Gint Silins
Scientific Tracks Abstracts: Pharmaceut Reg Affairs
Does the current Australian system for pharmaceutical patents effectively balance the objectives of securing timely access to competitively priced pharmaceuticals, foster innovation and support employment in research and industry? Does the system provide ?balanced? protection for pharmaceutical product innovators and allowances for the generics industry? Apparently the answer is that it could do better, and it is for this reason that the pharmaceutical patent system is currently under review. After a much publicly criticized draft report, a review panel is due to deliver its final report, including its findings and recommendations, to the Australian Government by 30 May 2013. This presentation will review the rights of pharmaceutical product innovators and the generics industry under current laws as well under amended laws should the Australian Government ultimately adopt the recommendations of the review panel. Topics to be addressed include proposed (1) changes to pharmaceutical extensions of term, (2) infringement exemptions, (3) introduction of an Orange Book equivalent, and (4) data exclusivity in exchange for the publication of clinical trial data.
Gint Silins is a registered patent and trade marks attorney in Australia and New Zealand, and a partner of Cullens Patent & Trade Mark Attorneys. His practice involves searching, filing and enforcing patents, designs and trademarks, largely in the personal care and health care industries, and more particularly in the fields of chemistry, biochemistry, cosmetics, nutraceuticals and pharmaceuticals. He holds a Bachelor of Science degree in chemistry with honors in biochemistry, and a Doctor of Philosophy degree in biochemistry.
Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report
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