One of the many highlights of the Peru Natura 2006 was a presentation made by Sylvia Bazán Leigh, a representative of the Instituto Nacional de Defensa de la Competencia y de la Protección de la Propiedad Intelectual (the Peruvian National Institute for the Defense of Competition and Protection of Intellectual Property, INDECOPI). (Peru Natura 2006 was a forum and exhibition for natural products and ingredients from the Andean Region held in Lima, Peru, in September 2006.) Mrs. Bazán discussed cases of what has been termed "biopiracy" for several Peruvian natural products and the actions that have been taken to challenge them. Specifically, the case of the traditional Peruvian food and medicinal plant "maca" was used as the primary example, although maca is just one of 32 other Peruvian botanicals that have been prioritized for protection against biopiracy (see Table 1 on page 46). Maca root (fresh or dried hypocotyl of Lepidium meyenii, Brassicaceae) is an herbaceous, perennial, cultivated crop, found only on the Andean central sierra of Peru (in Junín and Pasco) in the puna agro-ecological zone above 4,000 meters ( 13,123feet).
According to the Action Group on Erosion, Technology, and Concentration (ETC Group), "Biopiracy refers to the appropriation of the knowledge and genetic resources of farming and indigenous communities by individuals or institutions who seek exclusive monopoly control (patents or intellectual property) over these resources and knowledge. ETC group believes that intellectual property is predatory on the rights and knowledge of farming communities and indigenous peoples."( n1)(*). On May 1, 2004, the Peruvian Congress passed Law No. 28216, "The Law Protecting Access to Peruvian Biological Diversity and the Collective Knowledge of Indigenous Peoples." The definition of biopiracy according to this law is "unauthorized and uncompensated access and use of biological resources or traditional knowledge of indigenous peoples by third parties, without corresponding authorization and in violation of the principles established in the Convention on Biological Biodiversity (CDB). …"( n2) Law No. 28216 also established the National Commission for the Protection of Access to Peruvian Biological Diversity and to the Collective Knowledge of the Indigenous Peoples, hereinafter referred to as the "National Anti-Biopiracy Commission"
The National Anti-Biopiracy Commission has the task of developing actions to identify, prevent, and avoid acts of biopiracy with the aim of protecting the interests of the Peruvian State. Its main functions are as follows:
• Establish and maintain a register of biological resources and traditional knowledge,
• Provide protection against acts of biopiracy,
• Identify and follow up patent applications made or patents granted abroad that relate to Peruvian biological resources or collective knowledge of the indigenous peoples of Peru,
• Conduct technical evaluations of the above-mentioned applications and patent grants,
• Issue reports on the cases studied,
• Lodge objections or institute actions for annulment concerning the above-mentioned patent applications or patent grants,
• Establish information channels with the main intellectual property offices around the world, and
• Draw up proposals for the defense of Peru's interests in different forums.( n3)
In the case of alleged biopiracy involving maca root, the process actually began in mid-2002, 2 years prior to the establishment of the National Anti-Biopiracy Commission, after discovering that patents had been granted in the United States of America for "inventions" related to maca root. INDECOPI solicited the participation of several institutions in order to form a Working Group to analyze the granted patents and to determine to what extent the patents could affect exports of maca products from Perú. The Working Group, coordinated by INDECOPI, was made up of representatives of the (Peruvian) Ministry of Foreign Relations, Ministry of Foreign Trade and Tourism (MINCETUR), National Environmental Council (CONAM), National Institute for Agricultural Research and Extension (INIEA), In International Potato Center (CIP), Peruvian Environmental Law Society (SPDA), Pro Biodiversity of the Andes Peru (PROBIOANDES), Peruvian Institute of Medicinal Plants (now Peruvian Institute of Natural Products, IPPN), and the Association for Nature and Sustainable Development (ANDES).( n4)
