1OVERVIEW ON LEGAL PROVISIONS ON COPYRIGHTS ANDPATENTS OF MEDICINAL PLANTS IN INDIADhruv Tripthi*IntroductionAll medicinal preparations were derived from plants, whether in the simple form ofplant parts or in the more complex form of crude extracts, mixtures, etc. Today, a large numberof drugs are made from plants. The majority of these involve the isolation of the activeingredient (chemical compound) found in a particular medicinal plant and its subsequentmodification. A semi-synthetic analogue of such a compound could typically be a usefulpharmaceutical product.A large proportion of such drugs have been discovered with the aid of ethno- botanicalknowledge of the traditional uses of the plant. The pharmaceutical company that makes such adrug applies for some form of intellectual property protection; the most favoured being thepatent. If granted, the patent gives the company the right to prevent anyone else frommanufacturing or selling the product. The company gets, in effect, a commercial monopoly. Inaddition, the source of the ethno-botanical knowledge is generally not mentioned. Thus boththe credit for the product and the financial reward generally go to the company. The countryfrom which the knowledge is obtained is simply treated as a source of raw material, whether ofknowledge or of a biological resource. This has led some activists to coin the term “bio-piracy”to refer to a commercially useful product that is derived from traditional knowledge withoutany return to the knowledge holder. Bio-piracy is a major issue in developing countries today.The rich knowledge base of countries like India in medicinal plants and health care hasled to a keen interest by pharmaceutical companies to use this knowledge as a resource forresearch_______________________________________________*Student of B.A, LL.B IX Semester, law college Dehradun
2and development programs in the hope of discovering and producing new drugs. In such asituation, the country is faced with a dilemma. On one hand, there is often a wish to sharebiological resources and knowledge, especially in relation to medicinal plants, althoughdifferent communities may have different conditions for imparting such knowledge. On theother hand, there is a natural wish for some return. This includes not only a wish for somebenefit, whether financial or non-financial, but also for credit or acknowledgment forcontributing to the final product.The intellectual property laws do not protect traditional knowledge adequately, so as to ensurebenefit sharing with and credit to the concerned community. India is presently consideringcertain legislative and other measures to safeguard these rights. The main legislative measuresare the Biological Diversity Bill, 2000, the Patents (Second Amendment) Bill, 1999 and theProtection of Plant Varieties and Farmers Rights Act, 2001.Meaning of PatentsThe word patent originates from the Latin patere, which means "to lay open" (i.e., to makeavailable for public inspection). More directly, it is a shortened version of the term letterspatent, which was a royal decree granting exclusive rights to a person, predating the modernpatent system. Similar grants included land patents, which were land grants by early stategovernments in the USA, and printing patents, a precursor of modern copyright.In modern usage, the term patent usually refers to the right granted to anyone who invents anynew, useful, and non-obvious process, machine, article of manufacture, or composition ofmatter. Some other types of intellectual property rights are also called patents in somejurisdictions: industrial design rights are called design patents in the US, plant breeders rightsare sometimes called plant patents, and utility models and Gebrauchsmuster are sometimescalled petty patents or innovation patents.The additional qualification utility patent is sometimes used (primarily in the US) to distinguishthe primary meaning from these other types of patents. Particular species of patents forinventions include biological patents, business method patents, chemical patents and softwarepatents.
3Meaning of CopyrightsCopyright is a legal concept, enacted by most governments, giving the creator of anoriginal work exclusive rights to it, usually for a limited time. Generally, it is "the right to copy",but also gives the copyright holder the right to be credited for the work, to determine who mayadapt the work to other forms, who may perform the work, who may financially benefit from it,and other related rights. It is a form of intellectual property (like the patent, the trademark, andthe trade secret) applicable to any expressible form of an idea or information that is substantiveand discrete.Copyright initially was conceived as a way for government to restrict printing; thecontemporary intent of copyright is to promote the creation of new works by giving authorscontrol of and profit from them. Copyrights are said to be territorial, which means that they donot extend beyond the territory of a specific state unless that state is a party to an internationalagreement. Today, however, this is less relevant since most countries are parties to at least onesuch agreement. While many aspects of national copyright laws have been standardizedthrough international copyright agreements, copyright laws of most countries have someunique features. Typically, the duration of copyright is the whole life of the creator plus fifty toa hundred years from the creators death, or a finite period for anonymous or corporatecreations. Some jurisdictions have required formalities to establishing copyright, but mostrecognize copyright in any completed work, without formal registration. Generally, copyright isenforced as a civil matter, though some jurisdictions do apply criminal sanctions.Most jurisdictions recognize copyright limitations, allowing "fair" exceptions to the creatorsexclusivity of copyright, and giving users certain rights. The development of digital media andcomputer network technologies have prompted reinterpretation of these exceptions,introduced new difficulties in enforcing copyright, and inspired additional challenges tocopyright laws philosophic basis. Simultaneously, businesses with great economic dependenceupon copyright have advocated the extension and expansion of their intellectual propertyrights, and sought additional legal and technological enforcement
