The Biden administration’s announcement was an important moment for Democrats, who have campaigned on a promise to lower the cost of prescription drugs.The Biden administration on Tuesday announced the first 10 medicines that will be subject to price negotiations with Medicare, kicking off a landmark program that is expected to reduce the government’s drug spending but is being fought by the pharmaceutical industry in court.The medications on the list are taken by millions of older Americans and cost Medicare billions of dollars annually. The drugs were selected by the Centers for Medicare & Medicaid Services through a process that prioritized medications that account for the highest Medicare spending, have been on the market for years and do not yet face competition from rivals.Drugs Selected for Price Negotiations1. Eliquis, for preventing strokes and blood clots, from Bristol Myers Squibb and Pfizer2. Jardiance, for Type 2 diabetes and heart failure, from Boehringer Ingelheim and Eli Lilly3. Xarelto, for preventing strokes and blood clots, from Johnson & Johnson4. Januvia, for Type 2 diabetes, from Merck5. Farxiga, for chronic kidney disease, from AstraZeneca6. Entresto, for heart failure, from Novartis7. Enbrel, for arthritis and other autoimmune conditions, from Amgen8. Imbruvica, for blood cancers, from AbbVie and Johnson & Johnson9. Stelara, for Crohn’s disease, from Johnson & Johnson10. Fiasp and NovoLog insulin products, for diabetes, from Novo NordiskThe final list had some overlap with what experts had anticipated. Its release was an important moment for Democrats, who have campaigned on a promise to lower the cost of prescription drugs. President Biden will mark the occasion with remarks at the White House on Tuesday afternoon — another sign that he intends to make lowering health care costs a theme of his 2024 re-election campaign.Medicare gained the authority to negotiate the price of some prescription medicines when Congress passed the Inflation Reduction Act last year, a signature legislative achievement for the president. Tuesday’s announcement is a key step toward those negotiations, which will unfold over the coming months, with the new prices taking effect in 2026. Additional drugs will be selected for price negotiations in coming years.The negotiation program is projected to save the government an estimated $98.5 billion over a decade. It is also expected to eventually reduce insurance premiums and out-of-pocket costs for many older Americans, though the magnitude of those savings remains to be seen.Medicare already pays reduced prices for drugs on the list, reflecting rebates that are passed down by pharmacy benefit managers, the middlemen that negotiate discounts with manufacturers. But before passage of the Inflation Reduction Act, Medicare was explicitly barred from negotiating prices directly with manufacturers.Republicans in Congress opposed authorizing Medicare to negotiate prices, criticizing the move as tantamount to imposing government price controls. Beyond Mr. Biden, other Democrats up for re-election next year have also sought to highlight the program as a major achievement.Polling by KFF, a health policy research organization, has found broad, bipartisan public support for allowing Medicare to negotiate prices. In a survey late last year, 89 percent of Democrats and 77 percent of Republicans said they favored the plank of the Inflation Reduction Act that authorizes negotiations.“There are very few issues in American politics that are popular no matter where you live or what your political party is,” said Leslie Dach, a longtime Democratic strategist and the chairman of Protect Our Care, a health care advocacy group.But Mr. Biden and his fellow Democrats face the challenge of drawing attention to the negotiation program. In a KFF survey in July, only a quarter of Americans were aware of its existence.Now that the list of drugs is public, their makers have until Oct. 1 to declare whether they will participate in negotiations with the government. Companies that decline to negotiate must either pay a large excise tax or withdraw all of their products from both Medicare and Medicaid, the federal-state program that provides health coverage to low-income people.Six pharmaceutical manufacturers — Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Johnson & Johnson and Merck — have taken the Biden administration to court in an attempt to block the Medicare negotiation program. The industry’s main trade group and the U.S. Chamber of Commerce have also filed suit.The suits make a variety of constitutional claims, including that the requirement that drugmakers negotiate or pay a fine violates the Fifth Amendment’s prohibition on the taking of private property for public use without just compensation.

