Biodiversity Mystery Theatre

. . . drawn from the files

of the United States Patent and Trademark Office

 

 

written and researched
by Jay McGown

translated into Spanish
by Alexandra Curi

edited
by Freida Morris

and

produced and distributed by
The Edmonds Institute
20319-92nd Avenue West
Edmonds, Washington 98020
USA

 

Biodiversity Mystery Theatre is a series of documentaries originally distributed on the Internet in July 2003. The series was later published in print versions, in both English and Spanish.

The reader is welcome to reproduce and distribute this material at will, provided that the writer, the editor, the translator, and the publisher are appropriated credited and the scripts are kept intact.


Biodiversity Mystery Theatre was developed with the help of grants from the C.S. Fund and the Funding Exchange


ISBN 1-930169-19-1

 


 

Contents

 

The Case

of the African Tumor Fighter

of the Mexican Bean Gene Claim

of the Soothing South Pacific Oil Nuts

of the Pentagon’s Big African Knowledge Grab

of the Pigeon Pea Patents

 


 

Biodiversity Mystery Theatre #1

 

Prologue: As the world awaits the next ministerial of the World Trade
Organization, (1) intellectual property issues remain center stage.
(2) Still unresolved are problems created years ago by the granting
of patents on living organisms and their pieces and products. Among the
persistent difficulties are questions of access and benefit sharing:
how to avoid biopiracy and to ensure a fair deal for those whose
biological materials and traditional knowledge may be part of other
people's patent applications.

 

And now, Biodiversity Mystery Theater

. . . featuring an international cast of characters

. . . in real-life tales drawn from the files of
the United States Patent and Trademark Office.

 

Today, "The Case of the African Tumor Fighter".
.

 

Pharmaceutical multinationals continue to deny affordable HIV drugs to
Africa, a continent buckling under the weight of AIDS. Yet, biotech giant Aventis has managed to access and patent promising new drugs from African plant life. Venturing into Gabon, Aventis has emerged with a US patent (#6,579,903, 17 June 2003) on compounds extracted from a little-known vine called Uvaria klaineri. According to Aventis' patent, the plant produces chemicals that inhibit cell growth. Aventis hopes to capitalize on this to develop new cancer drugs that interfere with the growth of tumors.

Many different Uvaria species are used in traditional medicine in West,
Central, and East Africa. In The Gambia, U. chamae bark and leaves are
used to treat stomach aches, bronchitis, and fevers. In Sierra Leone
and Ethiopia, the fruit of Uvaria species are important bush foods. In
many African countries, Uvaria medicines are used to treat jaundice and
malaria. In Tanzania, Uvaria are used to treat both people and
livestock.

Mystery Plant: With so many traditional uses, it comes as no surprise
that in the past decade several Uvaria species have been the subjects
of interest of industry researchers. In 1997, for example, a small US
company patented compounds from U. bevistipitata, a species found in
the Democratic Republic of the Congo, drawing allegations of
biopiracy.(3)

However, Aventis' source plant - Uvaria klaineri - is something of a mystery. Detailed botanical information about it does not appear to exist in public databases. Taxonomy sources at Kew Gardens, the Missouri Botanical Garden, and elsewhere contain no references to the species. Aventis' U. klaineri may be new to Western science or, perhaps, the company has used a novel spelling of the name of another plant, such as U. klaineana.

Whatever the case, the Aventis patent does disclose that the plant was
collected in Gabon's Gamba region. Gamba is an area of high biodiversity that is also an oil-producing area, with reserves exploited by Shell Oil. Since 2000, Shell has sponsored Smithsonian Institute (Washington, DC) biodiversity surveys in the areas of the company's Gamba oil and gas operations. According to the Smithsonian, foreign scientists generally have done little botanical investigation in Gamba. (4) A notable exception is a series of plant collections made in the 1990s by the Netherlands' Wageningen University. The Dutch team, which is working with Gabon's National Herbarium, discovered 47 new plants, including a new Uvaria species (U. annickiae) announced in 2002.

From Gamba to Frankfurt: Aventis' patent is silent on how the drug company acquired the plant sample and under what legal commitments and restrictions, if any. The inventors, a team of four, are all based at Aventis Germany in Frankfurt. The patent claims include methods for chemical synthesis of the U. klaineri compounds, potentially eliminating the need for Gabon to be further involved. In addition to the US patent already granted, Aventis has filed patent applications in Canada, Australia, and Europe. According to Aventis submissions to WIPO, (5) it will apply for patents in a total of 105 countries, including Gabon and other African countries.

Open Questions: "The Case of the African Tumor Fighter" poses a number of problems. What exactly is the poorly documented plant that is at the heart of the Aventis patent? How, why, and from whom did Aventis acquire the plant? Was the collection and transfer permitted and if so, by whom, and did the agreement, if any, fulfill obligations under the convention on Biological Diversity? (6) Have the knowledge and resources of traditional communities in Gabon or other countries been used? Has the patent been approved by traditional communities and the Gabonese government? Were just and valid material transfer and benefit-sharing agreements signed, or could this be a case of biopiracy?

