Intellectual Property Rights For Life Forms: A Legal Discourse To Indian Legal Framework
This article attempts to define and analyses the various legal regimes
governing intellectual property rights in the protection of life forms, the
patent on life forms, and plant varieties and sets forth regulatory options for
national governments to protect plant varieties while achieving other public
policy objectives relating to plant genetic resources.
A patent can be understood as an IPR relating to inventions and is the grant of exclusive right, for a limited period, provided by the Government to the patentee, in exchange for full disclosure of his invention, for excluding others, from making, using, selling, importing the patented product or process producing that product for those purposes.
It also identifies the international institutions and intergovernmental organizations that regulate intellectual property rights in plant varieties and plant genetic resources generally and describes the core obligations outlined in international intellectual property agreements.
Introduction
A life form is an entity or being that is living or alive. A life form can be anything from a virus or a plant to a human being. Traditionally, patents have applied solely to inventions, granted as a reward for ingenuity and to encourage innovation. Naturally occurring substances, like DNA, were exempt from such laws. Now the issue is should living things be patented?
The existing study describes and analyses the various international legal regimes governing intellectual property rights in the protection of life forms and plant varieties and sets forth regulatory options for national governments to protect plant varieties while achieving other public policy objectives relating to plant genetic resources. It identifies different sets of policy options for governments based upon the specific constellation of treaty commitments they have undertaken.
Central issues
The international community realized this around the early 1990's and fallout of this realization came out in the form of Trade Related Aspects of Intellectual Property Rights (TRIPs) agreement in 1994 and its enforcement on 1st January 1995. A patent is an exclusive right granted to the inventor or creator of a useful or improved article or a new process of making an article for a specified period. India is a member of the World Trade Organization (WTO) and a signatory to the WTO agreement on TRIPs.[1]
According to the TRIPs agreement, [2]India has amended its patent legislation which is governed by the Patent Act, 1970 on three occasions. The case of Diamond v/s Chakrabarty in 1980 led to the general trend of patenting inventions on living matter. In India, the position was made clear after the 2002 amendment to the Indian Patents Act. The amended act stated that life forms can be patented provided they satisfy the other requirements.
The improvements in the Indian patent regime have resulted in a significant upthrust in the promulgation and enforcement of patents in India. Now, India can boast of one of the best patent law regimes in the world.[3]
The relevant TRIPS provisions under review, says India, have three dimensions. Firstly, whether and what form of exclusion from patentability should apply to plants and animals per se (patenting of life forms). Secondly, the review could consider the effect of protection granted to micro-organisms and non-biological and microbiological processes (scope and definition of microorganisms).[4]
Thirdly, whether and what form of protection of plant varieties through sui generis systems is an effective form of protection (effectiveness of plant variety protection). Patenting of life forms, according to India, may have at least two dimensions. Firstly, there is the ethical question of the extent of private ownership that could be extended to life forms.
The second relates to the use of the IPRs concept, as understood in the industrialized world, and its appropriateness in the face of the larger dimension of rights on knowledge, their ownership, use, transfer and dissemination. International IPR regimes recognize formal systems of knowledge only, India maintains. Informal systems, e.g. the shrutis and smritis in the Indian tradition and grandmothers' potions all over the world get scant recognition.[5]
To create systems that fail to address this issue can have severe adverse consequences on mankind, some say even leading to our extinction, the Indian paper warns. India says there is clearly a case for re-examining the need to grant patents on life forms anywhere in the world.
Till such systems are in place, it may be advisable to:
Patent protection in India brings unique considerations for life sciences industry because of the typical statutory exclusions on certain aspects of innovations, for which no patent protection is available. Apart from the regular three leg test of novelty, inventive step and industrial applicability, Indian patent laws have specifically listed certain subject matters, which despite passing the three leg test, may not be protected.
