Dr. Karen Heilbronn Lee

Associate
Patents: Chemical & Life Science
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Overview

Karen has hands-on, high-level technical expertise in many aspects of the life sciences, more than a decade’s experience in private patent attorney practice and a strong commercial acumen honed by three years as an in-house attorney.

Karen’s practice predominately involves drafting and prosecuting biotechnology and pharmaceutical patent applications covering therapeutics, diagnostics, methods of human treatment or diagnosis, second medical uses, and methods of detecting, isolating or producing biological products or cells. She is well-versed in the notorious subject matter, support, enablement and inventiveness issues that these types of patent applications tend to attract in the major commercial jurisdictions around the world.

Karen has been extensively involved with the commercial side of IP, including advising on patentability and data requirements for new filings, freedom to operate, IP strategy, inventorship, ownership, collaborations, and assignments; and has assisted with numerous licencing deals. She has worked with a large range of clients, from start-ups to multi-national pharmaceutical companies; novice sole inventors to research institutes, hospitals, universities, tech transfer offices and corporates. She specialises in understanding her client’s needs and budget, and then tailoring patent strategies, specifications, claims and communications to meet the brief, providing upfront cost estimates and succinct, timely, commercially applicable and appropriately simplified advice.

Karen’s post-doctoral research at the University of Cambridge, UK, investigated Fc receptor signalling pathways within an autoimmunity laboratory and culminated in a Nature Medicine publication. Her PhD studies with CSIRO and the University of Melbourne investigated immunomodulation by immunotherapeutic peptides during vaccination with a live attenuated bacterial strain to an often fatal, acute inflammatory respiratory disease in pigs. These positions provided hands-on experience in a spectrum of research techniques applicable to vaccine development, microbiology, immunology, virology, biochemistry, cell biology, cell signalling, molecular biology, protein expression, microscopy including confocal microscopy, cytology and pathology.

Karen is a fellow of the Institute of Patent & Trade Mark Attorneys of Australia (IPTA), a member of the Intellectual Property Association of Australia and New Zealand (IPSANZ), and Australian Biotechnology Association (AusBiotech).


Dr. Karen Heilbronn Lee's Insights
Validity and infringement of diagnostic method claims
Ariosa Diagnostics, Inc v Sequenom, Inc FCAFC 101 The Full Court of the Federal Court of Australia has confirmed that Sequenom’s diagnostic method of detecting fetal DNA in maternal...
Ariosa Diagnostics, Inc v Sequenom, Inc FCAFC 101 The Full Court of the Federal Court of Australia has confirmed...
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Australia’s New Patent Box: Unboxed
Following a cacophony of dire warnings and lobbying over the past decade from the Australian biotechnology and medical sectors, and the sudden sharp focus of middle Australia on the...
Following a cacophony of dire warnings and lobbying over the past decade from the Australian biotechnology and medical sectors,...
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