This author was first made aware of the controversial maca patents in the United States from a presentation made at the Latin Pharma 2003 by Dr. Beatriz M. Garcia Delgado, department head of the Scientific Activity Organization at the National Center of Scientific Research (CNIC), Havana, Cuba. That presentation, titled "Importance of Patent Information," provided examples of patents that have been awarded to inventors in developed countries--particularly natural products companies in the United States, Japan, and European Union--that appear to be based on already existing traditional knowledge from Latin American sources. One main point of Dr. Delgado's presentation was that producers in developing countries need to become acutely aware of the increasing number of patents that are being issued to corporations in developed countries that may threaten the future ability of people in those developing countries to produce and market certain value-added forms of native plants, even when they are promoted for traditional uses. In these cases, the patents will most likely warrant challenge.( n5)
As part of the maca response strategy, the Working Group initially prioritized the investigation of 3 granted maca patents. They collaborated with scientists and maca exporters to compile documents on maca preparation and prior use with verified dates prior to the filing dates of the patent applications.( n4) The first prioritized patent for the Working Group was a World Intellectual Property Organization (WIPO) international application titled "Compositions and Methods for their Preparation from Lepidium," listing 132 countries for registration. This was Application PCT/US00/05607 filed by Pure World Botanicals, Inc. (South Hackensack, NJ, US) on March 3, 2000, claiming priority on the basis of application number US 09/261,806 of March 3, 1999, and published on September 8, 2000, in the Patent Cooperation Treaty (PCT) Gazette as WO 00/51548.( n6) It contains 54 claims referring to extracts, macamides, an extraction process, and therapeutic methods.( n7) The second priority was US Patent 6,267,995 (filed on March 3, 1999, and granted on July 31, 2001), also assigned to Pure World Botanicals, titled "Extract of Lepidium meyenii roots for pharmaceutical applications."( n8) And the third priority was US Patent 6,428,824 (filed on October 19, 2001, and granted on August 6, 2002), again assigned to Pure World Botanicals, titled "Treatment of sexual dysfunction with an extract of Lepidium meyenii roots."( n9) There is a subsequent Pure World patent of the same title as the 2000 WIPO patent, "Compositions and methods for their preparation from Lepidium," US Patent 6,552,206.( n10) (For a summary of these US patents, see Table 2 on page 50.)
Aside from the 3 initially prioritized patents for investigation, there have been other maca patents assigned in the United States, including "maca and antler for augmenting testosterone levels,"( n11) "Dietary Supplement,"( n12) "Herbal composition for enhancing sexual response,"( n13) "Topical compositions for enhancing sexual responsiveness,"( n14) and yet another patent assigned to Pure World Botanicals titled "Imidazole alkaloids from Lepidium meyenii and methods of usage."( n15)
The Working Group drew up a report titled "Patents referring to Lepidium meyenii (maca): Responses of Peru," which was submitted by the Peruvian delegation at the fifth session of the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore in May of 2003.( n7) According to a revision of the communication from Peru, dated February 28, 2005, and circulated by the World Trade Organization (WTO) Council for Trade-Related Aspects of Intellectual Property Rights on May 19, 2005, "The report shows some of the problems that a country like Peru has to face upon identification of a pending patent application or patent grant whose subject-matter concerns an invention obtained or developed from the use of a biological resource or traditional knowledge without securing the prior informed consent of the country of origin of the resource or the indigenous people owning rights in the knowledge, and without providing for any type of compensation to that country or indigenous people."( n3)
Pursuing the case of maca biopiracy has been made possible, in part, by participation from many interested parties including the following:
• Pro bono assistance of Washington intellectual property rights attorney Jorge Goldstein of Sterne, Kessler, Goldstein & Fox P.L.L.C. of Washington, DC;
• Those involved with the researching, compiling, and shipping of documentation to the attorneys;
• Financial support from the International Potato Center in Lima, Peru (a South American nonprofit group dedicated to research and conservation on potatoes and other Andean root crops and tubers) for the analysis of alcoholic extracts of maca and coordination of technical recommendations for new analysis on the extracts; and
• Those responding to the appearance of new problem cases to investigate.
