Not if you want to market the drug in the USA.
Regulatory agencies generally take a dim view of attempts to get around safety protocols by exploiting citizens of less-developed countries.
In addition to the clinical testing, there’s a ton of chemical testing that needs to be done as well to show that the product in its intended dosing form is safe, consistent, stable (short and long term stability), etc. This part of testing will likely be at least 4 or 5 years in order to collect all the appropriate data.
If Bob has financing, he can do it by hiring a contract pharmaceutical company (Patheoncomes to mind) to do all the formulation, stability, release and commercial manufacturing, and they have links to clinical trial companies as well in order to manage production times to support the clinical studies. He wouldn’t have to sell his miracle drug to BigPharma. Contract companies aren’t cheap, but they are accredited and have experience in getting your drug product through all the loopholes required for FDA/HPFBI/other country approval.
I should clarify - its not that you can’t conduct human trials overseas (in fact many humans trials do exactly this), but rather that its not a method to avoid the costly and lengthy oversight process. You are kept to the same standards no matter where you perform the study.
Very true! But that moves us away from the “basement” scenario proposed in the OP.
Bob should move to a country with lax or no drug laws and offer the cure to a few desperate patients. Word will spread like wildfire and in no time wealthy patients will be flying in from all over the world. After he’s fabulously rich and tired of living like a king he can reveal the secret and wait for his Nobel prize.
There are a lot of folks who have been screaming for patent reform for many years now. One of the things on the (fairly lengthy) list of common complaints is that patents don’t do a very good job of protecting people like Bob.
There are no patent police. If Big Evil Pharma Co decides to start producing Bob’s drug, what happens? Nothing. No one automatically tells them to stop producing the drug. No automatic procedures automatically kick in. Nothing happens.
If Bob wants them to stop producing the drug, Bob has to stop them himself. He does have the patent on his side, and while he legally is right, he has to take Big Evil Pharma to court, spending his own money on his own lawyers and court fees. Big Evil Pharma, knowing that they can make billions on this drug, can afford to spend a few million on legal fees to protect their investment. Most folks like Bob don’t happen to have a few million stashed away in their basement, so Big Evil Pharma knows that it can basically adopt the strategy of lawyering poor Bob to death.
Bob might get lucky. He might be able to partner up with someone who has deep pockets, and if Big Evil Pharma realizes they can’t lawyer poor Bob to death they might abandon their attack. If Bob can’t find anyone willing to take the risk, though, he’s screwed. He loses his house and his savings in a huge, costly legal battle that he just can’t sustain because he doesn’t have enough money to keep it going. He’s right, he has the patent, but he loses.
The rest of us lose too, because as long as the legal battle is raging, there’s a good chance that Bob and Big Evil Pharma both can’t make the drug.
Big Evil Pharma also has a research budget about the size of the GNP of some small countries. While the legal battle is raging, they can come up with a sightly different drug in the same general family as Bob’s wonder drug, but since it is a different drug it is not covered by Bob’s patent. Big Evil Pharma would have never come up with the drug on their own, but with Bob’s drug showing them 99 percent of the work they do manage to come up with something that works. They patent it, and start producing it. Bob can’t do anything about it, since it’s not covered by his patent. Big Evil Pharma keeps Bob tied up in the courts until their new drug gets out and gets a reputation. Then Big Evil Pharma drops its suits against Bob and he is free to produce his drug, but Big Evil Pharma is already producing a slightly different drug that basically does the same thing. Big Evil Pharma’s drug might even be an improvement over Bob’s drug.
How many folks buy the second drug that does almost exactly the same thing as Viagra, vs. how many folks buy the drug with the big name that everyone recognizes? Bob’s patent is now close to worthless.
Admittedly this is kind of a worst case scenario, but it does show that a patent alone doesn’t necessarily protect you. You need to be able to back up your patent in court, which little guys like Bob often can’t do very well.
Big Evil Pharma won’t have any reason to steal Bob’s invention before there’s some good supporting data. And by that time, Bob should be able to drum up some venture capital. He can then hire some lawyers at his startup, which isn’t such a big burden compared to the cost of developing a drug.
Also, Big Evil Pharma will still have to get the drug through FDA approval, and that process is interlinked with patent protections. Bob’s patent litigation will stall Big Evil Pharma’s clinical trials and possibly even prevent FDA approval until it’s settled (though I could be wrong here, I’m certainly no expert on patent law).
