Posted 3:03 PM by Luigi
More on the mamala tree

http://biz.yahoo.com/deal/041028/samoafacespatentstruggles_2.html

Thursday October 28, 6:00 am ET
By Alex Lash

A tree that grows on South Pacific archipelago nation of Samoa may be the source of a breakthrough AIDS drug, and the U.S. researchers working on the drug are trying to make sure Samoa and its people reap potential rewards with a most unusual license scheme. That may not be so easy.

U.S. researchers in the late 1980s isolated a compound found in the bark of the mamala tree, which grows in the Samoan rain forest, with the help of the island's traditional healers. The compound, Prostratin, could be an important tool in the fight against AIDS. In exchange for the Samoans' cooperation, two institutions currently working with Prostratin have agreed to channel a portion of any future commercial success back to Samoa. But a larger question looms: Can a country assert "national sovereignty" over a plant that grows elsewhere?

Mamala trees grow in tropical forests throughout the South Pacific, but researchers specifically credit Samoans in the western rain forests on the island of Savai'i for leading them to a potential AIDS breakthrough.

That gratitude has been codified in contract. The University of California, Berkeley, announced Sept. 30 it will work to genetically engineer Prostratin so that it need not be extracted from mamala tree bark. Given the rapid tropical deforestation across the world, a synthetic source of Prostratin could prove crucial to keeping Samoa's remaining forests intact.

"If we don't have the capacity for producing these drugs in a microbe, people will cut down rain forests to get trees, and there could be a hundred more drugs like this in that rain forest," said Jay Keasling, the UC Berkeley professor who will lead the genetic engineering project, which involves cloning the mamala tree genes and inserting them into e. coli bacteria so the bacteria pump out Prostratin in mass quantities.

The university signed a memorandum of understanding with the Samoan government to return half of all revenue derived from the genes or intellectual property that stems from the research. That portion will be further split: 50% to the Samoan government, 33% to the village of Falealupo, and the rest to other villages and the descendants of the two healers who identified the medicinal properties of the tree bark.

The Samoa case is playing itself out at a time of growing recognition of indigenous sources of drugs and other products. In recent years, companies that have patented products based on traditional knowledge have seen their patents challenged. For example, the European Patent Office revoked patents in 2000 for fungicide derived from the Neem tree of India, which Indians have used for centuries to make a wide range of products.

The United Nations ' intellectual property arm, the World Intellectual Property Organization, is monitoring a voluntary effort to build databases of traditional knowledge. These databases would gather uses of traditional plants and other natural resources and publish them for all to see. This would create what patent examiners call "prior art" — examples of uses that trump a patent claim — and keep traditional knowledge in the public domain.

It all started when Dr. Paul Alan Cox, an ethno-botanist familiar with Samoa from an earlier stint as a Mormon missionary, returned to the island in the 1980s to look for botanical cures in the wake of his mother's death from breast cancer. Once he learned the mamala tree was used locally to treat hepatitis, back pain, diarrhea, yellow fever and more — Cox sent samples to the National Cancer Institute in Bethesda, Md.

It turned out to be bad cancer medicine but a potential breakthrough as an anti-viral. The NCI and Cox received the patent on Prostratin as an anti-viral therapy in 1997.

One of the problems with HIV , the virus that causes AIDS, is that it lies dormant in human cells and survives bouts of virus-killing drugs. Once a patient has finished a treatment to knock out active viruses, the dormant ones awaken and create more havoc. Prostratin is shown to activate dormant viruses so they can be destroyed by anti-HIV drugs.

The AIDS Research Alliance of America of West Hollywood, Calif., is trying to determine if it will it work beyond the lab. That's where the Samoa licensing story gets more complicated.
The nonprofit ARA hopes to start testing Prostratin in people next year, said executive director Irl Barefield. No other organization may do so; in 2001, the ARA signed an exclusive license with the NCI to become the sole developer of Prostratin as an HIV treatment.

When it signed its license with the NCI in 2001, it also agreed to share 20% of development proceeds with Samoa. (The NCI license stipulates that licensees "begin negotiations for an agreement" with the Samoan government but doesn't specify further. Barefield said the 20% cut was "generous.")

At Berkeley, Keasling's work — which still needs funding to get rolling — isn't covered by the NCI patent because it is a production method, not a disease-specific treatment. "We don't offer anything for sale or manufacture in bulk or have a sales force," said Carol Mimura, executive director of the school's office of technology licensing. "We are strictly engaged in research."
For the university — or more likely, a company that licenses the Prostatin gene sequence and production methods Keasling produces — to develop an AIDS drug, it will have to sublicense from ARA. Sublicensees would not be required to reimburse Samoa in any way, said Barefield.
"That's a smart way to do it," said David Deits, a partner with Davis Wright Tremaine LLP in Seattle who specializes in international intellectual property matters. "If they impose an obligation that royalties on retail or wholesale sales of medications would have to go to the government of Samoa, that would be a problem."

A larger question looms, however, about Samoa's "national sovereignty" over the homalanthus nutans gene sequence, which Cox asserted when the Berkeley agreement was announced. "This may be the first time that indigenous people have extended their national sovereignty over a gene sequence," he said.

What this means from a legal standpoint isn't clear. Cox did not return phone calls by press time. If Berkeley professor Keasling patents the portion of the homalanthus nutans genome that makes Prostratin, he and the university are welcome to assign some or all of the patent rights to Samoa.

Also in question is whether Samoa has claim to commercialization benefits derived from the mamala tree when the tree grows in other countries across the South Pacific. Do native healers of New Zealand, Australia, Indonesia and other countries have the right to compensation? What about the governments of those countries? Do the agreements between ARA, UC Berkeley and the Samoan government set a precedent?

The greatest question of all, of course, is whether Prostratin can help fight HIV. That won't be known for at least a few years. In the meantime, Paul Cox, UC Berkeley and the people of Samoa are charting new territory in giving countries and their people greater control of the intellectual property waiting to be unlocked from their natural resources.