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Analysis of changes since the introduction of extension hydrocodone acute withdrawal of term provisions Based on the data presented above, it does not appear that there has been a significant change in the effective patent life provided for pharmaceuticals since the introduction of the current extension of term provisions in 1998. Further, the time taken to get PBS listing after ARTG registration has not increased significantly in that time, despite fluctuations within that period. Available estimates in the literature suggest that the cost of pharmaceutical R&D is increasing. However, no evidence was provided that the industry as a whole is suffering from inadequate profitability and that longer periods of patent protection are needed. Therefore, there does not appear to be an argument for increasing the length of extensions of term on the basis of a change in the average exclusive market period available. Comparison of extension length internationally In this section, extensions of patent term provided in Australia are compared with those in the United States (US) and the United Kingdom (UK). The comparison uses IP Australia's database buy xanax online xanax of extended pharmaceutical patents and matched, where possible, with the equivalent patents in the US and UK. The resulting dataset contained 340 and 339 extended patents where matches were identified in the US and UK respectively and 169 patents where extensions were provided in all three jurisdictions.

Before presenting the results of these comparisons, a summary of the differences in methods of calculating pharmaceutical patent extensions in key jurisdictions is provided. Figure 5.12: General Process for Regulatory and Patent Processing A B C D E F (Complete) application date Patent grant First clinical trials Submission of request to regulatory Marketing approval 20 year expiry date Extended final date Note: The scheme represented in Figure hydrocodone es cod no prescription 5.12 is based on clinical trials commencing after hydrocodone acute withdrawal the grant of the patent.

In the US and Japan, extensions of term are calculated with reference to the first clinical trials or the date of grant of the patent, whichever is later. Table 5.4: Comparison of Extension of Term Systems Country Max Effective Patent Life Calculation of extension AU 15 F=A+B+C+D - 5 US 14 F=C/2 +D EP/UK 15 F=A+B+C+D - 5 JP 15 F=C+D Figure 5.13 and Table 5.4 show that the effective life of extended pharmaceutical patents in Australia is the same as in the houghton generic xanax UK at the median and longer than those hydrocodone acute withdrawal in the US by 12 months at the median. Figure 5.13: Difference in effective patent life between Australia and other jurisdictions111 n=339 for US; 340 for UK; outliers not shown; positive means Australian effective life is longer Table 5.5: Difference in effective patent life between Australia and other jurisdictions United States United Kingdom Mean 5 months 0.5 months Median 12 months 0 months *Note: (a positive result represents longer period in Australia) 111 Source data: IP Australia. It is worth distinguishing between situations where the extended Australian patent receives a full 15 years effective patent life (53% of extended patents) and those where, because the 5 year limit is reached, hydrocodone acute withdrawal an effective patent life of less than 15 years is granted (47% of extended patents).

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