson Sirleaf, the former president of Liberia; and François Hollande, the former president of France, issued an open letter calling on Mr. Biden to support the proposed waiver.

On Capitol Hill, 10 senators including Bernie Sanders, independent of Vermont, and Elizabeth Warren, Democrat of Massachusetts, urged Mr. Biden to “prioritize people over pharmaceutical company profits” and reverse the Trump administration’s opposition to the waiver. More than 100 House Democrats have signed a similar letter.

“This is one of the key moral issues of our time,” said Representative Ro Khanna, Democrat of California. “To deny other countries the opportunity to make their own vaccines is just cruel.”

Katherine Tai, Mr. Biden’s trade representative, has held more than 20 meetings with various stakeholders — including global health activists, pharmaceutical executives, members of Congress, Dr. Fauci and the philanthropist Bill Gates — in recent weeks to try to chart a path forward.

“Ambassador Tai reiterated that the Biden-Harris administration’s top priority is saving lives and ending the pandemic in the United States and around the world,” Ms. Tai’s office said in a carefully worded statement Monday, after she spoke about the proposed waiver with the director general of the World Intellectual Property Organization, an arm of the United Nations.

In a letter to Ms. Tai last month, the Biotechnology Innovation Organization, a trade group, warned against giving “license to other countries — some of them our economic competitors — to hollow out our world-leading biotechnology base, export jobs abroad and undermine incentives to invest in such technologies in the future.”

One of the drug industry’s fears about a patent waiver for coronavirus vaccines is that it could set a precedent that would weaken its intellectual property protections for other medicines, which are central to how it makes money.

“The drug industry is extremely protective of its intellectual property,” said Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. “This kind of fierce resistance is a reflex of the pharmaceutical industry.”

It is not apparent, though, that such a move in the unique circumstances of the pandemic would have implications for intellectual property protections for other treatments after the coronavirus crisis has passed, industry researchers said.

In the 2000s, a handful of governments, including those of Brazil and Thailand, bypassed patents held by the developers of antiviral drugs for H.I.V./AIDS in an effort to clear the way for lower-cost versions of the treatments.

H.I.V. drugs, however, involve a much simpler manufacturing process than the coronavirus vaccines, especially those using messenger RNA technology, which has never before been used in an approved product.

In a Twitter thread, Mr. Amin offered another example: In the 1980s, Merck and GlaxoSmithKline had developed recombinant hepatitis B vaccines and held a monopoly with more than 90 patents covering manufacturing processes. The World Health Organization recommended vaccination for children, but it was expensive — $23 a dose — and most Indian families could not afford it.

The founder of Shantha Biotechnics, an Indian manufacturer, was told that “even if you can afford to buy the technology your scientists cannot understand recombinant technology in the least,” Mr. Amin wrote.

But Shantha, he added, went on “to produce India’s first home-grown recombinant product at $1 a dose.” That enabled UNICEF to run a mass vaccination campaign.