The government will soon announce the first 10 medications that will be subject to price negotiations with Medicare under a new law. Drugmakers are fighting the measure in court.The pharmaceutical industry, which suffered a stinging defeat last year when President Biden signed a law authorizing Medicare to negotiate the price of some prescription medicines, is now waging a broad-based assault on the measure — just as the negotiations are about to begin.The law, the Inflation Reduction Act, is a signature legislative achievement for Mr. Biden, who has boasted that he took on the drug industry and won. Medicare is the federal health insurance program for older and disabled people; the provisions allowing it to negotiate prices are expected to save the government an estimated $98.5 billion over a decade while lowering insurance premiums and out-of-pocket costs for many older Americans.On Tuesday, Johnson & Johnson became the latest drugmaker to take the Biden administration to federal court in an attempt to put a halt to the drug pricing program. Three other drug companies — Merck, Bristol Myers Squibb and Astellas Pharma — have filed their own lawsuits, as have the industry’s main trade group and the U.S. Chamber of Commerce.The suits make similar and overlapping claims that the drug pricing provisions are unconstitutional. They are scattered in federal courts around the country — a tactic that experts say gives the industry a better chance of obtaining conflicting rulings that will put the legal challenges on a fast track to a business-friendly Supreme Court.The legal push comes just weeks before the Centers for Medicare & Medicaid Services is scheduled to publish a long-awaited list of the first 10 drugs that will be subject to negotiations. The list is due out by Sept. 1; the makers of the selected drugs have until Oct. 1 to declare whether they will participate in negotiations — or face steep financial penalties for not doing so. The lower prices will not take effect until 2026.Earlier this month, the chamber asked a federal judge in Ohio to issue an injunction that would block any negotiations while its case is being heard.Lawrence O. Gostin, an expert in public health law at Georgetown University, said the Supreme Court might be sympathetic to some of the industry’s arguments. In particular, he pointed to a claim by drugmakers that by requiring them to negotiate or pay a fine, the law violates the Fifth Amendment’s prohibition on the taking of private property for public use without just compensation.“The Supreme Court is openly hostile to any perceived violation of the Fifth Amendment,” Mr. Gostin said, adding, “It would not surprise me at all to see these cases go up to the Supreme Court and have them strike it down.”For Mr. Biden and his fellow Democrats, that would be a painful blow. The president and Democrats have long campaigned on reducing drug prices and plan to make it a central theme of their 2024 campaigns. The White House press secretary, Karine Jean-Pierre, said in a statement that Mr. Biden was confident the administration would win in court.“For decades, the pharma lobby has blocked efforts to let Medicare negotiate lower drug costs,” she said. “President Biden is proud to be the first president who beat them.”Republicans opposed the drug pricing provisions, which they regard as a form of government price control. But the politics of the issue are treacherous for them. Because so many Americans are concerned about high drug prices, it is hard for Republicans to come to the industry’s defense, said Joel White, a Republican strategist with expertise in health policy.Instead, Republicans are focused on another priority of the drug industry: scrutinizing the practices of pharmacy benefit managers, which negotiate prices with drug companies on behalf of health plans. The drug companies say that by taking a middleman’s cut, the pharmacy benefit managers are contributing to the high cost of prescription medicines.For drugmakers, the stakes of the legal challenges are bigger than just their business with Medicare, their biggest customer. The industry fears that Medicare will, in effect, set the bar for all payers, and that once the government’s lower prices are made public, pharmacy benefit managers negotiating on behalf of the privately insured will have more leverage to demand deeper discounts.In conjunction with its legal campaign, the pharmaceutical industry is waging a public relations offensive. The industry trade group that filed one of the lawsuits, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, is running advertisements targeting pharmacy benefit managers, and industry executives are publicly arguing that the drug pricing provisions will lead to fewer cures. The implication is clear: Lower prices will mean a dent in revenues, which will discourage companies from developing certain drugs.