Some of the relevant subject matters related to life sciences industry that are excluded from patent protection in India are, inventions that could be contrary public order or morality or which cause serious prejudice to human, animal or plant life or health or to the environment - clause 3(b); inventions that are mere discovery of living or non-living substance occurring in nature- clause 3(c); inventions that are mere discovery of a new form of a known substance and does not have enhanced efficacy or the mere discovery of any new property or new use of a known substance or mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant - clause 3(d); inventions that are directed to a substance obtained by a mere admixture or a process for producing such substance - clause 3(e); inventions directed to methods of agriculture or horticulture - clause 3(h); inventions that are a process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or animals- clause 3(i);inventions that are directed to plants and animals in whole or any part thereof other than micro-organisms or essentially biological processes - clause 3(j); and inventions that are related to aggregation or duplication of the traditional knowledge - clause 3(p).[7]
India also provides a sui generis law to protect inventions/ innovations related with the development of plant varieties, which are commercially exploited by production and sale of seeds or plant material. However, protection under the Protection of Plant Varieties and Farmers' Rights Act is available only for notified varieties and any plant variety that is not in the notified list cannot be protected.[8]
In India considerable efforts at different levels have been made to strike a balance regarding legislative requirements and the interest of industry, particularly in IP for effectively securing the gains of huge investment of resources in developing the inventions/innovations.[9] The past decade has witnessed considerable improvements in Indian industrial policies and IP practices by adopting different procedural and policy measures, which have created conducive environment for the growth of industry and IP protection. India is undoubtedly advancing rapidly towards a strongly supported Industrial regime with strong IP environment.[10]
Genetic engineering techniques are currently being used to produce a wide range of new products, which the biotechnology industry believes will benefit all citizens. Most research involves plants and animals although some effort is now being put on genetically engineered microbes, such as nitrogen fixing bacteria, frost suppressive bacteria, and some microbial soil amendments.
Genetically Modified Organisms
A genetically modified organism (GMO) is an organism whose genetic material has been altered using techniques in genetics generally known as recombinant DNA (rDNA) technology. DNA technology is the ability to combine DNA molecules from different sources into the one molecule in a test tube. Thus, the abilities or the phenotype of the organism, or the proteins it produces, can be modified through the modification of its genes. The term generally does not cover organisms whose genetic makeup has been altered by conventional cross breeding or by "mutagenesis" breeding as these methods predate the discovery of the recombinant DNA techniques.
Genetically Modified Animals
Like bacteria and plants, animals can be genetically modified by viral infection. The genome of an animal embryo can be modified by the addition of synthetic chromosomes, targeted removal of certain genes, or addition of genes. The embryo can then be implanted into a mother to develop.
However, the genetic Modification occurs only in those cells that become infected, and in most cases these cells are eventually eliminated by the immune system. In some cases it is possible to use the gene transferring ability of viruses for gene therapy, i.e. to correct diseases caused by a defective gene by supplying a normal copy of the gene.[11]
Genetic Engineering and Plants
Herbicide tolerant plants won't die when sprayed with broad spectrum Herbicides, thereby allowing the herbicide to be used more Insect and disease resistant plants contain toxins and other factors produced by other organisms, including bacteria, scorpions and other venomous organisms. The toxins enable the plant to resist pests. Delayed ripening allows food to be shipped farther. For example, genetic engineering allows the regulation of ripening in the trademarked FLAVR SAVR tomato.
Environmental tolerance enables plants to become more drought resistant, freeze tolerant, and so on. This allows the geographic range of crops such as corn and soyabeans to expand, potentially intensifying monoculture cropping and transforming local economies.[12]
Genetic engineering and animals
Essential nutrients may no longer be required in animal feed if animals are engineered to no longer need these nutrients. Faster development may result from engineering animals that eat more or digest more efficiently so that they can grow larger and/or be slaughtered earlier. However, growing fast creates problems for the animal; some of these animals may be more prone to disease and stress. Environmental tolerance is a factor being engineered in certain animals that currently cannot tolerate cold or heat or wetness or dryness.
Human Genetic Engineering
Serious ethical issues arise even more starkly in the case of attempts to patent human genetic material or information. Human genetic engineering deals with the controlled modification of the human genome.[13]
Human genetic engineering means changing the genes in a living human cell. If a person had a lung disease caused by defective genes in the lung cells, he might be cured if there was a way to fix those genes. Scientists change the genes in living cells by putting the desired "new" gene into a little virus-like organism which is allowed to get into your cells and which inserts the new gene into the cell along ith the "old" genes.
Human Genome and IPR
In 1953, two scientists, one from the United States and the other from Britain, Dr. J.D. Watson and Dr. F.H.C. Crick, published in 'Nature' magazine an essay that was to revolutionise our understandings of the basic forms of life. Not just human life, but all forms of life. They provided a model for understanding the process of the transfer of genetic information between generations of the same organism.
