Patent extension, page-64

I’m referring to 10 years from now when the Recell patent expires. Right now, Avita would sue and win a patent lawsuit if anyone tried to copy with a generic version. After the patent expires, newcomers can compete, but they still must prove themselves with expensive and time-consuming clinical trials. Why? —Because there’s no guarantee that their generic product would be effective without clinical trials. We’re not talking about pharmaceuticals here; this is a device with several different mechanisms that may prove difficult to emulate.