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4-Patents: Freeing the Free Tree



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TITLE:  Freeing the Free Tree
SOURCE: Research Foundation for Science, Technology and Ecology, India
        International Federation of Organic Agriculture Movements, Germany
        The Greens/European Free Alliance in the European Parliament, Belgium
        by Linda Bullard
DATE:   Aug 2005

------------------- archive: http://www.genet-info.org/ -------------------


Freeing the Free Tree

A BRIEFING PAPER
on the
FIRST LEGAL OPPOSITION TO A BIOPIRACY PATENT: The Neem Case

Legal history was made on March 8th, 2005 in Munich, Germany when the
Technical Board of Appeals of the European Patent Office (EPO) revoked in
its entirety a patent on a fungicide made from seeds of the Neem tree,
concluding a ten-year battle in the world's first legal challenge to a
Biopiracy patent.


THE NEEM TREE

The botanic name of the Neem Tree is Azadirachta indica, which is taken
from the Persian name for the tree, Azad-Darakth, meaning "the free
tree."  The tree is a member of the mahogany family and is indigenous to
the Indian subcontinent.  Over the past century it has been introduced
and now flourishes in many countries of Africa, Central and South
America, the Caribbean and Asia.  Neem trees are attractive tropical
evergreens that can grow up to 30 meters tall and 2.5 meters in girth.
Their spreading branches form rounded crowns as much as 10 meters across,
and they may live for more than two centuries.

It is in India that the tree is most widely used.  It is mentioned in
Indian texts written over 2000 years ago and has been applied for
centuries in agriculture as an insect and pest repellent, in human and
veterinary medicine, toiletries and cosmetics.  It is also venerated in
the culture, religions, and literature of the region.  India has freely
shared its "free tree" and knowledge of its myriad uses with the world
community; but now, through the patent sytem, this important resource is
becoming the private property of a few corporations.


THE NEEM PATENTS

Sixty-five patents for products derived from the Neem tree have been
filed with the EPO to date, of which 22 have been granted, 28 are "dead"
for various reasons, and 9 are currently being examined.  These include
claims for insecticides, fungicidal effects, methods of extraction,
storage stable formulations of one of the active ingredients,
azadirachtin, contraceptives, and medical uses. Although some Indian
companies have claimed patents on the Neem, they are outnumbered 2 to 1
by multinational corporations, such as the U.S. pharmaceutical company
Rohm and Haas and the infamous agrochemical giant W.R. Grace.1

It is important to note that the Neem patents do not involve a
genetically engineered product; neither has the tree itself been
patented, nor any of its parts.


THE NEEM TREE AND BIOPIRACY

The Neem patents are resulting in major financial gains for their so-
called owners, while the communities which first understood the Neem's
uses and shared this knowledge with the rest of the world will not be
compensated at all.  The Neem patents are just one in a large catalogue
of genetic resources originating in the South over which intellectual
property rights are being asserted by a few multinational corporations
originating, for the most part, in the North.  The Northern patent system
was not equipped to recognise or reward as inventive the products of
community innovation processes such as those which created the various
uses of the Neem today.  It is only when these uses are described in the
terms of Western science and technology that an "invention" is deemed to
have taken place and an individual "inventor" or a set of individual
"inventors" is allowed to be rewarded with the monopoly property rights
that a patent confers.  This is the mechanism through which a massive
transfer of biological and intellectual wealth is taking place--from the
"Third World" to the North.

One direct impact of the corporate monopoly on the Neem made possible by
the patent system is a staggering increase in the companies' demand for
seed.  The fungicide claimed in the USA/Grace patent cannot be produced
without naturally-occurring Neem seeds.  A processing plant set up by
Grace in India can handle 20 tons of seed per day.  Almost all the seed
collected - which was previously freely available to the farmer and
healer - is now purchased by the company, causing the price of Neem seed
to skyrocket beyond the reach of the ordinary people.  Neem oil itself,
used for lighting lamps, is now practically unavailable, as the local oil
millers are not able to access the seed.  Poor people are losing a
resource vital for their survival - a resource that was once widely and
cheaply available to them.

