A remarkable model for benefit sharing.

The benefit-sharing model is the result of 15 years of effort made by the Kani tribe, scientists in Kerala, and the state government.
The story begins with a wild plant called arogyapacha (scientific name: Trichopus zeylanicus). For many years, when allopathic medicines failed to cure critical liver diseases, the local population in and around Thiruvananthapuram used to get cured with a concoction called malamarunnu (literally, medicine of the mountain) that the Kani elders prepared out of arogyapacha.
"Even though people used to come to our mountains for our malamarunnu, we continued to live in penury as we never charged any money for the treatment. We even treated dozens of patients who could not get their various diseases cured in various medical college hospitals across Kerala," reveals Kuttumathan Kani, a leader of the tribe.
The penurious plight of the Kanis, numbering about 16,000, continued till a team of scientists working on the All-India Coordinated Research Project on Ethnobiology, led by Dr P Pushpangadan, went trekking through the tropical forest hills way back in December 1987.

Says Dr Pushpangadan, "We went were to survey the Kani tribal settlements, but we got exhausted after a long walk. When they saw us tired, some of the Kani tribesmen, who were our guides, offered us fruits of a plant. We ate them and found that we could go on trekking for hours without fatigue." It was the beginning of a remarkable discovery. The tribals said they got the fruits from a magical plant, which the scientists identified as arogyapacha.

Dr Pushpangadan, who then headed the Thiruvananthapuram-based Tropical Botanic Gardens and Research Institute, immediately realised the potential of arogyapacha. "The tribal knowledge of forest plants holds the key to several new discoveries and wonder drugs," he points out. The scientist lost no time in convincing the Kerala government about the importance of joining hands with the tribals.

Soon a team headed by Dr Pushpangadan conducted detailed chemical and pharmacological investigations on arogyapacha. The investigations showed that the leaf of the plant contained various glycolipids and some other non-steroidal compounds with profound adaptogenic and immunity-enhancing properties. Pushpangadan's research institute successfully developed a scientifically validated and standardized herbal drug based on the traditional knowledge of the Kanis.

In 1995, the Tropical Botanic Gardens and Research Institute sold the herbal drug formula to the Arya Vaidya Pharmacy in Coimbatore, Tamil Nadu, for a licence fee of Rs 1 million to produce the drug for seven years. While transferring the technology for production of the drug to the pharmaceutical firm, TBGRI agreed to share the licence fee and royalty with the tribal community. The licence fee and the 2 per cent royalty on profits from the formulation were to be shared equally by the TBGRI and the Kani tribe.

The herbal medicine that the pharmacy produced clicked in the market as the demand for the arogyapacha-based formulation called Jeevani zoomed. Today the medicine is sold at the rate of Rs 160 for a jar of 75 grams. Officials at the Arya Vaidya Pharmacy reveal that the bulk of their exports to southeast Asian and Western countries consist of Jeevani.

Kani says the prime concern of their community members in the beginning was to evolve a viable mechanism for receiving such funds. "So we formed a registered trust called the Kerala Kani Welfare Trust with the help of the Kerala government and voluntary groups."

Every year, the amount due to the Kani tribals from Jeevani trade is transferred to the trust and the money is used for welfare activities of the Kanis. In between, TBGRI also trained dozens of tribal families to cultivate the plant around their dwellings in the forest. In the first year itself, each family earned about Rs 8,000 per mensem on the sale of leaves from cultivation of arogyapacha.

Sufficiently impressed, the United Nations shortlisted the Kani tribal venture two years ago as a global model for a benefit-sharing experiment. The UN noted that this was the first time a local community was being compensated for imparting the secrets of a rare medicinal plant, which had led to the development of a successful herbal drug.

"It is a remarkable venture in material transfer and benefit sharing from tribals. I do not think a similar project has happened elsewhere in the world," Dr Pushapangadan says.

Jeevani continues to be an effective herbal drug for many common illnesses. It is a general tonic for all kinds of exhaustion, fatigue, feeling of weakness, and mentally stressful situations. The tonic increases fresh energy and vigour in a system worn out because of any constitutional disease or from overexertion.