ETA: But Big Evil Pharma will certainly try to develop a “me-too” drug under its own patents. Most of the time this sort of development only happens after the original gets FDA approval – why try to develop an alternative to a drug that’s likely to fail?
Or the cure doesn’t actually work on humans. (After all, he discovered it while working with mice.)
Too many of those desperate patients die horribly from the effects of Bob’s wonder drug.
Their survivors attack Bob with machetes.
Again, the problem with this is, why does Bob believe he has an effective cure for cancer? He’s sitting around in his garage, playing with pharmaceuticals, and mixes Chemical X with Chemical Z, there’s a poof of smoke, and viola! A cure for cancer! Except why in the world does Bob think Chemical XZ is a cure for cancer, until it’s tested on humans?
Bob can mix all the chemicals he wants in his garage, but it is impossible for him to discover a cure for cancer in his garage, because a cure for cancer can only be discovered by clinical trials. Promising lines of treatment could conceivably be invented in a garage, but not actual treatments.
Look, the analogue we’re looking at here is the discovery of pennicillin. Accidentally have some moldy plates, notice that bacteria don’t grow on the mold, and BAM! Cure for bacterial diseases, and off to fame and fortune. Except, not really. You don’t have anything, not a thing, except an interesting line of research.
The world is full of guys in their garages who have invented cures for everything under the sun. And almost all of these supposed treatments have turned out to be worthless or worse than worthless, including most of the treatments handed down from antiquity. So how do you tell whether leaches and mercury are effective treatments for cancer, or ineffective/dangerous quack treatments? You can’t tell from your garage, and anyone who thinks they can is by definition a quack–EVEN IF THE TREATEMENT TURNS OUT TO REALLY WORK.
I will patent this as the “Machete Cure” for quackery.
I appreciate your help. I did though state that this was a hypothetical question, and for the purposes of the discussion, Bob does indeed have a miracle cure. The importance is in how Bob goes about turning this into fame and fortune, against a sea of Pharma & FDA troubles.
You are putting skepticism where none is necessary–just pretend he has a cure, and go from there.
Reading all the hurdles described above I’d be tempted to contact a media organisation or agent and let them provide some publicity and hype for me which would help me get some much needed momentum. But the trick would still be to sell it to them.
Assuming Bob knows that he has a cure for cancer then the “move to somewhere with lax drug laws and cure people” is pretty much the only possible approach he can take. The reason that no-one will take him seriously is there is no way for Bob to know this for sure, and without that he basically has nothing, in the real world the more sure he is that he has something, the less seriously that the people with the money will take him.
What is it exactly about spending millions of dollars on lawyers that allows this to occur? Shouldn’t “I have the patent, motherfucker” be a fairly defensible legal position even if you can only afford a just out of legal school lawyer.
Assuming that someone might suddenly emerge from their basement with a cure for cancer is like assuming that someone might emerge from their basement with a plan that will change the world’s economy into one in which everybody’s standard of living will quickly rise to three times what it is today and there will never be a recession again or like assuming that someone might emerge from their basement with a device that will allow us to produce sufficient amounts of energy from a hitherto unknown source to power the entire world for the indefinite future. Yes, perhaps it’s possible that this might happen, but it’s absurdly unlikely. There are people making such claims all the time. They’re virtually always nuts or scam artists. Those of us who aren’t experts in cancer or economics or physics can’t listen to all of them. We have to allow the experts in those subjects to weed them out.
I disagree. Bob can’t turn his miracle cure into fame and fortune unless he can convince other people that his miracle cure actually works. And how can he do that? With scientific evidence. Simply holding a press conference and announcing that you have a miracle cure won’t get you anywhere, since thousands of quacks peddle worthless treatments. In order to make money Bob has to show somehow that his miracle cure isn’t snake oil. And he can’t do that in his basement. He needs to conduct his treatment on actual human beings who actually have cancer, and show that his treatment is safe and effective. And nobody’s going to let him administer his treatment unless he can show convincing results from animal trials.
Your scenario is like if Bob had the plans for a perpetual motion machine. But unless he can actually build one, no one is going to believe him. A few notes scribbled on a cocktail napkin won’t get him anywhere.
