Biden Confronts Coronavirus Vaccine Patents

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.

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.

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.

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.

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.

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.

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John C. Martin, 69, Dies; Led Drugmaker in Breakthroughs

John C. Martin, who became a billionaire by developing and marketing a daily single-dose pill that transformed H.I.V. into a manageable disease and who popularized another drug that cures hepatitis C, died on March 30 in Palo Alto, Calif. He was 69.

His death, in a hospital, was confirmed by Gilead Sciences, based in Foster City, Calif., where he was chief executive from 1996 to 2016 and executive chairman from 2016 until he retired two years later. The cause was head injuries suffered the day before, when he fell on a sidewalk while walking home in Old Palo Alto, according to the Santa Clara County medical examiner.

A chemist who rocketed from research director to chief executive of Gilead in six years, Dr. Martin turned a struggling pharmaceutical firm with a staff of 35 into a $100 billion company based in Foster City, Calif., with some 12,000 employees.

Gilead jolted the industry with several major scientific breakthroughs, beginning with the development of the first anti-influenza pill, Tamiflu, which the company licensed to the Swiss drugmaker Hoffman-La Roche in 1996. Its advance against hepatitis C came in 2014, with the marketing of Sovaldi, which has been said to cure 90 percent of patients with that liver virus.

Atripla, which combined Truvada with Bristol-Myers Squibb’s Sustiva in a single pill, replacing as many as 32 separate medications that some patients were taking daily to treat the virus, which can lead to AIDS.

The single-pill treatment was meant to be more than a convenience. By making it easier for patients to self-medicate, they were more likely to take the full doses that were prescribed, reducing the risk that they could become breeding grounds for drug-resistant strains of the disease.

During Dr. Martin’s tenure, Gilead also created remdesivir in 2009, which proved ineffective in its original mission, to treat hepatitis C and other viruses, but which turned out to be a therapeutic weapon during the Covid-19 pandemic.

While the company’s annual revenue soared past $20 billion and its products were hailed as medical miracles, the federal Department of Health and Human Services successfully claimed that Gilead had infringed government patents in making Truvada. The company also drew fire from state and federal regulators over the prices it charged — $1,000-a-month for Sustiva and $1,000 for each hepatitis pill.

donated drugs in some cases and that it had partnered with local manufacturers in developing countries to produce discounted generic versions of some treatments for H.I.V. and hepatitis C.

“John’s legacy,” Daniel O’Day, the company’s chief executive, said in a statement, “will be felt for generations to come, living on through the scientific progress made under his leadership and the programs he championed that expanded access to medications for people around the world.”

the $11 billion takeover of Pharmasset, a developer of antiviral drugs, in 2012. In addition to running Gilead, Dr. Martin was president of the International Society for Antiviral Research from 1998 to 2000.

His marriage to Ms. Martin ended in divorce. Among his survivors are their son and daughter, his three siblings and his partner, Lillian Lien-Li Lou, who was listed in a recent filing as the secretary-treasury of the John C. Martin Foundation, whose stated mission is to improve health care for medically-underserved populations.

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