Hailing the successful experiment, Council of Scientific and Industrial Research Director General Raghunath A Mashelkar recently wrote, "India has pioneered one of the first models of benefit sharing."

Yoga, ayurveda being documented to stop patent misuse

Bitten by patent rows over basmati and turmeric, India doesn't want to be caught off guard again by the West, certainly not when it comes to its ancient healing systems of yoga, ayurveda, unani and siddha.

A task force appointed by the government for protecting traditional knowledge and intellectual property is fast completing the documentation of yoga postures and techniques as well as formulae in ayurveda, siddha and unani - all Indian traditional medicinal systems.

The aim is to stop foreign practitioners and individuals, including Indian expatriates, from claiming copyrights.

"Most of the misuse has been done by people of Indian origin living outside India and multinational companies. By the documentation, we hope we would be able to control it largely," V.K. Gupta, head of the task force, told IANS.

"We have identified 1,500 yoga postures and thousands of formulae in Indian medicinal systems from ancient books to document and make it available for the office that grants patents and copyrights to trademark it as our public property."

He said the documentation process - including texts, voice and visuals - would be completed by March 2007.

"Most of the documentation is done," Gupta said, adding that around 100 experts had been working on it for the last three years.

"We have referred to 54 ancient books to research on ayurveda, 35 for unani and 15 for siddha and have documented 50,000 formulae in ayurveda and 24,000 in unani," Gupta said.

He said the task force has created a database of 10 million pages.

Under a Rs. 100-million project, the health and family welfare ministry would be preserving all possible details of yoga postures in a multi-media digital library - Traditional Knowledge Digital Library (TKDL).

The data will be made available in five international languages, and 11 countries, including the US, Britain, Japan and China, would be able to access it.

The task force has found that at least 150 yoga postures that were developed and practised in India for ages - the system finds mention in Vedic scriptures - have been pirated in the US, Europe and in Japan.

It says yoga is a $30 billion industry in the West.

The task force says the US Patents Office has so far issued 134 patents on yoga accessories, 150 yoga-related copyrights and 2,315 yoga trademarks while Britain has approved at least 10 trademarks relating to yoga training aids.

Bikram Chowdhury, a Los Angelus-based multi-millionaire yoga guru, has popularised "hot yoga" - he reportedly developed 26 postures and two breathing exercises performed in a certain sequence in 105 degree heat - and claimed copyrights over it.

Chowdhury even sent legal notices to studios that practised this form of yoga, but later sought a secret agreement with them before the case went for trial in San Francisco.

In the past decade, a number of "specialists" have also mushroomed in ayurveda, siddha and unani systems who have made a fortune out of it.

Little wonder then that the Indian government's move has pleased many.

"This is a very good move. We should protect the heritage our saints have developed and preserved for the good of human kind," said Nivedita Joshi, daughter of former cabinet minister Murli Manohar Joshi and a yoga instructor.

Joshi, who was all praise for the decision, said: "It could have been done only by the government. No individual could have done it as it's a heavily expensive thing."

"No Indian would appreciate anybody patenting yoga postures as their own. Why should we let one particular person make money of some thing, which has been ours from time immemorial?" Joshi told IANS.

K.M. Gopakumar, a lawyer who is researching patent laws, said: "Once documented and published, it will be in the public domain. The so-called lifestyle gurus cannot claim copyright and allege infringement by others who practise it," said

"The documentation is a mechanism of protecting it from misappropriation also."

India learnt its lessons from past controversies - when a US company was granted a patent on the wound-healing properties of turmeric. Another US firm was granted a basmati patent. India challenged both successfully.

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The Pharma Industry’s Dilemma

The Global Pharmaceutical Industry is at the Cross Roads due to Low Productivity And High And Unaffordable Costs of R&D with few products in the pipeline and expiry of Patent protection for many Blockbusters.

Needs new approaches to New Drug Discovery necessitated by :

- High Costs Of Research & Development

- Low Success Rates

- Rapid Obsolescence Of Drugs

- Evolution Of Drug Resistance

- Emergence Of New Diseases

- Poor Understanding Of Disease Processes

There are Three Approaches possible:

1.Growth of the companies to reach critical Mass to afford the currently unaffordable R&D.

