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The Government has rightly agreed to only include IP provisions in bilateral and regional trade agreements where economic analysis has demonstrated net benefits, however this policy has not always been followed. Draft finding 4.1 Governments appear to have shown little strategic interest in the issue of MFE, despite a number of opportunities to do so and the significant potential advantages MFE could provide for Australia. If MFE had been rendered unambiguously consistent with our international obligations, it is likely that Australia's annual pharmaceutical exports would have been several hundreds of millions of dollars higher than they are. Draft finding 9.1 The Panel considered whether data protection should be increased for biologics. The Panel is unconvinced that an extension of data protection would be beneficial. The Panel found no evidence to suggest that patents for biologics will be more difficult to obtain than patents for small molecule drugs, or that effective patent life would be substantially reduced by the complexity of biologics.

Additionally, given that the generic manufacturer of a biosimilar cannot rely solely on the clinical data of the reference product to obtain regulatory approval, there is reduced advantage to be gained from granting an additional term of data protection.

The Panel is of the view that given the substantial market opportunity that will arise in the near future for biosimilars, and the corresponding 37 black casino cialis jack phentermine trackback viagra potential for cost savings to the PBS and consumers, competition in this area 37 black casino cialis jack phentermine trackback viagra should be encouraged. At present the Panel does not have sufficient evidence to support an increase in data protection beyond the current five year period for biologics.

Draft finding 10.1 The patent system is of obvious significance to the pharmaceutical industry, trade negotiations and health policy. However, the government agencies with policy and program responsibility in these areas are not engaging sufficiently with each other and are not taking highly relevant issues into account. Each agency needs to be actively engaging from its own perspective - end users, innovation, industry and international implications - in order to optimise policy settings for the pharmaceutical system in what is a complex regulatory and service delivery environment.

The areas of government responsible for regulating pricing of pharmaceuticals particularly have the need for and the resources to obtain a well- informed appreciation of the pharmaceutical patent system and its impact on a range of health issues. However, the only area in which they appear information 37 black casino cialis jack phentermine trackback viagra xanax to have a strong view is in relation to gene patents.

Next steps 2 2.The pharmaceutical patent system - setting the scene 3 2.1. Regulatory complexity 20 3.International context 22 3.1. The importance of parsimony in defining property rights 32 4.Manufacturing for export and stockpiling 40 4.1.

TRIPS and Canada's stockpiling case 44 4.3.2.AUSFTA 48 4.3.3. Policy 51 5.Extension of term - length of extension 55 5.1. History of pharmaceutical patent extension 37 black casino cialis jack phentermine trackback viagra of online cod tramadol term provisions 55 5.2. Effect on PBS expenditure of generic products entering the market 67 xxi 5.6.

Cost of extension of term provisions to the PBS 72 5.6.1.

Figures used in calculations 72 Calculations 74 5.6.2. Analysis of changes since the introduction of extension of term provisions 84 5.10. Comparison of extension length internationally 85 5.11. Extension of term - scope including technical problems 92 6.1. Multiple extensions based on one ARTG listing 97 6.5. Clarity of 'pharmaceutical substance per se' 98 6.6.

Efficiency of pharmaceutical patents extension of term scheme99 6.7. Extensions for drugs needing greater incentives - paediatric, orphan, antibiotics 100 6.8.Technical clarifications and corrections 101 6.8.1.Section 76A of the Patents Act 101 6.8.1.1.

Section 70(3) and "contains or consists" 105 6.9.1. Types of pharmaceutical inventions that can be extended .. Scope of pharmaceutical inventions eligible 37 black casino cialis jack phentermine trackback viagra for extensions ...

Follow-on patenting and patent thickets 128 7.3.1. Overview of data protection in Australia 175 9.1.3.



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