Only further research . . . hopefully, carried out by those whose biodiversity is the subject of the patent . . . will provide the necessary answers.

 

Footnotes:

(1) To be held in Cancun, Mexico, in September, 2003.

(2) See Is the TRIPS review at a turning point?, a July 2003 paper by Genetic Resources Action International (GRAIN), available at <http://www.grain.org>, and TRIPS Council debates patents on life, traditional knowledge, and Article 27.3(b), Third World Network Information Service on WTO Issues, 11 June 2003, available at <http://www.twnside.org.sg/title/twninfo21.htm>.

(3) See Patents in Africa by GRAIN, <http://www.grain.org/docs/patentsafrica.doc>.

(4) See Biodiversity Assessment and Monitoring in the Gamba Complex, Gabon: Partnerships for Science, Conservation and Sustainable Development, Briefing Paper #1 of the Gamba Biodiversity Project of the Smithsonian Institution Monitoring and Assessment of Biodiversity Program, n.d., URL: <http://www.si.edu/simab/GabonBriefingPaper1.pdf>

(5) WIPO publication WO0246180, Klainetins and their derivatives, method for their preparation and use thereof.

(6) Both Gabon and Germany have ratified the Convention on Biological
Diversity (CBD). The official CBD website is <http://www.biodiv.org>.

 

For more information on this case:

Examine US Patent 6,579,903, issued 17 June 2003,"Klainetins and their derivatives, method for their preparation and use thereof". The full text of the patent can be found on the website of the United States Patent and Trademark Office: <http://patft.uspto.gov/netahtml/search-bool.html>. Enter the patent number and view the details.

 

Biodiversity Mystery Theatre was written and researched by Jay McGown, edited by Freida Morris, and produced by the Edmonds Institute.

 


 

Biodiversity Mystery Theatre #2

 

Prologue: As the world awaits the next ministerial of the World Trade Organization, (1) intellectual property issues remain center stage. (2) Still unresolved are problems created years ago by the granting of patents on living organisms and their pieces and products. Among the persistent difficulties are questions of access and benefit sharing: how to avoid biopiracy and to ensure a fair deal for those whose biological materials and traditional knowledge may be part of other people's patent applications.

 

And now, Biodiversity Mystery Theater

. . . featuring an international cast of characters

. . . in real-life tales drawn from the files of the United States Patent and Trademark Office.


Today, "The Case of the Mexican Bean Gene Claim".

 

Biotech giant Monsanto has filed for a patent on a gene to be genetically-engineered into soya (soybean) plants. The gene is a seed-specific promoter that can be used as a genetic "switch" in biotech plants to boost, for example, the oil content of seeds or the production of herbicide resistance proteins.

The source of the promoter gene is a bean variety collected in Mexico. That variety is held in trust for the world's farmers by the Cali, Colombia-based International Center for Tropical Agriculture (known by its Spanish acronym, CIAT) under an agreement with the UN Food and Agriculture Organization (FAO). The agreement prohibits the bean from being patented.

Observers may find it ironic that Monsanto is patenting promoter genes from Mexico at a time when the company is embroiled in controversy over genetic pollution to Mexican maize (corn). That controversy involves the unexplained presence of Monsanto promoter gene sequences in farmers' varieties of maize. (3)

Arcelin Genes: Monsanto's patent application (#20030046727) was filed on March 6th, 2003 and is titled "Arcelin-5 promoter and uses thereof". The application is currently under review by the US Patent Office. Arcelin genes initially aroused scientific interest when researchers theorized that the genes might play a role in the resistance of some P. vulgaris varieties to the Mexican bean weevil (Zabrotes subfasciatus). (4) But that interest has expanded because of the special characteristics of Arcelins. Whereas many seed proteins are produced by complicated systems involving several genes (systems that remain difficult to control with biotechnology), Arcelin genes are comparatively simple and can produce an unusually high proportion (over 35%) of protein in seeds, including genetically-engineered seed. (5) This seed-specific activity has drawn the attention of biotechnology firms.

Seven related Arcelin genes have been identified, all in Phaseolus vulgaris varieties from Mexico.(6) The first, called Arcelin-1, was found in a farmers' variety of P. vulgaris that was collected in the 1960s near the town of Arcelia (hence the name "Arcelin") in southeastern Guerrero state. The area is home to Náhuatl and Tlapaneco indigenous peoples. The Arcelin-5 promoter comes from another Mexican bean collected in the 1960s near the town of Jomulco, Nayarit. Jomulco is in a mountainous, volcanic region north of the tourist resort of Puerto Vallarta. It has a rich indigenous heritage and an archaeological site, "Los Toriles", considered among the most important in western Mexico.

In 1999, a Belgian research team inserted Arcelin-5 into the tepary bean (P. acutifolius) and Arabidopsis. The transgenic plants produced high levels of the Arcelin-5 protein, suggesting that the promoter remains active when moved to a different species. It was this seed-specific activity of the promoter that interested Monsanto, whose scientists took the Arcelin-5 promoter, sequenced it, inserted it into soya, and filed for the patent.

