Ann: Paradigms Supplementary Phase 2B Data, page-36

I guess it works sooo well that while it is not available by conventional prescription  people might want to go offmarket, or go to a vet, and buy a syringe, research the Paradigm trial dosage,  weigh themselves, figure out how many mg, and go to the trouble of injecting themselves with PPS from an unknown source that is not FDA approved and take all those risks...
... but once it’s available by prescription I know where I’ll be getting it from!

In terms of protection, it’s all spelt out in 51 Capital’s first report.....

“As PPS has been around for 70 years, it is off patent. As a protection, Paradigm have registered patents over the treatment of OA with Bone Marrow Edemas (BME) using PPS. We have conducted extensive research around these protections, as a drug off patent brings potentially increased competition and risk. However, Paradigm have protected this in several ways.

The first protection was to lock up the supply. 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.

However, should a competitor secure supply from elsewhere they would also then need to prove they are treating OA that does not have BME. This is the core part of the patent protection for Paradigm as nearly all OA has some level of BME present. If they treat OA and it has BME, it infringes on Paradigms registered patents. This significantly reduces the size of the addressable market and it is unlikely to be pursued by a big pharma due to the patent infringement.

Paradigm also have a layer of data protection that stops other companies from accessing their trial data for a period of 5-10 years depending on the geographic location. By prohibiting access to this data, a potential competitor must then conduct their own clinical trials in order to register a generic or similar treatment using PPS.

Should a global generic manufacturer attempt to manufacture a generic PPS treatment for OA, there are several hurdles to overcome. They would first need to secure FDA approved PPS, which is not possible via Bene under the existing supply agreement with Paradigm. If they tried to manufacture PPS themselves, or source supply elsewhere, it would then need to be approved by the FDA. This process would take several years and would involve clinical trials in all three phases. After this time, they would then need approval to treat OA but without BME. Otherwise they infringe on Paradigm’s patents.

It is highly unlikely that a competitor would attempt this, given the level of difficulty required. Being first to market also has significant benefit for Paradigm as doctors become comfortable using and recommending the drug Zilosul”