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European IP Bulletin, Issue 33, July 2006- Hot Topics

HOT TOPICS

1. Human Embryonic Stem Cell Research and the European Patent Conundrum

The Minister for Science and Innovation, Lord Sainsbury, was quick to welcome the recent decision of the EU Competitiveness Council to allow European funding for human embryonic stem cell research.  The UK has a strong scientific legacy to build upon in this controversial area, from the early discoveries made by Sir Martin Evans at the University of Cambridge in the 1980s to the creation of Dolly the Sheep by advanced cloning techniques at the Roslin Institute in Edinburgh in the 1990s.  The Human Fertilisation and Embryology Act 1990 is one of the most favourable regulatory regimes in Europe for carrying out embryonic stem cell research.  Substantial public funds have been invested by the UK government, for example in establishing the world’s first stem cell bank, hosted by The National Institute for Biological Standards and Control (NIBSC) in Hertfordshire. 

The main purpose of the intellectual property system is to reward investment in research and creative endeavour that leads to new products and technologies.  In particular, strong monopoly rights are awarded by means of patents for new and useful inventions.  The patent system is currently subject to some highly vocal criticism in the US, but in Europe the system is generally thought to be effective.  However, from time to time, the patent system can struggle to cope with controversial new inventions, such as stem cell technology.  This struggle is sometimes exacerbated by a long-standing requirement of European patent law to consider the ethical dimension of certain inventions, before a patent can be granted. 

One of the most famous of these inventions is the Oncomouse.  In 1984, a patent application was filed by the President and Fellows of Harvard College, claiming a method for producing transgenic non-human mammals with a predisposition to developing cancer.  The inventors intended this method to be used to produce laboratory animals (such as mice) that could facilitate the study of serious diseases.  The grant of the patent was opposed by a group of animal rights activists, amongst others.  One of the grounds relied upon was that the invention was contrary to morality, because it would involve excessive animal suffering that was unethical.  The European Patent Office eventually rejected this ground of opposition, deciding that the benefits of the invention outweighed the risk of suffering that would be caused. 

In order to prevent the laws in the various EU Member States diverging on questions of whether and how biotechnological inventions (such as the Oncomouse) should be protected by means of patents, in 1998 the European Commission introduced the European Biotechnology Patent Directive.  This contains a list of specific types of invention that are excluded from patentability on ethical grounds.  The following are deemed unpatentable in the EU:

• processes for cloning human beings
• processes for modifying the germ line genetic identity of human beings
• uses of human embryos for industrial or commercial purposes
• processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

 
By 2003, research on human embryonic stem cells held out the promise of potential cures for Parkinson’s disease, diabetes and heart failure.  In recognition of the positive UK environment for stem cell research, the UK Patent Office issued guidance notes on how it would treat UK patent applications for inventions involving human embryonic stem cells, within what the Office understood to be the ethical parameters set out in the Biotechnology Patent Directive.  Specifically, the UK Patent Office said that it was prepared to grant patents for inventions involving a certain type of stem cell that did not have the potential to develop into a viable human embryo, namely human embryonic pluripotent stem cells. 

Shortly afterwards, the European Patent Office issued its first decision on the patentability of human embryonic stem cell technology: the “Edinburgh Patent” decision.  The Edinburgh patent did not claim a process involving the use of human embryos for industrial purposes, since that is forbidden by the Biotechnology Patent Directive.  However, the technology described in the specification required the use of human embryos in the production of stem cells, i.e. the invention required human embryos to be destroyed before it could be worked. 

The European Patent Office decided to take a wider interpretation of the exclusion in the Biotechnology Patent Directive than the UK Patent Office had done in its guidance notes.  It reasoned that if the use of a human embryo was deemed ethically unacceptable, then any potentially inventive method or process that involved the prior destruction of a human embryo in order to obtain stem cells must also be ethically unacceptable.  The European Patent Office did not consider it relevant that human embryonic stem cell research was permitted in certain EU countries, such as the UK.  Thus, the patentee was only allowed claims to “non-human” stem cells. 

The Edinburgh Patent decision was followed in 2004 by the Examining Division of the European Patent Office, which rejected a patent application by the Wisconsin Alumni Research Foundation with claims that were directed to stem cell cultures.  Again, the reason given was that the invention required the use of a human embryo as a starting material.  This decision has been appealed and is now going forward on the question of the correct legal interpretation of the exclusion in the Biotechnology Patent Directive for “uses of human embryos for industrial or commercial purposes”.  In the meantime, the UK Patent Office (which is bound by decisions of the UK court, not decisions of the European Patent Office) continues to operate a more generous policy towards the patenting of human embryonic stem cells. 

Whilst any commercial reward from this technology is unlikely to come for many years, patent protection is likely to be critical in securing any such reward.  It is perhaps ironic that whilst patents claiming human embryonic stem cells have been granted by the US Patent Office, President Bush has recently refused to sanction federal funds for stem cell research, whereas in Europe, EU research funding is now to be forthcoming but the patent situation remains inconsistent and unclear.
 
Duncan Curley and Andrew Sharples have written a longer article on this topic entitled “Ethical Questions To Ponder in the European Stem Cell Patent Debate”.  It has just been published in The Journal of BioLaw & Business.  Reprints are available from the authors on request (dcurley@europe.mwe.com or asharples@europe.mwe.com). 

2. Creative Commons Licence Upheld by Dutch Court

In Curry v Audax, Rechtbank Amsterdam, Docket No. 334492 / KG 06-176 SR, 3/9/06, the District Court of Amsterdam, judging in summary proceedings, handed down the first known court decision involving a Creative Commons licence.
 
The Dutch local media celebrity Adam Curry posted photos of his family on www.flickr.com under a Creative Commons Attribution-Noncommercial-Sharealike 2.0 licence, which allows material to be reproduced for non-commercial purposes as long as the source is made clear. The photos carried the notice ‘This photo is public’ and a reference to the appropriate Creative Commons licence.

The Dutch Weekly Weekend, a gossip magazine, published these photos in a story on Curry’s children without seeking Curry’s prior permission, although a notice indicating that the copyrights of these photos were owned by Adam Curry was included.

Curry sued Audax, the publisher of Weekend, for copyright and privacy infringement. As to the copyright claim, Audax argued that it was misled by the notice ‘this photo is public’, and that the link to the Creative Commons licence was not obvious. Thus, Weekend had assumed in good faith that no authorisation from Curry was needed. Moreover, Curry had not incurred any damages by the publication of the photos in Weekend, since the photos were freely available to the public.

The court rejected this defence, stating that Audax should have carried out due diligence before publishing the photos, held that the photos were subject to the licence and that Audax should have followed its conditions. The court stated: ‘It may be expected from a professional party like Audax that it conducts a thorough and precise examination before publishing in Weekend photos originating from the Internet’. 

The court ruled that Audax violated two sections of the Creative Commons licence: Section 4a, which includes the obligation to provide a copy of the Creative Commons licence when distributing or publicly displaying a work; and Section 4c, which prohibits use of the work in a manner that is primarily for commercial purposes.

The court also ruled that Weekend must not use Curry’s pictures again or it would face fines of 1,000 euros for each photo used without permission.

The Dutch Court’s decision is especially noteworthy because it shows that: (i) photographs placed on a public website under the Creative Commons licence, which offers more flexibility than traditional copyright licences, have not become part of the public domain in such a way that anybody may use, reproduce or publish these pictures in any way and for any reason or purpose; and (ii) it is the user’s responsibility to pay close attention to applicable terms and conditions.

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