Genebank Details: In scientific publications, the Mexican source of Arcelin-5 is identified by its accession number in the CIAT genebank (G2771, G02771, or CIATBEAN-G 2771). The same seed is also held by the US Department of Agriculture (where it is designated PI 318702). The two genebanks list different collection dates (1962 and 1966, respectively) but they agree that the bean was collected by US researcher Howard Scott Gentry and that the bean is the source of the Arcelin-5 genes. Gentry was a prolific plant collector who died in 1993.

The Arcelin-5 source is subject to a trust agreement between CIAT and the UN Food and Agriculture Organization that stipulates that in-trust materials cannot be subject to intellectual property claims. Under the recently-completed International Treaty on Plant Genetic Resources for Food and Agriculture,(7) P. vulgaris (and CIAT's collections of it) will become part of a multilateral germplasm exchange system. A link to CIAT's material transfer agreement is provided below.

 

Table: The Origin of Arcelin Genes
(all from Phaseolus vulgaris) (8)

 Gene

 Accession

 Origin
(All in Mexico)

In trust?

Collection Date 

 Arcelin-1

G12882

 Arcelia, Guerrero

Yes

1966

 Arcelin-2

G12866

 Ciudad Guzman, Jalisco

 Yes

1966

 Arcelin-3

G12891

 El Tule, Jalisco

 Yes

1968

 Arcelin-4

G12949

 San Jose del Refugio, Jalisco

Yes

1968

 Arcelin-5

G02771

 Jomulco, Nayarit

Yes

1962

 Arcelin-6

G11051

 San Isidro, Jalisco

Yes

1978

 Arcelin-7

 G24591

 Venustiano Carranza, Chiapas

No

1992

 

Open Questions: If a variety cannot be patented, can specific genes copied from that variety be the subject of patents? If the bean that is at the heart of Monsanto's patent application was held in trust for the world's farmers, how can the bean's genetic constituents be patented? Whose job is it to enforce whatever rules apply? Will patent claims like that on the Mexican Gene Bean chill research on Arcelin genes, even public sector research? Will those who shared the bean with genebanks benefit from the inventions of those whose access the genebank collections? If not, why not?

Only further research . . . hopefully, carried out by those whose biodiversity is the subject of the patent . . . will provide the necessary answers.

 

Footnotes:

(1) To be held in Cancun, Mexico, in September, 2003.

(2) See Is the TRIPS review at a turning point?, a July 2003 paper by Genetic Resources Action International (GRAIN), available at <http://www.grain.org>, and TRIPS Council debates patents on life, traditional knowledge, and Article 27.3(b), Third World Network Information Service on WTO Issues, 11 June 2003, at <http://www.twnside.org.sg/title/twninfo21.htm>.

(3) Fragments of “35S”, a promoter gene from the cauliflower mosaic virus used in Monsanto's transgenic maize varieties, have been detected in Mexican farmers’ varieties of maize. Scientists theorize that the promoter may have come from Monsanto maize imported into Mexico as food (Mexico has not approved commercial planting of GMO corn).

(4) Goossens, A. et al. 1999. The Arcelin-5 Gene of Phaseolus vulgaris Directs High Seed-Specific Expression in Transgenic Phaseolus acutifolius and Arabidopsis Plants. Plant Physiology 120 (4): 1095-1104.

(5) De Jaeger, G. et al. 2002. Boosting heterologous protein production in transgenic dicotyledonous seeds using Phaseolus vulgaris regulatory sequences. Nature Biotechnology 20(12): 1265-8.

(6) Lioi L. et al. 2003. Lectin-related resistance factors against bruchids evolved through a number of duplication events. Theoretical Applied Genetics 2003 Jun 18 (online first article); URL: <http:/www.springerlink.com/link.asp?id=n1wn84j2p8qjk0q5>.

(7) For more information, see the homepage of the International Treaty on Plant Genetic Resources for Food and Agriculture at URL: <http://www.fao.org/ag/cgrfa/itpgr.htm>.

(8) Source: CGIAR System-wide Information Network for Genetic Resources (SINGER), URL: <http://www.singer.cgiar.org> and Lioi, L. et
al. Op. cit.

 

For more information on this case:

(1) Examine: "Arcelin-5 promoter and uses thereof", US Patent application #20030046727, filed on March 6th, 2003. The application can be accessed at the website of the United States Patent and Trademark Office: <http://appft1.uspto.gov/netahtml/PTO/search-bool.html> . Enter the application number to view the full text.

(2) Go to the website of CIAT (Centro Internacional de Agricultura Tropical) at <http://www.ciat.cgiar.org> and view the CIAT Material Transfer Agreement at <http://www.ciat.cgiar.org/pgr/mta.htm>.

 

Biodiversity Mystery Theatre was written and researched by Jay McGown, edited by Freida Morris, and produced by the Edmonds Institute.

 



 

Biodiversity Mystery Theatre #3

 

Prologue: As the world awaits the next ministerial of the World Trade
Organization,(1) intellectual property issues remain center stage.
(2) Still unresolved are problems created years ago by the granting
of patents on living organisms and their pieces and products. Among the
persistent difficulties are questions of access and benefit sharing:
how to avoid biopiracy and to ensure a fair deal for those whose
biological materials and traditional knowledge may be part of other
people's patent applications.