An example of this participation was obtaining copies of maca patents recently filed with the Japanese Patent Office by applicant Towa Corporation and hiring qualified translators to translate the technical documents from Japanese to Spanish.( n4) Japanese patent application number 2003-081157, filed on March 24, 2003, by Towa Corporation (published on January 8, 2004), is titled "Functional food product containing maca."( n16) Towa Corporation filed a subsequent Japanese Patent, application number 2004-123438, on April 19, 2004 (published on November 4, 2005), titled "Testosterone-increasing composition, testosterone-increasing food, testosterone-increasing skin care preparation for external use and testosterone-increasing medicine."( n17) [Editor's note: Use patents are issued based on the novelty of the claimed use, without the requirement that the patent holder prove the actual efficacy of the claimed use. In the case of maca and the increase of testosterone, this patent may be considered a novel use, even though all published human clinical trials on maca testing for possible increases of serum testosterone levels resulted in negative findings,( n18, n19) and several animal and in vitro studies have likewise found no effects on testosterone from maca.] But there have been many other Japanese maca invention patent applications in the meantime, none of which mention Peru. Examples include an application published on November 10, 2005, from applicant Suntory Ltd titled "Alcoholic drink containing maca extract";( n20) an application published on March 16, 2006, from applicant Yukihiro Hirose titled "Composition for preventing male climacteric disorder and beverage and foods including the same";( n21) and another application published on June 8, 2006, from applicant Nippon Menaade Keshohin KK titled "Improving agent of indefinite complaint accompanying with autonomic imbalance."( n22)
Actions taken thus far by Peru's National Anti-Biopiracy Commission against the Japanese patents include the submission of technical documents to the Japanese Patent Office in order for it to evaluate whether the Towa Corporation patent meets the requirements of novelty and inventiveness. Concerning the aforementioned US patents assigned to Pure World Botanicals, the current state of action in Peru is the coordination for the challenge of the US patents. However, Chris Kilham, an herb expert and author who has consulted with Pure World on various projects, has noted that Naturex of Avignon, France, a botanical extraction company which acquired Pure World in 2005, i.e., after the filing of the maca patents, has opened up the Pure World maca patents to all Peruvian entities. Kilham writes, "This means that any Peruvian company or trading outfit, large or small, can use the methods and information developed and patented by Pure World freely, and can market their maca products using that information. This is a significant development in the area of intellectual property rights as applied to maca. The Andean people, from whom the use of maca originates, have full and complete access to [Pure World's] patented processes and information" (e-mail to M. Finney, March 5, 2007).
Related Documents, Publications, and Events
In March 2005, the delegation of Peru presented to the WTO a document titled "Article 27.e(B). Relationship between the TRIPS Agreement and the CBD and Protection of Traditional Knowledge and Folklore."( n23) Later, in October 2005, the delegation of Peru presented to the WTO the document, "Analysis of Potential Cases of Biopiracy: The Case of Camu Camu (Myrciaria dubia)."( n24) And in November 2005, a seminar on the topic was held titled "Nuevos Retos para el Perú: Biopiratería, ¿cómo enfrentarla?" ("New Threats for Peru: How to deal with biopiracy?"). Related documents submitted to WIPO include "Patents referring to Lepidium meyenii (Maca): Responses of Peru"( n7) and "Patent system and the fight against biopiracy--The Peruvian experience."( n25) Additionally, in August 2005, INDECOPI published a report, "Analysis of potential cases of biopiracy in Peru."
Progress to Date
In relation to the validity of the patents related to maca, certain claims in the international patent application have been determined to not meet the novelty criteria, while other claims are not inventive. Additionally, certain claims found in US patents 6,267,995 and 6,428,824 have been analyzed by INDECOPI and determined that they do not meet the inventiveness level.( n4) In a communication filed with WTO in November 2006, the delegation of Peru concludes, "Peru's position is clear: despite the existence of useful tools for improving the patent system and verifying compliance with existing patentability obligations, especially as regards the novelty and inventive step criteria--the inclusion of the requirements to disclose the source and/or origin of biological resources, as proposed in document IP/C/W.473, is essential if the patent system is to reflect adequately the obligations arising from the CBD, obligations which Peru and all Member States are required to fulfill."(n26
Insufficient resources are available to challenge inappropriately granted patents, while there are new requests of maca patent cases to analyze. There are limitations and problems faced by countries like Peru in identifying, monitoring, and studying patent applications or granted patents that involved improperly granted rights or that weaken regimes for access to and/or protection of traditional knowledge.( n26)
