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No evidence is required to be submitted to support the certificate. The inhaling hydrocodone amount certificate requires only a description of the therapeutic goods for which approval is sought, and it is not necessary to provide patent application or registration numbers, even where an applicant declares that a patent exists.297 The situation in Australia can be contrasted with the position in the US. In the US, a generic company description prescription tramadol submitting a certification that the relevant patent is invalid, unenforceable, or will not be infringed must provide inhaling hydrocodone amount evidence in support of the application. The evidence must include a detailed statement of the factual and legal basis of the applicant's opinion.298 A mechanism for notification to a patentee that a generic manufacturer is seeking regulatory approval for a product that could infringe their patent would allow the inhaling hydrocodone amount patentee to determine whether its patent is likely to be infringed. The generic company may be undertaking genuine preparations to enter the market when the patent expires, or it may be the case that the generic might enter the market with a product that would not fall within the scope of a relevant patent claim. Possible policy solutions The majority of submissions received by the Review support increased transparency and disclosure in relation to the ARTG and patent information. Several options for improvement were suggested in these submissions, and these can be summarised as follows: •a generic applicant seeking to rely on data provided to the TGA by originators for the purposes of regulatory approval should be required to notify the originator sponsor and this inhaling hydrocodone amount should be done through the TGA;299 •ARTG listings should contain information about patents related to therapeutic goods; 300 •the Patents Register should include information about therapeutic goods based on that patent;301 and •Australia should introduce a system similar to the US publication known as the "Orange Book".302 The Panel favours wellbutrin xl vs adderall the introduction of a system that adopts some limited elements of the Orange Book. Introduction of an Orange Book system The Federal Drug Administration (FDA) in the US produces a publication called Approved Drug Products with Therapeutic Equivalence Evaluations. The publication is colloquially known as the Orange Book. The FDA is responsible for the administration of the Orange Book. The Orange Book contains a list of approved prescription drug products and their therapeutic equivalence evaluations. An addendum to the Orange Book contains patent and data exclusivity information relating to particular drugs. The drug names and any trade (brand) names are included, as well as the name of the applicant granted regulatory approval. A pharmaceutical company seeking regulatory approval for a new drug is required to provide information about any granted or pending patents that it has at the time of filing the application.



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