Share on LinkedInShare on LinkedIn

ARTICLE · 14 SEPTEMBER 2025

Part 2: Regulatory considerations for orphan drugs

Spruson & Ferguson Lawyers
Explore more from Spruson & Ferguson Lawyers

This article sets out the key regulatory considerations in Australia.

AustraliaIntellectual Property
Catherine Winbanks
Catherine Winbanks
Lucy Hartland
Lucy Hartland
Abrey Yeo
Abrey Yeo
Author LinkedIn connections

Following our first article on orphan drug development, which examined key patenting options and strategies, our second article sets out the key regulatory considerations in Australia.

Orphan drug patent strategy recap:

  • Start early, think long: broaden patent protection with primary and secondary patents covering additional commercially relevant aspects of the technology
  • Patent protection may be broadened by pursuing claims directed to the substance per se, medical uses, formulations & delivery routes, as well as claims directed to biomarkers, methods of manufacture and combination therapies
  • In Australia, patent term extensions can provide an additional 5 years protection for orphan drugs.

We operate a free-to-view policy, asking only that you register in order to read all of our content. Please login or register to view the rest of this article.

Register for freeORLog in

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

View source

Related Articles

Legal Intelligence Newsletters: sign up for the latest legal and regulatory news on your chosen topics

Read more about

Related Comparative Guides

See more popular content from

Article

Counterfeit Imports – Tougher Penalties At The Border

Australia strengthens its response to counterfeit goods importation through new legislation that creates strict liability offences and enables infringement notices at the border. The amendments aim to make counterfeit importing unprofitable by ensuring penalties and seized goods exceed potential profits. How will these changes impact intellectual property rights holders and importers operating in Australia?
AustraliaIntellectual Property
Pointon Partners
Pointon Partners
Article

Supporting ‘Human Artistry’: Wholly AI-Generated Recordings Disqualified From ARIA Charts In Australia

The Australian Recording Industry Association has amended its chart eligibility guidelines to exclude songs predominantly created by generative AI, sparking debate about the intersection of artificial intelligence and copyright law. This decision mirrors broader legal challenges facing courts and regulators worldwide as they grapple with determining when AI-generated or AI-assisted works deserve copyright protection and recognition.
AustraliaIntellectual Property
K&L Gates
K&L Gates
Article

How Can You Retain Intellectual Property When A Client Will Not Pay?

A service provider who has not assigned their intellectual property still owns it, regardless of what the invoice says. Under the Copyright Act 1968 (Cth), the creator owns copyright by default, and ownership moves only by written assignment. Paying a designer or developer does not transfer ownership on its own. That default gives service providers real leverage where a client refuses to pay. Retention and suspension clauses turn the default into a contractual right to withhold deliverables.
AustraliaIntellectual Property
LegalVision
LegalVision
Article

Controlled Foreign Company rules - UK:

In the Communications, Media and Technology Updater on 10 April, we commented on the proposals for the new In the Communications, Media and Technology Updater on 10 April, we commented on the proposals for the new Controlled Foreign Company (CFC) rules and their impact on IP rights following the release of a discussion document on 26 January 2010.(CFC) rules and their impact on IP rights following the release of a discussion document on 26 January 2010.
AustraliaIntellectual Property
Norton Rose Fulbright Australia
Norton Rose Fulbright Australia
Article

Updates To Malaysia’s Proposed Patent Linkage Framework

Malaysia is drafting its first patent linkage framework for pharmaceutical products, scheduled for implementation on 1 May 2027 following CPTPP ratification. The National Pharmaceutical Regulatory Agency has released draft guidelines establishing an administrative connection between drug registration and patent status, introducing notification requirements, suspension periods, and four application categories that will fundamentally reshape how innovators and generic manufacturers navigate market entry.
MalaysiaIntellectual Property
Spruson & Ferguson Lawyers
Spruson & Ferguson Lawyers
Article

Australia | Proposed Tranche 2 Privacy Act Reforms: Exposure Draft And Consultation Paper Released

The Australian Government has released an exposure draft of the Privacy Amendment (Personal Data Protection) Bill 2026, proposing the most substantial reforms to the Privacy Act 1988 in recent times. These changes introduce a fair and reasonable test for data handling, enhanced consent requirements, expanded breach notification obligations, and new rights including data erasure for large digital platforms.
AustraliaPrivacy
Spruson & Ferguson Lawyers
Spruson & Ferguson Lawyers
Article

New Zealand | The Changing Shape Of Patent Prosecution

New Zealand patent prosecution has evolved significantly since the Patents Act 2013, developing its own examination culture distinct from Australia. With inventive step now central to examination, fixed divisional deadlines, and compressed prosecution timetables, applicants must make strategic decisions earlier than in other jurisdictions to preserve claim scope and maintain flexibility throughout the patent process.
New ZealandIntellectual Property
Spruson & Ferguson Lawyers
Spruson & Ferguson Lawyers