The early, primitive discoveries came together and were explained by Watson and Crick. They proposed that the basic determinates of living matter were to be found in DNA, in a structure described as the double helix. DNA was the molecule which carried the genetic code that would unlock the truth known instinctively by farmers and described in a primitive but accurate way by Mendel. From that moment to this, the search has been undertaken to explore the DNA and to unlock its remaining secrets.[14]
Patenting In Biotechnology
Patenting in Biotechnology is a crucial issue because it involves life forms. This, in the world Context, apart from being hit by moral and ethical issues, has been criticized heavily on the basis of mere modifications on substances occurring in nature and its subsequent modification by human intervention.[15] The world has reached a stage where it can justify Biotechnology Patents and the debates and discussions on whether patenting on life forms should be granted as such.
"Broadly defined, biotechnology may be considered as the production of useful products from living micro-organisms and cell cultures, and as such it has been with us since the first nameless biotechnologist discovered that fermentation did interesting things to grape juice.[16]
Today biotechnology is most closely identified with work involving changes to the genetic make-up of an organism, the so-called genetic engineering. As a result of this engineering, new and improved drugs have been constructed. These include human insulin, interferon, vaccines, and treatments for a host of human afflictions such as septic shock, anemia, diabetes, AIDS, cancer, hepatitis, and heart attack.[17]
Biotechnology is also the area of human endeavour which has simultaneously produced controversy and modified higher life forms like the Harvard and Dupont mice, and, modified not so high life forms such as microorganisms for use in environmental areas such as oil spill cleanup technology.[18]
Therefore, the subject matter ranges from DNA sequences, microorganisms, genetically modified organisms, Plant variety and Animal Variety because they are produced using Biotechnology. Bio-matter is a term broad enough in scope to capture all "products" related to biotechnology. Compounds and organisms per se are what constitute bio-matter.[19] Within this category, there are two main groups of "products": living and non-living.
Examples of Non-living Bio-matter include, amino acids, peptides, proteins, fats and fatty acids, and nucleic acids. These kinds of compounds are better recognized when referred to by their more commonly known names of antibodies, hormones, enzymes, antibiotics, steroids, cholesterol, HLDL, VLDL, and DNA molecules. Although complex, they are all really just chemical compounds5. Also, under this head, somewhere between living and non-living, we have the Viruses.[20]
Bio-diversity of India will be an advantage for Biotech companies. Vast reservoir of scientific human resource with reasonable cost, wealth of R&D institutions, centers of academic excellence in Biosciences Vibrant Pharmaceutical Industry and fast developing clinical capabilities collectively point to promising biotech sector. Over 300 companies and 241 institutions use some form of biotechnology in agricultural, medical or environmental applications.
Diamond v. Chakrabarty[21]
To begin with, a panel of thirteen judges of the Court of Justice of the European Communities heard The Netherlands v European Parliament29. In response to a challenge to the validity of the European Biotechnology Directive30, the court commented: The biotechnological industry began to develop seriously after a decision by the US Supreme Court in 1980 that 'a live, human-made micro-organism is patentable subject matter' (Diamond v Chakrabarty).[22]
That case concerned an invention of a human-made, genetically engineered bacterium capable of breaking down crude oil. The Supreme Court held (by a 5:4 majority) that the micro-organism constituted a 'manufacture' or 'composition of matter' within the meaning of the Patent Act 1952 (The wording derived unchanged from the first Patent Act 1793, authored by Thomas Jefferson.). The court noted that the committee reports accompanying the 1952 Act indicated that Congress intended statutory subject matter to 'include anything under the sun that is made by man.[23]
Opinion of Judges in the Judgment
It was stated in the case that, A live, human-made microorganism is patentable. Respondent's micro-organism constitutes a "manufacture" or "composition of matter" within that statute.
In choosing such expansive terms as "manufacture" and "composition of matter," modified by the comprehensive "any," Congress contemplated that the patent laws should be given wide scope, and the relevant legislative history also supports a broad construction. While laws of nature, physical phenomena, and abstract ideas are not patentable, respondent's claim is not to a hitherto unknown natural phenomenon, but to a non-naturally occurring manufacture or Composition of matter - a product of human ingenuity "having a distinctive name, character [and] use.
The passage of the 1930 Plant Patent Act, which afforded patent protection to certain asexually reproduced plants, and the 1970 Plant Variety Protection Act, which authorized protection for certain sexually reproduced plants but excluded bacteria from its protection, does not evidence congressional understanding that the terms "manufacture" or "composition of matter" in do not include living things.[24]
The Indian Patent Act of 1970 did not earlier permit the granting of patents on life forms and related technologies. These and other substances in the areas of agriculture, horticulture, and curing or enhancing human animal or plant life were not patentable "on the grounds of law, morality, and health". In the case of food, medicine, drugs, and chemicals, only process
patents were allowed, since it is believed that the grant of product patents will inhibit the discovery of more efficient an economical processes for the manufacture of the same product.