While there are innumerable pro and con arguments concerning the ethics of bioprospecting and patenting medicinal plant extracts and their uses, it is exceedingly clear that there exists an enormous North-South divide in perception between those seated at the source of the traditional knowledge, in this case the indigenous people of the high Andes, and those who believe that they are innovators of that knowledge, e.g., researchers and product developers at phytomedicine companies in the United States, Europe, and Japan. This huge gap in perception is evidenced by public statements that have been reported by a former executive from Pure World, Qun Yi Zheng, PhD: "We really enhanced the equity of maca itself…We shouldn't be blamed, we should be thanked."( n27) More recently, Zheng was quoted as saying Peruvians "should not be so narrow-minded, but should instead be grateful. After we studied it, put money into the research, (maca) has become a useful commodity."( n28) Based on such statements (Dr. Zheng has confirmed the accuracy of the quotes), it appears that the patent owners believe they themselves have created a market for maca products, one that did not exist prior to the patents. Although the patent owners may not have created the initial market for maca, it may be true that their efforts have likely created an increase in the market demand for maca extracts. This author can assure the reader, however, based on his communications with maca producers and representatives of the National Anti-Biopiracy Commission, that the thank-you cards are not in the mail. Peru is interested in benefit sharing. Nevertheless, according to Kilham, Pure World erred in not sharing the patent rights with Peruvian communities: "They didn't do anything illegal, but it really was the last days of a particular way of doing business."( n29) Antoine Dauby, marketing manager for both companies, declared that, "We acknowledge that maca's beneficial properties were long ago discovered by indigenous Peruvians." He writes that the Pure World patent lets them grow, sell, and use maca as they have for centuries. "Our patent is for the extraction and isolation of maca's key ingredient--and nothing else" (e-mail to M. Finney, April 10, 2007). As a good faith gesture, he wrote, Naturex is offering to grant free licenses to Peruvian companies to use Pure World's MacaPure® in their products. Dauby also noted, "At Naturex, we believe in giving back to the communities where we do business. That is why we will open a corporate foundation in 2007 that will make social and economic development grants to these communities, including in Peru. In addition, Naturex is a member of the United Nations Global Compact, which means we believe in responsible corporate citizenship." In addition, according to Dr. Zheng, when Pure World was asked to help the Peruvians analyze the level of macamides and macaenes in their products,† Pure World offered its assistance. Further, when the Peruvian maca industry encountered a problem regarding authorization for sales of maca in European countries, Pure World shared safety data with them to help them overcome regulatory barriers in the EU market (Q. Zheng, e-mail to M. Finney, March 14, 2007).
To the Peruvian National Anti-Biopiracy Commission, however, the aforementioned patents are just another attempt to expropriate their traditional knowledge--in their words, akin to another rip-off in a long line of thefts taking place ever since the Europeans conquered the region about 475 years ago. There is a context. The native origin of capsicum fruit (Capsicum spp., Solanaceae) is the "upper course" (source region of the Amazon river), which is in the Peruvian Andes.( n30) (The source of the Amazon is lake Lauricocha in the Peruvian Andes. The river is still known as the Maranon in its "upper course" in the Andes.) Recent studies suggest that the ancestors of Capsicum may have evolved in the drier regions of the Peruvian and Bolivian Andes with subsequent migration north or east into tropical lowland regions.( n31, n32) Besides capsicum, other Solanaceae plants with origins in Peru, such as the potato (Solanum tuberosum, Solanaceae) and tomato (Lycopersicon esculentum, Solanaceae), among other economically important plants, are now cultivated worldwide. Another native plant, the cinchona tree (Cinchona spp., Rubiaceae) appears on Peru's national emblem, which serves as a constant reminder that the tree's bark was the original source of the antimalarial drug quinine. Jesuit priests first took the bark back to Spain in 1641. In the 19th century, the Dutch purchased seeds in order to plant cinchona trees in Java. Within 50 years Javanese plantations became the world's primary source of quinine)( n33, n34)
Is it just a matter of time before viable maca germplasm (seeds, cell-cultured plantlets, or tubers) is smuggled from the Andes and cultivation experiments begin in the mountains of Asia? This question is not merely academic. This author has been contacted in recent years by researchers in China asking for assistance in obtaining maca material from Peru for cultivation in China. The assistance to China was declined, colleagues in Peru were informed of the inquiry, and a strong suggestion was made that they do everything within their power to protect their national treasure, maca, from becoming a commodity like the potato, now cultivated worldwide.