 

And now, Biodiversity Mystery Theatre.

. . . featuring an international cast of characters

. . . in real-life tales drawn from the files of the United States Patent and Trademark Office.

 

Today, "The Case of the Soothing South Pacific Oil Nuts".

 

An Australian entrepreneur has patented nut oils from Canarium, a genus of trees from the South Pacific and Southeast Asia. The patent claims the oils as a treatment for arthritis pain.

From Sri Lanka to Samoa, nut-producing Canarium are used by indigenous people and traditional communities for food and medicine. In Melanesia and elsewhere, Canarium trees are also a source of timber for houses and boats.

The Patent: Queenslander Peter Hull has been granted a United States patent on Canarium nut oil (#6,395,313, 28 May 2002) and has filed equivalent patent applications in Australia and Canada. In an application submitted to the World Intellectual Property Organization (WIPO), Hull has stated that he intends to pursue his claims in a total of 127 counties.

The Product: Hull's anti-arthritis product is very simple. Oil pressed from Canarium nuts is mixed with a common skin cream called sorbolene and the mixture is then applied to the skin. Hull is selling his product, called "Arthrileaf", on various websites, including <get-arthritis-relief-now.com>. The sites include a notice that the product is the subject of intellectual property claims.

According to Hull's website, he became interested in medicinal uses of Canarium nut oil when he ran a pharmacy in the Solomon Islands in the 1980s. Hull observed that Solomon Islanders have a low incidence of arthritis, which he attributed to diet. Hull noticed nuts from C. indicum, called Ngali in the Solomons, because "they are found at every roadside market throughout the Solomons". (3) Ngali nuts are also popular in other countries. They are called galip in Papua New Guinea, nangai in Vanuatu, and kenari (or kanari) in Indonesia, among other names. There is no English common name in general international usage.

In Hull's patent the preferred Ngali nut oil pharmaceutical formulation is 5% nut oil and 95% sorbolene. The product - "Arthrileaf" - fetches US $30 for a 50-gram jar, and $40 for 100 grams. At an average internet retail price of $10 per gram of active ingredient, "Arthrileaf" can squeeze $10,000 in gross income out of every kilogram of nut oil. Per capita income in the Solomon Islands in 2002 was $570, according to the World Bank.(4)

Big Claims: Hull's patent uses the Solomon Islands term for C. indicum and claims "ngali nut oil". But the patent potentially applies not only to Ngali trees sown anywhere, but also to nut oils from other Canarium species grown across the region.

In the confusing passage intended to explain the source of ngali nut oil, (5) the patent identifies three Canarium species and four countries (Solomon Islands, Vanuatu, Papua New Guinea and the Philippines ) as sources of "ngali nut oil", but then says that the oil can also be extracted from other Canarium species and "hybrids thereof". In effect, the patent may cover use of nut oil from any Canarium species used to treat arthritis, including nuts from such trees as C. ovatum, the source of the pili nut of the Philippines, C. harveyi, grown in Samoa (where it is called mafoa), and C. album, a species used in Chinese traditional medicine. The patent text also asserts claims over "Ngali nut oil" that can be extracted from Canarium trees developed in future breeding programs.

Teaching the Owners: The ngali nut oil found in "Arthrileaf" currently is being sourced from a project in the Solomon Islands that is operated by the US NGO Conservation International (CI). CI is promoting nut oil trade in an attempt to reduce logging in the island forests. Hull's website describes his relationship with CI as a collaborative effort in which they are "working together to convince village elders that it is in their best interests to preserve & protect their rain forest, in order to harvest the Ngali nuts from it."

There's no word on what the Solomon Islanders think of this attempt to educate them about biodiversity management. Hull contends that "If successful, [the project] should see the eventual end of all logging activities in the Solomons." (6)

Internet information about the CI program does not make clear the organization's position on Hull's patent claims. (7) In the past, CI has supported "bioprospecting" efforts that seek to patent indigenous peoples' plants. (8)

Open questions: Few would stand in the way of Solomon Islanders who wish to sustainably harvest and sell ngali nut products, but "The Case of the Soothing South Pacific Oil Nuts" raises a number of issues: Is there any truly patentable innovation in Hull's product? Does the patent benefit indigenous peoples, or does it harm development of a market for Canarium oils from the Solomon Islands and other countries? Why did the US Patent and Trademark Office grant such a broad patent? What impact could such broad claims have on Canarium nut oil producers across the Pacific and Southeast Asia? Is Conservation International turning a blind eye to the patents, or does it support Hull's claims? Would the interests of indigenous peoples and traditional communities who produce these oils be best served by the withdrawal of the patent claims?

 

Only further research . . . hopefully, carried out by those whose biodiversity is the subject of the patent . . . will provide the necessary answers.

 

Footnotes:

(1) To be held in Cancun, Mexico, in September, 2003.

(2) See Is the TRIPS review at a turning point?, a July 2003 paper by Genetic Resources Action International (GRAIN), available at <http://www.grain.org>, and TRIPS Council debates patents on life, traditional knowledge, and Article 27.3(b), Third World Network Information Service on WTO Issues, 11 June 2003, URL:
<http://www.twnside.org.sg/title/twninfo21.htm>

(3) See URL: <http://www.theapothecary.com/arthritis.htm>.