“You can’t take hundreds of billions of dollars out of the pharmaceutical industry and not expect that it’s going to have a real impact on the industry’s ability to develop new treatments and cures for patients,” said Robert Zirkelbach, an executive vice president at PhRMA. He cited an analysis funded by the drugmaker Gilead Sciences that asserted the industry would lose $455 billion over seven years if companies negotiated with Medicare.A study released last month that was funded by the Biotechnology Innovation Organization, another trade group, warned that the pricing provisions would discourage innovation, resulting in as many as 139 fewer drug approvals over the next 10 years.But that assessment is at odds with an analysis by the Congressional Budget Office, which estimated that the law would result in only one fewer drug approval over a decade and about 13 fewer drugs over the next 30 years.President Biden and Democrats have long campaigned on lowering drug prices and plan to make it a central theme of their 2024 campaigns.Haiyun Jiang/The New York TimesIn addition, many new drugs “are not offering clinically meaningful benefit over existing drugs,” said Ameet Sarpatwari, an expert in pharmaceutical policy at Harvard Medical School. The Inflation Reduction Act, he said, might incentivize companies to focus more heavily on breakthrough therapies, instead of so-called me-too drugs, because the law requires the government to consider the clinical benefit of medications in determining the price Medicare will pay for them.Until now, Medicare has been explicitly barred from negotiating prices directly with drugmakers — a condition the industry demanded in exchange for supporting the creation of Part D, the Medicare prescription drug program, which was signed into law 20 years ago by President George W. Bush.Under the Inflation Reduction Act, the government will select an initial set of 10 drugs for price negotiations based on how much the Part D program spends on them. More drugs will be added in the coming years.Experts expect the initial list of drugs to include oft-prescribed medicines like the blood thinners Eliquis and Xarelto; cancer drugs like Imbruvica and Xtandi; Symbicort, which treats asthma and chronic obstructive disorder; and Enbrel, for rheumatoid arthritis and other autoimmune disorders.Medicare already pays discounted prices for those drugs. In 2021, the most recent year for which data is available, Medicare spent about $4,000 per patient for Eliquis and Xarelto, which at the time had sticker prices of $6,000 per year. The lower price reflects discounts extracted from drugmakers by pharmacy benefit managers negotiating on behalf of the private companies that contract with the government to manage Part D plans.But those negotiations are opaque and only modestly reduce Medicare’s spending. The rationale behind the Inflation Reduction Act’s drug pricing provisions is that because Medicare covers so many people, it can use its leverage to extract even deeper discounts.Merck sued the government in June over the drug pricing provisions. Three other drugmakers have also filed lawsuits: Bristol Myers Squibb, Astellas Pharma and Johnson & Johnson.Matt Rourke/Associated PressThe United States spends more per person on drugs than comparable nations, in part because other countries proactively control drug pricing. Surveys show that many Americans forego taking their medicines because they cannot afford them.Experts say the Medicare negotiation program is likely to translate into direct savings for seniors, initially in the form of reduced premiums made possible by reduced drug spending. And when lower prices take effect in 2028 for drugs administered in clinics and hospitals under another Medicare program, known as Part B, that could mean lower out-of-pocket costs for seniors covered by traditional Medicare who do not have supplemental insurance.Backers of the Inflation Reduction Act say that in addition to saving money for the government and patients, the negotiations will inject much-needed transparency into the complicated process of determining drug prices. If a company declines to negotiate, it must either pay a hefty excise tax or withdraw all of its drugs from both Medicare and Medicaid.“This is not a ‘negotiation,’” Merck said in its complaint. “It is tantamount to extortion.”Taken together, the lawsuits make a variety of constitutional arguments. In addition to the assertion that the government is violating the Fifth Amendment by unjustly taking property, they include claims that the law violates the First Amendment by compelling drug companies to agree in writing that they are negotiating a “fair price.” Another argument is that the excise tax amounts to an excessive fine that is prohibited by the Eighth Amendment.“If the government can impose price controls in this fashion on drug companies,” said Jennifer Dickey, a deputy chief counsel at the chamber’s legal arm, “it could do the same thing to any sector of our economy.”Biden administration officials say there is nothing compulsory about the law. They argue that the companies are free not to negotiate and that they can issue news releases or make other public statements disagreeing with the negotiated price. And they note that the government routinely negotiates for the purchase of other products and that the Department of Veterans Affairs already negotiates drug prices with pharmaceutical companies.“To me, Medicare is doing what it should do,” said Mr. Gostin, the Georgetown professor. “It’s a huge buyer of a product, and it’s basically using that clout, that bargaining power, to get the best price.”The drug industry “is throwing the kitchen sink at the government,” he added. “They’re looking for what sticks, and their arguments are directly targeted at the Supreme Court.”

