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Pharmaceutical Patent Term Extensions in Australia A standard patent lasts twenty years from the date of the patent (Patents Act 1990 (Cth) s 67). For most inventions, that term begins to deliver value soon after grant. For a pharmaceutical, it does not, because a medicine cannot be supplied in Australia until it has been entered on the Australian Register of Therapeutic Goods, and the clinical trials and regulatory assessment required for that can consume a decade or more of

Advertising a therapeutic good in Australia is not governed only by the general law against misleading conduct. It is subject to a dedicated regime in Part 5-1 of the Therapeutic Goods Act 1989 (Cth), supplemented by a mandatory Therapeutic Goods Advertising Code, and the regime starts from prohibition rather than permission. Certain goods may not be advertised to the public at all, certain claims may never be made, and everything else must meet standards of accuracy, balance

What a patent protects, how it is obtained through IP Australia, how long it lasts, and why patent grant and TGA approval are separate hurdles for a life sciences business.

How pharmaceutical patent disputes arise in the Federal Court, the interlocutory relief available at the outset, the issues fought at trial, and the remedies available at the end.

How generic medicines and biosimilars are registered and come to market while originator patents subsist, from springboarding to the choice between clearing the way and launching at risk.

Why TGA registration determines what a pharmaceutical patent is worth: the absence of patent linkage, section 26B notification, and extensions of term after Otsuka v Sun Pharma.

The chain of authorisations that runs from ODC cultivation and manufacture licences, through the TGA access pathways, to State and Territory prescribing rules.

Bayer’s Xarelto (rivaroxaban) blood-thinning agent has been the subject of patent disputes in many jurisdictions, including Australia. The UK aspect has taken an interesting turn. Bayer was initially granted a short period of preliminary injunctive relief in March 2024(PI). As a condition of the grant of the PI Bayer was, in accordance with usual practice, required to give an undertaking as to damages to pay compensation if it were subsequently established that the PI ought n

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

In an unusual move, on 9 June three Australian innovation patents claiming the use of Stelara to treat ulcerative colitis were revoked part way through the final hearing in a Federal Court patent infringement proceeding between Janssen Biotech and Samsung Bioepis. No reasons for the making of the revocation order have been published which makes it even more unusual – however the implication seems to be that Janssen decided to capitulate during the course of the hearing. Innov