Poonawalla says he’s in talks with Washington about clearing the way to sell some of the company’s earlier vaccine products in the U.S. market as low-cost generics. In President Donald Trump, he sees an ally in dismantling regulatory blockades.

“I think that'll be one of the good things that [Trump] might actually achieve if that goes well,” Poonawalla said.

In doing so, Poonawalla faces a big hurdle: The U.S. pharma industry, which has strong allies on both sides of the aisle in Congress, has successfully resisted most efforts to loosen patent and importation rules, and so far the Trump administration’s promises to allow cheaper drugs to be reimported from Canada have gone nowhere.

Poonawalla cites Bill Gates as his mentor, for his work helping bring affordable drugs to poor countries, and the Microsoft mogul’s charity has pumped cash into the Serum Institute, crediting the company with helping eliminate meningitis in hard-hit parts of Africa. But Gates, through his charity and Microsoft, has been a staunch defender of intellectual property rights, saying that charging higher prices in the Western world is the key to delivering low-cost protections in the developing world. (The Bill and Melinda Gates Foundation declined to discuss the Serum Institute beyond providing a list of their collaborations.)

“We fund research and we actually ourselves or our partners create intellectual property so that anything that is invented with our foundation money that goes to richer countries, we’re actually getting a return on that money,” Gates said in 2011. “By doing that we have more money to devote for research into neglected diseases and the diseases of the poor.”

The U.S. drug makers’ lobby is also adamant in opposing Poonawalla’s call for reforms to patent laws and protections for intellectual property, which give companies sole control over the scientific products they develop, in some cases for decades.

“Our IP system — including patents — promotes competition and is the foundation for new treatments, vaccines and cures for patients,” said a spokesman for PhRMA, the U.S. drug makers lobby, in a statement to POLITICO. “Many of the medicines being tested for Covid-19 exist today because of intellectual property and other incentives that drove their creation and development.”

The statement was blunt about what the big drug companies believe would happen if their protections lapsed: “Drastic and uncoordinated action by governments — like seizing patents — will further burden manufacturing infrastructure, divert resources and leave patients now and tomorrow worse off.”

Fighting health care inequality

Inequality of health care was the moral force behind the creation of the Serum Institute; it grew out of Poonawalla’s father’s conviction that poor children across India and Africa were dying in the millions of preventable diseases, mainly because the research advances of the West had yet to reach them.

It was the early 1960s and, in his early 20s, Cyrus Poonawalla determined that his family’s decades-old stud farm had "no future in the socialist India of the time," according to a biography on his website.

He fiddled with trying to design a sports car, before opting to revert back to a more literal type of horsepower: The Poonawalla Stud Farms had been donating horses to a government-owned institute in Mumbai for serum. Creating what’s known as passive immunity, serum purified from horse blood can be used to give people the antibodies necessary to fight off some diseases.

The elder Poonawalla started making tetanus serums in-house. Eventually, he moved on to tetanus and measles vaccines, of which there were major shortages around India and Africa at the time, his son recounted.

Today, the Serum Institute sells about 1.5 billion doses of a wide array of vaccines a year to 170 countries. A good portion of that volume is thanks to Gavi, the Vaccine Alliance, the public-private partnership that Gates founded 20 years ago. It uses donor money to help buy vaccines in bulk for poor countries that likely couldn’t afford them even at a few dollars a dose.

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