October 12, 2000
Rural Advancement Foundation Intl
The Golden Rice AstraZeneca saga is a case study in public science's
failure
to understand and address patent issues. In justifying their surrender of
Vitamin A enriched GM rice to the giant corporation, the researchers claim
they couldn't navigate the 70+ intellectual and tangible property conflicts
that could potentially scuttle their work. There are likely no more than
11
- and possibly as few as 4, patent conflicts and one outstanding tangible
property issue. A public sector group - including the people Golden Rice
is
intended to help - should meet to debate all the options and alternatives.
The contract and the events surrounding it should be investigated.
When shareholders confirm this week that the agricultural divisions of
AstraZeneca and Novartis will indeed merge under the new name, "Syngenta,"
they will probably be talking more about their market prospects for GM
crops
in the North than about the needs of poor farmers and malnourished
consumers
in the South. More of the discussion will be about the opportunities
created with the coming together of the two enterprises' Terminator and
Traitor patents than about Vitamin A deficiency in Asia. But, according to
RAFI's Research Director, Hope Shand, "Syngenta had better be giving some
serious thought to its deal on Golden Rice - and quickly, or they could
have
a major embarrassment on their hands."
Laying a not-so-Golden Egg: "The deal struck by Potrykus and Beyer (the
Swiss and German scientists who developed Golden Rice) with AstraZeneca was
totally unnecessary," Shand insists. "It should be thoroughly
investigated
by the public institutions who funded the research." News that Golden
Rice, a GM rice containing Vitamin A enrichment genes, was showing promise
first surfaced in January. By April, however, the financial backers of
the
research - including the Rockefeller Foundation, the Swiss Federal
Institute
of Technology, and the European Union - were letting it be known that
commercialization of the work in countries with Vitamin A deficiency (VAD)
could run afoul of between 70 and 105 patents, licenses, and Material
Transfer Agreements (MTAs - agreements governing technical property such as
germplasm) controlled by more than 30 public and private institutes. Their
alarm appears to have been kindled by a study the Rockefeller Foundation
commissioned from ISAAA
(International Service for the Acquisition of Agri-biotech Applications - a
bio-broker with offices in the UK, USA, and the Caribbean). The patent
search was conducted on behalf of the International Rice Research Institute
(IRRI) in the Philippines, spurred by concerns that if it adopted Golden
Rice it might be sued by other patent-holders. Despite their shock as to
the
number of potential intellectual property conflicts, the donors were
stunned
on May 16th when the two researchers independently signed a deal with
AstraZeneca turning over the future development of Golden Rice to the Gene
Giant. The agreement was negotiated through another biotech bargainer,
Greenovations, which is a spin-off of the University of Frieburg where one
of the inventors has his lab. In return for exclusive monopoly control of
Golden Rice in the North and in sales to larger farmers in the South,
AstraZeneca agreed to make the technology freely available to the South's
poor farmers. At the time, Beyer and Potrykus told the media that the
dizzying muddle of conflicting intellectual property claims necessitated
the
deal. Aside from clearing away intellectual property hurdles, AstraZeneca
will also undertake additional research related to the environmental and
health issues surrounding Golden Rice before releasing seeds to the market,
they suggest, sometime around 2003. At the time of the deal, some of the
donors were actively exploring public sector avenues for completing this
work in Australia, Asia, and Europe. All of the donors were apparently
aware that the inventors were considering commercial options but did not
expect an agreement to be reached unilaterally or so quickly. Their public
sector efforts came to an abrupt halt. Nine years and millions of dollars
of public funding were surrendered to a multinational corporation.
The media continued to talk of the gaggles of patents and haggles of
licensing from May through August. On August 3rd, Monsanto, which had
jettisoned its own rice programme some months earlier, garnered cheap
publicity by proclaiming that its warehouse of rice-related patents would
be
licensed gratis to the Golden Rice project. The next day, Potrykus told the
Washington Post, "I consider the Monsanto offer important because I can
now
use this case to tell other companies, 'Look, Monsanto is giving me a free
license. Won't you do the same?' It's an important first example." It now
appears that only one Monsanto patent is a factor in most countries in the
South that have high levels of Vitamin A deficiency.
Potrykus' comments beg the question: Why didn't the public researchers,
backed by their donors, attempt to clear possible patent constraints before
striking a deal with AstraZeneca?
At the beginning of September, AstraZeneca let it be known that as few as
four patents and two MTAs might have to be negotiated. RAFI now
understands
that only one MTA continues to be a problem.
Counting Eggs Before They Hatch: At the beginning of October, RAFI received
a copy of ISAAA's IP audit on Golden Rice. The ISAAA study identifies 70
patents and 16 technical property constraints (MTAs and other licenses)
that
could have implications for Golden Rice commercialization. RAFI's review of
the claims indicates that no more than 11 patents potentially complicate
the
completion of the project. RAFI's analysis focuses on the 60 countries that
are designated by the World Health Organization (WHO) as having clinical or
severe levels of Vitamin A deficiency.
Although there are technically 70 patents, many of the same patents are
replicated with different codes in the United States and the European
Patent
Office. In fact, there are only 44 patents applicable in any one country.
Of the 44 patents, 26 are for process claims. These patents are not
applicable if the product using the process is made in a country where the
patent does not apply.
