AIDS Drug Patent Revoked In US

eldavojohn writes "Doctors Without Borders is reporting that four patents for tenofovir disoproxil fumarate, a key AIDS/HIV drug, have been revoked on grounds of prior art. This is potentially good news for India & Brazil who need this drug to be cheap; if the US action leads to the patent being rejected in these countries, competition could drastically lower prices. But the ruling bad news for Gilead Sciences. The company has vowed to appeal. We discussed this drug before."

I can feel the kindness

[Jangchub]

Nice. Squeezing a buck out of the poorest and sickest people in the world. Gilead Sciences makes the *channers look like Mother Teresa in comparison. Par for the course in the Pharmaceutical industry.

Re:I can feel the kindness

[Smordnys s'regrepsA]

Big Pharma is corrupt as all heck. They don't "research new drugs," they research how to make minor changes to existing drugs so they can re-patient. They just had an ex-industry insider (from relatively high in the ranks) condemn them to our congressmen.

Don't get me started on how much of the "research" money comes from the government.

I'll willing to accept that there might be a perfectly rational, moral reason the drugs are priced the way they are... but I haven't heard it yet.

Re:I can feel the kindness

[Lost Engineer]

The research is largely proving that the drugs are effective and safe. This costs good money, and few will do it it there's not something in it for them.

I'm not defending big pharma or any company in particular.

Re:Cool...

[Anonymous Coward]

Now if they stop granting patents on chemical compounds and their use and return to granting patents only on synthesis and novel purification methods

I do not understand what you are saying. They do not issue patents for finding and identifying the chemical structure and physical properties of compounds found in nature. They will issue a patent for finding a medicinal use of a compound found in nature. But mostly we are talking about libraries of compounds that are developed and claimed by a company. If the compound is rigorously novel, then they would have an automatic patent on the work up for the compound. So they have never issued patents like "I claim NaCl." Overall, I think that the posts here are way too critical of pharmaceutical companies. It is true that there are *WAY* too many hands in the cookie jar and these companies are spending some times as little as one seventh of their money on actual research, but this is not the complete rule. Inside some of the companies are dedicated chemists and physicians who *have* to return profit to their shareholders to stay in business.

Re:I can feel the kindness

[foobsr]

A thing to remember though is that the average cost of developing a new drug easily runs into hundreds of millions of dollars and that they need to make that back to stay in business.

This is why they struggle so hard, quote [nybooks.com]: " In 2001, the ten American drug companies in the Fortune 500 list (not quite the same as the top ten worldwide, but their profit margins are much the same) ranked far above all other American industries in average net return, whether as a percentage of sales (18.5 percent), of assets (16.3 percent), or of shareholders' equity (33.2 percent). These are astonishing margins. For comparison, the median net return for all other industries in the Fortune 500 was only 3.3 percent of sales. Commercial banking, itself no slouch as an aggressive industry with many friends in high places, was a distant second, at 13.5 percent of sales." (emphasis mine)

CC.

Re:I can feel the kindness

[Anonymous Coward]

From "Excess in the pharmaceutical industry" by Marcia Angell, http://www.cmaj.ca/cgi/content/full/171/12/1451 [www.cmaj.ca]

Although the pharmaceutical industry claims to be a high-risk business, year after year drug companies enjoy higher profits than any other industry.

In 2002, for example, the top 10 drug companies in the United States had a median profit margin of 17%, compared with only 3.1% for all the other industries on the Fortune 500 list.1 Indeed, subtracting losses from gains, those 10 companies made more in profits that year than the other 490 companies put together.

Re:I can feel the kindness

[jellie]

That's ridiculous. Drugs are not priced based on market forces. In fact, there are no market forces. Assuming you have insurance, then the drug's cost to you is not the real cost - nor is the "market" price related to the cost to the company. Amgen and Roche are in a battle over dialysis drugs [nytimes.com]. With kickbacks, reimbursement rates, and other strange financial dealings, the prices become complicated. Look at Genentech too. Their main competitor to Lucentis, their drug for wet age-related macular degeneration, is Avastin, another one of their drugs! Yet Lucentis costs about 40 times as much as Avastin. That has nothing to do with the market. So what do they do? They try to prevent ophthalmologists from purchasing Avastin to use as treatment for AMD, by halting sales to compounding pharmacies.

The barrier to entry is also extremely high (though this might be necessary to ensure there aren't fakes). As a patient, you have little choice. Do you honestly shop around for the cheapest doctors when it comes time for surgery? You don't have much say in what the doctor will order for you, and you have essentially no say in who your anesthesiologist will be.

Re:I can feel the kindness

[MD-PhD Student]

The academic medical center lab I work in is trying to develop a new cancer therapeutic. We'll be starting up phase I (toxicity) clinical trials soon. The reason academia (what the NIH funds) can't completely bring a new drug to market is multifactorial: It's pretty much impossible to get much past a phase II (dosing and efficacy) trial in academics because phase III (therapeutic vs. gold standard) trials usually take thousands of patients and years to complete and are as expensive as hell. Even if you can get past phase III (and it takes up to 15 years and half a billion dollars from when something works in the lab until it's routinely given to patients), we still can't manufacture therapeutics on a large (commercial) scale in the lab. Part of the reason we use industry to bring therapeutics we've developed to market is that we are just not (in academics) set up to do it on our own. I don't particularly like working with private companies but we really have no other option.

Perhaps the NIH should buy a small generic pharmaceutical producer to make the drugs we develop. The FDA should also be less stringent in the drugs it approves: once you figure out toxicity and dosing, the therapeutics should be routinely available. Yes, there will be unforeseen toxicities associated with the therapeutics that we don't know about because we've only used the therapeutic on a couple of hundred people, but how many people are dying/suffering large morbidity because it takes that extra ten years to get a therapeutic to market?

Private ownership of publicly funded research

[flappedjack]

One of the real problems here is the Bayh-Doyle Act of 1980, which allowed publicly funded researchers (including universities) to patent or otherwise own the intellectual property rights of inventions funded by your tax dollars and mine.

Before 1980, companies had to do all the research work themselves. If they were assisted by a university's research lab, and if that lab were funded by the Federal government, then intellectual property rights would be held by the government. If Whatsamatta U discovered how to synthesize an enzyme, for instance, no one could ever patent that process. The fruits of publicly funded research were public.

After Bayh-Doyle, everything changed. Universities could patent their publicly funded discoveris, so they were free to enter into partnerships with corporations - the universities, funded by the government, do the lion's share of research. The corporations figure out how to turn discoveries into marketable goods. Everyone wins - except for the people who actually paid for the research in the first place: US taxpayers.

Re:Big Profits for Pharma is Great news!

[Anonymous Coward]

I just wish someone would make a list of the top 50 drugs in the last 50 years and who made them and how they were financed.

DISCLOSURE: I work in biomedical research and involved in one of the companies working on buyouts listed below.

There isn't a list because the public isn't supposed to know. The vast amount of research is done at Universities or publicly funded labs. Drug companies take the results and reap the profits. Most, and I mean the vast majority, of medical breakthroughs were done on the public dime.

Hell, Canada's medical research system puts ours to shame and they're "evil socialists". They've developed portable MRIs, live heart imaging systems, etc and thats just in the past few years. Now American investors are looking at buying them up. Not for research but for the profit.

Re:Big Profits for Pharma is Great news!

[GraZZ]

The Canadian provincial health plans don't cover pharmaceuticals.

Sorry, US citizens are being gouged.