• Introduction

• Protecting Codified TK

• TKDL - A tool for prevention of misappropriation of TK

• Annex. 1

Introduction

 

Traditional knowledge is a vast treasure of knowledge susceptible to misappropriation because of its immense potential. Traditional knowledge, particularly, related to the treatment of various diseases has provided leads for development of biologically active molecules.

 

Biopiracy of codified Indian traditional knowledge continues, primarily since, this information exists in local regional languages. The language barrier prevents patent offices from searching this information as prior art, before granting patents. Formulations used for the treatment of human ailments from traditional knowledge are time-tested since they have been in practice for centuries. The reliability of the traditional medicine systems coupled with the absence of such information with patent offices as prior art, provides ground for biopiracy and wrong grant of patents on therapeutic formulations derived from traditional medicine systems.

 

Misappropriation of Traditional Knowledge

 

The wrong grant of patents on non-novel/inventive/inventions related to traditional medicines, based, is of great concern to the traditional knowledge-rich nations. Some examples detailed in Annex. 1 illustrate the biopiracy of traditional knowledge. In many of these cases, the TK-holding country had to fight for revocation of the granted patents. Revocation of patents involved huge cost and time, and is not always a feasible option for all wrongly granted patents based on traditional knowledge.

 

Protecting Codified Traditional Knowledge

 

Patent examiners, in the international patent offices, while examining the patentability of any claimed subject matter, use available resources for searching the appropriate non-patent literature sources. Patent literature, is usually wholly contained in several distinctive databases and can be easily searched and retrieved whereas non-patent prior art is often buried somewhere in many obscure and diverse resources. A need was therefore felt to create a more easily accessible non-patent literature database on traditional knowledge of India.

 

Traditional Knowledge Digital Library - A tool for prevention of misappropriation of traditional knowledge

 

TKDL contains information from Indian Systems of Medicine (ISM), viz., Ayurveda, Unani, Siddha, Sowa Rigpa as well as Yoga available in public domain. For this, traditional knowledge from the existing literature in local/ regional languages such as Sanskrit, Urdu, Arabic, Persian and Tamil is converted into a digitized format, and is available in five international languages including English, German, Spanish, French and Japanese. Traditional Knowledge Resource Classification (TKRC), an innovative structured classification system for the purpose of systematic arrangement, dissemination and retrieval, has been formulated and is continuously updated for the relevant terms in the ancient texts. The information is structured under section, class, subclass, group and subgroup. The TKRC is structured similar to the International Patent Classification (IPC) due to familiarity and use by the patent examiners worldwide. The TKDL database currently comprises more than 5.0 lakh formulations/ practices that have been transcribed from ISM and Yoga texts.

 

Each text is read, medicinal formulation/ practice identified and converted into a structured format using TKRC by domain (Ayurveda, Unani, Siddha, Sowa Rigpa or Yoga) experts. The codes are then fed into the data entry screen. The content (prior art) from ancient texts are also saved in the database. The translated version of all the TKRC codes is ported in the database. The abstraction is done by the subject experts. The codes once saved in metadata directory are converted in different languages including English, German, French Japanese and Spanish. The converted format of the formulation is thus easily understandable by all.

 

The TKDL application with its associated classification system i.e., TKRC converts text in local/ regional languages into English and other languages as mentioned above. It may be noted that content in TKDL is knowledge-based conversion, where data abstracted once is converted into several languages by using Unicode, Metadata methodology. As a value addition, traditional terminology is also converted into modern terminology, for example, Jwar to fever, Turmeric to Curcuma longa, Mussorika to small pox etc.

 

The TKDL bridges the important gap between formulations existing in local languages and the patent examiner at a global level, since the database provides information on modern as well as local names in a language and format understandable to patent examiners.

 

Annex. 1

 

Some examples of biopiracy of traditional knowledge

Curcuma (Curcuma longa L.)

 

The rhizomes of turmeric are used as a spice for flavouring Indian cooking. It also has properties that make it an effective ingredient in medicines, cosmetics and dyes. As a medicine, it has been traditionally used in India for centuries to heal wounds and rashes.