4Copyright and the InternetAs the Internet has became more prevalent, the need for copyright protection there hasalso become a necessity. Today, copyright law has been adapted to protect Internet items, justas it has been adapted through the years to protect various other new mediums. It protectsoriginal work or work that is fixed in a tangible medium, meaning it is written typed, orrecorded. But because it was not designed specifically for the internet, in some areas copyrightlaw on the Internet can be as clear as mud.Copyright and the Internet: The International FrameworkRecently, International Copyright law rested on the Berne Convention for the Protectionof Literary and Artistic work and the Agreement on Trade-Related Aspects of IntellectualProperty Rights (TRIPS) of 1995. Issues relating to sound recordings and performances wereaddressed in Rome Convention for the protection of Performers, Producers of Phonograms andBroadcasting Organizations (1961). Since 1974, the international Copyright Instruments havebeen managed by a special United Nations Agency- the worlds. Since 1974, the internationalCopyright Instruments have been managed by a special United Nations Agency- the worldIntellectual Property Organisation (WIPO).Knowledge relating to medicinal plantsMere knowledge is difficult to protect legally, as it is intangible. One kind of protection isby means of asserting an intellectual property right, such as a patent, copyright, or trade secret.In the case of medicinal plants, traditional knowledge relating to these plants does not fallwithin any of these established categories. On the other hand, the use of technology, includingbiotechnology, to develop a useful product using this traditional knowledge is generallyprotected. The issue of bio-piracy in relation to such useful and financially productiveknowledge has come into Knowledge relating to medicinal plants prominence as a result of thecases challenging the patent granted on neem and on turmeric.
5In the turmeric case, the US Patent and Trademark Office granted a patent on the “use ofturmeric in wound healing”. India successfully challenged this patent by showing that this useof turmeric was well known and that nothing new had been invented. The documents relatingto this traditional knowledge of India were unknown to the US Patent and Trademark Office.When they were brought to the attention of the Office they were considered to be “prior art”and the patent was revokedIn the case of neem, the patent challenged referred to improving the storage stability of aninsecticide containing neem seed extracts. This patent could not be revoked as the patentholder (W.R.Grace & Co.) had improved on existing knowledge. While neem based insecticideswere well known, they did not have the storage-stability claimed in the patent. The patentedcomposition could thus be distinguished from the traditional knowledge.The cases of turmeric and neem are illustrative of the dilemma facing India in relation to thetraditional knowledge of medicinal plants. On the one hand, traditional knowledge is notdocumented in an easily accessible form so as to be considered “prior art”. On the other hand,where traditional knowledge is available as to the property of a particular plant, it can bemodified so as to be distinguishable from the original traditional knowledge for legal purposes.The end result is that a particular company may get the sole right to manufacture and sell theactive chemical compound derived from a plant, although communities may have used theplant for the same or similar purpose over a long period of time.The Patents (Second Amendment) Bill, 1999 has a limited form of protection for traditionalknowledge. It states that an Indian patent may be opposed or revoked if the invention wasanticipated having regard to the knowledge, oral or otherwise, available within any local orindigenous community in any country. This would need to be reciprocated by other countriesfor Indian traditional knowledge to be adequately protected. India has adopted a combinationof methods for the protection of medicinal plants. Wherever a pluralistic legislative frameworkis adopted, the efficacy of the system depends to a large extent on the amount of frictionbetween the parts. As each legislative proposal has been promoted by a different
6Governmental Department, it could be difficult for the national interest to be promotedwithout close co-operation between the different Authorities involved.Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs)In the fast developing world of today, when multilateral trade between different countries isthe order of the day, the agreement on TRIPs, which was signed by 138 Countries (as on July,2000), was by far the most important legislation to have been drawn up in order to provideprotection to the IPR holders against the differences in legal provisions on IPRs in variouscountries.TRIPS is an important international agreement, which:-Obliges new standard for various types of IPRs.Includes the multilateral trading system in which trade law and jurisprudence are takenin consonance with Intellectual Property Law and provides for effective disputesettlement process by WTO.Includes detailed standards for domestic enforcement of IPRs, both within as well asacross the borders of a country.Obliges protection on IPRs related to food, medicine and drugs in developing countries.Provides for higher level of protection for geographical indications and reversal ofburden of proof for process patentees.All WTO members were given one year i.e. up to January, 1996 to phase in these changes intotheir IPR or other laws and regulations. Developing and other countries were given anadditional four years time i.e. up to January, 2000 and the least developed countries ten yearsi.e. up to January, 2006. A further period of five years i.e. up to January, 2005 was given todeveloping countries for introducing the product patents in the field of technology excludedthus far from their patent laws. Therefore, developing countries effectively have time up toJanuary, 2005 to promulgate regulations on product patents on food, medicines and drugs (9).
