AusBiotech at odds with recommendations in IP Draft Report


AusBiotech has provided a submission in response to the Productivity Commission’s Intellectual Property (IP) Arrangements Draft Report, disagreeing with numerous recommendations in regard to patents and data protection.

AusBiotech made the submission to the Draft Report (released in April 2016) after also making a submission to the Issues Paper on Australia’s Intellectual Property Arrangements (November 2015).

AusBiotech said in its submission on behalf of members that it does not agree with the recommendation that the Innovation Patent system should be abolished, and instead proposes serious consideration be given to improving the system. AusBiotech said that the objects clause proposed is not suitable and that patent extension period should not be decreased. Extensions to patent life for health technologies like pharmaceuticals are important because the regulatory and reimbursement processes consume years of patent life - and the period or the possible period of the patent influences the decisions of and value to investors.

In response to the Commission's recommendation to amend the definition of an “inventive step” in Australia to bring it into line with the definition used in Europe, AusBiotech raises the question of when the analysis was conducted, before or after the ‘Raising the Bar’ legislation was enacted, and is this recommendation relevant since the changes took effect in 2013 to align with Europe. AusBiotech said it supported the ‘Raising the Bar’ Act and would like to see it given time to settle and its impact properly assessed before further changes are considered.

AusBiotech supports an extension to data exclusivity periods for biologics and an efficient and effective IP system for Australia, which balances the needs of innovators and third parties. Australia’s five-year data exclusivity provision lags global competitors and collaborators such as the United States (up to 12 years), Canada (eight years), the EU (up to 11 years), Japan (eight years) and even countries like Russia and China (six years). This puts at risk investment in Australia’s rapidly growing domestic pharmaceutical and biotechnology sectors.

The balance required here and the real patient impact is likely to make it harder for biotechnology companies to develop and deliver new medicines in Australia, and further challenge the sustainability and growth of the emerging Australian biotech industry. In short, these changes recommended by the Productivity Commission, could have a negative impact on social value.

The full submission can be found at the AusBiotech website.