Example: Imagine the following scenario. You hire two groups of professionals – one to handle your FDA submissions, and a second to handle your intellectual property portfolio. On the one hand, your IP lawyer is arguing under oath that your new device is new, useful, and non-obvious – different from all the other prior art that came before it. On the other hand, your FDA team is trying to bootstrap the invention into some preexisting category to avoid the expense of 510k approval. To achieve this objective, the FDA team is arguing under oath that the device is similar to things that came before it.

Now fast forward 5 years. You were successful in the independent efforts to obtain your FDA approval and your patent, and your product is in production and enjoying a great deal of commercial success. Now you have a new threat – that is, a rising competitor on the horizon. Your business people go to a trade show and come back and report that the new competitor has a very similar device to yours. You reverse engineer it, and your R&D team believes the new competitor is infringing your patent. Eager to protect your market space, you bring a patent infringement action against the competitor. What does the competitor do? Uses the FOIA process to unearth the documents you submitted to the FDA, and argues successfully in court that your patent should not have been granted because it was not new and novel, it was already known in the art. You lose not only the lawsuit, but your patent and your market space in the process.

This is a scenario that does not need to happen. It can be avoided by careful coordination between your IP and FDA teams. At Altera Law Group, we work closely with others who know the FDA process as well as know the patent process, to ensure a coordinated effort on your behalf.