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Journal of Intellectual Property Law & Practice Advance Access originally published online on August 30, 2008
Journal of Intellectual Property Law & Practice 2008 3(11):718-731; doi:10.1093/jiplp/jpn161
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© The Author (2008). Published by Oxford University Press. All rights reserved

Stem cell patents on a knife edge

Amina Agovic*
Legal context: Hundreds of millions of dollars are poured into human embryonic stem cell (hESC) research worldwide making stem-cell technology heavily reliant on patent protection. This article examines challenges posed by the (non)existence of ‘morality’ or ordre public clauses to patenting of human embryonic stem cells in Australia, the European Union, and the United States.

Key points: HESC patents are easily granted in the United States and to an extent in Australia, while, on the other hand, there is a temporary halt on issuing any hESC patents at the European Patent Office (EPO). The paper considers the interpretations of section 18(2) of the Patents Act 1990 (Cth) in two key decisions by the Deputy Commissioner of Patents in Australia and the strong patent protection granted to the Wisconsin Alumni Research Foundation (WARF) stem-cell patents, including the challenge posed to the validity of those patents in the United States Patent and Trademark Office (USPTO). In contrast, the paper also highlights previous decisions and current non-decisiveness of the EPO on this issue.

Practical significance: What role could and/or should ethics play in the patent system? The paper draws on the ethical conflicts depicted earlier in the text and discusses whether the patent system is and/or should be an appropriate authority to handle ethical issues in relation to stem-cell inventions.

Key Words: Some nations have sought a total ban on therapeutic stem cell research (cloning of embryos for research purposes); some prefer a moderate approach, while others have failed to ban even human reproductive cloning. • Due to significant investments poured into hESC research, stem cell technology is heavily reliant on patent protection. As a result, patents issued for stem cells lie at the heart of the stem cell debate. • This article analyses issues surrounding patentability of hESC in Anglo-America, including recent decisions by patent offices and considers whether the patent system is and/or should be an appropriate authority to face these concerns head on.

Correspondence: * PhD Candidate/Researcher at the IPR University Centre, University of Helsinki. Email: amina.agovic{at}helsinki.fi


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