In an effort to combat the injustice of Biopiracy there were attempts to
introduce a mechanism for "prior informed consent" into the EU Directive
on "Legal Protection of Biotechnological Inventions."  But this highly
controversial legislation was finally enacted in July 1998 without any of
the proposed protective measures built in.  Transposition of this
Directive into national law has proved complicated, however, and the
European Commission is late in producing a mandated report on its
functioning.  Another focus of attention has been the Convention on
Biological Diversity (CBD), the aim being that this international legal
instrument require its Parties to insure that patent applications
involving biological resources identify the source of the material and
provide measures for prior informed consent of the communities so
identified.  Vast NGO energy was also directed at TRIPs (Trade-Related
Intellectual Property Rights), the multilateral agreement on patent
regimes which formed part of the original General Agreement on Tarifs and
Trade (GATT).  But the most direct approach to fight these Biopiracy
patents in Europe was to actually oppose one within the legal system
which granted it and thereby attempt to create case law.


CHRONOLOGY OF THE CASE

On December 12, 1990 the multinational agribusiness corporation W.R.
Grace of New York and the United States of America as represented by its
Secretary of Agriculture, filed a European Patent Application with the
European Patent Office (EPO) on the basis of a U.S. priority application
of December 26, 1989, covering a method for controlling fungi on plants
by the aid of a hydrophobic extracted Neem oil.  This was the third
application for a Neem-derived product which had been filed by W.R. Grace.

After a very difficult and controversial examination procedure, the grant
of a European patent for this application was published on September 14,
1994, with the number 436257, the main claim having been restricted by
the EPO to:

"A method for controlling fungi on plants comprising contacting the fungi
with a neem oil formulation containing 0.1 to 10% of a hydrophobic
extracted neem oil which is substantially free of azadirachtin, 0.005 to
5.0% of emulsifying surfactant, and 0 to 99% water."

Nine months later a Legal Opposition to this patent was filed jointly by
three "plaintiffs":  Magda Aelvoet, MEP, then President of the Green
Group in the European Parliament, Brussels, Dr. Vandana Shiva, on behalf
of the Research Foundation for Science, Technology, and Natural Resource
Policy, New Delhi, India, and the International Federation of Organic
Agriculture Movements (IFOAM), based in Germany and represented by its
then Vice-President (and future President), Linda Bullard.  The three
partners consciously chose to oppose this particular patent in part
because of who its "proprietors" were:  They wished to illuminate how
governments of wealthy countries - in this case the United States - and
multinational corporations - in this case the infamous W.R. Grace (whose
exploits are chronicled in the book and movie "A Civil Action") - collude
to steal biological resources from the south by means of the patent
system.  It is also not by accident that these particular three Opponents
joined forces to launch the Opposition:  an organization from the country
where the resource was stolen, an international organization representing
organic users and producers of Neem products throughout the world, and an
environmental political party, well positioned to pursue changes in the
legal system itself to outlaw Biopiracy.  And from within these
organizations it was women who initiated the action and sustained it - an
Indian, a Belgian, and an American.

Although the Opponents filed the original Opposition without benefit of
legal representation, they soon afterwards authorized Prof. Dr. Fritz
Dolder (Professor of Intellectual Property, Faculty of Law, University of
Basel, Switzerland) to represent them, and he functioned in that capacity
for the ten years it took to bring the case to a close.

The Opponents claimed that the fungicidal effect of hydrophobic extracts
of neem seeds was known and used for centuries on a broad scale in India,
both in Ayurvedic medicine to cure dermatological diseases, and in
traditional Indian agricultural practice to protect crops from being
destroyed by fungal infections.  Since this traditional Indian knowledge
was in fact ubiquitous in Indian culture from ancient times, they
asserted that the patent in question lacked two basic statutory
requirements for the grant of a European patent, namely "novelty"
(Article 54 of the European Patent Convention [EPC] and "inventive step"
(EPC Article 56, in the U.S. called non-obviousness).