Experts have hailed these aspects of the Act as amongst the most socially progressive in the world.[25]
The problem is that the phrase "plants and animals other than microorganisms" does not cover parts of animals and plants, nor does it include altered plants and animals and therefore allows the patenting of biological organisms. Also the worlds "other than microorganisms" prevent the exclusion of microorganisms from patentability and make patenting of microorganisms compulsory.
Since microorganisms are living organisms, making their patenting compulsory is the beginning of a journey down the slippery slope that leads to the patenting of all life. The best example of this slippery slope can be seen in the history of United States patent law where the granting of patents to microorganisms signaled the taking of a first step to granting patents to so-called higher life forms.
In 1971, General Electric and one of its employees Ananda Mohan Chakrabarty applied for US patent on a genetically engineered pseudomonas bacterium. Taking plasmids from three kinds of bacteria, he transplanted them into the fourth. As he explained, "I simply shuffled genes, changing bacteria that already existed".
The John Moore Case
In 1976, a leukemia patient, John Moore had surgery at the University of California to remove a cancerous spleen. The University was later granted a patent for a cell line called Mo, removed from the spleen, which could be used for producing valuable proteins. The long-term commercial value of the cell line has been estimated at over $1 billion. Permission had not been sought of John Moore for the use of his body parts.[26]
Moore demanded the return of the cells and control over his body parts. In 1984, he filed a lawsuit claiming that his blood cells were misappropriated while he was undergoing treatment for leukemia at the University of California, Los Angeles Medical Center. During his treatment, Moore's doctor developed a cell line which proved valuable in fighting bacteria and cancer. The UCLA Board of Regents filed a patent claim on this cell line and commercially developed valuable antibacterial and cancer-fighting pharmaceuticals.
Moore claimed that he was entitled to share in profits derived from commercial uses of these cells and any other products resulting from research on any of his biological materials. In a significant 1990 California Supreme Court decision, the court established that a donor does not have a "property right" in the tissues removed from his or her body.[27]
The court further reasoned that to favour John Moore's claim would "...hinder research by restricting access to the necessity raw materials," thereby interfering with the progress of science.[28]
Protection of the Indigenous Communities
Genetic manipulation raises serious ethical and moral concerns with regard to the sanctity of life. For indigenous peoples, any violation of the natural law and the natural order of life is
Abhorrently wrong. Scientists are genetically manipulating existing life forms, altering the course of natural evolution, and creating new life forms. Genes are living organisms which reproduce, migrate and mutate. The full impact of genetically manipulated life forms cannot possibly be anticipated.
Indigenous people must engage in community education and discussion about the full scope of this project and the potential dangers of genetic manipulation. It is imperative that indigenous communities become fully aware of the implications of this project, and learn whether any genetic sampling is being conducted or is proposed to take place in their areas.
Protection of Life Forms
The distribution of property rights over biological resources has been a. longstanding concern in international law. Indeed one of the cardinal principles of international law since decolonisation has been the permanent sovereignty of states over their Natural resources.[29]
Law in the area of life patenting has been developing in the west for the last two decades, keeping pace with the developments in biotechnology. According to Iver P Cooper "Biotechnology is a new word for an old idea, the idea of a technology based on the use of other living things". The advancements in this area proved that genetic constitution of living beings can be altered.
This resulted in the emergence of genetic engineering as a scientific revolution which promises even the creation of new life. The subject matters of biotechnological inventions are micro-organisms, hybrid plants, genetically engineered animals, Gene therapy, genetically engineered vaccines and new antibody technology, Recombinant DNA technology popularly known as genetic engineering, used for developing disease resistant plants, herbicide resistant crops human genes and cell lines. The high commercial potential of genetic researches made this branch of science a focal point of trade and investment.[30]
The new biotechnological approach implies that crops. as such are not the raw materials, but rather the compound in them starch, protein, fats and oils etc. As such, producers of such commodities, farmers, fishermen and big multinational companies will all be competing with each other for selling their commodities in the international market - a competition between unimaginable unequal.
