How TRG and ARTG Regulation Shapes Patent Strategy

Guide to Australian patent law for life science companies.

A pharmaceutical patent does not exist in isolation. Its commercial value is determined as much by the regulatory system administered by the Therapeutic Goods Administration as by the Patents Act 1990 (Cth) itself, because it is entry on the Australian Register of Therapeutic Goods, not the grant of the patent, that permits a medicine to be sold.

 The two systems run on separate tracks, yet at several points the regulatory track determines what a patent is worth, when it can be enforced, and how long it lasts.

This guide explains those points of connection for patent owners and their competitors.

Registration and patents are seperate systems

The first principle is also the one most often misunderstood. The TGA assesses the quality, safety and efficacy of a medicine, and nothing else. It does not examine the patent position of the product before it, and it has no power to refuse or defer registration because a patent subsists over the originator's medicine. A competitor's generic or biosimilar may therefore be entered on the Register while the originator's patents remain in force, and the patent confers no protection at the point of registration at all.

Some other jurisdictions tie marketing approval to patent status, so that the regulator's decision is bound up with the patent position of the product. That connection is known as patent linkage, and Australian law has never adopted it. The consequence for a patent owner is direct. Enforcement is entirely a matter for the courts, and an owner who wishes to keep a competitor off the market must bring proceedings and, in practice, seek an injunction. The regulator will not do it for them.

How a patent owner learns a competitor is coming

If registration proceeds regardless of patents, the practical question for a patent owner is how it will discover that a competitor is approaching the market at all. The answer lies in a single certificate.

A sponsor whose application relies on the originator's clinical data must certify one of two things to the TGA (Therapeutic Goods Act 1989 (Cth) s 26B):

• that it believes on reasonable grounds that it will not market its product in a manner that infringes a valid claim of a patent, or

• that it has notified the patent owner that the application has been made

Only the second form gives the patent owner any warning, and sponsors almost invariably give the first. They are entitled to do so where they consider the relevant claims invalid or not infringed, and it requires them to tell the patent owner nothing.

The result is a structural blind spot. An originator is not routinely notified that a competitor has sought registration, and commonly draws its first inference of an impending launch from the competitor's movement towards a Pharmaceutical Benefits Scheme listing. Because listing triggers an immediate and effectively permanent price reduction, that inference must be acted upon quickly, which is why applications to restrain generic entry so often reach the court urgently.

When registration starts the clock

Extension of term

The most valuable connection between the two systems runs in the patent owner's favour. A standard patent lasts twenty years, but regulatory approval consumes years of that term before a medicine can be sold, so the Patents Act allows the term of a patent claiming a pharmaceutical substance to be extended by up to five years (ss 70–79A).

Registration is what starts the clock.

An extension is available only where:

• goods containing the pharmaceutical substance are included on the Register

• at least five years have passed between the date of the patent and the first regulatory approval, and

• the application is made within six months of that inclusion or of the grant of the patent, whichever is later (ss 70, 71)

  
  

Two features of the regime regularly catch patent owners out. The extension is calculated from the earliest regulatory approval of any substance falling within the claims, even where that approval belongs to a competitor's product, so a patent covering several substances may yield a far shorter extension than expected.

The position is currently unsettled

This area is in flux, and materially so. In Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd [2025] FCAFC 161, the Full Court held that a pharmaceutical substance is limited to an active pharmaceutical ingredient, so that claims directed to a formulation do not qualify for an extension of term, a construction that departed from practice that had stood for close to thirty years.

The present position is therefore:

• existing extensions granted on formulation patents are themselves vulnerable to challenge

• the High Court granted special leave to appeal on 12 March 2026, all seven justices sitting, and the appeal is expected to be heard later in 2026

• IP Australia has resumed processing extension applications it considers unaffected, while continuing to hold those that may relate to pharmaceutical formulations

• filing deadlines continue to run in the meantime, and are not suspended by the appeal

  
  

Any strategy built upon the extended term of a formulation patent accordingly rests on ground that may move.

Where to from here

For a pharmaceutical patent, regulation is not a separate concern to be handled by a different team. Registration determines when a patent's term may be extended, defines the space in which competitors may lawfully prepare, shapes what a patent owner will know of an impending launch, and can decide an infringement case on the strength of a regulatory document.

Those who fare best treat the Patents Act and the Therapeutic Goods Act as a single strategic problem and plan for both together, and early. With the availability of extensions of term now before the High Court, the interaction between the two systems is a matter of live and practical importance.

Seeking further advice

For more on the topics raised in this guide, please review our further guides on how generic medicines and biosimilars reach the Australian market, patent litigation, and extensions of term for pharmaceutical patents, as they are published. If you need specific advice, please contact Wayne Condon at Biopharmalex.

Wayne is one of Australia's most experienced life sciences and intellectual property lawyers, and has acted in many of the leading pharmaceutical patent cases of the past three decades.

This guide states the law at July 2026 and is general information only, not legal advice.