This report presents the results of the technical and legal analysis carried out with respect to invention patents related to Lepidium meyenii (or "maca"). Likewise, it aims to draw attention to a series of elements and problems associated with this type of patent of particular importance for Peru.
Objective: The objective of this report is to present the results of the technical and legal analysis carried out regarding patents for invention related to Lepidium meyenii (or "maca"). Likewise, it is intended to draw attention to a series of elements and problems associated with this type of patents of particular importance for Peru.
Description of the problem: The patents referring to Lepidium meyenii or maca are one more example, of many existing ones, of how the intellectual property system - through invention patents - is oriented mainly in the United States of America, to the privatization of biological and genetic components and materials in an isolated state, as part of larger inventions. In this case, these are resources for which Peru (as the country of origin) has a series of rights that are not taken into account or respected. This same case refers to knowledge that, although difficult to document, has been widely used by ancient Peruvians for a long time. This is evident from the fact that many food, nutritional and medicinal uses or applications of maca, claimed in these patents, have been traditionally used by the indigenous peoples of Peru.
This situation is in no way particular to Peru. Ultimately, several countries with a high concentration of biological diversity with industrial and commercial potential suffer exactly the same problem in terms of the way in which the intellectual property system and patents in particular are used. In this sense, possibly some of the conclusions and final recommendations of this report have validity beyond the Peruvian and particular reality of Lepidium meyenii.
INDECOPI Initiative: At the beginning of 2002, some institutions such as the ANDES Association, PROBIOANDES, ETC GROUP, and some public sector institutions, drew attention to the patents granted in the United States of America for inventions related to maca. Faced with the possible violated rights of Peru as a country of origin, the infringement of the rights of its indigenous peoples as holders of ancestral knowledge on different uses of maca and the possible commercial effects that these patents could have on Peruvian producers and exporters of maca, The National Institute for the Defense of Competition and the Protection of Intellectual Property (INDECOPI) took the initiative in mid-2002 to convene a working group to analyze the patents granted and pending applications referring to Lepidium meyenii and its consequences and, likewise, evaluate alternatives to face them.
Content of the report: The report is divided into ten points or topics that, in turn, have been subdivided due to their degree of complexity and specificity. The first part addresses issues of context and the normative political framework within which the problem of patents relating to maca occurs. A second part describes Lepidium meyenii and offers an idea of its botanical, biological, commercial value, among others. Then, Peru's response to this situation is presented. The next part looks at the patents themselves. Some variables and problems associated with the patent system are immediately described and, finally, some suggestions and recommendations are made on how to face the issue.
2. Brief description of the context: patents, biological diversity and "biopiracy".
2.1 A look at the general context: The access, use and appropriation of biological materials (and associated indigenous knowledge) originating from developing countries with great biological wealth by institutions in developed countries constitutes a permanent, very old process and that is widely documented.
The use of less obvious and far more sophisticated mechanisms than the physical force and control of these materials is, on the contrary, a rather recent phenomenon. Intellectual property and, especially, invention patents (specifically in the biotechnological field) are part of the mechanisms through which the law legitimizes certain forms of property allocation.
This direct or indirect appropriation of biological materials and indigenous knowledge through the use of invention patents has been called "biopiracy" in recent years.
Biopiracy is at the very base of the controversy over who and under what circumstances can invoke rights over inventions and products derived from biological materials, relying in many cases on the use of indigenous knowledge associated with them. This is much more accentuated after the entry into force of the Convention on Biological Diversity (CBD) in 1993, in a context in which certain basic principles have been established to access these resources and knowledge and to legitimize and regulate their use.
The CBD seeks, as one of its main goals, to balance the imbalance between those who have capacities to commercially and industrially use biological resources and their components (industrialized countries) and those who do not have these capacities but do possess the raw material, that is, these resources and their components (developing countries). To this end, the CBD establishes rules and principles on the conditions for this access and use and how the benefits derived from such use should be shared fairly and equitably.
2.2 Intellectual property rights; Invention patents: Intellectual property rights have as a common objective to compensate the creative and intellectual effort of human beings, both on an artistic and scientific level. This need to compensate for creative effort is already recognized as a fundamental right since the Universal Declaration of Human Rights of 1948.
Copyright, Invention Patents, Business Secrets, Trademarks, Plant Breeders' Rights, are some of the basic instruments and tools of intellectual property. Each of them has been designed over time to protect the interests and property of authors, inventors, entrepreneurs, improvers, among others.
