Early Notification of Generic Medicine Applications in Australia – Quo Vadis ?

In March this year the Office of the United States Trade Representative ( USTR ) published the 2025 National Trade Estimate Report on Foreign Trade Barriers. On page 19 of that Report the following statement was made :

Under the FTA, Australia must notify a pharmaceutical product patent owner of a request for marketing approval by a third party for a product claimed by that patent owner. Australia must also provide measures in its marketing approval process to prevent persons other than the patent owner from marketing a patented product during the patent term. U.S. and Australian pharmaceutical companies have expressed concerns about delays in this notification process. The United States has also raised concerns about certain provisions in Australian law regarding potential civil damages in cases where a patent owner seeks a preliminary injunction. The United States will continue to monitor these issues.

One month later the USTR published the 2025 Special 301 Report ( Report ). The Report is the result of an annual review of the state of IP protection and enforcement in U.S. trading partner nations around the world.

At page 29 of that Report a similar statement was made to the effect that the U.S. pharmaceutical and medical device industries have expressed concerns regarding the policies of several trading partners, including Australia, on issues related to pharmaceutical innovation and market access. In particular, concerns were expressed about delays by Australia in its implementation of the notification process as required, for example, under Article 17.10.4(b) of the United States-Australia Free Trade Agreement ( USAFTA ) which was signed in 2004.

Article 17.10.4 of the USAFTA relates to pharmaceutical products and Article 4(b) relevantly states :

(b) if [ Australia ] permits a third person to request marketing approval to enter the market with:

(i) a product during the term of a patent identified as claiming the product; or

(ii) a product for an approved use, during the term of a patent identified as claiming that approved use,

[ Australia ] shall provide for the patent owner to be notified of such request and the identity of any such other person.

Australia purported to comply with Article 17.10.4(b) by introducing s 26B into the Therapeutic Goods Act which, in its now current form, provides that all applicants seeking to register or list a generic ( or biosimilar ) product in the Australian Register of Therapeutic Goods ( ARTG ), must provide a certificate ( s26B certificate ) declaring either that :

(a) acting in good faith, it believes on reasonable grounds that it is not marketing, and does not propose to market, the therapeutic goods in a manner, or in circumstances, that would infringe a valid claim of a patent that has been granted in relation to the therapeutic goods;

OR

(b)

(i) a patent has been granted in relation to the therapeutic goods; and

(ii) the applicant proposes to market the therapeutic goods before the end of the term of the patent; and

(iii) the applicant has given the patentee notice of the application for registration or listing of the therapeutic goods.

The s 26B certificate is permitted to be given late in the registration process and is commonly provided only shortly before actual therapeutic product listing on the ARTG. In most circumstances the generic/biosimilar applicant provides a certificate under s 26B (1) (a) i.e. the patent owner is not usually given prior notification of the impending generic product registration. Clearly, it is therefore open to debate whether s 26B, in practical terms, complies with the intention ( and even the literal wording ) of article 17.10.4(b) of the USAFTA.

In February 2019 the Australian Therapeutic Goods Administration ( TGA ) published a consultation paper title “ Whether the TGA should publish that a prescription medicine is under evaluation – Transparency Reforms “ ( Consultation Paper ). The Consultation Paper identified four options :

Option 1: Maintain the status quo i.e., no publication of information for new medicines under review.

• Option 2: Publication that a prescription medicine has been accepted for evaluation for all new chemical entities (including biological prescription medicines), extensions of indications, and all generic and biosimilar medicines.

• Option 3: Publication of all applications at two different time points depending on whether the medicine is a new medicine (on acceptance for evaluation) or a generic medicine or biosimilar (on approval but before registration on the ARTG).

• Option 4: Publication of applications for innovator medicines of highest public interest, but not generic or biosimilar medicines.

Following the consultation process, the TGA announced that the Government had approved the implementation of transparency measures for prescription medicines, in respect of the:

• early publication of major innovator medicine applications; and

• earlier notification of generic/biosimilar medicine applications to the innovator.

In March 2020 the TGA published a further consultation paper titled , rather long-windedly, “ Prescription medicines transparency measures – implementation of generic medicines early notification to innovators of an application and publication of innovator applications ( March 2020 Consultation Paper ).

Following the March 2020 Consultation Paper a system was implemented whereby innovator medicine applications for new active substances, new combinations and new indications were published on the TGA website ( Measure 1 ).

However, no reforms which would have resulted in publication of the fact that evaluation of an application for ARTG registration of generic/biosimilar medicine was underway ( Measure 2 ) were implemented.

Surprisingly, on 9 October 2020, the TGA announced that neither of the proposed Options 1 and 2 for notification to innovators on which it had sought further comment would be adopted as Measure 2. Instead the proposal was that only the first applicant for a generic or biosimilar would need to notify the patentee of a relevant patent when their application is accepted for registration by the TGA. All other applications by subsequent generic / biosimilar applicants would have been subject to the existing notification scheme i.e. the s26B certification scheme.

This more limited notification proposal was not well received by either the innovator or the generic/biosimilar side of the sector and, consequently, this proposal was also shelved. On 21 December 2023 the TGA website was updated simply stating :

“ Views were mixed regarding earlier notification of generic and biosimilar medicine applications to the innovator. None of the options canvassed during consultation received consensus support and therefore the proposed measure was not progressed.”

So where does that leave things ? The pharmaceutical lobby in the US is a powerful force and one which undoubtedly has the ear of the Trump administration. The “ Big Pharma “ lobby in the US is clearly unhappy with the operation of the Pharmaceutical Benefits Scheme but, in a rare show of solidarity both sides of Australian politics have pledged to protect the PBS. It is not inconceivable, however, that the US might turn its focus on more low-hanging fruit in the shape of the notification procedure mandated by the USAFTA and this may be something the Australian government would be willing to compromise on. Our prediction is that there will be movement on this issue within the next 12 months – watch this space !

© BIOPHARMALEX

July 2025