Recent legislative changes have removed a reporting burden from patentees applying for pharmaceutical extensions of term.
Section 76A of the Australian Patents Act (the Act) was introduced alongside the pharmaceutical extension of term scheme in order to collect data regarding each granted extension. It was intended to assist in evaluating whether pharmaceutical extensions of term were achieving their stated goal, namely encouraging pharmaceutical R&D in Australia.
Section 76A required patent holders who were successful in obtaining a pharmaceutical extension of term to report certain information about the costs of R&D spending on the pharmaceutical to the Department of Health. Particularly, the return had to detail the following information:
- the amount and origin of any Commonwealth funds spent in the R&D of the drug which was the subject of the extension
- the name of any entity which is in receipt of Commonwealth funds with which the patentee has a contractual agreement
- the total amount spent on each type of R&D, including pre-clinical research and clinical trials, in respect of the drug which was the subject of the extension.
In its 2016 report on Australia’s Intellectual Property Arrangements, the Productivity Commission concluded that s76A was not performing its intended function due to a lack of clarity and compliance. It therefore recommended that the provisions be substantially reformed and expanded in order to improve data collection.
It its response to the Productivity Commission Report, however, the Federal Government did not accept the recommendation. The Government considered that as its ability to access and analyse relevant data was now far greater than when the provisions were introduced, s76A was no longer necessary. For example, relevant information is available in clinical trial data from the Therapeutic Goods Administration. As the Commission did not identify a convincing rationale for imposing this regulatory burden the Government instead proposed that s76A could be repealed.
Following the Government’s response, the Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Act 2018, commenced on 25 August 2018, which has now repealed section 76A.
This welcome repeal removes an unnecessary reporting burden on patentees.