PAR and Coke, page-16

patent efficacy and the commercial realities. The following observation by 51 capital is likely the most commercially significant protection in the USA and most western nations that will offer the treatment and imo superior to any form of ip protection.

' Currently the only FDA approved supplier of PPS for human use is a German company – Bene pharmaChem (Bene). Paradigm have secured the supply of PPS from Bene for the treatment of OA, as well as their other patented indications. Should another company try to source supply via Bene it would breach this agreement. It’s worth noting that Bene are solely a manufacturer of PPS and have a commercial supply and license arrangement with Paradigm.'

A patent is an expensive and often illusory means of "protecting" a private "right". However when a nation regulates the supply the protection levels are stratospheric and free until a competitor can satisfy the bureacracy it is as good or better.
certainly patents are necessary enhancements but if you have the only Government approved product in your offering you are a long way in front