Back to Corevalve and Sapien again, and hot on the heels of yesterday’s news that Medtronic had stumped up some $84M in settlement of its patent infringement case, comes news that the FDA is considering extending the regulatory review period for the Sapien Valve.
This is all about a foible of the U.S. regulatory and intellectual property world, which concerns the overlap between these two seemingly unconnected processes. In fact when you think about it they’re not unconnected at all, because the patent holder can’t exploit its intellectual property commercially unless its product is on the market.
The case being considered by FDA is that the patent rules allow device makers such as Edwards to request a patent extension of up to 5 years for products subject to regulatory review prior to marketing, as was the case with Sapien. The length of time the device spent under review determines the amount of time by which a patent may be extended.
The FDA has determined that the applicable regulatory review period for Sapien is 2,473 days, of which 2,106 occurred during the testing phase of the regulatory review period, while 367 days occurred during the approval phase. Having chucked all the cards up in the air and watched them land, Edwards has settled on a request to extend its patent by 1,757 days. Don’t bother doing the math because it doesn’t quite work.
If anyone wants to petition the FDA with regard to the request, they have until April 23rd when it will presumably consider making a decision.