I think the answer to my own question is in the Wholesale/Institutional investor report - referenced below
Risks as I see them:
1/ Could the patents be challenged on the basis of the claims not being novel enough
2/ How many of the important patents in key markets are filed but not approved - re. will they be approved?
3/ Separate, but something I have not been completely put at ease on - the progress of stem cell therapies as an alternative treatment.
It seems a lot of the above (at least questions 1 and 2 can be found in the below report - or at least an attempt to give some reassurances.
I have enough conviction in this opportunity to put a large holding (in percentage terms) into my portfolio at this stage.
REF: http://paradigmbiopharma.com/wp-content/uploads/2018/12/20181203_Paradigm-Biopharmaceuticals-Ltd-ASX.PAR-Wholesale-SI-Note-03122018.pdf
(Underline/bold is my own)
p.34First Layer - Patent Protection
Over the last 10 years we have seen the use of Medical Resonance Imaging (MRI) in the diagnosis andunderstanding of orthopaedics increase dramatically. This is relevant as MRI is used to identify bruising of thebone – BMEL, which is obviously the basis of determining whether to use iPPS as a treatment. Paradigm alsoknow that it would be hard to get IP on PPS treating OA due to ‘Prior Art’. But armed with the knowledge thatessentially all OA has BMEL, Paradigm first secured the IP around using PPS to treat BMELs and then secondly(under application) is securing the use of PPS to treat OA with concurrent BMEL. This in itself was quite ingeniousas the global patents for BMEL are broad, granted in practically all major markets (US, EU, Japan etc) andimportantly cover the use of PPS for all BMEL (and BMEL with anything else) – so the indications are far greaterthan just OA i.e. acute injuries through to BMEL from surgeries.
Current patent applications are for BMEL and OA and are based on the view that by treating BMEL you can treatthe symptoms of OA and it is thought the underlying cause.
This strategy of treating BMEL/OA with PPS means anyone treating OA with PPS must prove there is no BMELand they are not treating the BMEL or they are infringing the patents.
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