Empowering Medicare to negotiate prices directly with drug makers has been a Democratic goal for 30 years, one the pharmaceutical industry has fought ferociously.WASHINGTON — For decades, as prescription drug costs have soared, Democrats have battled with the pharmaceutical industry in pursuit of an elusive goal: legislation that could drive down prices by allowing Medicare to negotiate directly with drug makers.Now they are on the verge of passing a broad budget bill that would do just that, and in the process deliver President Biden a political victory that he and his party can take to voters in November.Empowering Medicare to negotiate prices for up to 10 drugs initially — and more later on — along with several other provisions aimed at lowering health care costs, would be the most substantial change to health policy since the Affordable Care Act became law in 2010, affecting a major swath of the population. It could save some older Americans thousands of dollars in medication costs each year.The legislation would extend, for three years, the larger premium subsidies that low- and middle-income people have received during the coronavirus pandemic to get health coverage under the Affordable Care Act, and allow those with higher incomes who became eligible for such subsidies during the pandemic to keep them. It would also make drug makers absorb some of the cost of medicines whose prices rise faster than inflation.Significantly, it also would limit how much Medicare recipients have to pay out of pocket for drugs at the pharmacy to $2,000 annually — a huge benefit for the 1.4 million beneficiaries who spend more than that each year, often on medicines for serious diseases like cancer and multiple sclerosis.Lower prices would make a huge difference in the lives of people like Catherine Horine, 67, a retired secretary and lung recipient from Wheeling, Ill. She lives alone on a fixed income of about $24,000 a year. Her out-of-pocket drug costs are about $6,000 a year. She is digging into her savings, worried she will run out of money before long.“Two years ago, I was $8,000 in the hole,” she said. “Last year, I was $15,000 in the hole. I expect to be more this year, because of inflation.”Between 2009 and 2018, the average price more than doubled for a brand-name prescription drug in Medicare Part D, the program that covers products dispensed at the pharmacy, the Congressional Budget Office found. Between 2019 and 2020, price increases outpaced inflation for half of all drugs covered by Medicare, according to an analysis from the Kaiser Family Foundation.The budget office estimates that the bill’s prescription drug provisions will save the federal government $288 billion over 10 years, in part by forcing the pharmaceutical industry to accept lower prices from Medicare for some of its big sellers. Opponents argue that the measure would discourage innovation and cite a new C.B.O. analysis that projects that it would actually lead to higher prices when drugs first come on the market. The Biden PresidencyWith midterm elections looming, here’s where President Biden stands.A Sudden Shift: With progress on major legislation and falling gas prices, President Biden faces the challenge of making those successes resonate.Struggling to Inspire: At a time of political tumult and economic distress, Mr. Biden has appeared less engaged than Democrats had hoped.Low Approval Rating: For Mr. Biden, a pervasive sense of pessimism among voters has pushed his approval rating to a perilously low point.Questions About 2024: Mr. Biden has said he plans to run for a second term, but at 79, his age has become an uncomfortable issue.A Familiar Foreign Policy: So far, Mr. Biden’s approach to foreign policy is surprisingly consistent with the Trump administration, analysts say.Drugs for common conditions like cancer and diabetes that affect older people are most likely to be picked for negotiations. Analysts at the investment bank SVB Securities pointed to the blood thinner Eliquis, the cancer medication Imbruvica and the drug Ozempic, which is given to manage diabetes and obesity, as three of the first likely targets for negotiation.Until recently, the idea that Medicare, which has about 64 million beneficiaries, would be able to use its muscle to cut deals with drug makers was unthinkable. Democrats have been pushing for it since President Bill Clinton proposed his contentious health care overhaul in 1993. The pharmaceutical industry’s fierce lobbying against it has become Washington lore.“This is like lifting a curse,” Senator Ron Wyden, Democrat of Oregon and the architect of the measure, said of the Medicare negotiation provision. “Big Pharma has been protecting the ban on negotiation like it was the Holy Grail.”Senator Ron Wyden is the architect of the drug-price negotiation measure.Haiyun Jiang/The New York TimesDavid Mitchell, 72, is among those who would be helped. A retired Washington, D.C., public relations man, he learned in 2010 that he had multiple myeloma, an incurable blood cancer. He pays $16,000 out of pocket each year for just one of four medicines he takes. He also founded an advocacy group, Patients for Affordable Drugs.