Invention patents were conceived in the 15th century in England as a way of rewarding inventors' creative ability. Over time, a regulatory system for patents has been structured with elements of national scope and others of international scope. It is universally recognized that an invention can be patented in any technological field that is new, inventive and industrially applicable. The patent holder is empowered to exclude third parties from the use, commercialization and exploitation in general of said invention without his authorization. As a counterpart to this exclusive right and in order to promote continuous scientific and technological progress, the inventor must describe his invention and make it public so that from there the process of human creation and innovation can continue.
The technology, originally focused on the improvement of equipment, tools, artifacts and their generation processes, has come to be developed in fields that work directly with biological material. Biotechnology and, in particular, genetic engineering, are based on the possibilities of manipulating biological or living matter and transforming it for commercial and industrial purposes. Certainly, the patent system has had to respond and adapt to this new situation.
Countries have advanced differently in terms of whether or not to allow legal protection of inventions derived from biotechnology. While, understandably, the developed countries and leaders of this technological revolution have been much more determined to authorize patents on these inventions, the less developed countries have raised some reservations. With the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization (WTO), certain minimum standards were established for the protection of intellectual property rights contained therein. Although the scope of these standards continues to be discussed, as a general rule, countries allow the patenting of biotechnological inventions (some with more limitations than others).
2.3 Biological diversity and its importance: In simple terms, it is recognized that biological diversity constitutes the material basis for the subsistence of life on Earth and, in particular, for the maintenance of human life. As a source of medicines, food, clothing, seeds, pollinators, biological controllers, environmental services, among others, biological diversity - at its ecosystem level, species and genes - is essential to satisfy the basic needs of survival and comfort of Man.
The importance of biological diversity can be measured from an economic perspective (the global market for genetic resources and their derivative products ranges between US $ 500 and US $ 800 billion, including in this calculation the biotechnology sector, agribusiness, the cosmetic sector , horticulture, among others); from a political perspective (fifteen megadiverse countries concentrate 75% of the planet's biological diversity); from a social and cultural perspective (millions of people and indigenous and local communities around the world literally depend on biological diversity for their daily and immediate subsistence) and an ecological or environmental perspective (the environmental services that provide elements of biological diversity and certain ecosystems are also vital for the "health" of the environment).
2.4 "Biopiracy": Biopiracy should be understood as a political rather than a legal concept. Biopiracy refers to situations in which there is a direct or indirect appropriation of biological, genetic or traditional knowledge resources by third parties. This appropriation can occur through physical control, through intellectual property rights over products that incorporate these elements (obtained illegally) or, in some cases, through the invocation of rights directly over them.
There is abundant literature on different forms and cases of biopiracy worldwide. In Peru and the Andean region in general, plants such as quinoa, ayahuasca, grade blood, maca itself, colored cotton, among others, are some of the classic examples used of cases in which, sometimes Using the current legal system itself, a legal situation is legitimized (that a third party is deemed to be the legitimate owner or holder of a right) at least unfair and questionable from the point of view of the principles and spirit of the CBD. Obviously, in the event that traditional materials or knowledge are used in violation of current legislation, this biopiracy becomes clearly illegal.
As previously mentioned, the CBD tries to balance the situation between countries rich in biological diversity and those that, depending on their technological advances, can take advantage of and use this diversity in the pharmaceutical, biotechnological, agro-industrial and other sectors. For megadiverse countries this is particularly important as they concentrate a large part of this diversity and it is estimated that the annual global market for genetic resources reaches US $ 500-800 billion (ten Kate and Laird, 2000). Beyond the accuracy of the figures, the magnitudes show that this is a market to which the megadiverse countries certainly contribute substantially but from which in most cases they do not benefit.
3. Political and normative advances in Peru, the Andean region and the international context regarding access, traditional knowledge and intellectual property.
The CBD does not arise only as the commitment of States to conserve a biological diversity that is rapidly deteriorating globally. The big business (or "great bargain") of the CBD was to respond precisely to the problem of biopiracy and the inequitable way in which some take advantage of biological and genetic resources without taking into account the rights and interests of others. With this, the paradigm of freely accessible resources or classified as "common heritage of humanity" was changed to a situation where the sovereign rights of the countries over them were recognized. The States agreed that in order to access these resources, the benefits derived from such access and use must be shared fairly and equitably (Article 15 of the CBD).
Discussions around the issue of access to genetic resources continue to be some of the most intense and complex in the CBD. In order to assist countries in their internal processes for developing policies and regulations on the matter, in 2002 the Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Distribution of Benefits were approved (Decision VI / 24 of the COP, 2002) which are guidelines and a reference guide (non-binding) on the legal elements that could be taken into account when designing access policies and standards.