In addition, the Opponents charged that the patent was contrary to
"morality," Article 53 (a) of the EPC, because the so-called inventors
claimed monopoly property rights on a method which forms part of the
traditional knowledge base of India - in essence stealing it - and theft
is regarded as immoral in European culture.  Finally, they cited the
formal grounds of "insufficient disclosure" (EPC Article 83) and "lack of
clarity" (EPC Article 84) in calling for the revocation of the patent.
Subsequently, the Opponents requested an additional ground for
opposition, namely that the patent constituted de facto a monopoly on a
single plant variety, which is barred by Article 53 (b) of the EPC.

It took five years for the case to come before the Opposition Division of
the EPO.  During this period the Opponents submitted evidence and
affidavits gathered to support the claims they had made in the initial
Opposition.  Finally an Oral Proceeding was scheduled on May 9th and
10th, 2000, before the Opposition Division of the EPO in Munich.

At midday on the first day of the hearing demonstrators gathered in front
of the EPO building holding banners reading "No Patents for Theft" and
carrying signs representing all the European patents which had been
granted or were pending on the Neem.  A 2-metre tall Neem tree was
symbolically "freed" from patents for public use by a delegation of
scientists and farmers from India and Sri Lanka. They then presented to a
representative of the EPO packages of signatures of 100,000 Indian
citizens demanding that all patents on the Neem be revoked.

To support the substance of its case, the Opponents had brought two
expert witnesses from India:  Dr. Udai Pratap Singh of Varanasi
(Professor and Head Department of Mycology and Plant Pathology, Institute
of Agricultural Sciences, Banaras Hindu University) and Mr. Abhay
Dattaray Phadke of Puna (Managing Director of Ajay Bio-Tech (India)
Ltd.).  Dr. Singh is widely regarded as India's greatest expert on Neem
from the scientific community.  Mr. Phadke is an agronomist and had
commercialized a Neem product in India (without claiming patent
protection), following a development phase and extensive field trials
with farmers.  Interestingly, Mr. Phadke had once worked for Rhone-
Poulenc and had proposed that they commercialize the Neem product;
however, that company declined, judging that it would never be possible
to obtain a patent on such a product, which would make it commercially
uninteresting to d.  He also personally provided samples of his Neem
fungicide, called "Neemark," to W.R. Grace.

The patentees first attempted numerous manoeuvers to have the Opposition
declared inadmissible  on procedural grounds - claiming, for example,
that since there were three Opponents, they should have paid three
Opposition fees (never mind that the two "proprietors" had paid only one
Application fee), or that the fee had not been paid in time, or that the
non-European Opponent was not duly represented at the time of filing the
Opposition.  However, one after the next, the Opposition Division found
in favor of the Opponents on all the procedural questions, leaving the
room each time to confer, and then returning to announce their decision
and resume the proceedings.

Then the first witness was called, Mr. Phadke.  His testimony was
lengthy, extraordinarily detailed, supported by a great deal of
documentation, and absolutely crushing.  Dr. Singh was not allowed to be
present during the hearing so as not to influence his testimony.  For a
day and a half he waited patiently in the hall outside for his turn to
testify, but was never called, as sufficient evidence to overturn the
patent was supplied by the first witness.

At the end of Mr. Phadke's testimony, the Opposition panel ruled that the
patentee's claim of novelty had been destroyed on the basis of clearly
demonstrated prior public use.  According to Dr. Dolder, it is difficult
and quite rare to defeat a patent on the basis of novelty, but here it
happened.  At that point it could have been all over, but the lawyers for
USA/Grace submitted an "auxiliary request" which amended their Neem
formulation slightly, so that it fell just outside the parameters
described by Mr. Phadke:  The concentration of Neem oil contained in the
preparation was now specified as 0.25% ONLY, no more, no less.  In
practical terms, this altered claim would have been useless to the
patentee, because the percentage was so narrowly defined that it actually
no longer constituted a monopoly (in other words, it would have been very
easy for a competitor to avoid infringing the patent).  Nonetheless, this
amended claim was immediately examined, and this time the Opposition
Division ruled that even in amended form, the "invention" was lacking an
inventive step.  Thus, the patent was revoked in its entirety.

