Sharewise Presentation 22/7/24, page-54

PZ99280 Posts. 107 08/12/19 11:55 Post #: 41855306Originally posted by Eire2011:


”Yes it was interesting that Scott flagged the IP risk as being a significant one, and this is something that has concerned me, and that initially made me reluctant to invest (although I'm now very happy that I got over that little hesitation). Nevertheless, the risks in this area are perhaps more complex that has been flagged here, and imo still very much need to be taken into account.I've no doubt that PAR has got the best available advice, and has done absolutely everything it can to protect itself in this area, but, in my experience, legal advice is very seldom unequivocal. Below are my opinions only, as always DYOR

First, PAR has, or is in the process of applying for, patents around the treatment of multiple conditions, in multiple jurisdictions, all with differing rules and processes - we're probably just not big enough, and don't have the resources, to take on more than one or two challenges at a time, so a partner with deep pockets and lots of in-house legal resources is going to be critical.

Second, the way it generally works with patents, once they've been granted, is that if a competitor produces a rival product that you believe infringes your patent, you have to issue a patent infringement notice, and then take court action to enforce it - you don't get any help from the government or the patent office, and since you're unlikely to get an injunction, the opposing arguments would have to play out in the courts, which could take years, and cost heaps. At the end of the process you might win, and get damages, but these things are always very unpredictable, and the losing side can always appeal, potentially right up through the whole Federal court system .... not a happy prospect.

Third, the exclusive supply arrangement with Bene could itself be challenged on the grounds that it's anti-competitive under EU competition law - possibly it could be challenged under national law too. I'm not saying that it is, but someone else could say that...

.Fourth, we don't have visibility into Bene's supply agreements with other pharmas, which probably pre-date the agreement with PAR. Could, hypothetically, another pharma use Bene manufactured PPS to make up its own injectable version? Since iPPS is being used as an anti-thrombotic in Europe, someone presumably, is doing just that, unless Bene is supplying it directly.

Fifth, while it may be true that J&J gave up the attempt to cut Bene out of its supply chain, and manufacture its own PPS, this was presumably a business decision based on the economics pertaining at the time. PPS is pretty much a niche product (500 scripts per annum in Australia), but a $9 billion a year OA market is something else again, and I'm not convinced that it's beyond the competence of a major pharma to reverse engineer PPS to the satisfaction of the FDA, etc. (although it might take them a fair while)

.Sixth, there are already generic versions of PPS on the market, and available for order through the Internet with a doctor's prescription, at a much lower price than the named version. In theory, in the US it isn't legal to import your own medications, but in practice lots of people do it, and the FDA seems happy to take no action when they do. So a non-FDA approved generic is a high risk imo, especially if the indicative pricing structure that PAR outlined at the AGM is actually the business plan. At those sorts of $$ I think it's likely that almost every uninsured American with OA and an Internet connection is going to go online, and I'm not sure how that could ever be prevented.

These are just a few of my concerns, and I'm sure there are lots more that I haven't thought of. Given the size of the prize, I think IP challenges of one sort or another are pretty much a given, so let's not be too relaxed about this.
On the positive side it looks like we'll be first to market, and that's definitely a big advantage, and I'm hopeful that we'll have a two year head start at least.

I’m planning to top up my holdings on Monday, so still very confident.”

This was posted some 4 and half years ago, but I
think still has much relevance to our present
situation.