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Data protection and the patent system 179 9.1.5.1.Submissions 180 9.2. Integrated approach to the pharmaceutical system 201 10.1. Analysis 203 Appendices 207 Appendix A: Terms of reference 207 Appendix B: Relevant buy xanax without a perscription provisions from international agreements 208 TRIPS Agreement, Part II, Section 5 208 AUSFTA - Chapter 17 210 Article 17.9 - Patents 210 17.10: Measures related to certain regulated products 213 Appendix C: List of submissions 221 Appendix D: Abbreviations 223 1. Introduction 1.1.Focus of the inquiry The panel has been asked to review the effectiveness of the Australian patent system in providing timely access to affordable pharmaceuticals and medical treatments and supporting innovation. This includes an analysis of the current pharmaceutical extension of term provisions, which have not been reviewed since their introduction in 1998. Other issues considered include granting of patents for new formulations, methods and uses of known pharmaceuticals; and international IP agreements and strategies for extending market exclusivity. The Australian pharmaceutical system operates within a wider global system buy xanax without a perscription of pharmaceutical research, development and supply. Australia is a small market and a net importer of technology and medicines. The review has considered the Australian system in these contexts and in respect of an environment where many participants are multi-national companies, with far larger markets outside Australia than within. It has also considered how the international agreements to which Australia is a party impact on the pharmaceutical system.

The review recognises the complexity of the system and buy xanax without a perscription of the regulatory environment, and interactions between: the IP system; the Therapeutic Goods Administration, which is responsible for the registration of therapeutic goods for supply in Australia; and the Pharmaceutical Benefits Scheme, through which the Government subsidises the cost of most medicines supplied in Australia.

For the purposes of this review, a pharmaceutical patent is taken to be a patent for a medicine or a patent that directly relates to a medicine.

A pharmaceutical patent includes (but is not limited to) patents with claims for active ingredients, new formulations and methods of use. For example: •a new active ingredient developed to treat a condition •a new way hydrocodone relapse affects thought pattern of formulating the medicine cost of oxycontin on the street to provide some benefit, such as improving its absorption in the body •a new method of producing a medicine •a new use for the medicine in treating a different condition. 1.3.Report structure The draft report has the following structure: •Setting the scene - the rationale for having a patent system and the value of pharmaceutical patents for innovation and R&D and challenges for developing an optimal system in which the level of protection, and reward, provided by patent rights does not unduly restrict further innovation. (chapter 2) •The international context - the importance of understanding the economics of IP in national and global economies; the implications for Australia of being a small economy; and the importance of a positive agenda and parsimony when negotiating trade agreements. (chapters 3 and 4) •Extensions of term - the rationale for having an extension of term scheme, an evaluation of the effectiveness of extensions in encouraging investment in R&D buy tramadol india and the impact of extensions on the cost of drugs. (chapters 5 and 6) •Patent scope and validity - how the patent system buy xanax without a perscription is used by pharmaceutical companies to buy xanax without a perscription protect investments and maintain market share; patent landscapes around high-earning drugs; the importance of high standards for the grant of a patent and the high costs of litigation. (chapters 7 and 8) •Data exclusivity and biologics - the term of data protection in Australia; interactions between data protection and patents; and the unique challenges of biologics. (chapter 9) •Integrating elements of a complex, highly regulated system - regulatory processes in the Australian pharmaceutical system and the silos that administer these processes: developing a more integrated approach to policy development and evaluation.



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