More information on the current status of the maca biopiracy cases is available from the Instituto Nacional de Defensa de la Competencia y de la Protección de la Propiedad Intelectual (INDECOPI) at the following address: Calle de la Prosa 138 - San Borja, Peru; phone: (511) 224-7800 or (511) 224-7777; fax: (511) 224-0348; Web: http://www.indecopi.gob.pe.
(*) Biopiracy has several definitions depending on whether one refers to Peruvian statutes or international treaties. According to Jorge Goldstein, an attorney representing Peruvian protesters of a Pure World patent for maca (discussed in this article), Peruvian Law No. 28216 defines "biopiracy" narrower than does ETC, as follows: "unauthorized and uncompensated access and use of biological resources or traditional knowledge of indigenous peoples by third parties, without corresponding authorization and in violation of the principles established in the Convention on Biological Biodiversity (CDB). …" While both definitions might be thought to apply primarily to genetic and biological resources that are misappropriated, i.e., a nonpermitted access to secret know-how of the community or in violation of the Biodiversity Treaty, the ETC is less restricted. The ETC definition would actually apply to maca bought in the public markets for the purpose of searching for the active ingredients that cause their well known effects in order to obtain intellectual property (IP) rights. According to Goldstein, the ETC definition puts forth the concept that obtaining IP rights, even based on publicly accessible knowledge, is illegal.
† According to a peer reviewer of this article, maca clinical researcher Gustavo F. Gonzales, MD, PhD (Instituto de Investigaciones de la Altura, Universidad Peruana Cayetano Heredia, Lima, Peru), "It is my opinion that macamides and macaenes are not the [primary) active compounds in maca. This is based [on the fact] that these compounds are extracted in a lipidic fraction. However, most of the effect of maca is in the aqueous fraction, in which levels of macaenes and macamides probably are negligible. It is very strange that after publication of Zheng et al in 2000 (Urology) nobody has demonstrated biological properties for macamides" (e-mail to M. Blumenthal, May 28, 2007). Dr. Zheng responded to the above as follows: "We have always indicated that macamides and macaenes are unique but never said they are the only actives in Maca. As we all know, [the] herbal extract itself is the active and in some case it is not active enough when you isolate one single compound or single group of compounds. There are synergies [that] need to be studied in herbal medicine. I do not see the evidence that 'most of the effect of maca is in the aqueous fraction,' as the reviewer said. For what we studied, most [of the] chemical compounds are in the lipid fractions [i.e.,] the material used for our study published in Urology" (e-mail to C. Cavaliere, June 4, 2007).
Table 1: List of Vegetable Biological Resources Prioritized by the Peruvian National Commission against Biopiracy
Legend for Chart:
A - RANK(*)
B - PERUVIAN NAME
C - ENGLISH NAME
D - BOTANICAL NAME AND FAMILY
Lepidium meyenii, Brassicaceae
2 Camu camu
Myrciaria dubia, Myrtaceae
3 Uña de gato
Uncaria tomentosa, Uncaria guianensis, Rubiaceae
4 Maiz morado
Zea mays, Poaceae
Caesalpinia tara, Fabaceae
Smallanthus sonchifolius, Asteraceae
7 Sacha inchi
Plukenetia volubilis, Euphorbiaceae
Gentianella alborosea, Gentianaceae
Cyclanthera pedata, Cucurbitaceae
Phyllanthus niruri, Euphorbiaceae
11 Sangre de grado
Dragon's blood croton
Croton lechleri, Euphorbiaceae
12 Algodón de color
Gossypium barbadense, Malvaceae
Pouteria lucuma, Sapotaceae
Annona cherimola, Annonaceae
Oxalis tuberosa, Oxalidaceae
Ullucus tuberosus, Basselaceae
Tropaeolum tuberosum, Tropaeolaceae
18 Palo de rosa
Aniba rosaeodora, Lauraceae
19 Tarwi o chocho
Lupinus mutabilis, Fabaceae
Chenopodium pallidicaule, Chenopodiaceae
21 Cascarilla o quina
Cinchona micrantha, Rubiaceae
22 Ratania o palo hurón
Krameria triandra, Krameriaceae
Jatropha weberbaueri, Euphorbiaceae
Desmodium molliculum, Fabaceae
Geranium dielsianum, Geraniaceae
Bixa orellana, Bixaceae
Calycophyllum obovatum, Rubiaceae
Abuta grandifolia; syn. Cissampelos
Maytenus macrocarpa, Maytenus
Minthostachys setosa, Lamiaceae
Lochocarpus nicou, Fabaceae
32 Hojas de paico
Chenopodium ambrosioides, Chenopodiaceae
33 Hojas de guanábana
Annona muricata, Annonaceae
(*) Plants are listed in order of priority as assessed by the
Peruvian government, based on patents issued on each plant.