Peru quickly ratified the CBD (Legislative Resolution 26181, 1993) and, after its entry into force in 1993, one of the priority issues for the implementation of its article 15 at the national level was to establish rules and regulations on access to genetic resources, fair and equitable sharing of benefits, and protection of the knowledge, innovations and practices of indigenous communities.
This same concern at the national level was also echoed at the regional level among the countries of the Andean Community of Nations (CAN) and in July 1996, Decision 391 of the CAN on a Common Regime on Access to Genetic Resources was approved. This norm - law in each of the CAN countries: Venezuela, Colombia, Ecuador, Peru and Bolivia - specifically determines the common rules of how, who and under what conditions it is possible to access the genetic resources of the region.
The Regional Biodiversity Strategy for the Countries of the Andean Tropics (Decision 523 of the CAN of 2002) and the National Strategy for Biological Diversity (Supreme Decree 102-2001-PCM) are, in turn, instruments of policy and planning in matters of biodiversity in the which the genetic resources component (and the traditional knowledge of indigenous peoples) form a core part of the action plans and activities to be carried out both in the regional and national contexts.
Certainly, the standards referred to or that could be related to genetic resources are not limited to Decision 391 and the regional scope. Internally, Law 27300, Law for the Sustainable Use of Medicinal Plants (2000) and Law 27821, Law for the Promotion of Nutritional Supplements for Alternative Development (2002) are two recent examples of legal regimes with an impact on how and what Conditions exist for the use of components of biological diversity, in this specific case medicinal plants or those with nutritional properties, respectively.
Regarding traditional knowledge, the issue is also a priority and strategic for the countries of the region. This is reflected as already indicated in the lines of action of the Regional Strategy. It has also been mentioned in Decision 391 itself and in Decision 486 of the CAN on a Common Regime on Industrial Property. However, only Peru has a specific law - Law 27811, which establishes the Regime for the Protection of Collective Knowledge of Indigenous Peoples Linked to Biological Diversity (2002) - aimed at protecting this knowledge and establishing the rules for its use. and use.
In the specific context of invention patents, in a novel way and marking a milestone in the legislation on this matter, Decision 486 of the CAN has expressly established that: a) isolated biological components are not patentable (that do not clearly imply an invention ), and b) that in the case of inventions that incorporate biological or genetic components, or traditional knowledge, the granting of the patent title is subject to proving the legal provenance of these materials and knowledge, which may be a denied or even annulled patent if this requirement is not met. In other words, the regime is conditioned on compliance with other legal norms, including the CBD, Decision 391 and, in the case of Peru, Law 27811.
As noted above, the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets certain minimum standards for the protection of intellectual property rights. It should be noted that although these requirements are not explicitly contemplated in TRIPS, nothing prevents the establishment of this type of measures, for the benefit of countries such as Peru (and other megadiverse countries).
4. What is maca?
In Peru, the Incas and their ancestors domesticated more than 180 cultivated species of plants over several millennia. This was feasible due to the existence of great ecological and climatic diversity, the availability of thousands of plant species, and the Andean people who developed agriculture. One of those Andean crops is maca, which until recently was practically unknown.
The plant, known in Quechua as maca, maka, maino, ayak chichita, ayak willku; in Spanish, maca; In English, maca, Peruvian ginseng, is native to the central highlands of the Peruvian Andes, where it has been cultivated for many centuries for its thickened roots, which are edible. It is a magnificent example of a plant domesticated by the ancient Peruvians that has contributed to the feeding of the Chinchaisuyo inhabitants, in an environment with low temperatures and strong winds. In these areas, these climatic factors limit the cultivation of other species. For centuries, maca was used to barter for other foods or pay taxes.
4.1 Historical background: Maca is briefly described in part 1 of Pedro Cieza de León's work of 1553 entitled "La Crónica general del Perú". Vásquez de Espinoza, who visited Peru in 1598, also provides a short description of maca in his "Compendium and Description of the West Indies", and Father Bernabé Cobo, who visited Peru between 1603-1629, also includes it in his "History of the New World" (Ochoa & Ugent, 2001).
In Book 4, Chapter XV, Father Cobo (1956) says that "in the single province of Chinchaycocha a small plant was cultivated, which does not rise from the ground, called maca where there is no other plant, any of which is cultivated for the sustenance of men by frequent snows and frosts. This plant produces a root shaped like a cermeny pear, white as a turnip inside, which served them as bread, green and dry, as they keep it, for the whole year. a strange property, that by keeping its natives with this root not only do they not go down, as in the other provinces of Peru, but they multiply every day more, for which they say this root has virtue ". Seeing the value of the food, the Spanish tax collectors demanded that the inhabitants of the province of Chinchaycocha pay them with maca crops.
