Most chemical substances for human health, agricultural or veterinary applications must be approved by the appropriate regulator before being sold in Australia. The regulators require substantial information, including experimental data, on safety, quality and efficacy. As part of its intellectual asset management strategy, any company selling or seeking to sell such products should carefully consider how best to manage or use the data.
Third parties may seek to use information submitted to the regulators for a generic product, to avoid reproduction of data already submitted by the originator, or to gain competitive intelligence.
Therapeutic goods for humans are regulated by the Therapeutic Goods Administration (TGA). The Australian Pesticides and Veterinary Medicines Authority (APVMA) regulates agricultural and veterinary products.
The World Trade Organisation’s Agreement on Trade Related aspects of Intellectual Property rights (Article 39.3) protects application data against both ‘unfair commercial use’ and disclosure. The Australia-United States Free Trade Agreement also includes relevant provisions.
Data exclusivity provisions in the Australian regulatory framework provide periods of time within which the originator’s data cannot be used by a generic competitor as part of the approval process for an equivalent generic product.
The provisions are designed to balance the competing interests of:
- the originator, seeking reward for their efforts in generating data and providing new medicines/chemicals; and
- the generic competitor, seeking to provide competitively priced products without ‘reinventing the wheel’.
Data exclusivity provisions can provide the originator with very effective protection for a period. The provisions come to the fore in situations where the originator does not have patent protection, for example if the patent has expired because an extension of patent term was unavailable or getting regulatory approval took significantly longer than usual.
Below, we summarise the applicable data exclusivity periods:
Click here to view table.
Consistent with their international obligations, the TGA and APVMA resist the disclosure of ‘Commercially Confidential Information’ (CCI). Requests by third parties for information are governed by the Freedom of Information Act 1982.
Consultation provisions require that the regulator consult with the originator before releasing any information, and the originator has the opportunity to request a review by the Administrative Appeals Tribunal.
The TGA recently completed a consultation process on its disclosure of ‘Commercially Confidential Information’. In its draft approach, CCI is defined, in broad terms, as information:
- specifically identified
- having the necessary quality of confidence
- identified to the TGA as being confidential, and
- of such a nature that its release would diminish its value or otherwise cause damage to the originator.
The TGA confirmed it ‘takes all reasonable steps to ensure that CCI provided to it by a company is protected’, subject to its legal obligations, including under the FOI Act.
A company working in commercial fields in which regulatory approval is mandatory should, as part of its intellectual asset management strategy, monitor the relevant product registration register for applications made and data provided.