 

In 1995, Suman K. Das and Hari Har P. Cohly of the University of Mississippi Medical Centre were granted a US patent (5, 401,504) on use of turmeric in wound healing. The Council of Scientific & Industrial Research (CSIR), India, New Delhi filed a re-examination case with the US Patent & Trademark office (USPTO) challenging the patent on the grounds of existing of prior art. CSIR argued that turmeric has been used for thousands of years for healing wounds and rashes and therefore its medicinal use was not a novel invention. Their claim was supported by documentary evidence of traditional knowledge, including ancient Sanskrit text and a paper published in 1953 in the Journal of the Indian Medical Association. Despite an appeal by the patent holders, the USPTO upheld the CSIR objections and cancelled the patent. The turmeric case was a landmark judgment case as it was for the first time that a patent based on the traditional knowledge of a developing country was successfully challenged. The USPTO revoked this patent in 1997, after ascertaining that there was no novelty since the findings by innovators having been known in India for centuries.

 

Neem (Azadirachta indica A. Juss.)

 

Neem extracts can be used against hundreds of pests and fungal diseases that attack food crops; the oil extracted from its seeds can be used to cure cold and flu; and mixed in soap, it provides relief from malaria, skin diseases and even meningitis. In 1994, European Patent Office (EPO) granted a patent (EPO patent No.436257) to the US Corporation W.R. Grace Company and US Department of Agriculture for a method for controlling fungi on plants by the aid of hydrophobic extracted Neem oil. In 1995, a group of international NGOs and representatives of Indian farmers filed legal opposition against the patent. They submitted evidence that the fungicidal effect of extracts of Neem seeds had been known and used for centuries in Indian agriculture to protect crops, and therefore, was unpatentable. In 1999, the EPO determined that according to the evidence, all features of the present claim were disclosed to the public prior to the patent application and the patent was not considered to involve an inventive step. The patent granted on was Neem was revoked by the EPO in May 2000. In March 2006, EPO also rejected the challenge by the USDA and the chemicals multinational, W. R. Grace to the previous decision to cancel their patent on the fungicidal properties of the seeds extracted from the neem tree.

 

Basmati Rice  (Oryza sativa L.)

 

Rice Tec. Inc. had applied for registration of a mark “Texmati” before the UK Trade Mark Registry. Agricultural and Processed Food Exports Development Authority (APEDA) successfully opposed it. One of the documents relied upon by Rice Tec as evidence in support of the registration of the said mark was the US Patent 5,663,484 granted by US Patent Office to Rice Tec on September 2, 1997 and that is how this patent became an issue for contest.

 

This US patent was unique in a way, claiming a rice plant having characteristics similar to the traditional Indian Basmati Rice lines and with the geographical delimitation covering North, Central or South America or Caribbean Islands. The USPTO granted the patent to Rice Tec on September 2, 1997. The said patent comprised 20 claims covering not only novel rice plant but also various rice lines; resulting plants and grains, seed deposit claims, method for selecting a rice plant for breeding and propagation. The claims 15-17 were for a rice grain having characteristics similar to those from Indian Basmati rice lines. The claims 15-17 would have come in the way of Indian exports to US, if legally enforced.

 

Evidence from the IARI (Indian Agricultural Research Institute) Bulletin was used against claims 15-17. The evidence was backed up by the germplasm collection of Directorate of Rice Research, Hyderabad since 1978. Scientists from CFTRI-Central Food Technological Research Institute (CSIR-CFTRI) evaluated the various grain characteristics and accordingly the claims 15-17 were contested on the basis of the declarations submitted by them on grain characteristics.

 

Eventually, a request for re-examination of this patent was filed on April 28, 2000. Soon after filling the re-examination request, Rice Tec chose to withdraw claims 15-17 along with claim 4.

 

Biopiracy of traditional knowledge is not limited to India alone. In fact, there have been several examples from other countries where traditional knowledge biopiracy has become a concern. Some of these examples are given below:

 

Kava (Piper methysticum G.Forst.)

 

Kava is an important cash crop in the Pacific, where it is highly valued as the source of the ceremonial beverage of the same name. Over 100 varieties of Kava are grown in the Pacific, especially in Fiji and Vanuatu, where it was first domesticated thousands of years ago. In North America and Europe, Kava is now promoted for a variety of uses. French company L'Oreal - a global giant with US $10 billion a year in sales - patented the use of Kava to reduce hair loss and stimulate hair growth.

