PAR 5.88% 24.0¢ paradigm biopharmaceuticals limited..

Paradigm patent rejection, page-39

  1. 1,717 Posts.
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    Well, then you're feeling exactly as the OP wished you to feel.

    We've been over all of this a million times on here. All patent protection is moot until someone else gets supply from Bene to treat OA/BMEL (which isn't going to happen). Then they'd have to vye with our existing BME patents. The only other path is creating a therapeutic biosimilar (good luck with that) after which they'd have to do the same.

    Things to remember:

    1. Only Zilosul is going through Phase III trials (not generic iPPS)
    2. Only Zilosul will be approved to treat OA/BMEL if it gets a label (not generic iPPS)
    3. ANY other version of iPPS will have to go through the same Trials as PAR have had to with Zilosul (from the very start, and without the Right of Reference to Zilosul's safety and efficacy record)
    4. Bene have the only DMF for iPPS with the US FDA
    5. Zilosul will get 3 years of Regulatory Exclusivity from the US FDA upon receiving a label (under the 505b2 pathway)
    6. PAR have exclusive supply in all major pharmaceutical markets from Bene, for treatment of OA/BMEL, for 25 years after commercialisation
    7. PAR purchase Bene's uniquely-signatured iPPS in bulk ware form and therefore have the final step in the processing of "Zilosul" (IP)

    The patent protections are but a layer of spit and polish on the galvanized steel position PAR have assured themselves with exclusive supply of the only DMF form of iPPS. The OP is playing with readers, as they have been doing for a long time on this topic.
 
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