Anybody know about drug patents?
Question:
Let’s say that I empirically discover that some common food item is a useful psoriasis treatment. Say it was, tomato juice. Would there be any point in pursuing a patent on it? Let’s see what the issues are. I probably have at least half of them wrong, and would like to hear from anyone who can clarify any of them. I *think* you can patent a new use for something, so the patent office would grant a patent for the use of tomato juice to treat psoriasis (goofy, ain’t it?). Well, I’d have this fine piece of paper, it would cost about $20,000 to get. But, until I do about $20,000,000 in testing, the FDA won’t let me claim that it’s good for treating anything. So, I can get a patent cheap, but the FDA approval, even for tomato juice, would cost mondo? That’s pretty goofy, too, if that is the way it works. OK, say I hock the Chevy, spend the $20m on testing. Now I, and I alone, can advertise, "J’s psoriasis treatment: pure tomato juice!". In the first month, I sell ten thousand cans of tomato juice at the inflated cost of $5.00 each. No giant drug company can offer tomato juice for psoriasis, because I have this patent. The only problem is, any schmuck can buy tomato juice at the grocery for $1.00 a can, and I don’t get a penny. So, what is my patent, and FDA approval, worth? Is this a real scenario? Or, would there be a way to turn that patent into real money? (Actually, if I could pull what the Hollywood studios did, I could still get rich. Every time you buy a blank videotape, you pay a few cents into a fund that the studios split, because you *might* illegally copy one of their copyrighted works onto it. Your government at work. So, maybe I could sue every food company on earth, and get a penny from every can of tomato juice, spaghetti sauce, ketchup, etc, because they might be bought by someone treating their psoriasis!!?!? Oy, what a country!) J. P.S. — NO, NO, NO, I am not really saying that tomato juice does anything useful for p, and you Pagano/nightshade guys, I hope you are not too offended at my choice of example!
Response:
>Let’s say that I empirically discover that some common food item is a >useful psoriasis treatment. Say it was, tomato juice. Would there be >any point in pursuing a patent on it?
Not really. Especially not for *you*, either. :) A patent is designed to give you a monetary incentive to invent. Knowing *you*, you’d just share the danged ’secret’ anyway, and get on with life (with the rest of us), plaque-free, right? >Let’s see what the issues are. I probably have at least half of them >wrong, and would like to hear from anyone who can clarify any of them.
I think you’ve got the important ones more than half *right*, actually. >I *think* you can patent a new use for something, so the patent office >would grant a patent for the use of tomato juice to treat psoriasis >(goofy, ain’t it?). Well, I’d have this fine piece of paper, it would >cost about $20,000 to get.
I think if you studied up on patent law, and its history, and did the research and whatnot yourself, the basic fees over the entire 20-year life of the patent work out to just $7,540. Need Adobe Acrobat to read the schedule, but here it is: http://www.uspto.gov/web/offices/ac/qs/ope/ptofee2000.pdf Actually, as a "small entity," the costs are about half that. >But, until I do about $20,000,000 in testing, the FDA won’t let me >claim that it’s good for treating anything. So, I can get a patent >cheap, but the FDA approval, even for tomato juice, would cost mondo? >That’s pretty goofy, too, if that is the way it works.
Well, no. The costs involved in testing are for hiring doctors, nurses, etc., for compensating study patients for their time and risk-taking, for bookkeeping and all that other good stuff. I have no idea if there are "filing fees" with the FDA, but you could probably assume that there are. The whole cost, including preliminary testing (which you’ve already done prior to patenting, right?), averages around $100 million. However, if you can do the same level of testing, and produce the same quality of documentation, for a hundredth or a thousandth the cost, that would not (or *should* not) be any sort of "strike" against your FDA applications. >OK, say I hock the Chevy, spend the $20m on testing.
*NICE* car!! Probably comes with one of those JATO units, right? >Now I, and I alone, can advertise, "J’s psoriasis treatment: pure tomato >juice!".
Legally, yes. However, anyone *can* advertise tomato juice for psoriasis, and since your testing is a matter of public record with the FDA, they can all show that their claims have support (so the FTC, for example, can’t do anything about them). *You* have to file lawsuits in order to get them to stop, as no agency of the US gov’t will in any way protect your patent *for* you. You need to prove, in a court of law, that they are infringing on your patent, or scare them enough that they’ll settle. >In the first month, I sell ten thousand cans of tomato juice at the >inflated cost of $5.00 each. No giant drug company can offer tomato >juice for psoriasis, because I have this patent.
I’d make the price a bit higher. Since the giant drug companies can afford $1,000-an-hour lawyers, and you can’t (yet), they might decide to do it simply because you’re not much of a threat. More likely: they’ll do some in-house testing, discover the "active ingredients" in tomato juice, and patent them themselves, which will leave you high and dry, as their product will be more pure and potent. >The only problem is, any schmuck can buy tomato juice at the grocery >for $1.00 a can, and I don’t get a penny. So, what is my patent, and >FDA approval, worth?
Not a lot. You’ve gotta sell $100,007,540 worth of tomato juice in the next 20 years (that is, if your patent is granted *immediately*, which it won’t be). At $5 a can, that’s 20,001,508 cans, or over a million cans per year, on average. And that’s just to break even. Considering your patent and test results are a matter of public record, everyone will be buying the $1.00 cans, as you say. While they’re *technically* forbidden to even *use* the method described in your patent, it’s still up to you to find every person doing so, and file a lawsuit against them. So now you’ve gotta pay the expense of hiring a private army of spies, illegally looking at medical records, tracking each and every psoriatic’s supermarket purchases, and then bugging people’s houses with video transmitters in order to make sure that no psoriatic is using tomato juice for their psoriasis except that which you’ve sold. This would probably take several billions of dollars, thus jacking up the number of cans you’ve gotta sell in order to just break even. Shoot. I forgot about the army of lawyers you’d have to hire to actually file all these lawsuits. Add another billion cans. >Is this a real scenario? Or, would there be a way to turn that patent >into real money?
Not that I can see. The problems in enforcing your patent are, to say the least, staggering. Also, this amusing scenario assumes that the patent examiner thinks that using tomato juice for psoriasis is ‘new’. While it might be useful, I think it could be easily argued that, given the number of things that have been tried, tomato juice must not be a new idea. Of course, the non-newness would have to be documented, but I’d bet, given the Law of Large Numbers, that several psoriatics has been "skunked" and found relief from the good-old destinking process. If one of them has been written about in the medical literature, your patent is sunk. >(Actually, if I could pull what the Hollywood studios did, I could >still get rich… …Oy, what a country!)
Yeah, oy! Of course, the video tape recorder manufacturers and the video tape manufacturers were basically the same folks, and could "threaten" that if they didn’t get their way, there’d be no videos at all in the US. I don’t think the same could be said for your tomato juice. >P.S…. …and you Pagano/nightshade guys, I hope you are not too >offended at my choice of example!
Actually, it’s been written here on this newsgroup before that some studies have found ingestion of tomato to actually *relieve* psoriasis, to some extent, so the "nightshade people" have probably already been offended. :) – Dave W. http://members.aol.com/psorsite/
Response:
>P.S. — NO, NO, NO, I am not really saying that tomato juice does >anything useful for p, and you Pagano/nightshade guys, I hope you are >not too offended at my choice of example!
Hehehehe! You read my mind. All I could think is what are all the Pagano fans out there going to think. Jena>
Response:
Related Posts