The panel had not found in favor of the Opponents on their charge that
the patent constituted a de facto monopoly on a single plant variety or
that it was a violation of "public order and morality."  On the other
hand, they accepted the Opponents argument that patents should not be
granted for common traditional knowledge, but pointed out that this
argument should be used for establishing "prior art" and is not a
question of morality in the sense of the European Patent Convention.

The USA and W.R. Grace appealed to the next level within the EPO, the
Technical Appeals Board, demanding that the decision of the Opposition
Division be overturned and submitting yet another modified formulation of
their original claim.

Five more years of deadlines and submissions ensued before the case once
again reached the level of an Oral Proceeding at the EPO.  In the
meantime, W.R.Grace filed for bankruptcy (following criminal indictment
for the deaths of hundreds from asbestos contamination), shortly after
transferring its patent rights to a company which had begun as a research
group within W.R. Grace, then became Grace Biopesticides Division before
being sold and renamed Thermo Trilogy.   This company specialized in what
they referred to as  "biorational" pesticides, but in 2001 Thermo
Trilogy's assets, including its patents, were acquired by Certis, a
wholly-owned subsidiary of the Japanese company Mitsui & Co., which is
now one of the largest providers worldwide of "safe food" technologies.
Throughout these business mutations, the United States of America has
remained the constant "coproprietor" of the patent.

Although two days had been set aside to examine the Appeal, the case was
so compelling that the five-memberTechnical Board of Appeals needed only
two hours to reach its decision.  It had earlier declined to hear Mr.
Phadke again, or Dr. Singh, although the work of both was referred to
during the proceedings.  The patentees had renewed their attempts to have
the case declared inadmissible on procedural grounds, but the panel did
not even discuss these questions.  A second "auxiliary request" amending
the formula of the product was refused on the grounds that it enlarged
the scope (Article 123(2)).  Then the main body of the patent was
examined with regard to novelty, disclosure, and inventive step.  After
hearing the Opponents' arguments, the Board went into closed conference
to come to a decision.

Shortly after 11 a.m. on March 8th, the Chairman announced, "The Appeal
is dismissed.  The patent is revoked."


JURISPRUDENCE

Unlike the Opposition Division, the EPO Board of Appeal based its
decision on the scientific paper by Dr. U. P. Singh, considering that it
represented "the closest prior art" and, in addition, was not disputed by
the appellant (who had objected to Mr. Phadke's testimony with the
argument that "most people" are unable to recollect dates and figures
with such accuracy as he had demonstrated!).  On the basis of the Singh
document alone, the Board judged that patentee's main claim failed for
lack of an "inventive step," that is, to a person skilled in the art it
would have been "obvious to try to use formulations such as those defined
in the claim for controlling fungi on plants."  This, together with the
rejection of the reformulated auxiliary request as noted above, was
sufficient to destroy the patent.  There is no further recourse for the
United States and its partner corporation to claim monopoly property
rights on the Neem fungicide product:  It is irrevocably revoked.   (For
a more detailed and technical analysis of the decision, see Dr. Dolder's
"Concise Legal History" of the case.)

The Neem patent challenge now becomes part of case law within the
European patent regime and will hopefully have an impact not only on the
Neem patent applications which are still pendintg, but also on ALL
Biopiracy patents which have been filed in the EPO.  One of its main
achievements was to validate the use of affidavits and testimony, and to
secure recognition of the intellectual accomplishments of traditional
societies as a means to establish "prior art" when evaluating the novelty
of a claimed invention.

"Moreover, the opposition division agrees with the Opponents that no
patents should be granted for anything which was known previously, for
example as part of common traditional knowledge [emphasis added].
However, under the EPC this is not a matter of Article 53(a) EPC, but is
a question of novelty or prior public use."2

Revocation of the Neem patent shows that it is possible to defeat
Biopiracy, but doing so will require that this historic precedent be
further developed and transposed into overarching  international legal
frameworks. The revocation has no direct effect, for example, on Neem
patents in other legal regimes.  However, following the final ruling of
the EPO, the "Ad-hoc Open-ended Working Group on Access and Benefit-
sharing" of the Convention on Biological Diversity (CBD) invited the
Opponents in the Neem case to submit their experience regarding "the
occurrence, nature, extent and cost of misappropriation of genetic
resources [, deriva-tives] and associated traditional knowledge."  The
immediate interest shown by the Working Group is an encouraging sign that
the precedent set by the defeat of this Neem patent can be fed into other
binding international treaties and legal instruments, such as TRIPS3 of
the World Trade Organization, and possibly even the EU Patenting
Directive, which is currently under review.


