Data exclusivity is a significant form of protection to branded pharma in Australia, yet many companies may not be aware of the subtle differences that protection has compared to protection provided by other countries.
In Australia, innovators enjoy data exclusivity protection by which certain information provided to the regulatory authority (the Therapeutic Goods Administration of Australia (TGA)) for the purposes of obtaining regulatory approval for prescription medicine remains confidential and cannot be accessed or referenced by a third party. This includes the results of safety and efficacy in clinical trials.
Under the Therapeutic Goods Act (1989) (“the Act”), the Secretary is prohibited from using information which is deemed “protected” under the Act. The Act provides that certain information is ‘protected’ if it meets the following criteria:
- the information concerns a new active compound (i.e. not a device) which is contained in an application to register a therapeutic good and which has not been previously included in the ARTG
- the information is not in the public domain and the sponsor has not given written permission for the Secretary (of the ARTG) to use the information
- the therapeutic good has been included in the Register for less than 5 years.
In effect, the data exclusivity provisions prevent others from relying on and referencing this data in order to obtain regulatory approval for their generic or biosimilar product during the data exclusivity period, even in the absence of patent protection.
This data exclusivity period runs for 5 years, beginning on the date of marketing approval. It applies in relation to therapeutic goods which contain a “new active component” which has not been previously included in the Australian Register of Therapeutic Goods (ARTG). The protection covers an active component having a therapeutic effect and includes both biologics and small molecule actives.
The data exclusivity provisions only protect a new active component. It does not protect secondary products with a prior-registered active component, for example, a new dosage of a prior registered drug, a combination multiple active components which are already individually registered, new formulations, new routes of administration or new indications of prior registered drugs. This provision prevents a situation where the data exclusivity period is reset by filing for a second-generation product of an old active (such as a new formulation) every 5 years. A consequence of the “new active component” provision is that any subsequent applicant who seeks to register will be unable to rely on a data exclusivity period to protect their product and thus must rely on patent protection as their only mechanism to block a competitor from entering the market. However, in some cases, the relevant information is often still protected by the data exclusivity for the prior registered active because the 5-year term has not yet expired.
There is no separate or additional period of data exclusivity for products which relate to biological pharmaceutical products or have paediatric indications or which have orphan drug status. These products enjoy the same protection as discussed above.
Under the Australian provisions, it is still possible for a third party to seek regulatory approval during the data exclusivity period. However, the applicant cannot rely on or reference any confidential information provided to the TGA by the first applicant in support of their subsequent request for approval. In practical terms, this means that if a third party wishes to obtain approval of a generic or biosimilar product during the data exclusivity period, they can, but they must submit their own data package to the TGA to support their application.
It is important to note that the protection provided by the Act may be forfeited if the confidentiality of the information is not maintained. For example, should clinical trial results be published for any reason, a subsequent applicant seeking approval of an equivalent product will be permitted to use the results in their own application. With that said, in practice, supporting a subsequent application by relying solely on information available in the public domain in Australia is rare. However, although this situation is not common, it does provide an avenue for competitors to bypass the data exclusivity period.
For more information on data exclusivity in Australia, please see:
- Section 25A(2) Therapeutic Goods Legislation Amendment Act 1998 and Section 25A Therapeutics Goods Act 1989
- TGA Approach to Disclosure of Commercial Confidential Information.