Wayne is highly professional, measured and insightful. He ensures that he does his best in everything and delivers exceptional outcomes each time. He is highly meticulous and takes great care to give advice and provide his services to a high standard. I have been working with Wayne for a couple of years now and I have never felt disappointed by his work. I trust him entirely with my needs and I know I can rely on him to give me the most accurate and well-thought out legal advice and plans. I highly recommend him for all biotech founders or anyone interested in biotech services especially when it comes to IP, trademarks and collaborative agreements.
Clarissa Yates, PhD
CEO & Founder,
Ketim Technologies
Welcome to Biopharmalex
Australian IP & Life Sciences Lawyers driving innovation and strategic expertise.
Experience a different kind of law firm
Life sciences is an area of law that requires a very different kind of lawyer. One that understands the complex and ever-evolving nature of the industry. And one that looks at the challenges of life sciences through an experienced, strategic and innovative lens.
Biopharmalex is an independent law firm committed to championing innovation with forward-thinking solutions to life science legal issues. As your legal life sciences partner, we bring decades of experience and industry knowledge to the table.
We offer a full spectrum of legal services to support life sciences businesses at every stage.
Intellectual property
In life sciences, IP is key to market competitiveness.
Our focus is to get your company the earliest possible Australian market entry and patent litigation is where we excel.
This is a critical area of life sciences law where you really need a determined expert on your team, and with over 40 years in life sciences patent litigation acting for generic pharmaceutical and biosimilar companies, we provide unparalleled focus in helping ensure our clients’ interests are prioritised.
Regulatory advice
Regulatory hurdles needn’t hold you back. We’ve helped many local and international life sciences, medical device, agricultural and veterinary care companies avoid or overcome regulatory issues standing in the way of product registration.
When the stakes are high, we don’t back down. Where necessary, we’ve challenged the decisions of government procurement entities and regulatory authorities to help drive success for our clients.
For businesses new to Australia, we smooth the entry into this market with general advice on how to navigate Australia's regulatory requirements.
Consumer and marketing law
In the highly competitive life sciences industry, your unique brand identity matters.
Beyond patents, issues such as trademarks, copyright and competitor marketing strategies can also pose significant risks to your success.
We work with our clients on proposed advertising and marketing strategies with a view to avoiding disputes and minimising risk. But should disputes arise, we leverage our formidable expertise to defend your interests in misleading advertising claims, trademark disputes, and copyright litigation.
Competition law
Competition law is rewriting the rules of life sciences, here and overseas.
Our team has been on the front lines of this evolving legal landscape, having already played a key role in some of Australia’s leading competition law cases in the pharmaceutical sector.
As competition law continues to reshape the industry, we provide forward-thinking legal counsel to help our clients stay ahead of regulatory and legal challenges.
Commercial agreements
Settling disputes is one thing, but the real success lies in sealing a well-crafted deal.
From a simple NDA or Materials Transfer Agreement to a complex licensing arrangement, we can help turn your opportunities into clear, binding agreements.
Our purpose
Innovation. Growth. Support.
"With over four decades as an intellectual property litigator, my passion has been helping life sciences companies navigate complex IP, regulatory, and competition law challenges. For the past 25 years, I’ve focused on supporting generic pharmaceutical and biosimilar businesses, protecting their innovations, and representing them in critical patent cases, often as part of a global team.”
Wayne Condon
Founder and Principal of Biopharmalex
News & headlines
Biopharmalex has built a hard-earned, solid reputation for its professionalism and excellence in legal services. From high profile cases to mentions in the local press, find all the current and archived Biopharmalex news and information here. You will also find updates on topical life sciences issues so you can stay informed about what’s going on in the life sciences legal world in this part of the globe.
July 2025
The TGA has recently updated its guidance for what to do if the sponsor of a therapeutic good changes.
Third parties, such as manufacturers, cannot lawfully transfer the sponsorship of an ARTG entry to another person. If someone wants to become a new sponsor of a product that is already on the ARTG under the name of another sponsor, they either need to arrange for the current sponsor to transfer the sponsorship to them, and then notify the TGA, or apply for a new ARTG entry in the name of the new sponsor.