Table 2: Summary of Prioritized US Patents
United States Patent 6,267,995
Zheng, et al. July 31, 2001
Inventors: Zheng; Bo Lin (Wayne, NJ),
Kim; Calvin Hyungchan (Fort Lee, NJ),
Wolthoff; Stephen (Fort Lee, NJ),
He; Kan (River Edge, NJ),
Rogers; Lingling (Parsipanny, NJ),
Shao; Yu (River Edge, NJ),
Zheng; Qun Yi (Wayne, NJ)
Assignee: Pure World Botanicals, Inc.
Extract of Lepidium meyenii roots for pharmaceutical applications
An isolated composition obtained by extracting Lepidium meyenii roots is provided. The composition is substantially free of cellulose and comprises between about 5% and about 9% of benzyl isothiocyanate, between about 1% and about 3% of Lepidium sterol component, between about 20% and about 30% of Lepidium fatty acid component, and about 10% or more of macamide component. The composition is prepared by a process which comprises contacting Lepidium meyenii roots with a first aqueous solvent of about 90% vol-% or more water, then separating the residual Lepidium meyenii root material from the first contacted aqueous solvent, then contacting the residual Lepidium meyenii root material with a second aqueous solvent which comprises a mixture of an alcohol and water having about 90 vol-% alcohol or more to form a liquor, and then finally concentrating the liquor to obtain the composition. The composition can be used for treating cancer and sexual dysfunction.
United States Patent 6,428,824
Zheng, et al. August 6, 2002
Inventors: Zheng; Bo Lin (Wayne, NJ), Kim;
Calvin Hyungchan (Fort Lee, NJ),
Wolthoff; Stephen (Fort Lee, NJ),
He; Kan (River Edge, NJ),
Rogers; Lingling (Parsipanny, NJ),
Shao; Yu (River Edge, NJ),
Zheng; Qun Yi (Wayne, NJ)
Assignee: Pure World Botanicals, Inc.
(South Hackensack, NJ)
Treatment of sexual dysfunction with an extract of Lepidium meyenii roots
NOTE: The abstract provided for this patent is identical to the wording in the 2001 patent above.
United States Patent 6,552,206
Zheng, et al. April 22, 2003
Inventors: Zheng; Bo Lin (Aurora, CO),
He; Kan (River Edge, NJ),
Shao; Yu (Ledgewood, NJ),
Zheng; Qun Yi (Wayne, NJ)
Assignee: Pure World Botanicals, Inc.
(South Hackensack, NJ)
Compositions and methods for their preparation from Lepidium
The invention relates to compositions that can be isolated from Lepidium plant material and to methods for their isolation. The compositions are useful for treating and preventing cancer and sexual dysfunction.
PHOTO (COLOR): Photos ©2007 Ed Smith, Founder & Chairman of Herb Pharm: www.herbaled.org
PHOTO (COLOR): Drying maca (Lepidium meyenii) roots Photo ©2007 Ed Smith, Herb Pharm
PHOTO (COLOR): Fresh (undried) maca roots Photo ©2007 Ed Smith, Herb Pharm
PHOTO (COLOR): Three generations of maca farmers in Peru. Photo ©2007 Ed Smith, Herb Pharm
PHOTO (COLOR): Peruvian child sitting on a bed of drying maca Photo ©2007 Ed Smith, Herb Pharm
PHOTO (COLOR): Preparing maca to dry Photo ©2007 Ed Smith, Herb Pharm
PHOTO (COLOR): Grandmother and granddaughter maca growers Photo ©2007 Ed Smith, Herb Pharm
(n1.) Action Group on Erosion, Technology and Concentration. Biopiracy. Ottawa, ON: ETC Group; 2006. Available at: http://www.etcgroup.org/en/issues/biopiracy.html.
(n2.) Congreso de la Republica del Peru. Ley No 28216: Ley de protección al acceso a la diversidad biológica Peruana y los conocimientos colectivos de los pueblos indigenas. El Peruano Diario Oficial--Normas Legales. May 1, 2004; XXI(8714):26758-26759.
