How generic and bio-similar pharmaceuticals reach the Australian market?

Guide to Australian patent law for life science companies.

A standard patent ceases twenty years from the date of the patent, or up to twenty-five years where the term has been extended in respect of a pharmaceutical substance (Patents Act 1990 (Cth) ss 67, 70–79A). The complete specification has been open to public inspection since publication, but until the term ends the patent owner alone may exploit the invention. On cessation that exclusivity falls away by operation of the Act, and any person may thereafter exploit the invention, making, selling, using or importing the medicine without licence or payment.

Pharmaceutical patents rarely cease alone. An originator medicine is ordinarily protected by a portfolio, comprising a compound patent over the active ingredient together with secondary patents over formulations, dosage regimens, methods of treatment, processes, and particular salts or crystalline forms, each with its own term. The question for a prospective entrant is accordingly not whether the patent has ceased, but which patents subsist, what their claims cover, and when each expires.

This guide explains how generic medicines and biosimilars answer that question and come to market in Australia.

What are generic medicines and biosimilars?

A generic medicine is a copy of a chemically synthesised originator drug. It is registered on an abbreviated basis, the sponsor demonstrating bioequivalence with the reference product rather than repeating the originator's clinical trial program.

A biosimilar is the analogous product for a biologic medicine, being a large molecule produced in living cells. Because a biologic cannot be replicated exactly, a biosimilar is instead shown to be highly similar to its reference product, with no clinically meaningful difference in quality, safety or efficacy. The distinction carries commercial consequences: biosimilars cost more to develop, are less readily substituted at the point of dispensing, and have only recently begun to generate patent litigation in this jurisdiction.

What the Act permits before the term ends

Developing a competing product takes years. Were that work itself an infringement, the practical monopoly would extend well beyond the statutory term, and the Act addresses this through two exemptions.

Springboarding

A pharmaceutical patent is not infringed by acts done solely for purposes connected with obtaining regulatory approval, whether in Australia or in a foreign jurisdiction (s 119A). A sponsor may therefore develop its product, conduct bioequivalence studies and compile its registration dossier during the term, so as to be in a position to launch upon cessation. The exemption is confined to those purposes.

Experimental use

Acts done for experimental purposes relating to the subject matter of the invention are likewise exempt, including experiments directed to determining whether a patent is valid or whether a proposed product would infringe it (s 119C).

Both exemptions permit preparation. Neither disposes of the patents themselves, which remain to be navigated before any commercial supply.

Registration and the absence of patent linkage

No medicine may be supplied in Australia unless it is entered on the Australian Register of Therapeutic Goods. The Therapeutic Goods Administration assesses quality, safety and efficacy, and its function ends there. It does not examine the patent position of the medicine before it, and it has no power to refuse or defer registration because a patent subsists over the reference product.

A sponsor, being the person or company that applies for registration and takes legal responsibility for the medicine in Australia, whose application relies on the originator's clinical data must give the Administration a certificate, and it may choose between two forms. It may certify that it believes on reasonable grounds that it will not market the goods in a manner that would infringe a valid claim of a patent, or it may certify that it has notified the patent owner that the application has been made (Therapeutic Goods Act 1989 (Cth) s 26B).

The Data exclusivity caveat

Separately from the patents, the originator's clinical data is protected for five years from first registration, during which the Administration may not rely upon it to register a competing product (s 25A). Data exclusivity differs from a patent in two respects that matter.

The patent that subsist

Where a patent claims a pharmaceutical substance, its term may have been extended by up to five years (ss 70–79A), and the Register must be examined before any entry date is fixed.

That exercise is presently attended by uncertainty. In Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd [2025] FCAFC 161 the Full Court held that an extension is available only for a patent claiming the active ingredient itself, and not a formulation, departing from some three decades of practice. The High Court granted special leave in March 2026 and the appeal remains undetermined as of the the date this guide is published, so entry dates calculated by reference to extended formulation patents rest on an unsettled footing.

Where the subsisting patent claims a particular therapeutic use rather than the compound, a sponsor may seek registration for the unpatented indications alone, omitting the patented use from its product information.

The efficacy of that course depends on the market. In the leflunomide litigation the High Court held that a generic registered only for arthritic conditions did not infringe a patent claiming the treatment of psoriasis, the supplier having no reason to believe its product would be put to the patented use (Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 253 CLR 284).

What to do when launching a generic or bio-similar?

Every prospective entrant must eventually elect between two courses. The first is to clear the way, removing the subsisting obstacles before supply commences, whether by seeking revocation of the blocking patents, opposing them before grant, or negotiating a licence. The rosuvastatin litigation illustrates that course taken to its conclusion, the High Court holding the patents protecting Crestor invalid for want of an inventive step (AstraZeneca AB v Apotex Pty Ltd (2015) 257 CLR 356).

The second is to launch at risk, entering the market while the patent position remains unresolved. The advantage is priority of entry. The exposure is that, should the patent be upheld, the entrant is liable for damages or an account of profits, and the sum claimed may exceed its own revenue, its entry having depressed prices across the whole market. The risk is not one-sided. An originator that obtains an interlocutory injunction upon the usual undertaking as to damages, and whose patent is later held invalid, may be ordered to compensate the entrant it excluded (Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2018] FCA 1556).

Conclusion

Generic and biosimilar entry sits at the intersection of patent law, therapeutic goods regulation and pharmaceutical pricing, and is best approached as one problem rather than three. The patent estate should be mapped early, the statutory exemptions used to be ready upon cessation, any proposed carve-out tested against the commercial reality of the indication, and the election between clearing the way and launching at risk made deliberately, with the exposure quantified. Originators conduct the same analysis in reverse. With the availability of extensions of term now before the High Court, entry dates across the industry are in a state of flux.

Seeking further advice

For more on the topics raised in this guide, please review our further guides available on the Biopharmalex website.

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.