A Week Ago, I Could Not Find the Evil in This

I literally wrote, "I Cannot Find the Evil Here," regarding the Trump Administration's move against Gilead for violating the CDC's patent on "Truvada for PrEP," which used the drug as a prophylactic treatment for HIV.

Well, it turns out that the nature of the CDC patent is such that their attempted enforcement of their claims would allow big Pharma to "Evergreen" (maintain their drug monopoly) basically forever.

It turns out that the patent is not on the drug, but on the fact that taking one pill a day will prevent HIV infection.

This is wrong on a number of levels.

First, the PrEP treatment was not an invention, it was a discovery, which should not be patentable, and second, if upheld, this will provide drug makers with the ability to acquire IP based exclusivity forever:

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.

“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.

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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.

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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.

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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.

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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.

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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.
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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.”

FYI, "March-In Rights" are a provision of Bayh-Dole, the 1980 law that privatized the proceeds of most federally funded research.

The "March-In Rights" allow the federal government to license patents to other entities if the patent holder fails to meet the, "Health and safety needs of consumers."

Despite the egregious actions of big pharma, "March-In" has never been applied.

I would prefer for the Bayh-Dole to be completely repealed, but the case for "March-In" is incontrovertible.