The official text of the 12-country Trans-Pacific Partnership (TPP) Agreement between Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the US and Vietnam was released yesterday, a month after the TPP Agreement was finalised.
In yesterday’s media release, the Australian Minister for Trade and Investment Andrew Robb welcomed the release of the text of the TPP Agreement, stating that the release ‘provides the Australian public with an opportunity to examine the text and more fully understand any areas of the negotiation that are of interest to them’.1
The intellectual property provisions of the TPP Agreement are contained in Chapter 18. Chapter 18 implements a number of measures that provide robust protection for intellectual property rights. Chapter 18 also promotes cooperation between the signatories to the TPP Agreement with respect to the protection and enforcement of intellectual property throughout the TPP region.
While much of the TPP Agreement reflects Australia’s current intellectual property laws and policies, concerns have been raised in relation to a number of provisions of the Agreement, including the treatment of technological protection measures and the penalties imposed for disclosing trade secrets. In relation to trade secrets, while the final text requires each country to provide for criminal procedures and penalties for acts including the unauthorised misappropriation of trade secrets, the defences available with respect to such acts are unclear and may negatively impact upon journalists and whistleblowers.
The TPP Agreement does, however, resolve one of the issues the subject of recent media attention, namely data exclusivity2 for biological drugs.3 As foreshadowed in our earlier announcement, the final text makes it clear that Australia did not compromise on the five year exclusivity period it currently offers, despite the US pushing for a more generous period of at least eight years during the course of the negotiations.
Each country will now follow its own domestic treaty-making process with regard to approval of the TPP Agreement. In Australia, this will involve the tabling in Parliament of the TPP Agreement text and an accompanying National Interest Analysis, after which time a Joint Standing Committee on Treaties will conduct an inquiry and report back to Parliament.
The intellectual property provisions in the TPP Agreement are complex and we will provide further updates on particular areas of interest in the following weeks.
1 Media Release: Minister for Trade and Investment, ‘Text Released for Historic Trade Pact (TPP)’ (5 November 2015) <http://www.andrewrobb.com.au/Goldstein/LocalIssues/tabid/123/articleType/ArticleView/articleId/1961/TEXT-RELEASED-FOR-HISTORIC-TRADE-PACT-TPP.asp>
2 Data exclusivity refers to a period in which clinical data used by an originator company to obtain marketing approval is unable to be used by follow-on pharmaceutical developers, such as generic manufacturers, to obtain approval for their own product.
3 Biological drugs include ‘biologics’, which are large molecules usually derived from living cells, and include proteins, DNA vaccines, and antibodies, and their follow on products, ‘biosimilars’, which are similar to but not identical copies of originator biologics.
Authors: John Afaras Principal, Sarah McKeith Solicitor