(4) GNI per Capita, 2002, in World Bank Development Indicators Database, July 2003, URL: <http://www.worldbank.org/data/databytopic/GNIPC.pdf>

(5) The patent, for example, appears to use the word "varieties" as a synonym for species and the word "hybrids" when referencing the products of breeding:

“Ngali Nut Oil is the oil obtained from the nuts of several varieties of Ngali Nut Trees grown in the Solomon Islands, Vanuatu Papua New Guinea and the Philippines. The three most common varieties of Ngali Nut Trees are Canarium Indicium, Canarium Solomonesis and Canarium Harveyi. At this stage no work has been done in creating hybrids of the Canariu [sic] species.

"It will be understood by those skilled in the art that the current invention is not restricted to the aforementioned varieties of Ngali Nut Tree and includes any hybrids thereof."

(6) See URL: <http://www.theapothecary.com/arthritis.htm>.

(7) Information on CI’s Melanesia programs can be found at the following URL: <http://www.conservation.org/xp/CIWEB/regions/asia_pacific/melanesia/
melanesia.xml>
.

(8) For example, CI was a partner with Bristol-Myers Squibb in the US government-funded International Cooperative Biodiversity Group project in Surinam (see URL: <http://www.fic.nih.gov/programs/icbg.html>) and has promoted bioprospecting in Southeast Asia (see Biodiversity Prospecting in Indonesia, CI Policy Paper, n.d., URL: <http://www.conservation.org/xp/CIWEB/publications/books_papers/
policy_papers/Biopros.txt>
).

 

For more information on this case:

(1) Examine US Patent 6,395,313, issued 28 May 2002, "Treatment of arthritis and other similar conditions". It can be viewed on the website of the United States Patent and Trademark Office at <http://patft.uspto.gov/netahtml/search-bool.html>. Enter the patent number to view the full text.

(2) Check out the "Arthrileaf" website: <http://www.get-arthritis-relief-now.com/>

(3) Contact Peter Hull: phone +61 7 4945 3892, fax +61 7 4945 3999

 

 

Biodiversity Mystery Theatre was written and researched by Jay McGown, edited by Freida Morris, and produced by the Edmonds Institute.

 


 

Biodiversity Mystery Theatre #4

 

Prologue: As the world awaits the next ministerial of the World Trade Organization, (1) intellectual property issues remain center stage. (2) Still unresolved are problems created years ago by the granting of patents on living organisms and their pieces and products. Among the persistent difficulties are questions of access and benefit sharing: how to avoid biopiracy and to ensure a fair deal for those whose biological materials and traditional knowledge may be part of other people's patent applications.

 

And now, Biodiversity Mystery Theatre

. . .featuring an international cast of characters

. . . in real-life tales drawn from the files
of the United States Patent and Trademark Office.

 

Today, "The Case of the Pentagon's Big African Knowledge Grab".

 

The US Defense Department has made sweeping patent claims on African indigenous knowledge. Military medical researchers have obtained one US patent (#6,403,576, 11 June 2002) and filed a further patent application (#20030032578, 13 February 2003) elaborating their African "invention". The patent and application cover ways to treat protozoan infections in humans and animals. Licenses for plant extracts claimed in the patent have been offered for sale by the Pentagon.

The patent claims cover an entire therapeutic approach that the research team identified by studying African medicines and medical methods. Included in the claims are treatments for serious diseases including leishmaniasis and trypanosomiasis (sleeping sickness). Under the patent, the Pentagon is selling licenses to pharmaceutical companies for drugs extracted from six different African medicinal plants. While the need for effective treatments for these diseases is acute, the case draws attention to how patents may misappropriate indigenous knowledge.

Background: The half dozen "inventors" listed on patent #6,403,576 include US researchers and at least two Africans, scientists from Nigeria and Cameroon. The team's leaders are Joan Jackson, a US military medical researcher, and Maurice Iwu, a Nigerian scientist who has long collaborated with US researchers. In 1994, Iwu and Jackson were co-inventors in a patent owned by the US Army on African medicinal plants (#5,290,553). In 1991, Iwu patented medicinal uses of an African yam (#5,019,580) for Shaman Pharmaceuticals, a US bioprospecting company that has since fallen on hard times.

The Iwu-Jackson collaboration came to public notice in 1994, when the pair were recipients of one of the first grants given by the US government's controversial International Cooperative Biodiversity Group (ICBG) bioprospecting program. Patent #6,403,576 is a product of that ICBG project, which, interestingly, included a benefit-sharing arrangement the details of which have never been made public.

In the 90s, Iwu drew the attention of indigenous peoples and NGOs when he began to attend Convention on Biological Diversity meetings as a representative of the Nigerian government. The meetings focused on protecting indigenous knowledge. A charismatic speaker, Iwu extolled the value of indigenous knowledge, but his participation was considered divisive by some. His patent record raised questions.

