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can certain diseases/illnesses be cured
ChadTower:
--- Quote from: boykster on March 31, 2008, 04:04:59 pm ---If my company patented the "cure", our monopoly on treatment vs cure would be fleeting and only last a couple of years. It is possible for companies to get patent exclusivity extensions on pharmaceuticals they are actively selling, but no way on something their sitting on.
--- End quote ---
I bet there are ways to fudge the testing status to extend that. There is probably a reason some stuff takes many years to get FDA approval.
boykster:
--- Quote from: ChadTower on March 31, 2008, 04:08:59 pm ---I bet there are ways to fudge the testing status to extend that. There is probably a reason some stuff takes many years to get FDA approval.
--- End quote ---
Actually no; the reason that many pharmaceuticals are SOO expensive when they are "on label" is directly due to the fact that there is such a short window to recoup discovery and development costs. The patent is generally filed at the time of 'discovery', and doesn't offer any sort of buffer for approval time.
Its not uncommon for a drug to reach market and only have a single year or two of exclusivity before generics hit the market. The bulk of the patent is eaten up by development and approval time. I've never heard of a case where a patent was extended for a non-marketed pharmaceutical - and generally the 'extension' is for a new indication or delivery method, rather than just a blanket extension.
No company would purposely extend their clinical trial testing phases - that's the single most expensive phase in bringing a drug to market.
Jdurg:
--- Quote from: pinballjim on March 31, 2008, 04:29:05 pm ---
--- Quote from: boykster on March 31, 2008, 04:15:00 pm ---Its not uncommon for a drug to reach market and only have a single year or two of exclusivity before generics hit the market.
--- End quote ---
:dizzy:
No.
Patents can be extended to make up for time lost in the FDA approval process.
--- End quote ---
Not unless the FDA says so. Typically, the FDA will say "We'll extend your exclusivity if you do x-and-x." NEVER have they said "Well, it took us a while to approve this so we'll extend your right to exclusivity for a while."
Boykster pretty much hit the nail on the head with his last post.
In addition, "fudging" the testing status would result in criminal prosecution of a pretty significant level, and some SEVERE backlash from not only the FDA and other controlling organization across the world, but from your employer as well. You do NOT make up anything when dealing with drugs or clinical data unless you want to blacklist yourself and wind up in prison.
boykster:
I'm not going to argue the legal ins and outs of patents and exclusivity; I'm not a lawyer, I'm a software guy. I have seen first-hand products reach approval and have short time on market prior to generics being available.
Drug patents are valid for 20 years, and are generally filed for at the time of discovery. The lifecycle of drug development is: Pre-clinical testing R&D (1-3 years), Clinical Research Trials (2-10 years), NDA Review for approval by FDA (2mos - 7years). It is not inconceivable for a drug to be discovered and run through this timeframe at the cost of nearly a billion dollars, and receive approval by the FDA with only a few years of patent protection left.
The FDA can't impact the duration of the patent, but it can grant 'exclusivity' for a certain drug (5-7 years of exclusive marketing approval) but only if certain requirements are met. Patent protection and exclusivity run concurrently thus exclusivity doesn't extend the patent, but rather it only ensure approval exclusivity for that drug for a particular indication. If a drug has approval for more than 1 indication, and only one of those indications has exclusive status, a generic manufacturer can still produce and market the drug for the other indications.
Its not a perfect system, but it does work.
shmokes:
I'm not concerned. Drug companies are enormously profitable. You have to be to get a "Big" moniker. We've got Big Tobacco, Big Oil, Big Pharma, etc. :)
Anyway, patents and the prospect of making billions of dollars encourage research and innovation. But generics make badly needed treatments available to the masses. We have to strike the right balance, keeping both vitally important goals in mind. I can't say I've studied the issue well enough to say that I think the patent period should be longer or shorter, but my gut tells me that that I'd lean toward shorter, if anything.
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