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For drugs which have been hydrocodone oxycodone versus accorded an extension, this is the maximum period provided under the scheme. However, the effective patent life may be decreasing for the 25% of patents receiving the shortest effective patent life. This suggests that where there are unusually long delays, the period of delay may have increased slightly over time. Comparing these patents, where possible, with equivalent patents in the US and UK, there appears to be a relatively even mix of cases where the delay in gaining regulatory approval is specific to Australia and where the delay is seen worldwide.107 Figure 5.9: Effective Patent hydrocodone oxycodone versus Life Provided Under Current Provisions - Percentiles by Year Year of TGA approval mean median 5th percentile 25th percentile 75th percentile 95th percentile For all patents granted an extension Jan 1999 - Dec 2012; approved between 1995-2012 Merck, Sharp and Dohme propose a possible mechanism to give more extended patents a 15 year effective life, which is also suggested in a number of other submissions: ... the five year cap on the length of an extension of term should be either totally removed or increased to ensure that all the eligible pharmaceutical patents achieve 15 years of hydrocodone 10/325 effective term.108 Regardless of arguments hydrocodone oxycodone versus whether this was truly the policy intent, or whether the intent is more correctly stated as a scheme that allows extensions more in line with those granted elsewhere and up to a maximum of 15 years, there are important considerations that should be taken analitica tecnica tramadol into account in considering any adjustment to the terms granted under the scheme. More extended patents could be provided with an effective life of 15 years if the existing limit was changed. Where extended patents do not receive a 15 year effective patent life, it is because the maximum extension of 5 years has been granted. IPTA submits that if the limit on the length of extensions under section 77(2) were increased from 5 years, or removed, more patents would be provided with a 15 year effective life.109 This approach is suggested in a number of submissions. 110 However, this would also mean allowing total patent terms of up to 20 years plus the allowable limit (with the possibility of 35 years in some cases if the limit was removed entirely). The existing method of calculating the length of extensions set out in section 77(1) would maintain a maximum effect patent life of 15 years. Changes since 1998 This section will consider what, if any, changes have occurred since the extension of term provisions were introduced, including xanax xr anxiety disorder consideration of the time taken for TGA approval and PBS listing as well as the cost of pharmaceutical R&D. The current method of calculating extensions takes account of the time taken in assessing applications for registration by the TGA. Therefore, this time would only be of concern where the five year maximum extension prevents a 15 year effective patent life being provided. As shown in Figure 5.10, the time taken for TGA approval has not been a significant factor in determining the effective patent life provided under the current extension of term provisions. Figure 5.10: Effective Patent Life vs TGA Approval Time104 Time from TGA Application to Registration n=446; for all patent extensions under the current provisions where TGA application and registration dates are avilable. In its submission to the Review, AusBiotech suggested that the time taken to get PBS listing after ARTG registration is increasing, reducing the exclusive marketing period of pharmaceuticals on the PBS. In Australia there has been a decade-long trend in increased delays, with the average time between a positive TGA recommendation and PBS listing increasing steadily from 13.6 graph oxycontin hydrocodone oxycodone versus months in 2000 to 34.2 months in 2009.111 However, this is not supported by other studies or data collated on extension of term pharmaceuticals.



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