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 none of the Neem patents 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 hydrophoobic 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 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 produce. 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
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 transferred its patent rights to the Thermo Trilogy
company, which had begun as a research group within W.R. Grace and
then became Grace Biopesticides Division before being sold. Thermo
Trilogy specialized in so-called “biorational” pesticides. 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
Technical 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.” The Board
did not explain the grounds for its decision, but it may be assumed
that the reasoning of the Opposition Division was upheld, that the
patent did not satisfy the requirements for novelty and/or inventive
step. A written decision which does provide the grounds for the decision
of the Board will be sent to both parties. In any event, the United
States and Thermo Trilogy have no further recourse on this particular
patent: It is irrevocably revoked.
JURISPRUDENCE
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 pending, but also on ALL Biopiracy
patents which have been filed in the EPO. It is important to note that
the case was won on the basis of affidavits and testimony, and that
the intellectual achievements of traditional societies were recognized
officially as a means to establish “prior use”:
“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.
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 1994. The next year 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 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; www.navdanya.org
The Greens/European Free Alliance in the European Parliament: +32 2 284-1692;
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