“Drugs don’t work if people can’t afford them, and too many people in this country can’t afford them,” Mr. Mitchell said. “Americans are angry and they’re being taken advantage of. They know it.”Still, the measure would not deliver every tool that Democrats would like for reining in prescription drug costs. The negotiated prices would not go into effect until 2026, and even then would apply only to a small fraction of the prescription drugs taken by Medicare beneficiaries. Pharmaceutical companies would still be able to charge Medicare high prices for new drugs.That is a disappointment to the progressive wing of the party; The American Prospect, a liberal magazine, has dismissed the measure as “exceedingly modest.”Prescription drug prices in the United States are far higher than those in other countries. A 2021 report from the RAND Corporation found that drug prices in this country were more than seven times higher than in Turkey, for instance.The pharmaceutical industry spends far more than any other sector to advance its interests in Washington. Since 1998, it has spent $5.2 billion on lobbying, according to Open Secrets, which tracks money in politics. The insurance industry, the next biggest spender, has spent $3.3 billion. Drug makers spread their money around, giving to Democrats and Republicans in roughly equal amounts.At a media briefing last week. Stephen J. Ubl, the chief executive of PhRMA, the drug industry’s main lobbying group, warned that the bill would reverse progress on the treatment front, especially in cancer care — a high priority for Mr. Biden, whose son died of a brain tumor.“Democrats are about to make a historic mistake that will devastate patients desperate for new cures,” Mr. Ubl said, adding, “Fewer new medicines is a steep price to pay for a bill that doesn’t do enough to make medicines more affordable.”But Dr. Aaron S. Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, said he believed the measure would spur innovation, by “encouraging investment in important new products rather than encouraging pharmaceutical companies to try to keep pushing the same product and delaying generic entry as long as possible.”President Bill Clinton proposed a contentious health care overhaul in 1993. Doug Mills/Associated PressIn 1999, after his health care plan failed, Mr. Clinton resurrected the idea of Medicare prescription drug coverage. But this time, instead of proposing that Medicare negotiate with companies, he suggested leaving that to the private sector.“At that point, what we were trying to do was to accommodate the recognition that Republicans were lockstep in opposition to any type of government role,” said Tom Daschle, the former Senate Democratic leader.But it took a Republican president, George W. Bush, and a Republican Congress to push the prescription drug benefit over the finish line.Medicare Part D, as the benefit is known, had the backing of the drug industry for two reasons: The companies became convinced they would gain millions of new customers, and the bill contained a “noninterference clause,” which explicitly barred Medicare from negotiating directly with drug makers. Repealing that clause is at the heart of the current legislation.The architect of the benefit was a colorful Louisiana Republican congressman, Billy Tauzin, who led the House Energy and Commerce committee at the time. In Washington, Mr. Tauzin is best remembered as an example of the drug industry’s influence: He left Congress in January 2005 to run PhRMA, drawing accusations that he was being rewarded for doing the companies’ bidding — an accusation Mr. Tauzin insists is a false “narrative” created by Democrats to paint Republicans as corrupt.Joel White, a Republican health policy consultant who helped write the 2003 law that created Medicare Part D, said the program was designed for private insurers, pharmacy benefit managers and companies that already negotiate rebates for Medicare plan sponsors to use their leverage to drive down prices.“The whole model was designed to promote private competition,” he said.In the years since Medicare Part D was introduced, polling has consistently found that a vast majority of Americans from both parties want the federal government to be allowed to negotiate drug prices. Former President Donald J. Trump embraced the idea, though only during his campaign.President Biden is on the verge of being able to sign legislation that could save older Americans thousands of dollars in medication costs annually.Tom Brenner for The New York TimesThe new legislation targets widely used drugs during a specific phase of their existence — when they have been on the market for a number of years but still lack generic competition. The industry has come under criticism for deploying strategies to extend the patent period, like slightly tweaking drug formulas or reaching “pay for delay” deals with rival manufacturers to postpone the arrival of cheap generics and “biosimilars,” as the generic versions of biotechnology drugs are called.The drug maker AbbVie, for instance, piled up new patents to maintain a monopoly on its blockbuster anti-inflammatory medicine Humira — and it has reaped roughly $20 billion a year from the drug since its main patent expired in 2016.Ten drugs would qualify for negotiation in 2026, with more added in subsequent years. The bill outlines criteria by which the drugs would be chosen, but the ultimate decision would rest with the health secretary — a provision that Mr. White, the Republican consultant, warned would lead to “an incredible lobbying campaign” to get drugs on the list or keep them off it.Analysts say the bill would hurt drug makers’ bottom lines. Analysts at the investment bank RBC Capital Markets estimated that most companies affected by the measure would bring in 10 to 15 percent less revenue annually by the end of the decade.But while PhRMA has warned that a decline in revenue will make drug makers less willing to invest in research and development, the Congressional Budget Office projected that only 15 fewer drugs would reach the market over the next 30 years, out of an estimated 1,300 expected in that time.The Senate is expected to take up the bill as early as Saturday, then send it to the House. If it passes, as expected, it will pierce the drug industry’s aura of power in Washington, opening the door for more drugs to become subject to negotiations, said Leslie Dach, founder of Protect Our Care, an advocacy group.“Once you lose your invincibility,” he said, “it’s a lot easier for people to take the next step.”

