The Morality of Patenting hESC inventions in Europe: Brüstle v Greenpeace
In its close alignment with Lawford Davies Denoon (LDD), LRMN has been speaking with Alexander Denoon, Partner at LDD, who has been keeping track of the developments concerning an on-going court case on the subject of patenting human embryonic stem cell (hESC) inventions.
On Tuesday 18th October 2011, the Court of Justice of the European Union published it's decision regarding the case of Brüstle v Greenpeace, declaring that a process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented.
While this is certainly an unwelcome development for embryonic stem cell research, it is not as destructive to progress in this field as has been widely suggested and certainly, there have been no reports of any single research project that has been threatened, suspended or cancelled as a result of this case to date. Even if the decision does prohibit some patents regarding embryonic stem cells, there are a variety of technical and regulatory reasons why this would not actually affect any development of the UK cell therapy industry. By way of example, it will be virtually impossible to obtain regulatory approval for a “generic” human embryonic stem cell, thus prolonging the commercial life of future products beyond that provided by patents alone.
Many multi-billion pound industries have flourished despite the absence of basic patent protection, achieving success as a result of obtaining protection for “downstream” products and technologies. We expect that patent protection will certainly be achievable for a number of highly profitable “downstream” innovations related to the delivery of stem cell therapies, such as patents on aspects of their manufacture, storage and distribution, surgical implantation devices, and clinical use. The development of monocloncal antibodies was plagued with patent concerns in its infancy, but this did not prevent the development of life-changing products such as Herceptin.
Stem cell therapies offer the only realistic hope on the horizon for the treatment of a wide variety of severe, often degenerative, medical conditions. The UK cell therapy sector has a positive future despite this decision, which we are certain has not impeded on the huge potential for this industry to thrive to ultimately deliver NHS patient benefits.
For further legal analysis, please click here to see the note prepared by Alex Denoon and James Lawford Davies for the Genetics Politics Institute (GPI) Stem Cell Action Coalition.
The LRMN, in association with LDD, will keep you posted on any further implications from the decision or from subsequent guidance from future interpretation.