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Well, there’s really two parts to how we handle matters for medical devices. The first part is protecting the device and see if you can get protection for it at the patent office. And the second part is whether it can bring that product to market, where they’re going to have freedom to operate issue.
We usually start with getting something on file that’s quick, just to preserve the idea. We are in a first-to-file world right now, so it’s a race to the patent office. The sooner you get there, the better. So typically, we file as quickly as we can on medical devices with just simple provisional applications to protect them. And then we start the process of commencing with freedom to operate. And that involves doing a search at the patent office, either in the United States or foreign countries, depending on what the client wants to clear; and that search can take anywhere from a week to three to four weeks to get done.
Once it comes back, we get a stack of patents to look at to see if we think they’re going to be conflicting with the new products that are coming out. That analysis is done and if we see if we have a problem with a particular patent, we pull the client in, and we sit down, and we have a discussion with them and say, “Look, we’re concerned. We need to look at more detail on this particular patent. We have to go back and look at the file history, the record of the proceedings before the patent office, the give-and-take between the patent examiner and the owner of that patent, and what was said to see how that patent is construed and to be interpreted.”
If we think it’s a problem, we then have a conversation about possibly changing the design to avoid the patent, or potentially going to the patent owner and asking for rights in that patent. It can go in multiple directions. Sometimes it’s a simple process, where the patents come back and there’s no issues, and we can give it our blessing, go into the market and sell without fear of getting sued for patent infringement by a competitor.
Philadelphia, PA intellectual property lawyer Martin Belisario talks about his firm’s approach to medical device IP.