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However, no evidence has been provided to the panel that such inventions are subject to the same extent of cost, delay and risk as pharmaceutical products or that these new uses are not being developed and made available to canada hydrocodone shipped the Australian market ambien zolpidem due to a lack of incentive.

The guiding principle for any change to the intended scope of pharmaceutical patents eligible for an extension of term is that changes should only be made if it is clearly in ambien zolpidem the national interest to do so. Convincing evidence to warrant expanding the scope of extensions to method patents has not yet been provided to the Panel.

Furthermore, with respect to the argument that extensions should be available in Australia for methods of use and manufacture to more closely match the Australian scheme with schemes in the US, Europe and Japan, expanding or reducing the scope of the pharmaceutical extension so that Australian legislation matches that in other countries for its own sake does not represent a sound argument for doing so. As stated previously, it should only be done where it is clearly in the national interest. Draft Recommendation 6.1: The Government should maintain the current approach that allows extensions for drugs and formulations but not for methods of use and manufacture, which will continue to provide an incentive for the development and supply of active pharmaceutical ingredients and new formulations, without adding to the existing cost of medicines in Australia. Multiple extensions based on one ARTG listing In public hearings, GMIA proposed that only one patent should be able to be extended per ARTG registration, as is the case in the US. Under the US system, applicants are required to nominate which patent will receive an extension based on the FDA approval. This means that it is not possible to receive hydrocodone overnight delivery no prescription extensions to multiple patents for a single approval.128 Under the Australian scheme, provided that various timing requirements are satisfied, there is no barrier to the extension of multiple patents on the basis of a single, first ARTG registration. As shown in Table 6.ambien zolpidem 1, there have been 77 instances identified (covering 179 patents, which is 32% of all extended patents) where this has occurred.

Table 6.1: Frequency of Instances of One or Multiple Patent Extensions based on a single ARTG Registration128 No. of Instances 381 60 11 5 0 1 Necessarily, where there is more than one patent receiving an extension of term for the ambien zolpidem same ARTG listing, all patents have been filed more than five years prior to ambien zolpidem the pharmaceutical receiving ARTG approval.

Therefore, the approved product typically incorporates the multiple inventions disclosed in the patents. Multiple extensions per ARTG-registered product may increase the total length of the monopoly granted in relation to the product.



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