ARTICLE
23 February 2023

The Neem Patent Case

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Khurana and Khurana

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Neem Patent: Protecting the Traditional Knowledge of India

India i.e., ‘Bharat', is a country, “which has been nurturing a tradition of civilization over a period of about 5,000 years. India's ancient scriptures consist of the four Veda, 108 Upanishads, 2 epics, Bhagavad-Gita, Brahma sutras, eighteen Puranas, Manu smriti, Kautilya Shastra and smritis.” One of the most complicated issues in India is to protect the Traditional Knowledge which is possessed by the people as inheritance from their ancestors, but is not protected since it doesn't contain any inventive character. This knowledge is called ‘Sacred Intangible Traditional Knowledge', and the three key articulations that must be characterized to define the terms “Sacred”, “intangible” and “Traditional Knowledge” are as follow. Sacred is mainly used to refer to the expressions of Traditional Knowledge that relates to spiritual beliefs or traditions or something religious. Intangible “which simply means incorporeal, when applied to property, would include intellectual property.”

Traditional Knowledge “is a living body of knowledge that is developed, sustained and passed on from generation to generation within a community, often forming part of its cultural or spiritual identity.” One of the most important factors is that Traditional Knowledge has some ancient roots, and is mostly orally passed from one person to another.

Traditional Knowledge Protection

Traditional Knowledge is not protected under the existing Indian Patent Act, 1970 because Traditional Knowledge in itself is not considered as an innovation as stated under Section 3(p) of Indian Patents Act, 1970, thus not considered as invention and hence, cannot be patented. Section 25 and Section 64 of the Indian Patent Act, 19701, provides certain grounds for revoking patent applications for protecting Traditional Knowledge. The Copyright Act, 19572 of India also doesn't specifically provide for the protection of traditional culture, artistic work or folklore but Section 31A provides for protection of unpublished Indian work. However, Copyrights Act requires certain criteria to be fulfilled and protection is for limited time period.

Biopiracy

Biopiracy is not a legal concept but termed as a socio-political device where indigenous people, their Traditional knowledge and also their biological resources are illegally used by the companies or researchers who from this knowledge later claim the IP Rights over the products which have been gotten from the knowledge of those resources. Biopiracy by its name suggests that there is piracy of various biosphere elements which includes micro-organisms, plants, animals etc. In 2000, Council of Scientific & Industrial Research (CSIR) study found that 80% of the total medicinal patents made by US and UK were from seven medicinal plants of Indian origin. In 2003, there were around 15000 patents made by US and UK from the Indian origin medicinal plants and later in 2005 the patents increased to 35000 which shows the interest of developed countries in the knowledge of developing countries. In addition to this, the patent examiner who comes for inspection is from developed countries and not from the developing countries which gives the former a free hand to steal and use traditional medical knowledge.

Biopiracy is inherently an act of appropriation of traditional knowledge by individuals and corporations for commercial gain but there are existing difficulties in protecting such knowledge that allow attempts and possibilities at appropriation. Such difficulties include:

  1. Collective Resource: The exclusive rights conferred by Intellectual Property Rights are usually given to the individual ownership of knowledge but traditional knowledge protection is usually provided to a community at large.
  2. Criteria of novelty in IPR: : Most traditional knowledge is not based on scientific methods of assessment and evolves organically with the help of communities as a response to new challenges and needs. The evolution of such knowledge across generations means that the novelty or innovative factor is non-existent. Thus, such knowledge often fails to meet the criteria of novelty required for IPR patents.
  3. Limited Protection under IPR: Traditional knowledge requires protection for an indefinite period simply because it is associated with the living practices of an indigenous population. These practices may also be vulnerable to appropriation. The Indian Patents Act does not allow for evergreening of patents.
  4. Problem of Benefit -Sharing: When it comes to sharing monetary and other benefits after commercialization of a traditional practice through a legal procedure, it is sometimes difficult to identify the beneficiary. For instance, in the mid-1990s, scientists at the Tropical Botanic Garden and Research Institute (TBGRI) developed and patented a drug called “Jeevani”. Although TBGRI ended up signing a benefit-sharing agreement with a trust with members from the Kani tribe, not all Kani people agree with the arrangement claiming traditional rights on beneficial properties of the herb.
  5. Lack of adequate documentation: Traditional knowledge is usually a product of learning through experience and oral traditions passed over centuries. It may have been generated, transmitted, and strengthened through rituals, songs, oral history, human interactions, ceremonies, languages, experiences and practices. These traditions are often inaccessible to the patentee or the concerned authority due to the lack of formal documentation.

Over the years, there have been several national and international policies/conventions to secure the rights of source countries as well as indigenous populations over traditional knowledge. At the national level in India, one such intervention is the Traditional Knowledge Digital Library which was created to overcome the problem of documentation and availability of information about traditional knowledge in the public domain.

The Neem Dispute

The neem tree (Azadirachta indica) originates from the Indian subcontinent and now grows in the dry regions of more than 50 tropical countries around the world. The neem tree has multiple uses. It is mentioned in Indian texts written over 2000 years ago and has been used for centuries by local communities in agriculture as an insect and pest repellent, in human and veterinary medicine, toiletries and cosmetics. It is also venerated in the culture, religions and literature of the region. The neem tree, is known in Sanskrit as “sarva-roga nivarini”. It is also seen as a prominent resource in the country.

