After more than a year of controversy, the federal government filed a lawsuit accusing Gilead Sciences (GILD) of infringing patents on a pair of HIV prevention pills and unfairly reaping hundreds of millions of dollars from research funded by taxpayers.
The patents are held by the Centers for Disease Control and Prevention, which helped fund academic research into HIV prevention that later formed the basis for a pair of pills — Truvada and Descovy — that are sold by the drug maker. The Department of Health and Human Services contended that Gilead refused to reach a licensing agreement despite “multiple attempts” at reaching a deal. “Gilead’s conduct was malicious, wanton, deliberate, consciously wrongful, flagrant, and in bad faith,” the suit states.
“HHS recognizes Gilead’s role in selling Truvada and Descovy to patients for prevention of HIV. Communities have put these drugs to use in saving lives and reducing the spread of HIV,” HHS Secretary Alex Azar said in a statement Wednesday. “However, Gilead must respect the U.S. patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs. The complaint filed today seeks to ensure that they do.”
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A two-edged knife: without companies doing drug development this pill would not exist, nor would it without taxpayer moneys. As tax moneys have assisted in the development, the concept of royalties paid back by the drug makes sense. Unlike with vaccines (with government support) those who need this pill due to lifestyle choices should also expect to participate in the cost.
KJ, point taken. Pharm development is so intensely complex and risky, it makes Solyndra losses ($500,000,000) seem like pocket change.
Anyone who think Harvard MD/PhD pharm-researchers are going to allow fact-clumsy goofs like Mr. Sanders and Ms. Warren to lecture them about their lives, s/he should sober up, STAT. They’ll just do pharm deals with Beijing, Moscow, Paris, or elsewhere. And the USA will keep falling apart.
It is like when a country steals an inventor’s hard-earned patent. That may happen once — and there will NEVER be another inventor like that, again. No inventor will go down that path, again. Cheating happens only once.
As for claims, “well, Salk didn’t get royalties” — the facts. He was tenured faculty. The patents belonged to his employer. Salk had NO patent rights to sell, to anyone. Facts don’t make pretty headlines — and headlines don’t pay the bills.
Hi Kathryn J,
I agree that without some development work beyond taxpayer research, there would be medicines that would not exist.
As for the PrEP pills, I don’t recall hearing from AIDS activists that they believe people should not participate in the cost – or pay for a pill, if that’s what you meant. Their argument has been about Gilead paying royalties back to the government.
Beyond that, not sure what you mean by ‘lifestyle choices.’
Regards
ed at pharmalot
I concur with Russ. New drugs require research AND development (R&D). The research was funded by taxpayers, but the development (clinical trials, approval, manufacturing) was not. The Complaint was inaccurate there. The tax dollars only paid to allow a patient to go read about the discovery in a book on the shelf of a library while they continue to get infected with HIV. The investment in the development came from Pharma (including all the drugs that didn’t make it).
There’s a deeper issue here than just getting Gilead to lower their prices (which will happen next summer anyway when the generic comes out with Teva partnership). More political strong-arming. It also sends the wrong message when patents are attacked by the same government that grants them in an ostensibly free-market economy.
To Russ and Stephen,
I’m aware of the costs and failure rates of clinical trials, generally speaking, but thanks for the numbers, Russ.
And Stephen, I understand your point. I think there is some validity to both arguments over the obligations and opportunities stemming from research that is funded with taxpayer dollars. This has actually been going on for decades and perhaps the outcome of this lawsuit will add some clarity.
Meanwhile, Gilead has just sent me its comment which, not surprisingly, argues that it paid for the R&D that led to the invention of the product. And I have updated the story to reflect this. More to come, obviously, if not today, but certainly going forward.
I appreciate that you took the time to write.
Regards,
ed at pharmalot
That’s rich considering Rumsfeld is a major stockholder in Gilead. I guess trump doesn’t like him.
Mr. Writer: were there clinical trials? If so — who paid for them? What did they cost?
What is the clinical trial failure rate, among govt patents? 97%?
Facts. Without them, failure is always the outcome.
Hi Russ
Thanks for the note.
I understand your point and in the story I noted that Gilead has argued the prices charged for its pill was used to fund innovative research.
Through the months of controversy, however, Gilead has otherwise not offered specifics about the cost of pertinent trials.
I’ve asked Gilead for comment concerning the suit, as noted in the story, and will update the post with any information the company is willing to provide.
Thanks for stopping by,
ed at pharmalot
Sir: thx for reply. Let me help you, as so many political gas-bag know-nothings fail to actually do any first-hand research —
1. Cost of clinical trials — can be greater than $2,000,000,000. Taxpayers do NOT pay for those.
2. Failure rate in clinical trials — as high as 97%. A very high risk game.
If the political gas-bags think they can do a better job — why haven’t they?
Answer: because they know nothing. Zero. Beyond useless. They also have avoided hard work, too.
Looking for more money for medicine? Why is smoking tolerated? Illegal drugs? Heavy booze? “Wild living?” There’s $500,000,000,000+/year in costs, right there.