I wasn’t going to write about the Hatch-Waxman experimental use exception, but I changed my mind after I read an article about the possibility it could get to the Supreme Court.
The case in question is Bayer v Barr, decided by the Court of Appeals for the Second Circuit, considering a pay-for-delay deal. This kind of deal is very normal in the US pharmaceutical industry, where a patent holder pays an infringer not to infringe and not challenge the patent. Excuse me, has the world gone upside down?
Here is what the Hatch-Waxman experimental use exception basically says. A generic drug manufacturer does not infringe a patented drug if it uses that drug to get information it can file with the FDA for its generic drug approval. However, if it does file for the approval with the FDA, then the generic drug manufacturer does infringe. But there are some incentives for generic manufacturers to challenge a patent’s validity: the first one to prove a patent invalid, gets 180 days of market exclusivity. Isn’t this the opposite of what is really happening these days because of pay-for-delay deals?
I do recognize the importance of other institution in this matter – FDA, FTC. Maybe even the Congress might be interested (well, I don’t think so, given the “rush” with which they did not get the Patent Reform bill through). But until happier times, yes, a Supreme Court grant of certiorari in this case (that covers both patent law and antitrust law) would be more than welcomed.
Instant Blog 