In his travel report to the departments of central Peru, from 1777 to 1778, the Spaniard Hipólito Ruiz indicates that the area of production and consumption of maca were the towns of Carhuamayo, Pampa de Los Reyes, Ninacaca and annexes of these curatos, currently belonging to the Carhuamayo and Ondores districts of the Junín department. Where it says that they are "... chips or turmoid roots, the size of hazelnuts ... very tasty but fiery and aphrodisiac, or that excite the venus; for what many believe that it lends fertility to men and women ..."
4.2 Taxonomy and biological characteristics: Maca is the only starch-producing cultivated cruciferous species. It is classified in the Brassicaceae Family, Lepidieae Tribe, Monoploca Section and Lepidium Genus, Lepidium meyenii species (Quirós & Aliaga, 1997).
The maca plant is herbaceous and is characterized by the formation of a rosette of short, decumbent stems with numerous leaves that grows almost close to the ground, which gives it great tolerance to frost. Within the soil, the part of the stem that is below the cotyledons (hypocotyl) acquires a fleshy structure that integrates with root tissue and ends in a thick root with numerous absorbent lateral roots. This hypocotyl-root is tuberous, succulent and turnip-shaped and is the edible part. The maca cultivars that exist today differ mainly by the color of the hypocotyls-roots that can be white, yellow, gray, purple, black, yellow with purple and white with purple. The leaves show dimorphism, being longer in the vegetative phase and shorter in the reproductive phase. The flowers are not very noticeable, with 4 sepals and 4 small white petals, with 2 or rarely 3 stamens. The ovary is oval and bicarpellar with a short style. The flowers are grouped in axillary racemes. The fruit is a silique with 2 seeds (Quirós & Aliaga, 1997).
Maca is self-pollinating, reproduces predominantly by self-pollination, and produces fertile, trinucleated pollen grains. It has 2n = 8x = 64 chromosomes, it is a disomic octoploid. It produces seeds that have almost no dormancy and germinate in 5 days at 25 ° C (Quirós et al. 1996; Quirós & Aliaga, 1997).
4.3 Genetic diversity, related wild species, and their conservation: Even though there is little information about the endemic Lepidium species of the Andes, those that are known are classified in the Dileptium and Monoploca sections. All of them, including maca, grow in high-altitude habitats, up to 4,500 m above sea level. Brako and Zarucchi (1993) reported six other Lepidium species in Peru distributed between the Departments of Ancash and Puno. However, some of those species are also found in Ecuador, Bolivia, and Argentina.
Toledo et al. (1998) reported a study with RAPD molecular markers of 29 entries of cultivated maca, which would represent approximately 80% of the known maca cultivars, and 27 entries of the wild species Lepidium bipinnarifidum, L. kalenbornii and L. chichicara from Ecuador, Peru and Bolivia, which are morphologically different from maca, and are classified in the Dileptium Section. All entries for each species formed separate clusters, and the authors concluded that none of the wild species studied are closely related to maca. They recommended studying the species L. solomonii (Bolivia), L. jujuyanum (Argentina) and L. weddellii (Peru) that are classified in the same Monoploca Section as maca. Furthermore, L. weddellii would be the only one that produces hypocotyls-thickened roots. The RAPD markers also showed a low level of polymorphism among the maca samples studied, which would indicate that maca has a very narrow genetic base. Similar results were reported by Kianian & Quirós (1991), using RFLPs and RAPDs with 30 cultivars and 21 wild species from Ecuador, Peru and Bolivia.
Chacón (2001) reported feral forms of maca that are known by the common name "shihua" and that are rarely found in cultivated maca fields.
The most important Lepidium collection in Peru is kept at the La Molina National Agrarian University (UNALM), which includes 93 maca accessions, 41 wild Lepidium species, and 38 progeny lines from selections. The International Potato Center (CIP) maintains 33 accessions, mostly duplicates from the UNALM collection, which are preserved as seeds (> 2000 / accession) in refrigeration at - 20 ° C. These seeds are obtained from 20 plants per accession, and their viability monitoring tests are carried out every 2 years. All accessions have been characterized by morphological descriptors.
CIP experts consider that the collections conserved ex situ do not represent the diversity existing in situ.
