The current requirement for extended-patent owners to provide the Department of Health with details of the amount spent on research and development (R&D) of the patented medicine is under review as part of an IP Australia consultation on reducing red tape for small business.
This reporting requirement was introduced in 1999 along with the current extension of term provisions, requiring the patent owners to report spend on R&D including details of the amount and origin of any Commonwealth funds.
The consultation paper says: “At the time, the Government was looking at ways to encourage pharmaceutical research and manufacturing in Australia…The requirement to report on R&D funding was intended to help the Government evaluate whether extensions of term were achieving this objective.”
The review of R&D data collection for extended-patents is part of the Government’s new discussion paper, Proposals to streamline IP processes and support small business, which also outlines 21 other proposals to align and simplify our IP processes, support small business and make some technical fixes relating to the regulation of IP attorneys.
The Federal Government has announced a consultation on ways to improve the IP system by reducing delays and complexity and better balancing the interests of innovators and competitors.
The consultation paper says that although the R&D spend reporting requirement was intended to help the government evaluate the impact of the extension of term scheme on industry investment in R&D, the usefulness of the data provided is limited as it only relates to a small sample of pharmaceutical R&D – namely those related to extended patents. The data is provided in an inconsistent way as it is not clearly defined.
“Providing the information places a burden on patentees that is currently not balanced by the Government or the public having a better understanding of the effectiveness of the extension of term scheme or government funds spent on R&D.”
Three options are provided for discussion: Option 1 – no change; Option 2 – no longer require patent owners to provide R&D information; or Option 3 – improve the reporting requirement to collect valuable and consistent data on R&D spending
At this stage, IP Australia says it does not have a preferred option and welcomes stakeholder views on this issue. IP Australia also invites suggestions as to the types of data that would properly inform policy in this area.
The review closes on 7 April 2015 and comments to inform the AusBiotech submission can be directed to Lorraine Chiroiu (lchrioiu@ausbiotech.org or 03 9828 1414) by this date. More information on the proposals and how to make a submission can be found in the IP Australia website.