- The Washington Times - Monday, January 22, 2007

JUNIN, Peru

In a small storefront on a bleak, wind- swept Andean plat- eau, Timotea Cor- dova, 80, offers an oxygen-deprived visitor a traditional elixir to ward off the breathless effect of the high altitude.

Dropping a few shriveled tuber roots into a blender, the Quechua Indian shopkeeper promises with a playful glance that the concoction will also be helpful later in the bedroom.

For hundreds of years, Quechua Indians have grown maca, a frost-resistant root that thrives in these frigid Andean highlands, to boost stamina and sex drive. The root, they believe, is nature’s bounty and belongs to everyone and to no one in particular.

Maca growers and indigenous organizations were outraged when, in 2001, a New Jersey-based company, PureWorld Botanicals, received a U.S. patent for exclusive commercial distribution of an extract of maca’s active libido-enhancing compounds that it named MacaPure.

Peruvian officials called the patent an “emblematic case” of biopiracy and are preparing to challenge it in U.S. courts.

The maca dispute is the latest collision between indigenous people and commercial interests over so-called “biological prospecting,” the growing practice of scouring the globe for exotic plants, microbes and other living things ripe for commercial exploitation.

Bioprospecting has huge potential for good, say researchers who go to sea, climb mountains and trek to obscure corners of the world in search of exotic and undiscovered species.

A 2005 United Nations University report concluded that 62 percent of all cancer drugs were created from bioprospecting discoveries.

The venom of a deadly sea snail found off the coast of the Philippines led Elan Pharmaceuticals Inc. to develop the painkiller Prialt, which U.S. regulators approved in 2004. The key ingredient in the breast cancer drug Taxol, owned by Bristol-Myers Squibb Co., is taken from the bark of the yew tree, and Wyeth’s kidney-transplant drug Rapamune comes from Easter Island soil.

But bioprospecting is mostly unregulated, and there are mounting calls to establish legal frameworks for such work.

U.S. rejected treaty

The Convention on Biological Diversity drafted at the 1992 Earth Summit in Rio de Janeiro entitled nations to a share of the profits from substances yielded by their flora and fauna. It was ratified by 188 countries — but not the United States, which says such a requirement stifles innovation and would undermine the patent system.

That hasn’t stopped some of the world’s poorest countries, which also hold the richest pockets of natural biodiversity, from fighting to apply the convention to international patent law.

India has had the most success, most recently persuading the European Patent Board of Appeals to invalidate a 1994 patent granted to U.S.-based W.R. Grace & Co. for an insecticide derived from neem seeds.

Peru and Brazil, both at the forefront of the biopiracy debate, have been less persuasive.

Brazil, which has some of the world’s strictest regulations to prevent the removal of genetic materials from the Amazon, has been hard-pressed to demonstrate a single case of biopiracy before the World Trade Organization.

Attempts by Peruvian indigenous groups, meanwhile, ultimately failed to overturn U.S. patents based on ayahuasca, a hallucinogenic plant used for centuries in religious and healing ceremonies, and nuna, a nutritious Andean bean that pops when toasted.

Peru hopes the MacaPure dispute will become a pivotal case in attempts to require all patent applications to disclose the source of genetic materials.

Alejandro Argumedo, a Quechua Indian agronomist and activist, said the French company Naturex, which bought PureWorld in 2005, has no right to “privatize knowledge that belongs to an entire region.”

Naturex marketing manager, Antoine Dauby, said the company acknowledges that maca’s beneficial properties were discovered long ago by indigenous Peruvians. He says its 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,” said Mr. Dauby. As a good-faith gesture, he said, Naturex is offering to grant free licenses to Peruvian companies to use MacaPure in their products.

Scientist wants gratitude

Qun Yi Zheng, PureWorld’s former president and chief scientist, said the company has invested more than $1 million and three years of research in the endeavor, and that it popularized maca as a worldwide Peruvian export.

Peruvians “should not be so narrow-minded,” Mr. Zheng said, but should instead be grateful. “After we studied it, put money into the research, [maca] has become a useful commodity.”

A wide range of potency-peddling, maca-based products — from powders and pills to jams and candies — have helped triple Peru’s exports of the plant from $1.3 million in 2000 to more than $3 million annually since 2003, according to the Exporters Association of Peru.

Japan was Peru’s biggest maca customer in 2005, followed by the United States, Germany, Belgium and Canada.

Mr. Zheng’s peer-reviewed study, published in the journal Urology in April 2000, showed that MacaPure greatly improved penile dysfunction in castrated rats. Peru contends that PureWorld’s alcohol-based extraction process simply mimics the centuries-old practice by Andean people of soaking dried maca root in Andean moonshine to release libido boosters.

But providing scientific proof to show PureWorld’s formula falls short of a “novel” and “useful” invention has proven elusive.

“We don’t have the technology for this analysis, and we have had to turn to a scientist in the United States who offered to do the analysis for free,” said Manuel Ruiz, a director at the nonprofit Peruvian Society for Environmental Law and a member of Peru’s National Anti-Biopiracy Commission.

Legal challenge

Peru has also enlisted the pro bono help of Washington lawyer Jorge Goldstein to prepare a legal challenge. He is examining, among other things, archives from rural Peruvian universities to demonstrate that the U.S. Patent and Trademark Office failed to consider “prior art” — pre-existing knowledge that could be used to overturn the patent.

Chris Kilham, who conducted the initial field research for MacaPure in the Peruvian highlands, said he can see the issue from both sides.

“PureWorld, which did all of this work, found compounds that nobody knew existed before,” said Mr. Kilham, a professor of ethnobotany at the University of Massachusetts at Amherst.

“On the other hand, the native people from whom the knowledge of especially the sexual applications of maca arise were not at all considered in these patents.”

The specter of biopiracy in Peru dates back to the 1630s, when Jesuit priests took bark from the Peruvian cinchona tree — the original source of quinine — back to Europe, where it was hailed as a miracle cure for malaria. Peru never got wealthy from the discovery.

Cinchona seeds were smuggled by the Dutch from Peru in the 19th century and planted in Java. Indonesia became the world’s primary source of quinine.

The image of the cinchona tree was put on the Peruvian flag — a constant reminder of Peru’s unrewarded contribution to one of the most important breakthroughs in medical history.

• AP biotechnology writer Paul Elias contributed to this story from San Francisco.

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