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King's College London - Health: More than a medical matter

European Court of Justice issues opinion on stem cell patenting

28 March 2011

By Nishat Hyder

Appeared in BioNews 601

An advisor to the European Court of Justice (ECJ) has issued a preliminary opinion stating that procedures involving human embryonic stem (hES) cell lines are not patentable.

The German Supreme Court sought clarification from the ECJ on the legal definition and scope of the term 'human embryo' under the European Directive for the legal protection of biotechnological inventions. In giving the opinion which, although is not binding, is rarely not followed by the court, Advocate-General Yves Bot said inventions that necessitate the destruction of the embryo and that use embryos as their base material should be excluded from patentability.

'The concept of a human embryo applies from the fertilisation stage to the initial totipotent cells and to the entire ensuing process of the development and formation of the human body', the Advocate-General said. Pluripotent stem cells, which do not have the capacity to turn into a human being, were specifically not included in the definition.

Under the current European Union guidelines it is unclear whether patents are available for techniques involving hES lines where they were derived from 'spare' human embryos left over from IVF that would have been otherwise destroyed. The opinion states that the only exception to the non-patentability of uses of human embryos concerns only inventions for therapeutic or diagnostic purposes, which are applied to the human embryo and are 'useful to it'.

The case concerns a patent granted in 1991 for a technique developed to generate nerve cells from hES lines to Professor Oliver Brüstle, Director of the Institute of Reconstructive Neurobiology at the University of Bonn in Germany. In November 2009, the German Federal Supreme Court referred the case to the ECJ following a challenge by Greenpeace in which the organisation claimed Professor Brüstle's patent was unethical because the hES lines were derived from human embryos.

The preliminary opinion will now be considered by the Grand Chamber, comprising of thirteen judges, and the final decision is expected in the next couple of months. However, already there is speculation among legal, commercial and research circles over the impact on investment within the European life sciences sector if the opinion is upheld.


Nature | 10 March 2011
Court House News | 11 March 2011
Opinion of Advocate General
European Court of Justice - Opinion - Brustle - Intellectual property | 10 March 2011
Science Business | 14 March 2011
Bloomberg News | 11 March 2011


17 December 2012 - by Julian Hitchcock 
In November the case of Brüstle v Greenpeace was remitted to the German Federal High Court. How would a national court interpret the controversial ruling of the Court of Justice of the European Union which held that patent rights could not be granted in the EU for the use of any entity 'capable of commencing the process of development of a human being'?... [Read More]
03 December 2012 - by Antony Blackburn-Starza 
The German Federal Court of Justice has ruled that a disputed patent held by Dr Oliver Brüstle, and the subject of a ruling by the European Court of Justice (ECJ) against the patentability of human embryonic stem cells, is valid in its revised form.... [Read More]
31 January 2012 - by Dr Amy Strange 
The recent ruling of the European Court of Justice (ECJ) excluding inventions relating to human embryonic stem cells (ES cells) from patentability has sparked a heated debate in the bioscience, ethics and law communities... [Read More]
22 August 2011 - by Antony Blackburn-Starza 
The United States Patent and Trademark Office (USPTO) has granted its first patent associated with induced pluripotent stem (iPS) cell technology to Professor Shinya Yamanaka of Kyoto University, Japan, for a technique used to reprogram fully differentiated somatic mouse cells into an embryonic-like state... [Read More]
19 August 2011 - by MacKenna Roberts 
Should human embryonic stem cell research be deemed unethical for its embryo destruction? The US court decision in Sherley v Sebelius on 27 July 2011 to allow federal funding of this research set a global precedent. The meaning of research was divided into two categories: that which directly involves embryo destruction and that which does not... [Read More]

21 February 2011 - by Gozde Zorlu 
The widespread patenting and privatisation of stem cell lines, data and technology could hinder medical research in this field, a group of scientists has warned in a paper published in Science this month.... [Read More]
26 May 2009 - by Selene Kaye 
On 12 May, the American Civil Liberties Union (ACLU) and the Public Patent Foundation filed a lawsuit challenging the US government's practice of granting patents on human genes - specifically, the BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer. In the last 20 or so years the... [Read More]
01 December 2003 - by BioNews 
US lawmakers have reached an agreement on part of a bill that would ban patents on 'human organisms'. The compromise was sought following claims that the original language in the Commerce, Justice and State Department appropriations bill might 'intentionally or inadvertently' harm technologies using embryos or embryonic cells. The proposed... [Read More]
25 January 2000 - by BioNews 
Patents for nuclear transfer cloning have been granted to the Edinburgh-based researchers who created Dolly the sheep, almost five years after they were filed for by the Roslin Institute. This is thought to be the most significant patenting in the field of therapeutic cloning, a market worth billions of pounds... [Read More]
04 October 1999 - by BioNews 
The parliamentary assembly of the Council of Europe last week approved a recommendation that 'neither plant, animal nor human derived genes, cells, tissue or organs' should be regarded as inventions and thereby be subject to patents. This declaration is in direct conflict with last year's European Union directive which allows... [Read More]

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