The federal government has ordered 600,000 doses of the monoclonal antibody treatment, which is meant for high-risk Covid patients early in their illness.With Covid treatments still in short supply in the United States, the Food and Drug Administration on Friday gave emergency authorization to a new monoclonal antibody drug that has been found in the laboratory to be potent against the Omicron variant of the coronavirus.The Biden administration said it would make the therapy immediately available to states free of charge.The authorization of the treatment, bebtelovimab, means that the United States now has four drugs available for high-risk Covid patients early in the course of their illness that have been found to neutralize the Omicron variant. While there is a greater menu of Covid pills and treatments now than at any other point in the pandemic, the drugs have been so scarce that doctors have been forced to make painful rationing decisions during the Omicron surge.The drug that the F.D.A. authorized on Friday is manufactured by Eli Lilly, which said on Thursday that it had signed a contract with the Department of Health and Human Services to provide the government with up to 600,000 courses of the treatment for at least $720 million. The company said it had already manufactured hundreds of thousands of doses and was ready to begin shipments within 24 hours.The Lilly drug has not been tested in a study that can show whether it can stave off severe disease. The F.D.A. said it should not be a preferred product and instead should be used only when alternative treatments are not “accessible or clinically appropriate.” Federal health officials have given a similar designation to a Covid pill from Merck and the Covid vaccine from Johnson & Johnson.However, there are data suggesting Eli Lilly’s drug is safe and may reduce the amount of virus that builds up in people who are sick with Covid.Like other drugs for recently diagnosed Covid patients, Lilly’s new treatment is authorized for people who are vulnerable to becoming seriously ill because they are older or have a medical condition like obesity or diabetes. People as young as 12 can be eligible.The drug is meant to be given as a quick intravenous injection by a health care provider, typically at a clinic or hospital. It must be administered within seven days of symptoms starting.Eli Lilly tested the drug in a mid-stage clinical trial before the emergence of the highly transmissible Omicron variant; the trial enrolled Delta-infected patients. Unvaccinated volunteers with an average risk of becoming seriously ill with Covid had their symptoms clear up faster when they were treated with the drug and had a lower level of virus in their bodies after five days compared with those who received a placebo, the F.D.A. said.The study also enrolled higher-risk people, some of whom were vaccinated, and examined whether the drug was safe for them. Across the company’s safety studies, the drug was found to cause rare instances of relatively mild side effects, including infusion-related reactions, itchiness and a rash.Monoclonal antibody drugs are synthetic versions of the antibodies generated naturally when the body fights off the virus. They were widely used during the Delta surge last summer, particularly in red states. But during the ongoing surge, the country’s supply of the drugs has been sharply reduced because two of the three authorized products are ineffective against Omicron.That left just one such treatment, made by GlaxoSmithKline, available. Biden administration officials have been shipping roughly 50,000 doses a week of the Glaxo treatment to states. The purchase of bebtelovimab will allow them to double the number of people receiving monoclonal antibodies that work against Omicron.Falling case counts and a gradual increase in the supply of two new treatments meant for the same group of high-risk patients — antiviral pills from Pfizer and Merck — are also helping ease treatment shortages.The Coronavirus Pandemic: Key Things to KnowCard 1 of 4Covid boosters.

Moderna’s patent application names several employees as the sole inventors of a crucial component of its coronavirus vaccine, excluding three government scientists.WASHINGTON — Moderna and the National Institutes of Health are in a bitter dispute over who deserves credit for inventing the central component of the company’s powerful coronavirus vaccine, a conflict that has broad implications for the vaccine’s long-term distribution and billions of dollars in future profits.The vaccine grew out of a four-year collaboration between Moderna and the N.I.H., the government’s biomedical research agency — a partnership that was widely hailed when the shot was found to be highly effective. The government called it the “N.I.H.-Moderna Covid-19 vaccine” at the time.The agency says three scientists at its Vaccine Research Center — Dr. John R. Mascola, the center’s director; Dr. Barney S. Graham, who recently retired; and Dr. Kizzmekia S. Corbett, who is now at Harvard — worked with Moderna scientists to design the genetic sequence that prompts the vaccine to produce an immune response, and should be named on the “principal patent application.”Moderna disagrees. In a July filing with the United States Patent and Trademark Office, the company said it had “reached the good-faith determination that these individuals did not co-invent” the component in question. Its application for the patent, which has not yet been issued, names several of its own employees as the sole inventors.