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Cellceutix Corporation Message Board

  • doc.feelgoode doc.feelgoode Jul 14, 2013 9:20 PM Flag

    Patents vs FDA market exclusivity

    Patents issued by the US Patent Office trump FDA protection. If the Patent Office determines that the claims in the filing are valid and that the application describes something truly novel. If the USPO determines the claims are valid and novel, then a patent is issued that covers the claims confirmed as novel and those claims receive 20 years of market and manufacturing exclusivity, a monopoly right is granted.

    My understanding is that the key moiety and its formulation into a therapeutic form had to be reworked for use against psoriasis. The reformulation was sufficiently different from that of the original use that a patent attorney drafted a description and claims on behalf of Dr. Menon and CTIX.

    Here's the bottom line, CTIX has already received the preliminary decision from the USPO, and he has said that they expect the patent to be published shortly. That publication will trump any exclusivity granted or not by the FDA.

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    • Patents -- Plural Form ... Yes I agree.
      Monopoly Right -- this is usually referred with price manipulation rights, not sure the term applies? It's not Viagra and with all the new drugs that are going in clinical trials for Psoriasis and the new ones approved in the last few years have really made this a competition.
      Key Moiety: Combination of already approved drugs; whether FDA views this as "Novel" I doubt it, but you have to hand it to Dr. Menon to understanding this...I think the guy is a brain.
      Bottom Line: We don't know enough yet regarding the single patent that will be published.
      It has now been 4 years since animal studies; let's move into the Phase II/III Human stage in early 2013. The main part of the trial will only be 30 days I believe.
      It's not like cancer trials which can take up to 5 years, we should know results very quickly here once the trial finally begins.
      I've been here a long time and it is very nice to see things moving into human trials.
      The question is: Will Prurisol truly be the "Best in Class?"
      About last Post: I mentioned PRINS which means Psoriasis induced by Stress that is expressed in RNA -forgot to mention that so everyone doesn't have to look it up. Maybe Prurisol is a component of a skin cream like Imiquimod or Aldara. That has been my best guess so far as to why there has to be "Components" to synthesize Prurisol...kind of a reverse engineering project, taking something that is non-oral and converting it to an oral. If this is the case, this would be another drug that would work with apoptosis cycle.
      I think Leo Uhrlich has done a good job at making the correct decisions, it just seems like forever.
      I tend to Underestimate and Prepare for the Worse sometimes, it is better to be surprisingly happy than surprisingly sad.

    • Lets not get ahead of ourselves. Patent exclusivity is longer but also looked at as less secure and subject to generic Pharma challenge through litigation. NCE is definitive. People put a higher risk premium on pure patent protection because generics defeat that protection all the time. Still it just means we should expect an NCE lacking attack within a week of successful results and a lower boost to SP say only 300 percent from P success.

    • Wow, Leo and Mennon were really worried about that misconception so they sent you (they're little mouthpiece) all over the internet to clear it up. Thank them for the information on our behalf, would you?

 
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