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Elite Pharmaceuticals, Inc. Message Board

  • eltp_dd eltp_dd Jun 4, 2011 3:24 AM Flag

    PATENT APPROVAL PROCESS & FDA INVOLVEMENT

    Hey guys, it's HappyDays. I'm having issues with my email account. Will use this account for now while I get the original one working again. Thought this is a good link to share with the board. I'll be gone the whole weekend, thought this can't wait til Monday. Have a nice weekend!


    Patent timeline/approvals and how FDA is involved:
    http://www.iploft.com/PTO-FDA.pdf

    Key take-aways:
    * All bio-technology patents are subject to FDA approval

    * The average prosecution time for a US patent is 3.4 years while the average biotech patent is 4.4 years.

    * Federal Drug Administration (FDA) approval usually requires 10 to 12 years of development and 100 – 500 million dollars in development costs. (Please note the 10-12 years are for the phases 1, 2, 3 + FDA review combined.)

    * Patent approval stragetically must come before FDA trials start in order to minimize the risk of another company patenting the invention first.

    * Issued patents drive FDA approval, speeding up the process.

    * Filing patent applications and receiving approved patents will attract investors that will provide the necessary capital to fund the costly FDA clinical trials.

    * One procedure to shorten the USPTO process is to make the application “special,” in which the USPTO examiner will process the special patent application before all other categories of applications. The USPTO provides special provisions for biotech inventions that allow a biotech patent to have “special” status. To qualify for a petition to make special, the company must be a “small entity,” which is a company with fewer than 501 employees or a nonprofit organization. The petition must also state that the patent applicant’s technology will be significantly impaired if a patent examination is delayed. If the situation calls for special status, the FDA approval process can be started earlier and can result in extended market exclusivity.

    * The “accelerated approval” process allows marketing products to patients with serious or life threatening conditions. A biopharmaceutical’s approval may be accelerated if there are adequate and well-controlled clinical trials that ascertain the biopharmaceutical’s clinical outcome will provide a considerable therapeutic benefit over existing therapies (again, not sure if ELTP products qualify)

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    • maybe this will help?

      This is very good to elite with FDA guidance for ELI-216


      Elite met with the FDA for a Type C clinical guidance meeting regarding the NDA development program for ELI-216. Elite has incorporated
      the FDA’s guidance into its developmental plan. Elite has obtained a special protocol assessment, or SPA, with the FDA for the ELI-216 Phase
      III protocol. Elite will conduct additional Phase I studies including, but not limited to, food effect, ascending dose and multi-dose studies.
      Elite has developed ELI-154 and ELI-216 and retains the rights to these products. Elite has currently chosen to develop these products itself but
      expects to license these products at a later date to a third party who could provide funding for the remaining clinical studies, including a Phase III
      study, and who could provide sales and distribution for the product. The drug delivery technology underlying ELI-154 was originally developed
      under a joint venture with Elan which terminated in 2002.
      According to the Elan Termination Agreement, Elite acquired all proprietary, development and commercial rights for the worldwide markets for
      the products developed by the joint venture, including ELI-154. Upon licensing or commercialization of ELI-154, Elite will pay a royalty to Elan
      pursuant to the Termination Agreement. If Elite were to sell the product itself, Elite would pay a 1% royalty to Elan based on the product’s net
      sales, and if Elite enters into an agreement with another party to sell the product, Elite will pay a 9% royalty to Elan based on Elite’s net
      revenues from this product. (Elite’s net product revenues would include license fees, royalties, manufacturing profits and milestones) Elite is
      allowed to recoup all development costs including research, process development, analytical development, clinical development and regulatory
      costs before payment of any royalties to Elan

    • thanks

 
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