+61 419 599 209
Welcome to Biopharmalex
A Different Kind of Law Firm
The Perceptive Choice
Biopharmalex was created to be a new kind of independent law firm for a challenging life sciences environment. We offer a unique perspective to help you address life sciences legal issues which arise in Australia and New Zealand. Our clients have the benefit of attentive and highly personalised service, decades of experience and deep industry knowledge, all at a price which represents exceptional value.
Legal Services
We provide exceptional legal assistance and support to our life sciences clients. Our core service offerings are set out below.
Regulatory Advice
Expert Guidance
We have assisted many local and foreign based life sciences, medical device, agricultural and veterinary care companies to avoid or overcome regulatory issues standing in the way of product registration. Where necessary we have assisted clients to mount administrative law challenges to the decisions of regulatory authorities and government procurement entities.
We also provide general advice on Australia's and New Zealand's regulatory requirements to clients who are new to this part of the world.
Intellectual Property
Our core strength
Although we advise and represent clients across all industries and in respect of all types of intellectual property our fundamental focus ( if you hadn't already guessed by our name ) is life sciences patent litigation. With experience gained over forty years and with a deep interest in the life sciences sector we provide unparalleled focus on helping our clients achieve their desired litigation outcomes.
Consumer and Marketing Law
The second front
Not all disputes in the life sciences sector involve patents. Brands, trademarks, copyright and competitor marketing strategies can also give rise to sometimes complex legal issues. We counsel clients on proposed advertising and marketing strategies with a view to avoiding disputes where possible but, when they arise, we represent clients in misleading advertising actions, trademark and copyright litigation.
Competition Law
New kid on the block
Globally, competition law issues have become important in the life sciences sector and Australasia is no different. We have significant experience in this developing area and were involved in advising at the early stages of one of Australia's leading competition law cases in the pharmaceutical sector.
Commercial Agreements
When you need to agree
We are not just good at dealing with disputes. We know that it is much more important to do the deal if you can. So we can help you to achieve that goal as well.
Whether it be a simple NDA or Materials Transfer Agreement or a complex licensing arrangement, or anything in between, we can document the deal.
Our founder
Wayne Condon is the founder and principal of Biopharmalex. Wayne has 4 decades experience as an intellectual property litigator in New Zealand and Australia. For the past 20 years his practice has been focussed on the life sciences sector.
Media Buzz
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.
Biopharmalex appears in Who's Who Legal 2019 ' Life Sciences '
May 20, 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 - whoswholegal.com.
Digital Health 2020
March 5, 2020
Biopharmalex has contributed the Australian chapter to the International Comparative Legal Guide to : Digital Health 2020 which can be viewed here
https://iclg.com/practice-areas/digital-health-laws-and-regulations/australia
Covid-19 and Australasian Courts
March 22, 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.
Biopharmalex again listed in " Best Lawyers Australia "
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
IAM Patent 1000
6 July 2020
IAM media has published its annual Patent 1000 listing of leading patent professionals. Biopharmalex is pleased to be represented - respondents said Biopharmalex founder and principal Wayne Condon “is a brilliant and diligent patent litigator who never fails to find a way to realise the client’s commercial objectives”.
Faster regulatory approval for generics in Australia
22 September 2020
The Australian Therapeutic Goods Administration (TGA) has launched a new initiative - the Early Scientific Advice - to enable applicants to request scientific advice on specific data before applying to register a medicine, Initially the service will provide advice to applicants on "biowaiver" justifications. For more information contact wayne.condon@biopharmalex.com.au
Reform proposals to address prescription medicine shortages in Australia
March 31, 2021
Australia's Therapeutic Goods Administration ( TGA ) has issued a consultation paper seeking comments on a number of proposals aimed at ensuring the on-going and reliable supply of important medicines in Australia. Comments are due by 17 May 2021.
In short there are four proposals :
Streamlining the review process for medicines that have a meaningful impact on generic drug access - particularly where a drug product has a single sponsor and there are no blocking patents or where there is a first generic entrant and imminent patent expiry of any blocking patent
Fee waiver or reduction to support medicines with limited commercial viability or in longstanding shortage
Shorter evaluation times and lower fees where it can be established that a medicine is being supplied to meet a very long-term shortage
An annual charge waiver to allow existing medicines registered on the Australian Register of Therapeutic Goods to remain there to permit the supply of non ARTG registered medicines meeting a shortage of supply.
Australian Budget 2021 - Patent Box introduced
May 13, 2021
In the Australian Government's Budget announcement this week there was welcome news for Australia's life sciences industry. The Government has announced that, from 1 July 2022 income derived from medical and biotech patents will be taxed at a concessional 17% corporate rate instead of 30% or 25% for small and medium companies.
Only patents applied for and granted after the Budget announcement on 11 May 2021 will be eligible and the patent must be Australian-owned. Further, the concessional tax rate will only apply to a portion of the income derived from that patent depending on the percentage of R&D undertaken in Australia.
The Government will follow the OECD's guidelines on patent boxes to ensure the model meets internationally accepted standards.
Get in Touch
DISCLAIMER: Everything displayed on this site should be regarded as general information only and in no way should it be interpreted as legal advice. You should contact a lawyer directly regarding your own situation. Note that a lawyer-client relationship will only be established after we have determined that there is no conflict of interest.
Liability limited by a scheme approved under Professional Standards legislation
Ground Floor, 470 St Kilda Road, Melbourne VIC 3004, Australia
PO Box 1292, Hawksburn 3142 Melbourne VIC Australia
+61 419 599 209