Iwu also leads the Bioresources Development and Conservation Program (BDCP), a US 501(c)3 non-profit organization with affiliates in several African countries. BDCP sponsors meetings and promotes plant medicines and biodiversity assessment projects in Africa. BDCP's main funding source is the US government. (3) It is unclear what, if any, relationship BDCP has with the patent claims, which are property of the US Department of Defense.

BDCP has intertwined relationships with InterCEDD, a pharmaceutical screening laboratory in Nsukka, Nigeria and Axxon Biopharm, a US company selling plant pharmaceuticals. (4) Axxon and BDCP have the same street address and suite number. InterCEDD lists BDCP's telephone number as its US contact point. BDCP and InterCEDD also share addresses in Lagos and Nsukka. Each organization - the non-profit, the lab, and the company - touts its relationship with the others. For example, Axxon assures potential customers of its quality control by stating that its products are issued "approval seals" by the InterCEDD lab, which Axxon describes as an "International Agency".

The Claims: The patent and patent application of "The Pentagon's Big African Knowledge Grab" are based on years of research on African traditional medicine, including plant collecting in several countries. The researchers tested more than 70 African medicinal plants known to be used against parasites. They identified the mode of action underlying the effectiveness of the medicines. They found that many of the plants contained cholesterol-mimicking compounds that interfered with the ability of parasites to take up and use the cholesterol available in humans and animals. By such interference with parasites, the traditional medicines inhibited infection.

Once the research team understood the mode of action of African traditional medicine, they filed for patent on the "invention". They claimed the entire method - the use of (any) cholesterol-mimicking compounds against any protozoan infection. The patent they were granted covers use of the method in humans and animals, whether the medicine administered is oral, topical, or injected, and whether the medicine is used to treat or to prevent infection.

Open questions: Given the enormous debt owed to traditional knowledge and bearing in mind that discovery is not invention, it may be asked whether the patent applicants made any patent-worthy innovation. They did describe how they came to understand the medicines and medical practices developed by a number of African peoples over a long period of time and they did contribute to the understanding of the underlying mode of action of many medicinal plants. However, the question remains: did their contribution deserved a patent? Why did the US Patent and Trademark Office (USPTO) deem this African knowledge to be a patentable invention belonging to the US Department of Defense (USDOD)?

Putting aside questions of whether a patent should have been granted by USPTO, there still remains the question of whether the patent will substantially benefit those whose indigenous knowledge so clearly guided the researchers' way. Will indigenous communities even be able to afford whatever products may be derived from this patent? Although there was a (ICBG) benefit-sharing agreement and it was signed by some Africans, the agreement has never been released (in unredacted form) for public scrutiny. How can we know what was provided for in the agreement and whether those who signed the agreement had the authority to make such deals for the African communities whose knowledge was being appropriated? Although the research team may consider the agreement to be just and fair, it is difficult to imagine a benefit sharing agreement of appropriate scope. Until prior informed consent is substantiated and the details of the access and benefit sharing agreement(s) are made public, this will continue to look like a case of people and organizations engaged in patenting ideas and plants that are not their own.

 

Only further research . . . hopefully, carried out by those whose biodiversity is the subject of the patent, will provide the necessary answers.

 

Footnotes:

(1) To be held in Cancun, Mexico, in September, 2003.

(2) See Is the TRIPS review at a turning point?, a July 2003 paper by Genetic Resources Action International (GRAIN), available at <http://www.grain.org>, and TRIPS Council debates patents on life, traditional knowledge, and Article 27.3(b), Third World Network Information Service on WTO Issues, 11 June 2003, URL: <http://www.twnside.org.sg/title/twninfo21.htm>

(3) Bioresources Development & Conservation Programme, US Internal Revenue Service Form 990 for Fiscal Years 2000 and 2001 (latest 990s available at URL <http://www.guidestar.org>).

(4) See the websites of these organizations: BDCP <http://www.bioresources.org>; InterCEDD <http://www.intercedd.com>; and Axxon Biopharm <http://www.axxonbiopharm.com>.

 

For more information on today's case:

(1) Examine US Patent 6,403,576 by visiting the website of the United States Patent and Trademark Office at <http://appft1.uspto.gov/netahtml/PTO/search-bool.html>. Enter the patent number to view the full text.

(2) Consider:

Indigenous Knowledge for Sale: African Medicinal Plants Offered for License by the Pentagon
Source: Federal Register, 27 May 2001

 Origin of Plant Extract

 Herbarium samples have been collected in:

 Aframomum aulocacarpus
(or A. aulococarpus)

 Gabon

 Aframomum danelli
(or A. danielii)

 Cameroon, Central African Republic

 Dracaena arboreai

 Nigeria, Tanzania, Zambia, Cameroon, etc.

