Gilead Delayed Introduction Of New Version of HIV Drug, With Fewer Side Effects, Maximizing Its Patent Monopoly And Profits
from the Big-Pharma-behaving-badly dept
Techdirt has been writing about “evergreening” for many years. It refers to the practice by pharmaceutical companies of making small changes to a drug, often about to come off patent, in order to gain a new patent that extends its manufacturer’s monopoly control over it. The New York Times has a story about the Big Pharma company Gilead Sciences that involves evergreening, but with a twist.
It concerns the drug tenofovir, which is used for treating HIV. Its patent expired in 2017, and Gilead naturally worked on a replacement that would extend its patent monopoly beyond that date. But Gilead stopped work on the new version in 2004. At the time, the company’s press release explained this was because it didn’t have “a profile that differentiates it to an extent that supports its continued development.” That’s a rather implausible excuse, since the technique of patent evergreening is based on the idea that even tiny changes to a drug justify granting a new patent. Drawing on “a trove of internal documents made public in litigation against the company,” The New York Times says there was another reason why work on the new version was halted:
The promising drug, then in the early stages of testing, was an updated version of tenofovir. Gilead executives knew it had the potential to be less toxic to patients’ kidneys and bones than the earlier iteration, according to internal memos unearthed by lawyers who are suing Gilead on behalf of patients.
Despite those possible benefits, executives concluded that the new version risked competing with the company’s existing, patent-protected formulation. If they delayed the new product’s release until shortly before the existing patents expired, the company could substantially increase the period of time in which at least one of its H.I.V. treatments remained protected by patents.
Despite those 2004 concerns over its “profile”, Gilead did introduce the new version, but just a couple of years before the 2017 expiry of the patent on the original version. As The New York Times notes, that was nearly a decade after it could have been made available had work on the new version not been paused. Because of this delay, Gilead has patents on its HIV drug that will run until at least 2031.
The delayed release is now the subject of state and federal lawsuits in which around 26,000 patients, who took Gilead’s older version of tenofovir, claim that the company exposed them to kidney and bone problems that could have been avoided. The company denies this:
In court filings, Gilead’s lawyers said that the allegations were meritless. They denied that the company halted the drug’s development to increase profits. They cited a 2004 internal memo that estimated Gilead could increase its revenue by $1 billion over six years if it released the new version in 2008.
But that makes no sense. Why would a canny Big Pharma company forgo an estimated $1 billion in revenue for apparently no reason? It certainly wasn’t because the new version’s “profile” was unsuitable, as its subsequent successful launch proves. Its hard not to see this as a calculated move to maximize sales and profits based on the (correct) assumption that drug prices would continue to rise strongly, making an extended patent monopoly even more valuable than a truncated one.
The move has certainly paid off for Gilead, but not for people with HIV. If the new version had been patented back in 2004, it would be coming off patent soon, which would mean cheap generics would be available, widening access to the drug. Moreover, as the lawsuits note, people would have been spared the serious consequences of taking a drug for years that had toxic effects on their bodies.
This is not the first example of Gilead behaving badly with its HIV drug. Back in 2019 Techdirt wrote about how Gilead was charging $24,000 annually per patient for a treatment, based on tenofovir, that was developed with US taxpayer money, and even patented by the US government. The cost of producing the treatment? Just $60 annually per patient.
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Filed Under: big pharma, drug patents, evergreening, hiv, side effects, tenofovir, truvada
Companies: gilead sciences
Comments on “Gilead Delayed Introduction Of New Version of HIV Drug, With Fewer Side Effects, Maximizing Its Patent Monopoly And Profits”
Another bad part of all this is that it will be pointed to by the anti-vaxxers as proof that you can’t trust vaccines.
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For anti-vaxxers everything is proof that you can’t trust vaccines. But, yeah, another example of greedy pharmaceutical companies isn’t going to help.
On the other hand, with these ridiculous profit incentives, what do we expect?
'Sure delaying means suffering but I'M not suffering so so what?