Based on this policy the US Patent office granted the first patent on an animal the Harvard On comouse the patent was for transgenic non-human mammal. The mouse disclosed in this patent was bearing activated ontogenesis in its genome as a-result of which it had an increased susceptibility to cancer . Even though this patent is generally referred to as the Harvard Oncomouse patent, the claims allowed under the patent were of considerable breadth and not limited to mice.[31]
Patenting of living beings in U.S. is no more confined to microorganisms. In 1995 the scientists at the University of Utah succeeded in. finding BRCA, the breast cancer gene. They got it patented in US and the small biotech company which they started, to commercially exploit the invention, turned to be a market gain. Subsequently, W. French Anderson of the national Institute of Health (NIH) of US obtained a broad patent on human gene therapy in 1995. Mammals, human genes and cell lines, nothing is left out now from the purview of patents in US.[32]
India being a member of the WTO was required to provide product patents on microorganism before Jan 1st, 2004, which has already been done vide the patent (Amendment) Act, 2002 as is evidenced by the following amended portion of S3 of the patent Act, 1970 (as amended 2002). Exclusion clause implies inclusion in "invention". Thus any process for the medicinal, surgical, curative, prophylactic ... or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products (in the case of plants) is not excluded from patentability and thus patentable.[33]
Indian Judicial Initiative
Calcutta High Court on 15th January 2002 has given a landmark decision allowing claim for grant of patent to genetically engineered microorganism called infectious bursitis vaccine. The appellant had filed a patent application for an inventive process of preparing infectious bursitis vaccine.
The application was rejected by the Patent Authorities on the ground that:
Contention of the appellant was that preparation of infectious bursitis vaccine is an invention because:
Taking into consideration the arguments of both sides, The High Court held as under:
The Protection of Plant Varieties and Farmers' Rights Act was passed by the Indian Government in 2001. After India became signatory to the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPs) in 1994, a legislation was required to be formulated. Article 27.3 (b) of this agreement requires the member countries to provide for protection of plant varieties either by a patent or by an effective sui generis system or by any combination thereof.
Thus, the member countries had the choice to frame legislations that suit their own system and India exercised this option. The existing Indian Patent Act, 1970 excluded agriculture and horticultural methods of production from patentability. The sui generis system for protection of plant varieties was developed integrating the rights of breeders, farmers and village communities, and taking care of the concerns for equitable Sharing of benefits. We attempt here to critically analyse the provisions of legislations for their effective implementation.
Plant Variety Protection.[35]
Plant variety protection, also called a "plant breeder's right," is a form of intellectual property right granted to the breeder of a new plant variety in relation to certain facts concerning the exploitation of the protected variety which require the prior authorization of the breeder. As in the case of patents, trademarks and industrial designs, prior examination and granting by the relevant authority is required to establish the breeder's right.
However, to understand more completely what a plant variety is, the UPOV Convention (Article 1(vi)) defines it as: "a plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a breeder's right are fully met, can be defined by the expression of the characteristics resulting from a given genotype or combination of genotypes, distinguished from any other plant grouping by the expression of at least one of the said characteristics and considered as a unit with regard to its suitability for being propagated unchanged."
The UPOV Convention
The UPOV Convention (Article 1(iv)) defines a breeder as: "The person who bred, or discovered and developed, a variety, the person who is the employer of the aforementioned person or who has commissioned the latter's work, where the laws of the relevant Contracting Party so provide, or the successor in title of the first or second aforementioned person, as the case may be." The breeder might be, for example, an amateur gardener, a plants man, a farmer or a scientist. The plant breeding techniques used can range from traditional crossing and selection through to new techniques, such as genetic engineering".
The UPOV Convention (Article 3) requires the grant of protection for the varieties of all plant genera and species in order to give breeders more encouragement to work with new species with the appropriate legal certainty.
The development of new plant varieties is protectable in most countries as a species of intellectual property right (IPR) derived from the International Convention for the Protection of New Varieties of Plants (UPOV). Countries which are members of the World Trade Organization (WTO) are obliged by Article 27.3(b) of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) to 'provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof'.[36]
The TRIPS Agreement does not specify which 'sui generis system' will meet its requirements, but most of the 153 members of the WTO have promulgated domestic legislation based upon the 1991 version of UPOV.[37]
The International Union for the Protection of New Varieties of Plants, known as "UPOV," is an intergovernmental organization with legal personality and which has its headquarters in Geneva, Switzerland. UPOV was established by the International Convention for the Protection of New Varieties of Plants (hereinafter referred to as the UPOV Convention), which was adopted in Paris in 1961. This was the point at which there was recognition of the intellectual property rights of plant breeders in their varieties on an international basis.