[Read Moderna’s filing with the United States Patent and Trademark Office.]The N.I.H. had been in talks with Moderna for more than a year to try to resolve the dispute; the company’s July filing caught the agency by surprise, according to a government official familiar with the matter. It is unclear when the patent office will act, but its role is simply to determine whether a patent is warranted. If the two sides do not come to terms by the time a patent is issued, the government will have to decide whether to go to court — a battle that could be costly and messy.The dispute is about much more than scientific accolades or ego. If the three agency scientists are named on the patent along with the Moderna employees, the federal government could have more of a say in which companies manufacture the vaccine, which in turn could influence which countries get access. It would also secure a nearly unfettered right to license the technology, which could bring millions into the federal treasury.The fight comes amid mounting frustration in the U.S. government and elsewhere with Moderna’s limited efforts to get its vaccine to poorer countries. The company, which has not previously brought a product to market, received nearly $10 billion in taxpayer funding to develop the vaccine, test it and provide doses to the federal government. It has already lined up supply deals worth about $35 billion through the end of 2022.Drs. Mascola, Graham and Corbett declined to comment. But in statements to The New York Times, the N.I.H. and Moderna confirmed the conflict, which has been simmering for more than a year behind closed doors.Dr. John Mascola, left, the director of the Vaccine Research Center at the N.I.H., with Dr. Anthony S. Fauci and President Donald J. Trump in March 2020.Doug Mills/The New York Times“N.I.H. disagrees with Moderna’s inventorship determination,” said Kathy Stover, a spokeswoman for the National Institute for Allergy and Infectious Diseases, the branch of the institutes that oversees vaccine research. “Omitting N.I.H. inventors from the principal patent application deprives N.I.H. of a co-ownership interest in that application and the patent that will eventually issue from it.”A spokeswoman for Moderna, Colleen Hussey, said the company had “all along recognized the substantial role that the N.I.H. has played in developing Moderna’s Covid-19 vaccine.”But she said the company was legally bound to exclude the agency from the core application, because “only Moderna’s scientists designed” the vaccine.Scientists familiar with the situation said they saw it as a betrayal by Moderna, which has received $1.4 billion to develop and test its vaccine and another $8.1 billion to provide the country with half a billion doses. John P. Moore, a professor of microbiology and immunology at Cornell University, called it a matter of “fairness and morality at the scientific level,” adding, “These two institutions have been working together for four or five years.”As is typical in the pharmaceutical industry, Moderna has sought a number of patents in the United States and overseas related to different aspects of its Covid vaccine technology. But experts said the disputed patent was the most important one in Moderna’s growing intellectual property portfolio. It seeks to patent the genetic sequence that instructs the body’s cells to make a harmless version of the spike proteins that stud the surface of the coronavirus, which triggers an immune response.While it has not publicly acknowledged the rift until now, the Biden administration has expressed frustration that Moderna has not done more to provide its vaccine to poorer nations even as it racks up huge profits.Activists have pleaded with the government to push Moderna to share its vaccine formula and transfer its technology to manufacturers who could produce it at a lower cost for poorer nations. But administration officials say they lack the authority to require the company to do so.A medical worker administers the Moderna vaccine in Philadelphia in May.Rachel Wisniewski for The New York TimesLast week, the advocacy group Public Citizen wrote to Dr. Francis S. Collins, the director of the N.I.H., urging him “to publicly clarify the role of the N.I.H. in the invention of the vaccine” and to explain what he intended to do “to ensure the contributions of federal scientists are fully recognized.” The group has not gotten a response.“It’s not just about bragging rights,” said Zain Rizvi, a drug policy expert at Public Citizen who researched Moderna’s patent filings. “It’s also about supply. Patents are development monopolies, and in a pandemic it is a terrible idea to have a private corporation have a monopoly on part of a lifesaving technology.”If the N.I.H. scientists were named as co-inventors on the patent, the agency would generally not need Moderna’s permission to license it to other companies or organizations, patent law experts said. In theory, that could help expand the supply of the Moderna vaccine.Moderna has pledged not to enforce its Covid vaccine patents during the pandemic. But a license from the government would provide additional legal reassurance to manufacturers and allow them to keep producing the vaccine after the pandemic, experts said.With a license from the U.S. government, “you’ve got the force of law rather than just a statement in the public domain,” said Ameet Sarpatwari, an expert on pharmaceutical policy and law at Harvard Medical School.But even with a license, manufacturers would lack crucial components for quickly making Moderna’s vaccine — including the recipe and the company’s technical know-how.A patent license is “just one piece of an otherwise