Of the 60 countries that suffer the most serious levels of VAD, 35
countries
recognize no patents related to Golden Rice.
Of the 25 VAD countries where Golden Rice patents have been recognized,
only
a dozen patents are actually relevant.
Of the 12 patents that are recognized in VAD countries, 7 patents are held
by four Gene Giants (AstraZeneca -1; Aventis - 2; Monsanto - 1; and DuPont
-
3 though the 3 DuPont claims are all identical). One patent - recognized
only in Mexico (of the VAD countries) is held by Yissum Research &
Development Co. - a biotech company spin-off of the Hebrew University of
Jerusalem. The remaining 4 patents are held by four public sector
institutions (University of Maryland; Centre National - France; National
Research Council of Canada; University of California).
But, only 12 countries have VAD and consume rice in sufficient quantity to
make them potential targets for introducing Golden Rice. Of these 12
countries, 6 have no patent conflicts for the production of Golden Rice.
At most, 11 patents can be considered a constraint to the project.
In sorting out the ownership conundrum, three points become clear. First,
only a very small percentage of the patents are relevant for the poor
countries suffering the most from Vitamin A deficiency. Second, only a few
patents held by the private sector actually conflict with the further
development of Golden Rice for the South. Of the four companies with
patents, two - Monsanto and Astra Zeneca - have already agreed to royalty
free licensing, leaving only two other major players, Aventis and Dupont to
agree to the same. Third, the abuse of MTAs as a market weapon to
frustrate
scientific advances has been underestimated and is in urgent need of
examination.
Trojan Trade Reps? "The researchers appear to have surrendered a decade of
public funding to the commercial and PR interests of the biotech industry,"
notes Julie Delahanty of RAFI, "The threat of a plethora of industry
patents that had no relevance to the development of Golden Rice turned the
project into a "Trojan Trade Rep" for northern industry's campaign to
impose
their IP rules on the world." Even though poor countries have every legal
right to utilize any technology not patented within their territories -
pressure from industry seems to have convinced public science - and its
funders - that they had to negotiate access to all the patents in order to
develop Golden Rice.
RAFI believes that a number of questions need to be answered in order for
the public to have confidence in any ongoing research related to Golden
Rice:
What were the terms and conditions of the contract with AstraZeneca? Were
there other related arrangements between any of the parties involved in
Golden Rice research and funding?
What was the substance of the initial report made by ISAAA on Golden Rice
prior to the publication of its later document in September? How many
conflicts did it identify and what was its advice? Why didn't ISAAA
researchers give a more accurate and transparent IP audit - taking into
account the rather limited number of IP constraints for most poor
countries?
What is the commercial potential for Golden Rice in the North and among
larger farmers in the South? In other words, what market was surrendered
to
AstraZeneca?
Action Needed: RAFI, along with many other civil society organizations, is
increasingly skeptical about the public health and environmental safety
aspects of any GM crop. A great deal more research will be needed in these
areas as well as a full examination of the socio-economic impact and other
alternatives, before Golden Rice can be considered. RAFI believes that
there are other more cost-effective strategies for addressing micronutrient
deficiencies in the South that not only meet human needs but also promote -
not restrict - biological diversity. RAFI also believes that the
technological and public relations disaster surrounding GM seeds is
continuing into biotech's second and third generations. As a Generation
Three product, Golden Rice requires forensic scrutiny since it is aimed
directly at poor consumers - in the centre of genetic diversity of the
world's most important food crop.
RAFI recommends three initiatives:
1. The public sector funders who supported this research should form a
consortium to conduct an immediate investigation of the events leading up
to the contract with AstraZeneca.
2. The funders, in cooperation with the Consultative Group on
International Agricultural Research (CGIAR) should discuss mechanisms that
could allow the issue of public scientific research and intellectual
property conflicts to be addressed to the Office of the High Commissioner
for Human Rights in the United Nations and the International Court of
Justice.
3. The consortium of donors should invite concerned organizations -
especially organizational representatives of the poor farmers and consumers
who are the focus of Golden Rice research - to meet and discuss not only
Golden Rice but the wider issue of meeting the micro-nutrient needs of
malnourished peoples. Hopefully, such a meeting would lead to a renewed
and
collective commitment to address this issue. Whether or not Golden Rice is
seen as part of the problem or part of the solution would be for the
meeting
to decide. Astra Zeneca (now Syngenta) should immediately surrender its
exclusive rights to the public sector, if this meeting asks it to do so.
The company should also assure the public that its own intellectual
property
claims will not interfere with the research or its final commercialization
if the work should eventually be acceptable for marketing.
Searching for Higher Ground: RAFI will continue to follow this issue
closely in the months ahead. "We don't want to suggest that patent
conflicts are not a major problem. They are." Hope Shand concludes. "But
the only clear intellectual property claim right now comes from ISAAA which
has applied for a trademark on the name Golden Rice." "The clear
conclusion," Julie Delahanty adds, "is that the public sector has not been
facing up to the complex issues and moral dilemmas associated with
intellectual property. It's time they got their head out of the sand and
looked around before it's too late."
(For further background, see RAFI Genotypes On Golden Pawns, June 20, 2000,
RAFI News Release "Patent Evils Threaten Public Goods," September 7, 2000,
and RAFI Occasional Paper, In Search of Higher Ground, September 7, 2000