(n3.) World Trade Organization. Article 27.3(B), Relationship between the TRIPS Agreement and the CBD and Protection of Traditional Knowledge and Folklore. Communication from Peru (Revision). Geneva, Switzerland: WTO Council for Trade-Related Aspects of Intellectual Property Rights; May 19, 2005; IP/C/W/441/Rev.1.
(n4.) Bazán Leigh S. Casos de Bio-pirateria para productos naturales y acciones adoptadas. In: Perú Natura 2006: Foro y exposición de Ingredientes y Productos Naturales. September 26-27, 2006, Hotel Plaza del Bosque, San Isidro, Lima, Perú.
(n5.) Brinckmann J. LatinPharma Expo 2003, Lima Perú: Natural Products Roundtable, Trade Show, Buyers/Sellers Meeting. HerbalGram. 2003;No. 60:68-70.
(n6.) Zheng BL, Kim CH, Wolthoff S, He K, Rogers L, Shao Y, Zheng QY. Compositions and Methods for their Preparation from Lepidium. WO Patent 00/51548. PCT Gazette, Section L September 8, 2000;12758.
(n7.) World Intellectual Property Organization. Patents Referring to Lepidium meyenii (Maca): Responses of Peru. In: Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, Fifth Session, Geneva, July 7-15, 2003. Geneva, Switzerland: WIPO. May 12, 2003; WIPO/GRTKF/ IC/5/13.
(n8.) Zheng BL, Kim CH, Wolthoff S, He K, Rogers L, Shao Y, Zheng QY. Extract of Lepidium meyenii for pharmaceutical applications. United States Patent 6,267,995. Washington, DC: United States Patent and Trademark Office (USPTO). July 31, 2001.
(n9.) Zheng BL, Kim CH, Wolthoff S, He K, Rogers L, Shao Y, Zheng QY. Treatment of sexual dysfunction with an extract of Lepidium meyenii roots. United States Patent 6,428,824. Washington, DC: United States Patent and Trademark Office (USPTO). August 6, 2002.
(n10.) Zheng BL, He K, Shao Y, Zheng QY. Compositions and methods for their preparation from Lepidium. United States Patent 6,552,206. Washington, DC: United States Patent and Trademark Office (USPTO). April 22, 2003.
(n11.) DeLuca DL, Sparks WS, DeLuca DR. Maca and antler for augmenting testosterone levels. United States Patent 6,093,421. Washington, DC: United States Patent and Trademark Office (USPTO). July 25, 2000.
(n12.) Hastings CW, Barnes DJ, Daley CA. Dietary Supplement. United States Patent 6,368,617. Washington, DC: United States Patent and Trademark Office (USPTO). April 9, 2002.
(n13.) Heleen PA. Herbal composition for enhancing sexual response. United States Patent 6,444,237. Washington, DC: United States Patent and Trademark Office (USPTO). September 3, 2002.
(n14.) Barone FV, Jacobsen C, Chumenko K. Topical compositions for enhancing sexual responsiveness. United States Patent 7,214,390. Washington, DC: United States Patent and Trademark Office (USPTO). May 8, 2007.
(n15.) Cui B, Zheng BL, He K, Zheng QY. Imidazole alkaloids from Lepidium meyenii and methods of usage. United States Patent 6,878,731. Washington, DC: United States Patent and Trademark Office (USPTO). April 12, 2005.
(n16.) Ogawa H, Mitsunaga T, Kawamura Y. Functional food product containing maca. In: Patent Abstracts of Japan--Publication number: 2004-000171. Tokyo, Japan: Japanese Patent Office. January 8, 2004.
(n17.) Ogawa H, Matsuo T. Testosterone-increasing composition, testoster-one-increasing food, testosterone-increasing skin care preparation for external use and testosterone-increasing medicine. In: Patent Abstracts of Japan--Publication number: 2005-306754. Tokyo, Japan: Japanese Patent Office. November 4, 2005.
(n18.) Gonzales GF, Cordova A, Vega K, Chung A, Villena A, Gonez C. Effect of Lepidium meyenii (Maca), a root with aphrodisiac and fertility-enhancing properties, on serum reproductive hormone levels in adult healthy men. J Endocrinol. 2003;176(1):163-168.