Few industries(barring perhaps the prison system) present a more compelling case for the government stepping in and nationalizing them than the pharmaceutical one that shows time and time again how utterly vile the CEO and execs of the respective companies are and how willing they are to spread suffering merely to make a little more money than the already obscene amounts they already make.
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Yeah no, the carceral system should at least have the state take over all the privately-run hellholes, and never have allowed, nay, created such a thing in the first place. Fixing that system is a whole other ball of wax.
Patents and copyrights have bee corrupted from their stated purpose of protecting the interests of creative people who into a means of extending corporate controls and increasing corporate profits.
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In the US, the constitution suffers the existence of patents and copyright NOT for authors/creators benefit, but “to promote the progress of science and useful arts”. Meaning it is for the benefit of the masses. The fact that “creators” benefit is somewhat incidental to its purpose.
Or in other words, the constitution allows congress to secure limit benefits to one group, but only for the long term profit of another(specifically the public)
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“Is there no balm in Gilead; is there no physician there? why then is not the health of my people recovered?”
(Jeremiah 8:22)
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So I guess that question has finally been answered.
Today I Learned there is a company called Gilead.
To me there should be State owned businesses in whatever areas are life-critical. Energy, communications, education, security (public) and healthcare. Not that there shouldn’t be any private activity there, it’s just that you can’t only think about profit when it comes to these areas and public businesses also act as breaks on predatory capitalism. It can be done and it works fine. And gives people choice or, at the very least, the only option.
“But, but public companies are inefficient!” – because the elected politicians are either incompetent or working towards their own interests instead of the collective interest. Also, private businesses fail too. Or enshitify.
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Food is life-critical. Should the government take over food? I think you need to add the condition that there are high natural barriers to entry.
Re: Re: Food Stamps...
The gov is hugly involved in food, from Food stamps to school lunch to who know what else the Gov is the biggest purchaser of food products in the US.
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Let alone that the FDA has the final say in just about everything that ever gets to the dinner table. The FDA regulations have been (unfavorably) compared to the IRS code in terms of complexity and breadth of control.
And that’s before even start looking at state and local regulations….
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And yet people are still poisoned by the food they ingest.
Big business complains about all the regs they have to bear, the consumer complains about being dead.
foodborne illness is serious
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Farm subsidy and research.
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High natural barriers? I think those would be few and far between, but if you’re thinking “high artificial barriers, then you and I are on the same page.
But if we’re going to go down this road, we’ll all agree that the entire recording industry is not essential in any meaningful way, but it certainly meets all the other requirements for government getting into the mix. I mean, look at what the gov’t has done vis-a-vis copyright for that industry – if that isn’t a man-made (artificial) barrier to entry into the big leagues, then I don’t know what is.
And yes, copyrights aren’t patents, I know that. But creativity is the same no matter what field or industry or medium or whatever you call it, if one is creative, then one will create. Regardless of how such creations might be protected.
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If you read my comment carefully I don’t say the govt should be the exclusive operator but yes, it should be in the food supply chain as well. Here we have a public company that maintains stocks of critical food items such as rice, beans, soy and others and use it to cushion people from abrupt price variations, shortages (due to climate issues for instance) and market manipulation from the big players. And it works.
I would be hesitant to accept the NYT as a reliable source on anything related to health or medicine at the moment.
There are many reasons for delaying a drug launch. It may well have been done solely due to profit, but I simply cannot trust that anyone at NYT is capable of comprehending even basic medical guidelines based on their recent coverage. Their editorial standards on medical topics also appear to be nonexistent, especially basic fact-checking.
If there are better sources investigating this, I would cite them.
One major flaw with this argument, just at first glance, is that few corporations prefer potential profits in a decade over sure profits now. They also eventually released the drug before the prior patent expired as well. It’s possible that they delayed it for profit reasons, it’s just not the sole explanation, and I don’t trust the NYT to abandon a narrative unsupported by facts.
In fact, it would be a first for their health & medicine coverage if they ever did so. The closest I’ve seen is they stopped demonizing SSRIs when they switched to targeting gender-affirming care.