25 October, 2015
Data exclusivity is an administrative restriction on regulatory agencies from using regulatory dossiers relating to registered therapeutic products to evaluate third party applications for registration, including in the context of establishing that a new therapeutic product is bioequivalent with an existing registered product. During the period of data exclusivity, a third party may not rely upon another manufacturer’s data, which limits their ability to efficiently pursue registration for equivalent products. Data exclusivity is separate from any patent rights that might subsist in a product.
Media and government press releases are reporting that the Trans-Pacific Partnership ("TPP") has been agreed. Based on the reports, the TPP will not require any change to Australia's 5 year data exclusivity period. Interested parties are now awaiting the release of the TPP text to scrutinise what is covered, how it will be implemented and to assess its impact.
In a previous article (please click here), we provided an update on the negotiations for the TPP. At the time, a key remaining issue was data exclusivity for biologics. Data exclusivity refers to the period during which data submitted to regulatory agencies (including the
Therapeutic Goods Administration) cannot be relied upon by the agency to evaluate applications for marketing approval by other medicine manufacturers. The period commences from marketing approval for the first product.
The practical effect of this period is that third party manufacturers must compile their own dossiers for safety, efficacy and clinical trial data, rather than demonstrating that their product is equivalent to products already registered with the agency by reference to the dossiers for those registered products. This represents a significant barrier to entry.
The US has a 12 year data exclusivity period, while other countries to the TPP have data exclusivity periods of between zero to 5 years. Australia, which has a 5 year period, was leading discussions resisting US requests to implement a uniform period of 8 years across all TPP countries. The ongoing discussions regarding data exclusivity apparently remained as a "red-line issue" until the 12 countries agreed the deal.
Although the text of the TPP has not yet been made public, a media release from the Australian Trade Minister provides that the "TPP will not require any changes to Australia's patent system and copyright regime" and that the Australian government "has delivered on its promise not to change Australia's existing 5 years of data protection for biologic medicines". The Office of the US Trade Representative has only commented that the TPP "includes commitments relating to the protection of undisclosed test and other data submitted to obtain marketing approval of a new pharmaceutical product", and has not specified what period will apply, or whether a consistent period will apply across all TPP countries.
The TPP creates the opportunity for increased market access across the 12 TPP countries, but will need to be enacted locally in each of those countries to create this open market. In Australia, the Labor opposition party has already indicated that it needs to see the final text of the TPP before granting its endorsement. While the execution of the TPP is a key milestone, there could still be delays until the open market intended by the TPP is established.
For further information, please contact:
Ben McLaughlin, Partner, Baker & McKenzie
Ben.McLaughlin@bakermckenzie.com