Except in certain exceptional circumstances ( e.g death or the winding up of a company ) a transfer of sponsorship must be made with the consent of the current sponsor.
The new sponsor must:
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notify the TGA within 3 months of the transfer, and
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provide the TGA with evidence of the relevant transfer event (preferably by completing and lodging the prescribed notification form.
Please let us know if you require assistance with a transfer of sponsorship or require further information about this updated guidance.
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22 July 2025
The Australian Therapeutic Goods Administration (TGA) has announced that its Unique Device Identification (UDI) regulatory framework for medical devices is now in effect following the approval of the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025. Additionally, the TGA has published new guidance and updated its website to reflect the commencement of the UDI regulatory framework, available via the TGA’s Unique Device Identification Hub.
Please contact us for more information about these changes or if you need compliance advice.
16 July 2025
There have been relatively few recent interlocutory ( preliminary ) injunction applications in pharmaceutical patent cases in Australia partly in recognition of the high bar which has been set patent holders to satisfy the balance of convenience assessment and the chilling effect of a contingent compensation claim against the patentee by the Australian Federal government should it ultimately be determined that the injunction ought not to have been granted.
The preliminary injunction application commenced last month by Regeneron and Bayer against Sandoz in respect of aflibercept ( Eylea ) is therefore interesting. The application is to be heard by Rofe J on 25 August . Her Honour refused a preliminary injunction application in a 2021 pharmaceutical patent case relating to dimethyl fumarate.
This case will be watched closely given that a number of biosimilar manufacturers are targeting this lucrative market. Sandoz has filed a cross-claim alleging the asserted patent is invalid on numerous grounds including lack of novelty, lack of inventive step, insufficiency and lack of support. It will be fascinating to see how the Court deals with the balance of convenience factors, in particular and whether any change in the Court’s approach to preliminary injunctions in the sector can be discerned.
We will report on the outcome in due course.
9 July 2025
The Australian Health Practitioner Regulation Agency (Ahpra) has issued new guidelines for medicinal cannabis prescribing
Medicinal cannabis can legally be prescribed by medical and nurse practitioners in Australia, giving patients who need it access to this medicine. However, Ahpra noted that there is evidence of poor practice in prescribing medicinal cannabis that is leading to significant patient harm.
The new Guidelines can be accessed here https://www.ahpra.gov.au/Resources/Medicinal-cannabis-prescribing.aspx
1 May 2020
Biopharmalex is delighted, once again, to be named in the latest 2021 edition of Best Lawyers Australia in the categories of Biotechnology Law and Intellectual Property Law.
22 March 2020
The Australian Federal Court has issued a notification that, unless specifically and individually excepted by the Court, all Federal Court of Australia listings that require in person attendance, including mediations and listings relying on video link from court premises listed up to 30 June 2020, are vacated. The Court is examining, as a matter of urgency, its capability to facilitate listings by remote access technology, without requiring in person attendance.
New Zealand is now at level 2 alert status. Whilst that remains the case New Zealand courts will move to limit in-person appearances by counsel, their clients, witnesses, and the general public.
Where possible, decisions will be made on the papers and certain hearings may occur by telephone or audio-visually. Courts have been reviewing the status of cases to identify matters that can be determined in this way. Courts will continue to observe the requirements of the Courts (Remote Participation) Act.5 March 2020
Biopharmalex has contributed the Australian chapter to the International Comparative Legal Guide to : Digital Health 2020
20 May 2019
Wayne is honoured to be included in Who's Who Legal 2019 ' Life Sciences ' as a leading practitioner for Australia in the life sciences sector.
Phone +61 419 599 209
Email wayne.condon@biopharmalex.com.au
Ground Floor, 470 St Kilda Road,
Melbourne VIC 3004, Australia
PO Box 1292, Hawksburn,
Melbourne VIC 3142, Australia