research reports and media, page-3879

I recall you mentioning this gentleman before, and he sounds like a leader in the field. Glad PAR have retained him for their patent work.

The situation with Arthropharm (Europe) wasn't necessarily to do with a patent challenge though, as I understand it. I don't know if Arthropharm even have patents to cover administration of the drug in animals etc. That isn't mentioned. According to legal reports, the HPRA in Europe (which covers medicines for human use as well as veterinary, incidentally) just went ahead and approved a generic biosimilar of Arthropharm/Catrophen's PPS (Cartrophen's PPS comes from Bene, Chanelles biosimilar does not).

Whether this could happen in the same way with a drug for human use, I don't know. Maybe rules are tighter for drugs for human use, again I don't know. It would have been fascinating for PAR holders if Arthropharm had been able to challenge this, because it would have given us a direct look-through to a case of a Bene PPS' unique individuality being challenged by a biosimilar. Alas, Arthropharm screwed the pooch and didn't get any kind of legal challenge in within the given timeframes, so didn't get to argue this case at all. We'll never know what would have resulted.

The snippet below from a Legal review of the case shows that, in the EU, "generics" can be approved after 10 years of the originator product being licensed. They didn't have to go through clinical trials the way we've been told they would have to (by research analysts covering PAR, but also by PAR themselves in the ASX announcement refuting Morgans' interpretation of their patent issue in the US). The HPRA simply approved Chanelles Osteopen product on the basis that it contained PPS and - whether assumed out of ignorance or not - that Chanelle PPS fell under "generic medicinal products that have the same composition and active substances in the same pharmaceutical form as a "originator" product which is already authorised".

https://www.irishlegal.com/articles/high-court-pharmaceutical-company-was-out-of-time-to-challenge-generic-s-marketing-authorisation


Had Arthropharm (Europe) not sat on their hands and missed the deadline to appeal the HPRA's approval of Chanelle's Osteopen - we might have seen their lawyers school the HPRA on chromotograpy and moieties and all the good stuff provided for in the research paper we've all recently read. We might even have seen the appeal upheld, giving us confidence that PAR could hold off biosimilars eating into our market even if it's years after our own approval. Instead, all we got was a clear insight that - given any opportunity - biosimilars and "generic" PPS formulations will be packaged into products and will take any sliver of a chance to eat our lunch from the word go. The only way to defend against this is to be hyper-vigilant, litigious - tie them all up in court at the earliest opportunity, and cover our ass with as much protection (via patents, sure, but also via research which can be leaned on in court, periods of regulatory exclusivity, and clarity from the Agencies upon approval that Zilosul has material differences to any "generic" PPS available). It looks like PAR/Bene are anticipating all of this and doing whatever they can - but this Arthropharm episode has made me doubt the line we've been fed that biosimilars would 100% need to go through clinical trials for the same indication first. All you apparently need (for a veterinary drug, in the EU, at least), is for a period of regulatory exclusivity to have ended, and an Agency (whether ignorant or not) to assume that the API you are using as a therapeutic is the same in a competitor product, and all of a sudden the burden of proof is not on your competitor - but on YOU to prosecute.