You invent cure for cancer in basement; now what? Call a lawyer? Patents galore?

Factual Questions
1

Supposing, Bob McBobson, a ‘mad scientist’, and not an academic or anyone notable, working in your basement invent a cure for ____ cancer (name the body part), (and for the purposes of this imaginary question, pretend Bob’s cure is a valid, “a miracle”.) Bob tested it on pet mice he bought, blah blah.

Now, though, what does Bob do next? The hard part has only begun. Does he call a patent attorney? How does he manage to make a profit from his discovery? Whom does he contact first – does he make a deal with GlaxoSmithaKlondike Inc? If so how to avoid them stealing your product, claiming they ‘changed’ the formula, and they have their own patent now? (And now Bob has to spend millions on Patent prosecutions that he doesn’t have).

How does Bob the Cancer Curer get his billions and Nobel prize credit? And if he does get paid, how much would it be? And how long? Would he have to wait 10 years before FDA approval?

2

First Bob has a loooong route to putting his drug on the market. Great his mice reacted well in his basement…the FDA needs a bit more.

So:

  1. Patent the chemical compound
  2. Find investors to underwrite clinical trials
  3. Find the investors get the lions share of everything and you control nothing
3

In [del]brief[/del] longer than I intended to write:

  1. Patent it. Bob will need help from a really good patent attorney with highly specific expertise, and it won’t be cheap or easy. That patent will protect him, though it’ll be awfully difficult for him to defend on his own.

  2. Publish the results. This will be a long and difficult process, especially since Bob isn’t in academia or accustomed to the process. He’ll have a much easier time if he can find a collaborator that has the right credentials and experience.

3a. Start running clinical trials. This is a hugely expensive and lengthy process – the average drug costs $150 million and several years before approval. If Bob’s results are truly amazing, he might be able to find some venture capital and start a company. That lets them produce some good preliminary results, so they can raise more money for the next phase of clinical trials. Rinse and repeat for each of the three plus phases required for FDA approval. Ta-da! At some point in the process, Bob probably sold the company to a larger pharmaceutical (cha-ching!) with resources and expertise in running clinical trials.

3b. Alternatively, he can just license the drug to another pharmaceutical company in exchange for royalties. That company will develop the drug and get it through FDA approval, and give Bob some cut from future drug sales.

The whole process could easily last a decade. Total development costs for a new drug average $500 million. Oh, and the drug has to make this back in the dwindling time it’s still covered by its patent…

Bob gets his Nobel prize in another decade or three, after his discovery has made a wide and powerful impact.

Not to rain on your parade, but it’s vanishingly improbably that there will ever be a “cure for cancer”. Cancer is not a single disease, but rather a diverse collection of disease. Each new case of cancer is practically unique. The best that Bob can really hope for is a new treatment that helps increase average survival time in subset of patients with a particular type of cancer (and only when the moon is full and…)

4

There are ways to extend that.

Pharmaceutical companies will sue generic drug makers when their patent runs out. BS you say? Sure it is. They do it anyway.

The court will issue an injunction against anyone making a generic version till the case is settled.

Sure the Pharma company will spend a few million in legal bills but they will make tens-of-millions while the case is litigated. They are almost guaranteed to lose the case but that is not the point. They delay entry of the generic drug by many years (yes it will take that long) all the while they rake in a substantial profit from their temporary monopoly.

This is SOP for them and you and I are the losers.

5

In terms of Bob’s finances, he’s in line for a few million from Big pharma but that’s pretty much it. The cost and risk associated with drug development increases by orders of magnitude the further down the line you go - so Bob’s only actually done the ‘easy’ bit of the process. He’s come up with a molecule that cures cancer in an animal model. His problem is that no one can conduct clinical trials on their own - you have to partner with a (massive) company sooner or later. They take on the risk of your compound dropping out -they take on the profits of curing cancer.

As far as the Nobel prize goes - it depends on how much of a scientific breakthrough Bob has made. If he’s uncovered an entirely new oncological pathway in the body, understood it, and exploited it with his cancer drug then he’s on his way to Stockholm (providing he communicates his results in some fashion). Last year’s Nobel prize in medicine was given for the discovery of telomerase, which is a good example of an entirely new biological mechanism being uncovered with applications to cancer.

OTOH, if Bob just has a compound but doesn’t really know how it works then he may have to put his acceptance speech back in the drawer. This would also torpedo his chances of his drug making it in step one above, as no pharma company is going to shower you with cash for a drug that has a black box mechanism of action. Or maybe it works by hitting a very well understood pathway, it just happens that the compound is incredibly good. This is not really Nobel prize stuff either.

I note that the OP didn’t actually specify that Bob had discovered a drug - you could construct scenarios around Bob inventing some unique anti-cancer lifestyle / diet / device-based thing.

6

God. I don’t work on cancer, but on other diseases. You would not BELIEVE how often I get calls from basement scientist crackpots who have developed some compound, natural product, invention etc… that they want me to test.

They always assume that they have done the hard part and all I have to do is “test it”.

They always backdown when I send them my guidelines for funding requirements, contract rates, overhead etc… It comes down to a lot of money.

I have enough of my own stuff to do without catering to crackpots. I imagine that big pharma is similar. never gonna happen.

7

Oh, so you’re the SOB keeping the Magic Miracle Guaranteed Grapefruit-Granola-Crystal-Sleevefish Cure from ever curing one case of impotent impetigo! Here I thought it was the Sri Patel Shriners.

(It’ll also cure bombastic flambosis of the anus if you apply it backwards and Fletcherize, but the results are messy.)

8

Here’s the thing.

Suppose Bob, a lone inventor working in his garage, discovers a cure for cancer. Except, what does that mean? He’s got some sort of treatment, and he thinks it will cure cancer. But the $100,000,000,000 question is, how does he know?

