[Ip-health] Ruling on stem-cell patents may spell end of research in Europe

Prof. Michael H. Davis michael.davis at law.csuohio.edu
Thu Apr 28 05:39:06 PDT 2011

To bemoan this is nonsensical. The decision says nothing about research, only patenting (unlike the US which is the opposite). The EU has a commendable history of research support. It spends billions on BERN with no patent involvement. There is no reason Europeans will be dissuaded from research just because private companies may have no patents. Plus of course they can get patents in the US (and a host of other countries forced to follow our lead) so that they can monopolize the market here, as is our willing tradition.

Michael H. Davis
Professor of Law
Cleveland State University
College of Law
Cleveland, Ohio 44115

Patent Attorney Admitted to Practice Before the US Patent and Trademark Office
Reg. No. 45,863

-----Original Message-----
From: Tahir Amin <tahir at i-mak.org>
To: ip-health at lists.keionline.org
Sent: Thu, 28 Apr 2011 8:26
Subject: [Ip-health] Ruling on stem-cell patents may spell end of research in Europe

 Ruling on stem-cell patents may spell end of research in Europe

 By Steve Connor, Science Editor
*Thursday, 28 April 2011*

A fledgling biosciences industry that promises to revolutionise medicine in
the 21st century could be destroyed by a French judge who has declared it
immoral to patent inventions based on cells derived from human embryos.

Some of Britain's leading biomedical scientists – including Sir Ian Wilmut
who cloned Dolly the sheep – have expressed their horror over a legal
opinion by Yves Bot, advocate-general of the European Court of Justice in
Luxembourg, that no one should be allowed to patent any invention that comes
out of research involving stem cells obtained from human embryos. This would
include potential treatments for incurable conditions ranging from heart
disease and Parkinson's to blindness and spinal cord injuries.

Sir Ian and 12 other leading stem- cell researchers said the ruling – if
followed by the judges of the European court – would effectively end all
research on embryonic stem cells, which have the unique ability to develop
into any of the dozens of cell types that make up the human body.

"Work on human embryonic stem cells is just completely undermined by this
[legal] opinion," Sir Ian said yesterday. "The consequences, if it was not
possible to patent these processes, is that companies would be much less
likely to invest in academic research if they were not allowed to protect
their inventions."

Mr Bot, a magistrate considered to be on the right of Nicolas Sarkozy's
conservative party, was required by the European Court to make a ruling on a
dispute that has dragged on through the German patent courts. In his legal
opinion, he says that stem cells derived from human embryos have the ability
to "evolve" into a complete human being and should therefore be legally
classified as embryos. This would prohibit them from being used in patent

"To make an industrial application of an invention using embryonic stem
cells would amount to using human embryos as a simple base material, which
would be contrary to ethics and public policy," said a court statement.

"The advocate-general considers that an invention cannot be patentable where
the application of the technical process for which the patent is filed
necessitates the prior destruction of human embryos for their use as base
material, even if the description of that process does not contain any
reference to the use of human embryos."

Professor Austin Smith, chair of the Welcome Trust Centre for Stem Cell
Research at Cambridge University, said that banning patents would
effectively remove the protection of intellectual property and lead to the
abandonment of vital research into a host of incurable diseases.

"This opinion by the advocate-general is threatening and undermining to our
research and to European research in general. Patenting is a key vehicle for
the translation [of university research] to deliver new products for
medicine," Professor Smith said.

"If the European Court were to follow this opinion, the reality is that all
patents in Europe that involve human embryonic stem cells will be dissolved
in Europe. This will wipe out the European biotechnology industry in this

The 13 Grand Chamber judges of the European Court of Justice will consider
M. Bot's opinion over the coming weeks and are expected to make a final
ruling on whether to ban past and future patents within six months.

Professor Pete Coffey, a stem-cell scientist at University College London
who is hoping to start a clinical trial to treat age-related macular
degeneration – a form of blindness, said that the effects of a ban on
patents would lead to British inventions being exploited in the United
States and other countries where patents are protected.

The British governmentwas spending millions of pounds trying to establish
links between UK universities and pharmaceutical companies interested in
developing therapies based on human embryonic stem cells. All this would be
jeopardised if patent protection were banned in Europe, he said.

"It's going to have a major impact in the UK's economy... it will hit
industry enormously."

*Uses for stem cell therapy*

*Blindness* British scientists are hoping to begin clinical trials using
stem cells that can develop into the light-sensitive cells at the back of
the eye, which degrade in age-related macular degeneration. Scientists in
the US are closer to using the cells to treat another form of blindness,
Stargardt's Macular Dystrophy.

*Spinal cord injury* American biotechnology company Geron has begun the
first clincial trial of human embryonic stem cells to treat spinal injury.
The cells will be injected into patients' spinal cords, hopefully to restore
lost nerve function.

*Parkinson's disease* Scientists hope to develop a laboratory model of
certain diseases, such as Parkinson's, using stem cells derived from
patients with the condition. In this way, they hope to create laboratory
"models" of the disease based on human cells, which can be used for testing
new drugs and treatments.

*Heart disease* Ultimately, the aim of stem cell therapy is to be able to
mend damaged tissues in situ, rather than replacing a whole organ. Heart
disease, for instance, could be tackled by injecting stem cells into the
damaged site and allowing them to re-populate the damaged area of the organ.
This would in theory be safer, cheaper and easier than carrying out a
whole-organ transplant operation.

Steve Connor

*Q&A: How this law could block the work of scientists*

*Q. What are embryonic stem cells?*

These are cells derived from a very early human embryo, usually only three
or four days after conception by IVF. They can be coaxed in the laboratory
to develop into any of the cells found in the human body. Scientists hope to
use them in revolutionary techniques, such as for testing new drugs or for
transplant operations to replace damaged tissue.

*Q. Why do scientists need to patent these inventions?*

In order to encourage pharmaceutical companies to spend the millions of
pounds necessary to develop a university project into a safe clinical
technique, scientists need to ensure their intellectual property is

*Q. Why is this suddenly an issue?*

It began with a court case in Germany when Greenpeace sued a Bonn University
scientist, Oliver Brüstle, who held a patent on a technique involving
embryonic stem cells. The court case went against Dr Brüstle and he appealed
to a higher court, which referred it to the European Court of Justice, which
asked its advocate general, Yves Bot, for his legal opinion on whether such
patents should be allowed. M. Bot has just given his opinion, saying that
patents involving human embryonic stem cells should be banned.

*Q. Does this legal opinion matter?*

The 13 judges of the Grand Chamber of the European Court will now consider
their advocate general's opinion. If they uphold it, all existing patents
will be dissolved if they involve human embryonic stem cells. Scientists
said this would be disastrous for the fledgling stem-cell industry because
drug companies would flee to other countries where their intellectual
property can be protected in law.

*Q. Can't the UK just ignore the European Court?*

No, the decision of the court is binding on member states.
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