Paradigm patent rejection, page-59

My understanding is that a PharmaCo must have a drug which is approved for human use, and then they can lodge a DMF with the relevant agency for recognition and protections around confidential aspects of the drugs creation such as manufacturing processes, drug formula etc. If others wish to reference that material as part of their own IND applications, they need the permission of the DMF holder.

Bene are the only manufacturer of an iPPS which has been approved for human use.

There is a bit more info on this below, from a Baker Young analyst report...