Even though first report on pesticide property of neem was reported in India in 1928, only after 30 years later systematic research work on neem was initiated. The past five decades witnessed intensive investigation and upward trend to scientific interest in neem and its diverse properties, resulting in large number of research publications, books and conferences at national and international levels. Since the 1980s, many neem related process and products have been patented in Japan, USA and European countries.

Brief Background of the case

The patent for Neem was first filed by W.R. Grace and the Department of Agriculture, USA in European Patent Office. The said patent was deemed to be a method of controlling fungi on plants comprising of contacting the fungi with a Neem oil formulation. A legal opposition was filed by India against the grant of the patent. The legal opposition to this patent was lodged by the New Delhi-based Research Foundation for Science, Technology and Ecology (RFSTE), in cooperation with the International Federation of Organic Agriculture Movements (IFOAM) and Magda Aelvoet, former green Member of the European Parliament (MEP).

A tree legendary to India, from its roots to its spreading crown, the Neem tree contains a number of potent compounds, notably a chemical found in its seeds named azadirachtin. It is used as an astringent in so many fields. The barks, leaves, flowers, seeds of neem tree are used to treat a variety of diseases ranging from leprosy to diabetes, skin disorders and ulcers. Neem twigs are used as antiseptic tooth brushes since time immemorial. The opponents' submitted evidence of ancient Indian ayurvedic texts that have described the hydrophobic extracts of neem seeds were known and used for centuries in India, both in curing dermatological diseases in humans and in protecting agricultural plants form fungal infections. The EPO identified the lack of novelty, inventive step and possibly form a relevant prior art and revoked the patent. Apart from this, several US patents were recently taken out Neem-based emulsions and solutions.

Grace Patent under the US Laws

Under the US laws related to Patents, the Grace patent appears to be an unexceptional example of American discovery, innovation and commercialization. The laws provide that the purification or any type of modification of a naturally occurring compound can result in the grant of a patent. As far as the Grace patent is concerned, it appears to satisfy 35 sections of the US Code3. Sections 101, 102 and 103 provide the requirements for the grant: (1) has some practical usefulness, (2) is novel in relation to the “prior art”4, (3) is not obvious from the “prior art” to a person of ordinary skill in the art at the time the invention was made, and (4) provides a description that is adequate to enable a knowledgeable person to practice the invention in the best mode. The fact that the invention is “obvious” to the Indian farmers does not defeat the purpose of the patentability in the United States. According to section 102(a) and (b), foreign knowledge can only defeat a U.S. patent's novelty claim if that foreign knowledge appeared in a printed publication before the invention or application by the U.S. applicant.

Analysis of the decision

Since the grant of the patent, Dr. Shiva, one of the activists in India, along with the International Federation of Organic Agriculture Movement and the Green Party in European Parliament, had been opposing it. Later, in 2000, the European Patent Office revoked the patent but the victory was short-lived as the revocation was followed by an appeal. Amidst the proceedings of the appeal, the opposers gave them evidence of farmers using this knowledge for a long time and also gave them information about the two scientists who had conducted research on neem before the patent had been granted.

The European Patent Office in Munich in 2005 dismissed an appeal against revoking a patent granted by it for the preparation of a fungicide derived from the seeds of the neem tree. The dispute was a long way to give confidence to the traditional users. Dr. Shiva, one of the three parties opposing the patent stated “It was pure and simple piracy. The oil from neem has been used traditionally by farmers to prevent fungus. It was neither a novel idea nor was it invented. It is the major victory that the appeal has been dismissed.”

Post-dispute

In India, after the neem patent controversy, the need to protect the traditional knowledge of India has gained importance. India has taken an initiative through TKDL (Traditional Knowledge Digital Library), which helps the examiners of Patent Offices to search for any information regarding substance or practice while granting patents and they can dismiss the grant of patent, if the substance or practice is already there in the TKDL list as Indian traditional knowledge.

Conclusion

The neem tree controversy is composed of a number of different facets. On an instinctive level, many Indians simply distrust any action taken by multinational companies. With their history of colonial exploitation and recent large-scale industrial accidents, Indians tend to see multinational companies as the enemy of Indian freedom. Moreover, many Indians are angry at the fact that the multinational companies seem continually to reap tremendous economic benefits from India, while the country as a whole remains very poor. Activist organizations, throughout the dispute, expressed outrage that Grace can use knowledge that is so commonplace in India to achieve million-dollar international profits. This fact only serves to intensify the sense that the international intellectual property regimes are rigged against developing countries such as India. The United States-and Western countries generally-must realize that while developing countries continue to perceive the distribution of economic benefits of intellectual property protections as skewed, there will be resistance to sharing biological resources. To make developing countries willing partners in exploiting the promise of biodiversity, the international community should consider devices for sharing benefits. If individuals or communities in developing nations feel that their knowledge is consistently being “ripped off,” they are unlikely to reciprocate enforcement of intellectual property laws. Therefore, the community must explicitly address the philosophical differences over the issue of patenting life, as this debate is likely to continue in new forms.

Footnotes

1 Act no. 39 of 1970.

2 Act no. 17 of 1957.

3 U.S.C. d 101, 102 and 103.

4 Prior art is any evidence that your invention is already known.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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