In the bad old days, inventions sometimes died with their inventors, since innovation was a closely guarded secret. The US government recognized that to grow stronger industry, this loss had to be stopped. They hit on the idea of a quid-pro-quo — inventors who disclosed and taught their inventions to the world would get a 17-year exclusive use thereof (post acceptance – this is now 20 years post filing). Hence was born the US Patent system, which has been copied by the world in one form or another.
Now, we’re trying to use this same Patent system to try to solve a number of societal problems, but this shoe just doesn’t fit every foot. Let’s talk in particular about the problem with new drugs and medications.
What “we the people” need to know about a new drug or medication is not how to make it, but what it does – both desired effects and undesirable side effects. What the businesses need to make new drugs available to us is a profitable business situation. This does not necessarily mean a short window without competitors manufacturing the drug. Often, all the uses of the drug have not been uncovered until long after the “manufacturing” know-how has been patented and the patents gone. What could be more valuable is a period of time where the company can market the drug for a particular use, without the fear of litigation that seems to haunt this industry.
So, here is an alternative quid-pro-quo. The filing company presents the findings of their clinical studies. If the examiner agrees that everything is done properly, the US government hands the company that went to this expense an indemnity from prosecution as long as the drug is used as dictated in the clinical study. This would be indefinitely, unless new findings invalidate the prior work, in which case the indemnity is lost for any continued use for that specified purpose, but the company is still not liable retroactively.
Another company could file a more detailed clinical study which might open up new ground, either at a higher dosage, or as a treatment for another condition. Maybe we would allow that a company that does a better study of the same usage is also allowed to market the drug with indemnity, if their study is sufficiently more advanced. Thus we would have companies competing with each other to get (and publish) more and more complete clinical data, by which they could capture pieces of the “safe prescription” battle-field.
And so we would grow up an accelerating body of knowledge, happily paid for by the drug companies, and our quality of life would increase.
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