7Convention on Biological Diversity (CBD)The prime objective in Article 1 of CBD is to conserve biological diversity on one hand and toprovide appropriate access to this resource for utilization. Moreover, the signatories of CBD arerequired to "respect, preserve and maintain knowledge" of indigenous communities. The use ofthe term "traditional" along with the term "knowledge, innovation and practices" implies allnotions of time bound and historical. As a result the traditional knowledge systems ofindigenous communities fall within the purview of this article. This usage of terms also bestowsownership of knowledge, innovation and practices upon indigenous local communities.Moreover, this article also encourages equitable sharing of benefits, thereby making theindigenous communities as stakeholders in benefits arising out of the utilization of knowledge,innovation and practices.The article 8j also emphasizes upon in situ conservation of knowledge, innovation and practicesof indigenous and local communities. Conservation of indigenous knowledge would therefore,include conservation of bio-resources being used.Article 15 emphasizes the access to genetic resources and reaffirms the sovereignty rights ofStates over their natural resources as an established principle of international law. Therefore, itindirectly implies that natural resources are under the ownership of States and cannot bepatented by individuals. Only the use of these bio-resources can be patented and in, that too,the traditional knowledge holders will have a stake.Article 16 makes a direct reference to IPRs by emphasizing on the access to and transfer oftechnology. It outlines that the access to and transfer of technology to the developing worldshall be facilitated under fair and favorable terms. In case of technology subject to patents andother IPRs, such access and transfer of technology shall be provided on terms, which recognizeand are consistent with effective protection of IPRs on mutually agreed terms.Article 17 and 18, stress upon the exchange of the information, which is to be facilitated bycontracting parties by all publicly available sources including indigenous and traditional
8knowledge. Most indigenous and traditional knowledge is based on the utilization of bio-resources becomes important.TRIPs and BiotechnologyAt the time of the TRIPs negotiations in the Uruguay Round, the US and the EU differed in theirapproaches to the patenting of biotechnological inventions. While the US believed that`anything under the sun made by man, except human beings, was patentable, the EU wasgrappling with strong internal resistance to patents on living organisms. Since the debate hadnot yet been settled in committing to revisit this provision within four years from the entry intoforce of TRIPs i.e. by 1999. Article 27.3(b) of TRIPs incorporates this minimal agreement.Article 27 of TRIPs requires that patents be made available, for both processes and products, inall fields of technology. Under Article 27.3(b), plants and animals, and essentially biologicalprocesses for their production may be excluded from patentability. However, microorganismsand microbiological or non-biological processes must be protected. While there is uncertaintyas what is "biological, clearly, microorganisms and microbiological processes are not excludedfrom patent protection despite resistance from some developing countries during the TRIPsnegotiations.Controversies Related to IPRsAlthough, CBD provides for access and sharing of biological resources on one hand and TRIPSprovides for exclusion of plant and animal material from patenting, yet, there has been a spurtin the arena of IPRs, which periodically give rise to controversies. Some such controversies areas given below:-The patenting of ancient herbal remedies, for instance, the US Patent (No. 5,401,504)given to the healing properties of turmeric, known for centuries to Indians.The US Plant Patent (No. 5751) on the "Ayahuasca Plant", which is considered sacredand used for medicinal purposes by Amazons indigenous people.
9The patenting of crop varieties whose name is similar to those grown for centuries incertain geographical areas, for instance, the term Basmati used by US Firm Rice-TecCorporation (Patent No. 5,663,484). The term Basmati is used for certain varieties of ricegrown in Northern India.The patenting of human genetic material, for instance, on the human cell line of Hagahaitribesmen from Papua New Guinea (US Patent No. 5,397,696).Conclusion:The potential for integration is great in India. Traditional medicine is widely understoodand greatly respected. Walk down an Indian street and you will see stalls set up as minitraditional hospitals where many poor people consult Ayurvedic doctors. At the same time,modern drugs are also widely used, particularly in urban areasNot only are we great practitioners of modern and traditional medicine, we also host a richsource of raw materials for both. Medicinal plants abound in the subcontinent, particularly inthe Himalayan regions in Kashmir, the Western Ghats and Pakistans North-West Frontier. Wehave huge reserves of herbal plants and remedies, many of which remain unknown to modernscience.There are already efforts to try and tap these reserves — many pharmaceuticalcompanies in India are screening wild herbs for medicinal uses and are making medicines withboth modern and traditional components. Such research and development efforts wouldbenefit from involving tribal people, who are often experts in local herbal remedies.The potential for integrating traditional medicine is great, so too are the challenges. The lack ofawareness about medicinal plants and widespread deforestation of areas rich in biodiversityposes an enormous threat. Human activity has put much pressure on the subcontinents wildflora and many plants have become rare, and precious information lost.In particular, many medicinal plants now stand on the brink of extinction because ofdevelopment in tribal areas that have historically provided most of these precious resources.
10Wild tuberous plants in Rajasthan, for example, are under severe threat from environmentalpollution.Protecting these resources and integrating them into modern medical practice would bringenormous benefits. Not only could we develop new drugs but we would also provide muchneeded job opportunities — from researchers and medical professionals to field workers andfarmers — in a country suffering an unemployment crisis.***********************