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European Biopharmaceutical Review

A Fresh Look

The European Patent Office (EPO) has recently issued guidance to examiners, indicating that the standard disclaimer used in patent applications to confirm that stem cells have been ‘obtained by means that don’t involve the destruction of an embryo’ is no longer required on moral grounds in some circumstances. Specifically, it should not be required if the patent application was filed after 5 June 2003.

While it has not been widely publicised, this subtle shift in position is highly significant and is thought to indicate an acknowledgement by the EPO of the exciting and valuable research work being carried out in this field and its potential to deliver effective stem cell therapies to treat a range of serious medical conditions. Of course, it may also hint at some recognition that practices have moved on and stem cells no longer have to be sourced from embryos.

Legislative Clarification


The change of approach is directly linked to a key date in the evolution of European patent law, when the Court of Justice of the European Union (CJEU) clarified that a parthenote (a cell where division is kick-started by a chemical or electrical method) is not an embryo, thus eliminating the need to source stem cells from an embryo altogether. Until recently, it was only possible to achieve patent protection for inventions involving stem cell research where the patent application was filed after 10 January 2008 with an accompanying disclosure stating that the stem cells had not been obtained from an embryo.

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Helen Henderson is a senior associate and patent attorney at intellectual property firm, Withers & Rogers. She specialises in advising pharma manufacturers about how to protect novel drug formulations and dosage forms, and she has a particular interest in biotech patents.

Dr Nicholas Jones is a partner and patent attorney at Withers & Rogers. A member of the company’s life sciences and chemistry group, he advises pharma and biopharmaceutical businesses about how to protect their innovations and enforce their intellectual property rights. He also advises UCL Business PLC, the technology transfer arm of the University of London.

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Helen Henderson
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Dr Nicholas Jones
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