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January 20, 2011
Freedom to Operate
A discussion with a colleague the other day brought up a point about drug patents. When you're thinking about the chemical matter you have for your project, one of the things you have to worry about is the patent situation. Are your molecules patentable? For that to be the case, you need novelty and utility. Utility is pretty much a given in this business - you wouldn't be interested in the compounds if they didn't do something - so novelty (prior art) is what we spend time wondering about.
There's usually a way through on that, though. I mean, sure, there are all these generic claims out there in other patent applications that take everything out to the asteroid belt, but you should only get worried about the stuff that the claims are teaching toward and the compounds that have been enabled (that is, actually made). Prior art is crucial, but it's also crucial to only pay attention to what deserves attention. (We last talked about this problem here).
Then there's "freedom to operate". In that case, you're asking not "can I get a patent on this", but "can I do anything with it without infringing someone else's patents". For FTO considerations, you have to look at what IP rights other people have (or are likely to have by the time you'll be ready to go). That can get rather involved, since patents are limited in several dimensions: time (they expire eventually), space (coverage varies country by country), and in "IP space" (what territory the claims stake out). Depending on what comes up, you might decide that you're in the clear. Or you might try to invent yourself out of a tight spot, if you can do that. Or you could pay someone for rights to their IP, or trade them some of yours, if you have something to trade.
But here's where we got to talking: in the drug business, where we're patenting particular chemical matter (and the use of it for particular medical needs), it seems like freedom to operate isn't as big a deal as it is in some other areas. That's partly because it's hard to get sweeping medical claims issued, and it's hard to make them stand up if they do. There have been attempts to stake out whole modes of action ("We claim the method of treating a patient in need of lowering their XYZ levels with any inhibitor of XYZase"), but fortunately, that hasn't taken hold.
So when you're talking chemical matter, does anyone know of drugs (or programs) that have been derailed in development just because of freedom-to-operate concerns? Drug patents get challenged all the time, often by generic companies, but those are patentability issues, trying to overturn the whole filing. But what about FTO? Any examples?
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