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The person who provides notice
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An applicant arguing that the patent is invalid or will not be infringed (Paragraph IV)
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An applicant submitting an application for licensure of a biological products as biosimilar or interchangeable
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An applicant arguing that the patent is invalid or will not be infringed (An allegation)
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An applicant with the 26B(1)(b) certificate, an applicant arguing that the patent will not be infringed is not required to give a notice to the patent holder
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An applicant arguing that the patent is invalid or will not be infringed
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Recipients of notification
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Owner of the patent and the MA holder
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The holder of biologic MA
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The MA holder
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The patent holder in cases where a patent will be infringed. The generic must certify to the TGA that the MAH has been notified
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Owner of the patent and the MA holder
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Timing of notification
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Within 20 days after the date the is application filed
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Within 20 days after the date the application is filed
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–
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After review of the application, but before marketing approval is granted
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Within 20 days after the date the application is filed
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