 Eupatorium odoratum
(or Chromoleana odorata)

 Tropical Americas, Asia, Africa

 Glossocalyx brevipes

 Gabon, Cameroon

 Napoleonaea imperialis

 Gabon, Cameroon

 

(3) Contact ICBG:
Dr. Joshua P. Rosenthal, Director
International Cooperative Biodiversity Group Program
Fogarty International Center
National Institutes of Health
Building 31, B2C39
31 Center Drive MSC 2220
Bethesda, MD 20892-2220
Phone: (301) 496-1653, Fax: (301) 402-2056
E-mail: Joshua_Rosenthal@nih.gov
Website: <http://www.fic.nih.gov/programs/icbg.html>

(4) Contact BDCP:
Dr. Maurice M. Iwu, Executive Director
Bioresources Development & Conservation Programme
11303 Amherst Avenue
Suite 2
Silver Spring, MD 20902-4600
USA
Phone: 301-962-6201
Fax: 301-962-6205

 

Biodiversity Mystery Theatre was written and researched by Jay McGown, edited by Freida Morris, and produced by the Edmonds Institute.

 

 


 

Biodiversity Mystery Theatre #5

 

Prologue: As the world awaits the next ministerial of the World Trade Organization, (1) intellectual property issues remain center stage. (2) Still unresolved are problems created years ago by the granting of patents on living organisms and their pieces and products. Among the persistent difficulties are questions of access and benefit sharing: how to avoid biopiracy and to ensure a fair deal for those whose biological materials and traditional knowledge may be part of other people's patent applications.

 

And now, Biodiversity Mystery Theatre

. . . featuring an international cast of characters

. . . in real-life tales drawn from the files of the United States Patent and Trademark Office.

 

Today, "The Case of the Pigeon Pea Patents".

 

First cultivated thousands of years ago,(3) today the pigeon pea (Cajanus cajan) is grown by farmers across the semi-arid tropics. In many parts of the world, pigeon peas are used not only as food but also in medicine and as forage. The diversity of local (common) names for Cajanus cajan reflects the plant's widespread utility and popularity: Depending on where you are, the shrubby pulse crop is called red gram, arhar, guandú, Congo pea, gungo bean, no-eyed pea, frijol de arbol, pois d'Angole, kachang gude, katjang bali, and many other names. In Puerto Rico it is called gandul, and arroz con gandules is a matter of national pride.

The genebank of the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) near Hyderabad, India, has more than 10,000 samples of pigeon peas.

The Patents: In August 2001, researchers from Insmed Inc., a $109 million biopharmaceutical company based in Richmond, Virginia, (4) filed four patent applications at the US Patent and Trademark Office for several medicinal uses of pigeon pea extracts. Three of the applications have been approved, while one remains under consideration.

The Insmed patents (6,410,596, 6,541,522 and 6,542,511) claim "invention" of pigeon pea extracts for treatment of diabetes, hypoglycemia, obesity, and atherosclerotic cardiovascular disease (clogged arteries). The patents cover use of the extracts in medicines, as a dietary supplement (e.g., to fortify breakfast cereal) and as an ingredient in a doggie diet treat for overweight pets.

In the patents, Insmed acknowledges a handful of uses of pigeon peas in traditional medicine and refers to 1957 and 1968 journal articles that describe the effects of pigeon peas and pigeon pea extracts on blood sugars. Insmed's claim of novelty is based in part on the assertion that the patents describe a purified plant extract whose dosage is easily measurable. According to the company, other pigeon pea extracts "contain a myriad of naturally-occurring organic compounds" that may interfere with medicinal effects. That impurity, the company says, "can result in an ineffective amount, i.e. too low a concentration, or a toxic amount, too high a concentration, of active compound administered."

The patents skirt reference to traditional use of pigeon peas in treatments for diabetes, hypoglycemia, obesity, and atherosclerotic cardiovascular disease.

A cursory survey of articles available on the Internet reveals that Insmed's patent applications do not mention a great deal of information directly relevant to the patent claims. For example:

* In 1997, the Botany Club of the University of Guyana advised readers of its newsletter that "Besides the fruit being an important nutritional component of the diet this plant possess various medicinal values ranging from cures for the everyday flu to the deadly diabetes. The leaves of Cajanus cajan are of major importance. . .the leaves and flowers can be boiled and taken orally for diabetes.”(5)

* In 1995, a University of the Philippines team in Quezon City tested specific health effects of five legumes, concluding that pigeon peas “could therefore be added to the list of foods for diabetics and hyperlipidaemics” (persons with a high level of fats in the blood, a condition related to atherosclerotic cardiovascular disease). (6)

* There are many citations of traditional medical use of pigeon peas in
India. A recent study of plant medicines by researchers in the Department of Pharmacology of the All India Institute of Medical Sciences in New Delhi tested pigeon pea extracts because they are used to treat diabetes in Ayurvedic medicine. (7)

A comprehensive review of indigenous knowledge and traditional medical practices with pigeon peas can be expected to reveal additional relevant examples from Asia, Latin America, and Africa.

Relationship to Shaman Pharmaceuticals?: The Insmed patents appear to be related to the work of the well-known bioprospecting firm Shaman Pharmaceuticals (San Francisco, California). One of the Insmed pigeon pea patent applications, filed on 2 August 2001, listed Shaman as the patent's assignee (owner). When the patent was issued on 1 April 2003 (#6,541,522), the assignee had been changed to Insmed.

