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Clause 8 Podcast Interview with Co-Author of the Hatch-Waxman Act

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Copyright © DrugPatentWatch. Originally published at

Former Congressman Henry Waxman was recently interviewed for the Clause 8 podcast about how he worked together with Sen. Orrin Hatch to pass the Hatch-Waxman Act and its aftermath.  Congressman Waxman also talked about his opposition to a recent proposal (The Hatch-Waxman Integrity Act) to prevent Orange Book-listed patents from being challenged at the Patent Trial and Appeal Board (PTAB), his 40-year career in Congress, the influence of generic and pharmaceuticals companies on Capitol Hill, the Orphan Drug Act, and many other subjects.  Some excerpts from the interview are provided below.

On working with – then – Congressman Al Gore to stop the passage of a stand-alone patent term extension bill before the passage of the Hatch Waxman Act:

A friend and colleague at the time was Congressman Al Gore in Tennessee and we talked about it and said, “This is really not a good bill for the consumers because if they have a longer monopoly of this drug, they could just keep prices high for it and there was no competitor that could come on the market even at the end of the patent.”  We rallied enough Democrats so that we had a third plus one of the house to stop the bill from passing on the suspension calendar. It was the very end of the session, as I mentioned, which meant the bill could come back but they had to get a rule to bring it up on the house floor.  The chairman of the Rules Committee was a good friend of Al Gore’s, another Southern Democrat, who was liberal and had been pro civil rights and was a friend of Al Gore’s father. Al Gore went to him and talking to him and said, “This is not a good bill because it’s going to raise the prices of drugs.  Don’t give it a rule.”  He agreed and we only had a week or two and the session ended.

On how he became involved with passing the Orphan Drug Act:

The Orphan Drug Act was as a result of a call that I got from a constituent who was suffering from Tourette syndrome. He called my office, because I was his representative, and he said, “There’s no drug to me to deal with my Tourette syndrome. There’s a drug called Haldol that I could get it overseas or in some other country,” but it wasn’t approved for use in the United States at that time and he wanted to be able to use this drug but it was seized from him when he tried to bring it into the United States. “What do I do now, Congressman?”

On whether he’s happy about the Hatch-Waxman Act in retrospect:

In retrospect, there are things I would’ve done differently but in matters that we didn’t think about . . . We got the essential of the trade-off and standards for new drugs and the ability for generic drugs to be on the market.  We wanted to give incentives through exclusivities along with the patent that drug companies would make the investment in a new drug and understand that by making the investment, they’re going to recoup what a monopoly would bring them.  When that monopoly was over, we wanted competition on the market by getting a generic out there.

The entire podcast interview is available at or via your favorite podcasting app.


Eli Mazour is a patent attorney at Harrity & Harrity, LLP and the host of Clause 8.  He specializes in helping technology companies build valuable, high-quality patent portfolios in an efficient manner.  Eli is known for developing and implementing innovative strategies for reaching favorable results at the U.S. Patent and Trademark Office.  He also has extensive experience in evaluating existing patent portfolios, identifying strategic areas for patenting, and creating processes for harvesting disclosures of patentable inventions.  Eli can be contacted at

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