In Australia, section 25A of the Therapeutic Goods Act 1989 (Cth) provides a five-year period of data exclusivity for certain information submitted in connection with the registration of therapeutic goods containing a new active component on the Australian Register of Therapeutic Goods (ARTG).

This protection applies to both biologics and small-molecule drugs. Section 25A prevents the Therapeutic Goods Administration (TGA), when evaluating another product for registration, from using certain protected information submitted in connection with the registration of therapeutic goods containing a new active component. The protection applies for five years from the date the original goods are registered on the ARTG.

In practice, this regime stops competing generic or biosimilar manufacturers from relying on the originator’s trial data to support their own applications for equivalent products. However, the protection under section 25A is essentially limited to information concerning a new active component. It does not provide a fresh five-year period merely because an existing active component is approved for a new therapeutic use.

Data exclusivity is distinct from, but concurrent with, patent protection. Whereas patents safeguard the underlying invention (subject to novelty, inventive step, and utility requirements), data exclusivity protects the informational output of the innovation process for a limited period, namely, the preclinical and clinical data generated to demonstrate safety and efficacy. The period of exclusivity recognises the substantial investment required to generate these data and prevents competitors from obtaining regulatory approval by relying on that investment during the protected period.

During the exclusivity window, the TGA cannot use the originator’s data to assess applications for biosimilar or generic products. While competitors may conduct their own independent trials to generate new data, this route is rarely commercially viable given the cost and complexity involved.

Mechanism in Australia

There is no separate application process for obtaining protection under section 25A. Rather, information meeting the statutory definition of “protected information” is protected by operation of the legislation. The five-year period runs from the date the relevant therapeutic goods are registered on the ARTG.

Section 25A imposes a statutory prohibition on the Secretary using protected information when evaluating other therapeutic goods for registration. If protected information were used contrary to that prohibition, the affected sponsor may have administrative law remedies available, depending on the circumstances. There appears to be limited Australian case law concerning enforcement of section 25A.

Europe

In Europe, a system often described as “8+2+1” applies:

• 8 years of data exclusivity, during which a generic or biosimilar applicant cannot rely on the reference product's dossier;
• followed by a 2 further years of market protection, during which a generic or biosimilar application may be assessed and authorised but the product cannot yet be placed on the market; and
• a possible additional 1 year of market protection where, during the first eight years, a new therapeutic indication is authorised and is considered to provide significant clinical benefit over existing therapies.

United States

The U.S. distinguishes between small molecules and biologics:

• for small-molecule drugs, 5 years of New Chemical Entity exclusivity is generally available where the drug contains no active moiety previously approved by the FDA. The US regime also provides 3 year exclusivity in certain circumstances for changes to previously approved drugs that are supported by new clinical investigations essential to approval.
• For qualifying biologic reference products, a biosimilar application under section 351(k) of the Public Health Service (PHS) Act generally cannot be submitted for review by the FDA until 4 years after first licensure of the reference product, and cannot be approved until 12 years after first licensure.

Key Comparisons

Australia affords 5 years of automatic data exclusivity for certain information concerning a new active component following ARTG registration. However, this protection does not provide a fresh period of exclusivity for a new therapeutic use of an existing active component.

By comparison, the European regime generally provides 8 years of data exclusivity followed by 2 years of market protection, potentially extended by a further 1 year in certain circumstances.

In the US, qualifying new chemical entities generally receive 5 years of exclusivity, while qualifying biological reference products benefit from a regime that prevents biosimilar applications being filed for 4 years and approved for 12 years after first licensure.

Data exclusivity is distinct from patents in that it protects regulatory data, not the invention itself and operates concurrently with patent rights. Data exclusivity provides a valuable additional layer of protection, which may be useful where patent protection is weak or is challenged.

However, because Australia's 5-year period is relatively short and limited to a new active component, patent strategy is particularly important for maintaining meaningful protection beyond the regulatory data-protection period.

For more information on data exclusivity, please contact Daniel McKinley or Dr Catrina Olivera.

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