So in other words, if Bob invents chemical XZ in his basement, and it’s a cure for cancer, Bob can’t do anything with it, because there’s no reason for anyone to believe chemical XZ is a cure for cancer. How does Bob get the evidence? It’s called research, and Bob can’t do the research in his basement.
As for getting a patent, sure, he can get a patent. It’s not particularly difficult, you can get a patent pro se if you know what you’re doing. If you’ve never patented anything before it might be a pretty confusing process, but you can hire a patent attorney to handle the paperwork for you fairly inexpensively, and guide you through the examination process. If you’re interested in how you’d go about getting a patent, I’d recommend Patent it Yourselfby David Pressman.
Except even when your patent issues you don’t have anything particularly valuable. More than 90% of all patents are commercially worthless. A patent doesn’t give you the right to sell your product, it just prevents other people from selling your product. And any medical treatment needs to be approved by the FDA, because quack medicine kills people. Oh, that horrible horrible FDA, requiring scientific evidence that treatments are safe and effective, holding back hero inventors like Bob!
Scientific evidence that the cure is safe and effective is absolutely required before Bob can get anywhere. If he doesn’t have that, he has absolutely nothing. Sure, he’s positive that his treatment works. Except millions of quacks feel the same way. How does Bob convince people he’s not a quack if he doesn’t have any evidence? He can’t, because he is a quack unless he has evidence.
Because no one will enforce the patent for you. You have to sue the patent infringer yourself. That means you have to hire a patent attorney, or a stable of patent attorneys. So if EvilMegaTech Inc infringes your patent, and ignores your politely worded letters, then you’ve got to sue them to stop them.
If the patent is worth millions of dollars, then it’s worth it for EvilMegaTech to spend a lot of time and effort fighting your infringement suit. Of course, the vast majority of patents are worthless, so it’s premature to worry about patent infringement before you’ve demonstrated that your product is worthwile.
And the confusing part about patent infringement is that most inventions have multiple inventors. If one inventor is working on a problem, you can be sure that there are dozens of others working on the same problem. So you invent chemical XZ in your basement, and are granted a patent. Except your competitors have probably patented chemical XY, XW, ZX, ZY, YX, and so on. Your patent is probably going to be fairly narrow. So there will be a thicket of interlocking claims from various patents, and it can be very complicated to determine exactly what you can sue over. So if you patent the car, and tomorrow EvilTech comes out with a four-wheel motorcycle, it could be pretty complicated to prove that their “four wheel motorcycle” falls under your patent.
One more thing. You can search patents at the US Patent and Trademark Office at USPTO.gov. For example, to give you an idea of what a patent might look like, here’s a random pharmaceutical patent:
A patent can be very complex. It’s not going to be as simple as writing “use grapefruit seed exctract to cure cancer” on a cocktail napkin and mailing it to the USPTO. And EvilMegaTech Inc. is going to have hundreds of patents themselves, and determining whether they infringe your patent or you infringe their patent can be very complex. That’s where the stables of lawyers come in.
Well, Bob could do a significant amount of preclinical research in a basement equipped like this. That could include a lot of tissue culture work and conceivably even some mouse or rat studies. But Bob would have to be pretty wealthy to fund even the earliest stages of his research program.
Malcolm Gladwell published an interesting article on the testing of potential cancer cures in the New Yorker a couple of weeks back. The outfit he’s describing is hardly garage-based, but it’s basically a speculative venture-capital set-up who, having done some groundwork, had to partner with a much larger pharmaceuticals company in order to fund the necessary trials. Furthermore, their potential breakthough was based on an almost entirely random, out of left-field compound.
A nice explanation of how not everything starts off as “Big Pharma”.
folks, folks, we should not let the preconceived notions ruin the hypothetical. Suppose it’s not a drug, maybe it is the “miracle bob ray” ™ that instantly kills tumors of patients on death beds and has them cured on the spot. So the proof of its effectiveness manifests itself instantly upon use in 95% of cases, not a year later if you cross your fingers.
Now what? Now rich/powerful people will steal your invention and tells you that “invention is not innovation”. Or some other such BS. But hopefully he will derive some benefit from consulting contracts, especially if the initial version is intentionally nerfed to less-than-miraculous level 