I don't know the exact details and I could be wrong, but my understanding is: There is IP around the production process (specifically the genetic strain of e-c

I don't know the exact details and I could be wrong, but my understanding is: There is IP around the production process (specifically the genetic strain of e-coli). Because the production process is biological, generics produced with a different process are not automatically approved by the FDA and have to undergo an expensive approval process. Thus the goal here is to devolop a process with open IP and get that process approved.