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Comment by TheAmazingIdiot | Hacker News Reader

Hmm. So the way I read this:

We have an old drug that helps diabetes to treat cancer.. The drug costs $.05/pill, for diabetes.

It will be called "Nocan", and feature a $24/pill cost, due to a new patent being granted. *

*Just like Eli Lilly with PMS-PMDD and name change of Prozac to Sarafem. All you need do is bribe FDA for new "disease" name, and you have another 17 yr patent.

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Orphan Drug Law. If you want someone to do all the work to actually prove it works, which is incredibly expensive, they must be compensated in some way.

There are certainly other ways to compensate people who do this research, but this way maps pretty well to our current laws.

Some drugs are very expensive, but most orphan drugs aren't. Average costs are between $25-60 million per drug.

http://www.palgrave-journals.com/biosoc/journal/v6/n1/full/b...

http://www.cptech.org/ip/health/rnd/evidenceregardingrnd.pdf

A somewhat similar corollary - 'Lovaza', sold by GSK. It contains Omega-3-acid ethyl esters.

Also widely known as fish oil, and is prescribed for the same reasons fish oil is recommended in supplementation. Only difference is fish oil is marginally less concentrated, much cheaper, doesn't have the 'pharma' tag and isn't prescribed.

In the industry it's known as one of the biggest cash cows for GSK - it's earned them many billions.

http://www.omegavia.com/lovaza-vs-fish-oil/

They might as well have called the drug "snake oil". It would have made more sense :-)

Patents are the foundation for knowledge trickle-down-theory.

Huh? How do you patent metformin? It's an extremely widely prescribed drug.

You don't. You patent "Nocan", a drug with an extremely similar (most would say "identical") chemical structure. Metformin is a diabetes medication, while Nocan will be a cancer drug, so they're totally different. The diseases aren't even handled by the same medical specialists. ;)

If metformin works for cancer the way aspirin does for heart disease, with an overall long-term prophylactic effect, people will just take metformin. It is very easy to get metformin.

I was going to say that your doctor won't be allowed to prescribe metformin, but I checked and the FDA is fine with your doc independently prescribing drugs for off-label use. The manufacturer of metformin isn't allowed to market it as an anti-cancer drug, but what doctor won't be aware of this?

at least it is a new indication, see the Makena Pricing Controversy to learn about what the Orphan Drug Law allows https://en.wikipedia.org/wiki/KV_Pharmaceutical#Makena_prici...

It's possible to receive a patent for applying a known drug to a new area.

First of all, are you sure about that?

Second of all, how does that even work? Metformin is very very widely prescribed.

It's called a "use" patent.

There are many different ways to patent a drug. Composition patents, formulation patents, use patents, etc.

The problem is that if you get a "use" patent, it only stops other company from promoting the drug for the use you patented. In the case of metformin, it's already available as a cheap generic.

So if a company were to conduct studies proving that it reduced the risk of cancer and got a patent on it, there is nothing to stop a doctor from prescribing the generic version.

So unless a company can find a way to recoup their R&D costs associated with running the trials, they won't bother.

I wasn't aware of use patents. Informative post, thank you.

So who would break patent law in the case that a doctor prescribes the $0.05 diabetes pills to a cancer patient?

The doctor? He doesn't really make a profit of this and at least over here in Austria, a doctor may prescribe any substance he wants as long as he can argue that it is for the well-being of his patient.

The producer of the diabetes drugs? They don't sell it as a cancer drug.

The apothecary? He's just following the doctor's orders.

Nobody would be sued because nobody is breaking any patent laws.

That's why you rarely (never?) see a drug company take an old, off-patent drug and try and get a patent for it (in it's original form) on a new disease. Since there is no way to recoup any investment costs, they simply don't make the investment.

What does happen is that drug companies will take an old, off-patent drug and modify it somehow so that it can be patented. They can do that a number of different ways: create a unique formulation of the drug, create a drug-device combination product or try and create a slightly modified (and hopefully improved) version of the original drug.

Under the current system, unless you have a patent (or marketing exclusivity from the FDA) you have no opportunity to recoup any investment you made in the drug.

The parent is saying you can patent "using Metformin to prevent Cancer" separately than "using Metformin to help with diabetes."

I'm not 100% sure of this, but I'm pretty sure that this is the way the FDA approval process for drugs work. You can't just 'decide' to prescribe Metformin for cancer one day.

A single drug has to go through the approval process N separate times for N separate applications/diseases.

Yes, you can. Doctors prescribe drugs for off-label use all the time. The FDA approves the marketing of drugs for specific health problems, but nobody cares about marketing metformin.

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