(n19.) Gonzalez GF, Cordova A, Gonzalez C, Chung A, Vega K, Villena A. Lepidium meyenii (maca) improved semen parameters in adult men. Asian J Androl. 2001;3(4):301-3.
(n20.) Matsumoto T, Kato M. Alcoholic drink containing maca extract. In: Patent Abstracts of Japan--Publication number: 2005-312430. Tokyo, Japan: Japanese Patent Office. November 10, 2005.
(n21.) Hirose Y, Hirose K, Nakajima H, Nakajima H. Composition for preventing male climacteric disorder and beverage and foods including the same. In: Patent Abstracts of Japan--Publication number: 2006-069970. Tokyo, Japan: Japanese patent Office. March 16, 2006.
(n22.) Yamada S, Nasu A, Iwata Y. Improving agent of indefinite complaint accompanying with autonomic imbalance. In: Patent Abstracts of Japan--Publication number: 2006-143664. Tokyo, Japan: Japanese Patent Office. June 8, 2006.
(n23.) World Trade Organization. Article 27.3(b), Relationship between the TRIPS Agreement and the CBD and Protection of Traditional Knowledge and Folklore. Communication from Peru. Biodiversity, Traditional Knowledge and Intellectual Property: Peru's Position in Relation to Disclosure of Origin and Legal Provenance. Geneva, Switzerland: WTO Council for Trade-Related Aspects of Intellectual Property Rights. June 8, 2005; IP/C/W7447.
(n24.) World Trade Organization. Analysis of Potential Cases of Biopiracy: The Case of Camu Camu (Myrciaria dubia). Communication from Peru. Geneva, Switzerland: WTO Council for Trade-Related Aspects of Intellectual Property Rights. November 7, 2005; IP/C/W/458.
(n25.) World Intellectual Property Organization. Patent System and the Fight Against Biopiracy--The Peruvian Experience. In: Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, Eighth Session, Geneva, June 6-10, 2005. Geneva, Switzerland: WIPO. May 30, 2005; WIPO/ GRTKF/IC/8/12.
(n26.) World Trade Organization. Response to Comments Contained in Document IP/C/W/469 Relating to the Peruvian Commutation IP/ C/W/458. Communication from Peru. Geneva, Switzerland: WTO Council for Trade-Related Aspects of Intellectual Property Rights. November 2, 2006; IP/C/W/484.
(n27.) Koerner BI. Viagra natural. Legal Affairs. November-December 2005. Available at: http://www.legalaffairs.org/issues/November-December2005/feature%5fkoern....
(n28.) Vecchio R. Libido-enhancing root in global dispute. The Associated Press. January 5, 2007.
(n29.) Drajem M. Andean nations seek US patent protection for native medicines. Bloomberg News. November 17, 2005.
(n30.) Wichtl M, ed. Brinckmann JA, Lindenmaier MP, trans. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, Third Edition. Stuttgart, Germany: Medpharm Scientific Publishers; 2004;104-106.
(n31.) Walsh BM, Hoot SB. Phylogenetic relationships of Capsicum (Solanaceae) using DNA sequences from two noncoding regions: the chloroplast atp B-rbcL spacer region and nuclear waxy introns. Int J Plant Sci. 2001;162(6):1409-1418.
(n32.) Tewksbury JJ, Manchego C, Haak DC, Levey DJ. Where did the chili get its spice? Biogeography of capsaicinoid production in ancestral wild chili species. Journal of Chemical Ecology. 2006;32(3):547-564.
(n33.) Prendergast HDV, Dollely D. Jesuits' bark (Cinchona [Rubiaceae]) and other medicines. Economic Botany. 2001;55(1):3-6.
(n34.) Kitchener S. The military experience of mefloquine malaria chemoprophylaxis. ADF Health. April 2003;4(1):34-38.
By Josef Brinckmann
Josef Brinckmann is the vice president of research & development at Traditional Medicinals, Inc. in Sebastopol, California; a consultant on market intelligence for medicinal plants and extracts for the International Trade Centre (ITC) of the United Nations in Geneva, Switzerland; editor of ITC's quarterly Market News Service for Medicinal Plants and Extracts; and a member of the Advisory Board of the American Botanical Council.