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August 05, 2010


"the trade group [GPhA] said that it was "extremely disappointed that [] legislation that could ultimately ban patent settlements [] passed out of the Senate Appropriations Committee," calling the addition of the pay-for-delay provision "a procedural façade with highly negative impact" and the Approproations Committee's passage of the provision "not the way the process should work.""


I concur completely with what this trade group said about how this provision was added. That provisions like these get attached to unrelated appropriations bills is one reason why the voters have an extremely low opinion of Congress. Whether or not you like this provision, it shouldn't be enacted in this matter. Put differently, the "end does not justify the means."

I have expressed my views regarding this issue in my blog at http://pharmachemicalscoatings.blogspot.com/2010/07/pharmaceutical-reverse-payments-and.html.


It was only a matter of time. We all knew pay-for-delay couldn't last much longer, especially with the FTC lobbying against it for so long. The good part is that it should result, collectively, in substantial savings to consumers.

Thanks as always for writing, Marilyn, but actually I DID mean the FDA, not the FTC. In order for a patent to be officially linked to a drug, so that the generic manufacturer has to take it into account, it must be listed in the FDA's "Orange Book." The FDA if it had the backbone could refuse to list a lot of the minor, subsidiary patents in their book right now and that would end a lot of the problem. The authors of the article I review suggest an administrative appeal, whereby a generic manufacturer could challenge a patent's listing in the Orange Book without having to go to court.

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