 

Ayahuasca [Banisteriopsis caapi (Spruce ex Griseb.) C.V.Morton]

 

For generations, Shamans of indigenous tribes throughout the Amazon basin have processed the bark of B. caapi to produce a ceremonial drink known as “Ayahuasca”. The Shamans use Ayahuasca (which means “wine of the soul”) in religious and healing ceremonies to diagnose and treat illness, meet with spirits, and divine the future.

 

American, Loren Miller obtained US Plant Patent (no.5751 issued in 1986), granting him rights over an alleged variety of B. caapi which he had collected from a domestic garden in Amazon and had called “Da Vine”, and was analyzing for potential medicinal properties. The patent claimed that Da Vine represented a new and distinct variety of B. caapi, primarily because of the flower colour.

 

The Coordinating Body of Indigenous Organisations of the Amazon Basin (COICA), which represents more than 400 indigenous tribes in the Amazon region, along with others, protested about the wrong patent that was granted on the plant species. They protested that Ayahuasca had been known to natives of the Amazon rainforest and is used in traditional medicine and cultivated for that purpose for generations. They argued that Miller could not have discovered it, and should not have been granted rights, which in effect, appropriated indigenous traditional knowledge. On re-examination, USPTO revoked this patent on 3rd November 1999. However, the inventor was able to convince the USPTO on 17th April 2001, and the original claims were reconfirmed and the patent rights restored to the innovator.

 

Quinoa (Chenopodium quinoa Willd.)

 

Quinoa is a staple food crop for millions in the Andes, especially Quechua and Aymara people who have bred a multitude of quinoa varieties. One traditional quinoa variety, Apelawa, is the subject of US patent 5,304,718 held by two professors from Colorado State University who claim the variety's male sterile cytoplasm is key to developing hybrid quinoa. The patent claims any quinoa crossed with male sterile Apelawa plants.

 

Hoodia [Hoodia gordonii (Masson) Sweet ex Decne].

 

For thousands of years, African tribesmen have eaten the Hoodia cactus to stave off hunger and thirst on long hunting trips. The Kung bushmen, San who live around the Kalahari desert in southern Africa used to cut off a stem of the cactus about the size of a cucumber and munch it.

 

In 1995, South African Council of Scientific & Industrial Research (CSIR) patented Hoodia’s appetite-suppressing element (P57) and hence, its potential cure for obesity. In 1997 they licensed P57 to British Biotech Company, Phytopharm. In 1998, Pfizer acquired the rights to develop and market P57 as a potential slimming drug and cure for obesity from Phytopharm for $ 32 million. The San people eventually learned of this exploitation of their traditional knowledge, and in June 2001, launched legal action against South African CSIR and the pharmaceutical industry on grounds of biopiracy. They claimed that their traditional knowledge has been stolen, and the South African CSIR had failed to comply with the rules of the Convention on Biodiversity, which requires the prior informed consent of all stakeholders, including the original discoverers and users.

 

Phytopharm conducted extensive enquiries but were unable to find any of the knowledge holders. The remaining San were apparently at the time living in a camp 1500 miles away from their tribal lands. The South African CSIR claimed that they planned to inform the San of the research and share the benefits, but wanted to make sure that the drug proved successful.

 

The two sides entered into negotiations for a benefit-sharing agreement, despite complications regarding who should be compensated: the person who originally shared the information, their descendants, the tribe, or the entire country. The San are nomads spread across four countries.

 

Later, in March 2002, a landmark agreement was reached in which the San were to receive a share of any future royalties. Since then however, hoodia has made entry into the grey market and to what extent the benefit sharing aids the San community is unclear.

 

The appropriation of elements of this collective knowledge of societies into proprietary knowledge for the commercial profit of a few is a major concern. Urgent action is needed to protect these fragile knowledge systems through national policies and international understanding linked to IPR, while providing its development and proper use for the benefit of its holders. Particular focus on community knowledge and community innovation, enterprise and investment, is very important.

The local communities or individuals do not have the knowledge or the means to safeguard their property in a system, which has its origin in very different set of cultural values and attitudes. The communities have a storehouse of knowledge about their flora and fauna, their habits, their habitats, their seasonal behaviour and the like-and it is only logical and in consonance with natural justice that they are given a greater say as a matter of right in all matters regarding the study, extraction and commercialization of the biodiversity. A legal mechanism/policy that does not obstruct the advancement of knowledge, and provides for valid and sustainable use and adequate intellectual property protection with just benefit sharing is what is needed.