Last night, finalisation 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 announced following more than five years of negotiations.
Although the TPP Agreement is set to ‘open substantial new trade and investment opportunities for Australia’1 by eliminating more than 98% of tariffs in the TPP region (such as on agricultural products, resource and energy products and manufactured goods), as well as provide a range of investment and services outcomes, recent media attention has focussed on intellectual property provisions, and in particular, data exclusivity2 for biological drugs.3
Although the full text of the TPP Agreement is yet to be released, in today’s joint media release, Prime Minister Malcolm Turnbull and Minister for Trade and Investment Andrew Robb state that the TPP ‘will not require any changes to Australia’s intellectual property laws or policies, whether in copyright, pharmaceutical patents or enforcement’ and that ‘Australia's five years of data protection for biological medicines will remain unchanged.’4
As the disagreement between the US and Australia on the issue of data exclusivity for biological drugs has gained some recent media attention, watchers of this space will be interested to hear that Australia has apparently not compromised on the five year exclusivity period it currently offers despite the US pushing for a more generous period of at least eight years.
Each country will now finalise arrangements prior to release of the text of the TPP Agreement, which will then be subject to approval by each member nation. In Australia, this will involve the TPP Agreement text and an accompanying National Interest Analysis to be tabled in Parliament, after which time a Joint Standing Committee on Treaties will conduct an inquiry and report back to Parliament.
We look forward to the release of the full text of the TPP Agreement in due course, and will provide further updates on the Intellectual Property aspects as they become available.
1 Department of Foreign Affairs and Trade, ‘Trans-Pacific Partnership Agreement: Outcomes at a Glance (6 October 2015) <http://dfat.gov.au/trade/agreements/tpp/official-documents/Pages/outcomes-at-a-glance.aspx>.
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.
4 Joint Media Release: Prime Minister of Australia and Minister for Trade and Investment, ‘Historic Asia-Pacific Trade Agreement opens new era of opportunities’ (6 October 2015) <http://www.pm.gov.au/media/2015-10-06/historic-asia-pacific-trade-agreement-opens-new-era-opportunities>.