very large jigsaw puzzle,” said Jacob S. Sherkow, an expert on biotechnology patent law at the University of Illinois College of Law. “The patent license does not build factories, it doesn’t source raw materials, it doesn’t train workers.”The N.I.H. could benefit financially from licensing out the patent. Several experts said it was difficult to know how much, but Mr. Sarpatwari estimated the agency could reap tens of millions of dollars.For the company, having patents solely in its name helps “support a narrative that Moderna was not just the lucky recipient of unprecedented massive investment by the U.S. government, but that Moderna made unique and essential contributions on its own,” said Christopher Morten, an expert on pharmaceutical patent law at Columbia Law School.That could help the company justify its prices and rebuff pressure to make its vaccine available to poorer countries.“Moderna wants exclusive ownership and control of this patent,” Mr. Morten said. “They want to be the only organization that decides where mRNA-1273 is made, how it’s made, who makes it, what price it’s sold for. And co-ownership of this patent is a threat to that control.”The story of the public-private collaboration has been one of the few bright spots of the pandemic. The three government scientists — especially Dr. Corbett, who emerged as a role model for young Black women in science and has worked to address vaccine hesitancy in minority communities — have been hailed as heroes.Moderna, a young company that had never before brought a product to market, became a household name virtually overnight. The vaccine is on track to bring in up to $18 billion in revenue for Moderna this year. The company has already booked deals for next year worth up to $20 billion. Sales of its vaccine both this year and next are likely to rank among the highest in a single year for any medical product in history.Dr. Graham, who was the Vaccine Research Center’s deputy director before his retirement, began his work on coronaviruses long before the pandemic. In 2017, he led a team of researchers, including Dr. Corbett, that figured out how to employ protein engineering to stabilize the spike proteins on the coronavirus before they fuse with other cells.Moderna, a young company that had never before brought a product to market, became a household name virtually overnight.Dmitry Kostyukov for The New York TimesThat technology, which has been patented by N.I.H. and several academic collaborators, is foundational to a number of coronavirus vaccines, including the ones made by both Moderna and its main competitor, Pfizer-BioNTech. But while BioNTech and other companies have paid to license the technology, Moderna has not — another sore point between the company and the government, a senior administration official said. Moderna declined to comment on it.Moderna and the government researchers had been working together for four years on projects involving other coronaviruses when the new one emerged in China. In January 2020, N.I.H. and Moderna “agreed to collaborate and jointly develop” a vaccine, Ms. Stover said.The Vaccine Research Center quickly zeroed in on the gene for the virus’s spike protein and sent the data to Moderna in a Microsoft Word file, Dr. Graham said in an interview last year. Moderna said at the time that its scientists had independently identified the same gene. The company’s chief executive, Stéphane Bancel, said Moderna plugged the data into its computers and came up with the design for an mRNA vaccine.“We had two teams working in parallel, to increase the chances,” Mr. Bancel told the M.I.T. Technology Review.When Moderna announced a year ago that the vaccine had been found in a key trial to be spectacularly protective, the N.I.H. called it “the N.I.H.-Moderna Covid-19 vaccine” in its own news release. Dr. Anthony S. Fauci, who oversaw the research in his role as director of the allergy and infectious diseases institute, said that the “vaccine was actually developed in my institute’s vaccine research center by a team of scientists led by Dr. Barney Graham and his close colleague, Dr. Kizzmekia Corbett.”Asked late last year about the comment, Mr. Bancel pushed back. “The vaccine technology was developed by Moderna,” he insisted.Consumer advocacy groups and government watchdogs have long complained that the N.I.H. is not aggressive enough in protecting and asserting legal rights to its work — to the detriment of taxpayers, who often face high costs for drugs developed with government funding and research.“It points to these broader issues that N.I.H. has with basically getting taken advantage of by pharma,” said James Krellenstein, a founder of PrEP4All, an AIDS advocacy group that successfully urged the Trump administration to sue Gilead Sciences, accusing the company of making billions by infringing on government patents for H.I.V.-prevention drugs. The suit is pending in the U.S. District Court in Delaware.Ms. Hussey, the Moderna spokeswoman, said that the “N.I.H. having rights under the patent application is not dependent on being listed as co-inventors.” She declined to answer additional questions about the rights she was referring to.Scientists from the agency are named on a minor patent application that does not confer licensing power over the technology covered by the primary patent application. Ms. Stover, the spokeswoman for the National Institute for Allergy and Infectious Diseases, said that none of the agency’s collaboration agreements with Moderna “include language controlling the licensing of inventions that might result from that work.”Kitty Bennett