The Trump administration appeared this month to finally act on a campaign promise to lower drug prices by taking the maker of an HIV drug to court for violating a government patent.
But as with all things Trump, what you see on the surface is not all that’s actually going on.
First, this is only about one drug, a crucial drug to prevent HIV, that was developed with taxpayer money. Its high price has been targeted by well-organized activists for the HIV/AIDS community because it costs more than 300 times as much in the United States as in Africa.
Second, and more importantly, the federal complaint may well help drug companies extend their patents and years of sales at inflated monopoly prices.
The patent covers the prescribed regimen that says the patient must take one pill daily—but not the pill itself.
“Evergreening” patents and sales exclusivity by the pharmaceutical industry is one of key factors in the high price of prescription drugs in the United States. It keeps cheaper generics medicines off the market.
The specific patent that the U.S. government wants to protect, and get paid for, is one of the controversial group of patents for a process. It covers the prescribed regimen that says the patient must take one pill daily—but not the pill itself.
High Prices Into Future
Critics think the government patent is weak. But they also worry that a court decision may validate patents for the regimen, which could create a government-supported precedent allowing drug companies to maintain monopoly prices for decades and possibly forever.
“This is a crucial medicine in the fight against HIV and AIDS,” said James Love, founder of Knowledge Ecology International, or KEI, an organization that has been pushing the U.S. government to demand royalties from drug companies it has granted sales licenses to keep the price down.
“However,” he warned in an interview, “I don’t think this particular suit with its controversial patent issue is the best way to go forward. This seemingly pro-consumer action could backfire on Americans.”
More than one million Americans live with H.I.V. and 40,000 people are infected every year.
The drug whose regimen is at issue is marketed under the brand name Truvada. It was developed to treat patients who already have HIV/AIDS with millions of taxpayer dollars funding U.S. scientists at the Centers for Disease Control and Protection and elsewhere.
Government researchers did follow-up studies that showed Truvada could also prevent HIV in patients, a huge step forward in the fight against AIDS. The prevention version of Truvada is marketed under the brand name Descovy.
New Use, New Patent
Prevention is a secondary use of Truvada. Patents for secondary uses, or for processes—telling patients what pill to take and when—have given drug companies essentially eternal monopolies on sales of those medicines.
“If the government protects this kind of patent, it could ultimately serve drug makers and enable them to keep recycling old patents,” said Love. His non-profit organization has been in the front of efforts to push Congress to force the Bush, Obama and now the Trump administrations to stop giving profitable, semi-permanent patent protection to makers of drugs developed through taxpayer-funded research.
Gilead Sciences, the San Francisco company given sales rights by the government, made about $3 billion on Truvada last year, without paying significant royalties to the U.S. government.
The government’s lawsuit filed in federal district court in Delaware accuses the drugmaker Gilead Sciences of exaggerating its contribution to the development of Truvada’s prophylactic regimen. In a statement, HHS Secretary Alex Azar said, “Gilead must respect the U.S. patent system, the groundbreaking work by researchers with the Centers for Disease Control and Prevention, and the substantial taxpayer contributions to the development of these drugs.”
The U.S. Government has rarely fought a major pharmaceutical corporation for royalties, though groups such as KEI and Public Citizen have been pushing for aggressive action related to drugs largely funded by American taxpayers.
Public Citizen praised the U.S. lawsuit against Gilead.
“The fact that the federal government sued a drugmaker over a medication developed in part with taxpayer money is a milestone,” Zain Rizvi of Public Citizen said in a statement. Gilead “has continued to reap billions in revenues while the rate of new HIV infections has not gone down.”
Gilead charges American patients with AIDS about $20,000 per year for the drug Truvada. The same/version of the drug sells in Africa for $60 per year. Truvada for PrEP is the term for applying the drug to prevent AIDS infection. PrEP is an acronym for pre-exposure prophylaxis. This preventive usage is crucial for public health strategies to eradicate HIV and AIDS by 2030, a target announced by Donald Trump this year.
As Seen on Television
Gilead was also given patents by the U.S. government for another drug developed with millions of taxpayer dollars, Harvoni. That drug, heavily advertised on television, is a crucial treatment for people infected with Hepatitis C.
In November 2018, the U.S. Preventive Services Task Force recommended that high-risk patients take a Truvada or PrEP pill every day. That is basically what the CDC had patented—the daily regimen for prevention.
Ponder that for a moment. Imagine if your physician or pharmacy could get a patent for writing “bid” on a prescription, meaning take a pill twice a day. Our Constitution authorizes exclusive patents for “limited times” to encourage “discoveries.” How instructing patients on how many times per day or what times to take a pill or apply a medication qualifies is a mystery.
Yale University’s Global Health Justice Program leadership, during Congressional hearings in May on PrEP access and costs, slammed Gilead for its refusal to share the proceeds from its sales of Truvada with the government or to significantly lower the price for patients in the United States.
In a letter to the House Oversight Committee, Yale’s health justice team also raised questions about the government’s patent of the secondary use and the treatment process. "We have serious concerns about the value that method of treatment patents like the CDC’s patents for PrEP (and still more other “secondary” patents),” the team wrote.
“Indeed, they are regularly used by the pharmaceutical industry to artificially extend patent protection on expensive brand name drug products, delay generic competition, and keep prices high,” the Yale letter continued.
However, wrote the Yale team, since “under current law, such patents are both valid and common…….we see no valid argument that government should not use its own method of treatment patents to promote fair prices,” and get royalties from Gilead to force lowering of prices.
Gilead Sues U.S.
Gilead says that the PrEP government patent for the U.S usage regimen isn’t legal. In a suit the company filed against the government in August, Gilead claims the use of Truvada for prevention of HIV was being discussed by medical researchers before the government filed its patent claim in 2006.
Stat Tahir Amin, head of the Initiative for Medicines, Access, and Knowledge, said, "I’m surprised the CDC was able to get these patents in the first place,” he told Stat’s Ed Silverman. “They may show some kind of utility, but they didn’t invent anything. The compounds were already known to treat and prevent HIV.”
Slow to Act
KEI’s Love said the government has been slow to act. “HHS could have exercised march-in rights three years ago on this drug paid for by U.S. taxpayers,” Love said. The government could have applied for a patent that guaranteed the royalty payments to America, not profits to Gilead. “But getting a patent for the procedure is another way of “evergreening” a patent – it makes the United States a patent troll.”
In addition, it’s not clear how royalties to the United States will be used to make Truvada cheaper or more accessible, an issue that HIV/AIDS activists want discussed.
If the government wins its suit against Gilead, the beneficiaries will include the CDC and NIH scientists, who, James Love says, stand to collectively receive about $150,000 in royalties annually.
Editor's note: Raw Story Chairman John Byrne is also the Board Chair for Prevention 305, a Florida nonprofit focused on preventing HIV and increasing PrEP uptake in Miami-Dade County, Florida.