4.4 Origin and geographical distribution: Very little is known about the origin of maca and a wild species that is considered as its ancestor from which it was domesticated has not yet been identified. Maca would have been domesticated by human groups from the Peruvian jungle called "Pumpush", who populated areas such as Cuncush Runa on the Bumbush or Bombón plateau, where the Chinchaycocha or Junín lagoon is located.
The Pumpush required the salt that was produced in the Cerro de la Sal in Tarma, Catamarca or Cachipuquio, located in San Pedro de Cajas and San Blas. The ancestral maca plants would have been one of their food sources and the process of their domestication would have started 1200 years before Christ in the surroundings of San Blas (Rea, 1992; Obregón, 1998).
According to Javier Pulgar Vidal, the word maca would come from the words Ma which means "high" (which has been cultivated or cultivated at high altitude) and Ca "food that strengthens". In Quechua, it would mean "food with strong flavor" (Obregón, 1998).
Maca is believed to have a wider geographical distribution in the 16th and 17th centuries. However, until a few years ago, the geographical distribution of maca was restricted to the surroundings of the Junín lagoon, in the central highlands of Peru. Traditionally, the large cultivation areas were found in the Department of Junín, in many communities in the districts of Ondores, Huayre, Carhuamayo, Tarma and Junín, and in the Department of Pasco in Ninacaca, Yanachachi and Vicco. Recently, its cultivation is spreading to other Departments such as Huancavelica, Ayacucho, Apurímac, Cusco and Puno. All these localities are located in the Suni and Puna agro-ecological zones, with an elevation between 3,500 and 4,500 m.
4.5 Nutritive and pharmacological properties of maca: The fresh hypocotyls-roots of maca contain 80% water and when they are dry they have a nutritional value similar to that of corn, rice and wheat. Its composition includes 55-60% carbohydrates, 10-12% proteins; 8-9% fiber and 2-3% lipids. Maca contains large amounts of essential amino acids and high levels of iron and calcium. It also contains fatty acids, of which linolenic, palmitic and oleic are the most important. It also contains sterols and alkaloids (Quiroz, et al., 1996).
The most important property known in the Andean tradition is its effect on fertility; This is the main quality attributed to maca since the 16th century, and considered as one of the factors for the increase of the population in the highest areas of Peru. It is also used to treat frigidity, sexual impotence and mental weakness (León, 1964, 1986; Obregón, 1998; Johns, 1980).
The effects of maca on fertility have been verified in rats, in which there is an increase in spermatogenesis, follicle maturation, and an increase in progeny by supplying them with an alkaloid extract of maca (Chacón, 1961); in guinea pigs, that fed with dry and powdered maca increases their fertility (100%) and their progeny (Alvarez, 1993; Jeri, 1999); in sheep, fed 80 g of maca for 15 days, increased semen volume, sperm concentration and sperm motility; in infertile cows, which regain fertility after feeding on maca (Pulgar, 1978). There are also reports on the use of traditional recipes to treat infertility in women and men (García and Chirinos, 1999). The properties of maca to improve fertility could be due to the presence of biologically active isothiocyanates derived from the hydrolysis of glucosinolates, specifically due to benzyl-isothiocyanate and p-methoxybenzyl isothiocyanate (Li, et al., 2001).
Maca is also known as an aphrodisiac, which cures frigidity in women and is a remedy for impotence in men (Pulgar, 1978; Obregón, 1998; García and Chirinos, 1999). Numerous testimonies on the successful treatment with maca for cases of frigidity, impotence and sterility are found in a Folkloric Clinic in Junín (León, 1986). This property of maca could be due to the presence of prostagladins and sterols in the hypocotyl-root, and of polyunsaturated fatty acid amides (Li, et al., 2001).
Another medicinal property attributed to maca is its anticancer effect (Quiroz and Aliaga, 1997). Sin embargo, existe una larga lista de artículos científicos que se refieren al efecto anticancerígeno del glucosinolato y del benzil isotiocianato de varias especies de la familia Brassicaceae a la cual también pertenece la maca (Wattenberg, 1977, 1983, 1990; Verhoeven et al, 1996). Desde que Johns (1980) aisló isotiocianatos de extractos de maca, es muy posible que la maca tenga también efecto anticancerígeno.
La maca es también tradicionalmente usado como un regulador de alteraciones de la menstruación y la menopausia, y alivia el insomnio y la disminución de la audición y la visión (Pulgar, 1978; Obregón, 1998). Además, esta planta se ha usado desde tiempos inmemoriales por sus propiedades para revitalizar (Obregón, 1998), para tratar la malnutrición, ayudar a la convalecencia y restaurar la habilidad física y mental (Quiroz y Aliaga, 1997).