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Posted by / 13-Apr-2018 21:11

But after that, all these extra, ideally multiple generics, will come in. Robin Feldman: And that is what happens across time.

Russ Roberts: So, basically-- Robin Feldman: And there's another kicker-- Russ Roberts: Yeah. And if I'm not breaking the law, then the minute the patent expires, I'm good to go. Russ Roberts: So, they still have to wait for that.

The problem that was identified and described extensively in 1984 with the Hatch-Waxman Act is that that was not happening.

We were supposed to see at the end of the patent term generics coming into the market, bringing the price down, and creating the vigorous competition that we love to see in markets. One, because it takes so long to get approval for a drug, that the generic company would have to start their approval process when the patent ended, and so it would be years before they might get to the market.

So, Hatch-Waxman created an artificial system in which, on paper, someone could be infringing the drug: You could go to the court and battle out all of the patent issues. What did Hatch-Waxman add--I could always say, 'I don't think this is a good patent,' 5 years into the life of a drug. And so you might just wait till the patent expires.

And the problem, get that all done so that as soon as the patent expires you can come into the market. 'I'm going to challenge it in court.' Obviously you could lose. And certainly when the patent expires, you have an incentive to produce a generic.

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That may be more complicated an answer than you wanted. You've gotten rid of this clinical trial barrier, hurdle. And that way you can hit the ground running, if it turns out that your patent that you are fighting is either, is invalid, or just expires and you'll be ready to go.' Is that right?