2. Find Innovative ways to make R&D more productive.

3. Net work And Collaborate with others to synergise efforts and optimise outputs.

Since vertical growth has limitations, the Strategy has been to merge with and acquire other companies

Ciba-Geigy-Sandoz (Novartis)

Marion-Merrill-Dow-Hoechst Roussel-Rhone Poulenc-

Rorer (Aventis)

Aventis-Sanofi

Richardson-Merrell-Proctor & Gamble

Kabi-Pharmacia-Upjohn

Bristol-Myers-Squibb

AHP-American Cynamide

Astra-Zeneca

Bayer-Sterling

Glaxo-Burroughs Wellcome- SKB

BASF-Knoll-Boots

Roche-Syntex

Pfizer - AHP-Pharmacia-Upjohn

Strategic Alliances Between Big Pharma & Little Biotech

Wyeth signed licensing agreement with Exelixis for drugs for metabolic disorders.

GSK works closely with Exelixis for pipeline cancer drug candidates.

Roche signed agreement with Maxygen to develop

r Factor VII a for intracerebral haemorrhage & trauma.

TERMS Of THE DEALS

Upfront Payments of $ 10 to $ 30 mio , milestone payments and royalties which could be as high as $ 100 mio to $ 500 mio. depending on successful developmental outcomes & blockbuster sales.

Einstein-Patent Examiner

Albert Einstein was born in 1879, and at 21, graduated in mathematics and physics from the Swiss Polytechnic Institute in Zurich. From age 23 to 30, Einstein worked as an examiner at the Swiss Patent Office in Bern. The primary job of Einstein, and of all patent examiners, is to understand and deal with definitions of inventions and discoveries. Once defined, an invention can be evaluated as to whether it is new or appropriate for patenting. Einstein honed his analytical skills in dealing with numerous invention definitions proposed by the patent applicants with whom he was dealing.

At the age of 26, while still employed as a patent examiner, Einstein made three of his greatest contributions to scientific knowledge. The year 1905 was an epoch-making one in the history of physical science, because Einstein contributed three papers to Annalen der Physik (Annals of Physics), a German scientific periodical. Each of them became the basis of a new branch of physics. In one of the papers, Einstein suggested that light could be thought of as a stream of tiny particles, in addition to being thought of as waves. This helped explain the photoelectric effect where light caused release of electrons from materials. In a second paper, titled "The Electrodynamics of Moving Bodies," Einstein presented the special theory of relativity, which allowed for time to be different for different observers. The third major paper concerned Brownian motion, an irregular motion of microscopic particles suspended in a liquid or gas. It confirmed the atomic theory of matter. It was not until Einstein was 30 years old that he held any academic position.

PATENT TROLL

Patent troll is a derogatory term used to describe a patent owner, frequently a small company that enforces patent rights against accused infringers, but does not manufacture products or supply services based on the patents in question. A patent troll may represent an entity who performs research or manufactures products incorporating the patented technology, though the troll itself does not.Patent trolls focus their business on the enforcement of intellectual property rights.

The key point of contention against patent trolls is not their non-practising status, nor that their assertions are necessarily invalid, but rather that "they are in a position to negotiate licensing fees that are grossly out of alignment with their contribution to the alleged infringer’s product or service". Indeed, the core controversy is over equitable issues rather than legal issues. In particular, some believe that patent trolls have an unfair advantage over manufacturers since they are relatively immune to the burdensome litigation tactics which are a traditional front line of defense by large entities against small entities. Others warn that tying the nature of a property owner to the nature of property rights poses a fundamental threat to equal protection under the law, notably in the US, under Article 1, Section 8 of the Constitution.
Some allege that use of the expression "patent troll" is primarily a public relations tactic that large corporations use to intimidate individual inventors in an effort to tilt the playing field in their favor. In this context, it is sometimes noted that the same large corporations that criticise patent trolls collect significant revenues enforcing their own patents against smaller or emerging competitors, including patents relating to technologies that they themselves do not implement in the marketplace.

Technology transfer offices and companies set up to administer patents of a group are usually not considered to be patent trolls .

FIRST INDIAN PATENT APPLICATION

Early bird: George Alfred DePenning made the first application for a patent in India