Biotechnology and Software Patent Law
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Biotechnology and Software Patent Law

A Comparative Review of New Developments

Edited by Emanuela Arezzo and Gustavo Ghidini

The new millennium has carried several challenges for patent law. This up-to-date book provides readers with an important overview of the most critical issues patent law is still facing today at the beginning of the twenty first century, on both sides of the Atlantic.
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Chapter 11: Patentability of Human Stem Cell or Synthetic Biology Based Inventions

Paul L.C. Torremans


Paul L.C. Torremans INTRODUCTION This chapter looks at biotechnological patents and more specifically at human stem cell patents and synthetic biology patents. But rather than look at these patents from a science perspective it is proposed to look at the challenges they pose and face in relation to patentability. Can human stem cells and synthetic biology inventions be patented or do they face serious problems when trying to meet the criterions for patentability? Are they non-patentable subject matter and which role does morality play? The starting point is clearly that living material is patentable. Article 27(1) TRIPS leaves no doubt about it and individual national patent law regimes cannot avoid this conclusion.1 In Europe Article 5 of the Biotech Directive2 confirms this by stating that human material in isolated form is patentable.3 Let us therefore turn to the criterions for patentability and examine the subject matter in more detail. 1 There are limitations though for those cases in which the DNA no longer fulfils the function for which it was patented, see Monsanto v Cefetra, case C-428/08, decision of the Grand Chamber of the Court of Justice of 6th July 2010, available at (accessed May 2011), where it was held that: ‘Article 9 of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions is to be interpreted as not conferring patent right protection in circumstances such as those of the case in the main proceedings, in...

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