In the early and mid-1990s, Shaman amassed an enormous private collection of medicinal plant samples and its researchers meticulously documented related indigenous knowledge. The company did so with many promises of benefit sharing. Most of those promises were not fulfilled before the company went bankrupt. At one time, Shaman was a media darling in some circles, but frequently faced deep suspicion from indigenous peoples and non-profits, and often had to defend itself against allegations of biopiracy.(8)

In 1995 and 1996, Shaman signed multi-year agreements with Lipha S.A. (France) and Ono Pharmaceutical Co. (Japan). Under these agreements, Shaman worked to identify plant extracts for the treatment of hyperglycemia and diabetes. (9) In 1997 and 1998, one of the Insmed researchers - Wayne Inman - was listed as an inventor on three Shaman Pharmaceuticals patents on plant extracts for treatment of diabetes. (10)

At one time, money from Shaman supported a much-ballyhooed benefit-sharing mechanism, an NGO called the Healing Forest Conservancy (HFC). HFC supported bioprospecting, promised funding for indigenous people when Shaman made it big, and even funded the Schultes Prize for Ethnobotany. Today, HFC no longer maintains a website and appears to have fallen on hard times. Its latest financial report, filed in November 2002, lists income of $14,750 against administrative expenses of $9,170. Its only 2001 grant (for $3,200) went to the Society for Economic Botany. And its Shaman Pharmaceuticals stock had a fair market value of zero. After paying a bank overdraft of $3,150 from 2000, as of December 31st 2001, the assets of the Healing Forest Conservancy totaled US $130. (11)

Open Questions: In the case of the Pigeon Pea patents, the salient innovations may not be those made by the Insmed researchers, but those made by the indigenous peoples and traditional medicine practitioners who originally developed pigeon peas and identified their medicinal uses. The use of pigeon peas in fighting diseases, including those diseases identified in the patents, appears to have been known (before the Insmed patents) in several regions of the world. Why wasn't this knowledge cited in the patent applications? Was there additional "prior art" available to but not cited by the researchers? Did the US Patent and Trademark Office identify use of indigenous knowledge in these patents and, if not, why not? Do the "inventions" cited in these patents have a relationship to the samples and indigenous knowledge collected by Shaman Pharmaceuticals and, if so, does Insmed acknowledge that debt and agree to fulfill the benefit-sharing promises made by Shaman and its NGO, HFC?

 

Only further research . . . hopefully, carried out by those whose biodiversity is the subject of the patents . . . will provide the necessary answers.

 

Footnotes:

(1) To be held in Cancun, Mexico, in September, 2003.

(2) See Is the TRIPS review at a turning point?, a July 2003 paper by Genetic Resources Action International (GRAIN), available at <http://www.grain.org>, and TRIPS Council debates patents on life, traditional knowledge, and Article 27.3(b), Third World Network Information Service on WTO Issues, 11 June 2003, URL:
<http://www.twnside.org.sg/title/twninfo21.htm>.

(3) Archaeological sites in Egypt give evidence of pigeon pea cultivation dating back to at least 2000 BC. Both Africa and South Asia are centers of diversity of Cajanus species, and many varieties of pigeon pea are cultivated in both regions. Scientists debate where the pigeon pea first was domesticated.

(4) Insmed's website is <http://www.insmed.com>. Company value figure from the NASDAQ stock exchange (www.nasdaq.com), as of 22 July 2003.

(5) Mohamed, Saudia. 1997. Cajanus Cajan. The Nature Zone Guyana. 1(1). URL: <http://members.tripod.com/~botanyclub/Nature_Zone/97NZ.htm#Cajanus%20cajan>.

(6) Panlasigui, L.N. et al. 1995. Glycaemic response in normal subjects to five different legumes commonly used in the Philippines. Journal of Food Science Nutrition. 46(2):155-60.

(7) Grover, J.K. et al. 2002. Medicinal plants of India with anti-diabetic potential. Journal of Ethnopharmacology. 81(1): 81.

(8) See, for example, Acción Ecológica. Biopiratería en Ecuador: Una lucha que comenzó en 1995 y aún continúa. URL: <http://www.prodiversitas.bioetica.org/nota38.htm>; Bioprospecting/Biopiracy and Indigenous Peoples, RAFI Communique, November 1994. URL: <http://www.etcgroup.org/article.asp?newsid=212>; and Bell J. 1997. Biopiracy's Latest Disguises. Seedling (GRAIN). June, 1997. URL: <http://www.grain.org/publications/jun971en.cfm>.(9) Shaman Pharmaceuticals Security and Exchange Commission form 10-K, filed 17 April 2001, URL: <http://www.sec.gov/Archives/edgar/data/891933/0000891933-00-000008-index.html>

(10) US Patents 5,837,255, 5,747,527, and 5,691,386.

(11) Healing Forest Conservancy US Internal Revenue Service Form 990-PF, filed 17 November 2002.

 

For more information on this case:

Examine US Patents 6,410,596, 6,541,522 and 6,542,511
by visiting the website of the United States Patent and Trademark Office at <http://appft1.uspto.gov/netahtml/PTO/search-bool.html>. Enter the patent number to view the full text.

 

Biodiversity Mystery Theatre was written and researched by Jay McGown, edited by Freida Morris, and produced by the Edmonds Institute.

 

 

 

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