THE NEEM CAMPAIGN

The Neem Patent challenge was initiated in solidarity with the Neem
Campaign of India, which was launched in 1993 by farmers in India who
feared that their genetic resources and traditional knowledge were coming
increasingly under foreign control through the legal mechanism of
patents.  They likened what they were experiencing to a modern form of
"enclosure of the commons" - but in this case it was not public land
being privatized but rather  public knowledge.  The idea for the case was
born at a meeting of social/environmental activists in Malaysia in 1993.
 In April and May, 1995 Magda Aelvoet and Linda Bullard travelled to
India at the invitation of Vandana Shiva to speak to NGOs, government
authorities and the press about the issue of Patents on Life, European
and international patent law, and the Neem patent challenge, which they
filed two months later.

In addition to the three "plaintiffs" who filed the Legal Opposition to
the patent, the following  organizations were listed as associating
themselves with and supporting the action: Karnataka Rajya Raitha Sangha
(India); Third World Network (Malaysia); the Green Group in the European
Parliament (EU); the European Coordination No Patents on Life!
(Switzerland); Rural Advancement Fund, International (Canada); Cultural
Survival Canada (Canada); the Cultural Conservancy (USA); the Edmonds
Institute (USA); Institute for Agriculture and Trade Policy (USA);
Washington Biotechnology Action Project (USA); Rio Grande Bioregions
Project (USA).  A broad coalition of other European NGOs also supported
the Opponents materially, physically, and morally.

Major funding for the legal costs and related expenses was generously
provided by:
- HIVOS, the Netherlands
- The Green Group in the European Parliament (followed by its successor,
The Greens/EFA in the European Parliament), Brussels, Belgium

Additional support was received from the Schweisfurth Foundation in
Munich, Germany, and the Edmonds Institute in Washington, USA.


PARTS OF THIS BACKGROUND INFORMATION WERE DRAWN FROM:

Intellectual Piracy and the Neem Patents, Research Foundation for
Science, Technology and Natural Resource Policy, Dehradun, India, 1993.
Campaign against Biopiracy, Research Foundation for Science, Technology
and Ecology, New Delhi, India, November 1999.

All legal documents connected with this case are available for inspection
by the public on the Web Site of the European Patent Office (http://
www.european-patent-office.org) in the "epoline" section: Enter the
Publication Number 0436257.

For further information, contact the offices of the Opponents:

Research Foundation for Science, Technology and Ecology: + 91/11-
26561868, -26968077, 26535422;
E-mail: vshiva@vsnl.com;
http://www.navdanya.org

The Greens/European Free Alliance in the European Parliament: +32 2 284-1692;
E-mail msomville@europarl.eu.int;
Web Site http://www.greens-efa.org

IFOAM: +49 228 926-5016;
E-mail n.Sorensen@ifoam.org;
Web Site http://www.ifoam.org

Linda Bullard:
E-mail Lbullard@free.fr

The lawyer for the Opponents, Dr. Fritz Dolder, is also available for
questions at fritz.dolder@unibas.ch

----------
1 A list of all the Neem patent applications at the European Patent
Office and their current status has been compiled by Dr. Ruth Tippe and
is available from Kein Patent auf Leben! (rtippe@keinpatent.de)

2 From "Decision revoking the European Patent..." of the European Patent
Office, ref. Neemfungicide, dated 13.02.2001, Application No./Patent No.
90 250 319.2-2117 / 0436257 / 01

3 A multilateral agreement on "Trade-Related Intellectual Property Rights"


--


GENET
European NGO Network on Genetic Engineering

Hartmut MEYER (Mr)
In den Steinäckern 13
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