What EVIDENCE does Bob has that his treatment cures cancer? He gave it to some cancerous mice, and the cancer went away? Fine, except how does it work on humans? What side effects did it have on the mice? He had cancer, he tried the treatment on himself, and the cancer went away? Except lots of people get better from cancer. How does he prove that his treatment is what made his cancer go away?

In order for Bob to even make the claim that he has a cure for cancer, he has to conduct clinical trials on humans. You can’t do that in your basement. So by definition no lone inventor can invent a cure for cancer, all they can do is invent a promising treatment that MIGHT work against cancer. Or maybe not. He can call up the hospitals and the pharma companies, but why should they treat him any differently than the thousands of quacks?

And importantly, why should Bob treat HIMSELF any differently than the thousands of other quacks? He’s got a promising line of treatment, but any scientist or doctor knows that promising lines of treatment are a dime a dozen, and there are plenty of treatments that seemed to work in animal trials or in vitro that don’t provide results better than placebo in clinical trials. Without those trials, Bob should know that he doesn’t have a god-damn thing, and Bob should know better than to imagine he has a cure for cancer. Bob should be able to look at his evidence, and conclude that no sane person would claim to have a cure for cancer based on that evidence.

Only a quack would feed grapefruit seeds to someone with cancer, watch as the person’s cancer goes into remission, conclude that grapefruit seeds are a cure for cancer, and start calling up the Mayo Clinic. This is what quacks do every day, that’s what makes them quacks. Bob can’t go beyond the quack level in his garage, he absolutely HAS to conduct clinical trials at a hospital, otherwise he’s just fooling himself, the history of medicine is absolutely stuffed full of practitioners who fooled themselves that their treatments worked.

9

heh. Yep, that’s me.

They often get offended when I give them an estimate on how much it will cost. I am a small academic operation. For a simple 6 month trial (simple meaning NO clinical human experiments or animal use), with one technical person working, it will cost between $100K-$150K. If I need to do animal work, it gets more expensive, depending on the animal. I won’t touch human stuff - that’s a whole 'nother ball game.

+1000!

10

I would make a .pdf file with my signature in it, posting the recipe for the cure online as many places as I could. Frankly, the satisfaction of curing cancer would be enough for me, but if you want to cash in, I’m pretty sure you could make a decent living on the lecture circuit for all time after that. At least big pharma can’t steal your thunder!

11

Quacks do this all the time too.

Wait until your “cure” kills someone, or fails to cure them. Your name will make it easy for them to find and sue you.

12

Don’t need a new monitor, but I did choke :smiley:

13

Well, you can (see, e.g., Human Centipede), but the medical community may not be very accepting of your results. :stuck_out_tongue:

14

The government would just appropriate the patent, for the “good” of society. They’d give you a small royalty and the rest of the world would just “nationalize” (or whatever the word is) like they do with the other drugs they want and can’t afford.

You’d be better off donating it to the public and then exploiting all the fame you’d get for bringing such a humane cure to humanity. Kind of like Jonas Salk. He made more out of his fame, then any money he could’ve gained from a vaccine.

15

When does the government appropriate patents? You can’t patent designs for nuclear weapons, but miracle cures are patented every day, and the government doesn’t go around invalidating them just because they’re really important.

People have a hard time understanding patents. All a patent does is give you the right to sue someone who infringes on your patent for twenty years. That’s it. You have to enforce your patent yourself. And a patent on “use grapefruit seeds to cure cancer” is only valuable if doctors think your treatment has a chance of working. And they’ll only think that if there’s some sort of evidence that it works.

And again, and again, you can’t get the evidence that your treatment works in your basement. You have to conduct clinical trials on humans, otherwise even the inventor has no reason to believe the treatment will work. There are literally thousands of promising treatments for diseases that were tested on humans and found not to work. How does the inventor know that his miracle cure isn’t one of them unless he actually conducts wide-scale tests? And there are plenty of examples of promising lines of treatment that were clinically tested and found successful, and used by doctors every day, but after many years of wide-scale use we look at the outcomes and find that the effect that was shown in clinical trials doesn’t show up.

16

My reading of the OP was that Bob had a lock stock and barrel cure. So, ceteris Paribus, you wouldn’t really NEED to worry about its ineffectiveness in this hypothetical, right?

17

If Bob puts his invention into the public domain, or offers to license his patent for free to all comers, is there a viable business mechanism for getting the drug through regulatory approval? (I gather testing the polio vaccine used public money and reasearch grants, but the process would have been less onerous then, wouldn’t it?)

18

To emphasize a point brought up by others, it’s not enough to just have data showing that the treatment cures cancer in mice. First of all, there’s a multitude of details that have to be determined in animal research. What sort of animal model is being used? What cancers are being cured, and at what rates? How does the treatment work? What’s an effective dosage? How about toxicity and side effects? Et cetera. Most of those questions will have to be answered in the “publish” step I outlined in my previous post, which will take a lot of time and money to investigate. Without good data, Bob will never be able to raise money (either from venture capitol or big pharma) so that he can start clinical trials in humans.

Even if Bob has really solid data showing that his treatment is effective in mice, that doesn’t mean the treatment will be effective in human patients. There are many examples of drugs that were amazingly promising in mice but nearly useless in humans. If you’re a mouse with cancer, we can cure you. Humans are rather trickier…

19

You could get funding from a generous and wealthy philanthropic group. The Gates Foundation is starting to fund drug development in much-needed but unprofitable areas like TB. But they haven’t gone very far yet… I’m not aware of any FDA approvals given to nonprofits, but I wouldn’t be surprised if there were a few rare examples.

20

Isn’t there a way to do a lot of this “overseas” to expedite the process (particularly human trials)?