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That's supposed to end at the end of the patent term.The problem that was identified and described extensively in 1984 with the Hatch-Waxman Act is that that was not happening.And so, it's difficult to get the process started without opening yourself to a large amount of liability.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 then, lastly, there were a lot of weak patents in the market that a generic company might have to fight off to get its way there. Russ Roberts: So, that's the glass half-full part of the story. You said that there are problems with weak patents that make it harder for generics. Under the Hatch-Waxman system, if I am a company that creates a new drug, I go to what's called the FDA Orange Book, and I list all the patents that I believe might relate to this drug. Robin Feldman: So there are 2 million patents outstanding in the system today. But, as a generic, I don't know that, a potential generic competitor, and it's costly to challenge it. The problem is that the Patent Office is overwhelmed.So, for all of those reasons, we were not seeing a large number of generics in the market. The generic company coming on has to then make certain representations about whether they might be infringing on one of these patents. A weak patent means that it ought to be invalidated. Many of them, if they were tested, would not stand up in court. And estimates are that it takes about two years for a patent to be approved.

But even before the generic drug system, the Hatch-Waxman system, came into place, if a drug company filed a weak patent, that might sit there and block out competition for a long period of time, even if it was relatively weak, because a would-be generic coming onto the market would have to risk trying to fight that off, but would have to make a choice about whether to do that even before it could get FDA approval. But, as a non-lawyer, a "weak patent" means it's kind of easily gotten around? Pharmaceutical patents are very complex and difficult. What seems perfectly obvious to you as an economist took our patent system much longer, and our regulatory system much longer, to come to u.And so we want to create enough incentives so drug companies will invest in this research.So, we give them a period of time in which they should be able to block out competition, be the only one in the market, and have a strong, healthy return on their investment. B.: A "weak patent" is a patent that has been approved by the U. Patent and Trademark Office, but for which the patent itself may not stand up in court were it actually to be challenged by a prior patent owner. Virginia Journal of Law and Technology 271, 2014; UC Hastings Research Paper No. Before I read your book, I thought I understand patents and generics. But after I read your book--let me give you the before. [Recording date: June 6, 2017.]Russ Roberts: Robin Feldman's latest book, which is the topic of today's discussion is Drug Wars: How Big Pharma Raises Prices and Keeps Generics off the Market....

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