International IPR Agreements Regulating Plant Varieties and Plant Breeders' Rights
The two major treaty systems that regulate different international IPR agreements that protect plant varieties and plant breeders' rights are as discussed as follows. The UPOV treaties adopt a sui generis system of protection (that is, a system that is unique, or of its own kind) especially tailored to the needs of plant breeders.
The TRIPs Agreement requires WTO Members to protect new plant varieties using patent rights, a sui generis system or some combination thereof. TRIPs provides states with this flexibility and because the treaty has an uncertain relationship to the previously adopted UPOV conventions, national governments face a wide array of options in choosing the intellectual property regime applicable to plant varieties. This section of the study outlines the requirements imposed by these two treaty systems, and Part III of the study then identifies and analyses these options.
The UPOV Convention established for members of the Union a legal framework with the following key features: [38]
Plant Variety Protection and the TRIPS Agreement
The TRIPs Agreement
TRIPs as a spur to plant variety protection, TRIPs' influence on plant variety protection stems from the following sources:
The following paragraphs briefly address each of these five issues. Subsequent sections devote more detailed treatment to the protection of plant varieties with patents and to the elements necessary to create an Effective sui generis system.
Although the UPOV Acts have provided IPR protection for plant varieties for more than forty years, their significance has recently been overshadowed by a different intellectual property treaty, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs or the TRIPs Agreement).
Adopted in 1994 as a treaty administered by the WTO,[39] TRIPs is the first and only IPR treaty that seeks to establish universal, minimum standards of protection across the major fields of intellectual property, including patents, copyrights, trademarks, industrial designs, integrated circuits and trade secrets.
Although the TRIPs Agreement devotes only minimal attention to plant breeders' rights or plant variety protection and does not even mention the UPOV Acts, its adoption has done more to encourage the legal protection of plant varieties than any other international agreement.
Under the TRIPS Agreement, all developing countries other than those categorized as least developed countries ("LDCs") had to provide intellectual property rights protection for plant varieties by January 1, 2000. LDCs have until January 1, 2005, to meet the same obligation.[40]
The relationship of TRIPs to the WTO and the international trading system
Unlike all prior intellectual property treaties, TRIPs is not a free-standing agreement concerned solely with IPRs. Rather, TRIPs is linked to a larger family of trade-related agreements concerning subjects such as trade in goods and services, agriculture, textiles and health-related restrictions on imports.
All of these agreements were adopted within the WTO during the Uruguay Round of trade negotiations held between 1988 and 1994. As such, TRIPs was part of a global "package deal."
Industrialized nations secured a commitment from developing nations to provide minimum standards of effective legal protection to intellectual property products, and in exchange developing nations received a commitment from industrialized countries to open their domestic markets to goods and other products manufactured in the developing world.[41]
The enforcement, review and dispute settlement provisions of TRIPs
In addition to its widespread adherence, the influence of the TRIPs Agreement can be traced to its unique provisions relating to the enforcement of IPRs within national laws, the review of those national laws by the TRIPs Council and the mechanism for settlement of disputes between states leading to rulings backed up by the threat of trade sanctions.
The UPOV Acts
The first UPOV Act was drafted in 1961, principally by industrialized governments seeking to provide protections for plant breeders in their own and overseas markets. The UPOV was later revised in Acts adopted in 1972, 1978 and 1991. As of July 2004, 55 states were parties to UPOV - 29 to the 1978 Act, 24 to the 1991 Act and 2 to the 1972 Act. (States Parties to the UPOV, Status on 30 June 2004).
As a result, this study will focus on the two most recent UPOV Acts. Many of the accessions to these Acts are quite recent, with a number of developing states and countries in transition to a market economy acceding in the 1990s. The 1991 Act entered into force on 24 April 1998 and on that same date the 1978 Act was closed to future accessions except by a few states already in the process of adhering to it.
Countries generally give domestic effect to the UPOV Act to which they are a party in one of two ways. In "automatic incorporation" states, courts and administrative agencies directly apply and enforce the Act, although implementing legislation is often needed to authorize administrative agencies to process applications to protect new plant varieties. In "legislative incorporation" states, by contrast, the UPOV Act does not become enforceable in domestic law until the state enacts a national plant variety protection law that conforms to the Act's requirements.
The 1978 UPOV Act
The 1978 UPOV Act adopts most of the international IPR obligations set out in Part I above, including a definition of the applicable subject matter and protected material, eligibility requirements, exclusive rights, national treatment, reciprocity, terms of protection and exceptions and limitations to exclusive rights. It does not, however, contain any provisions on MFN treatment or enforcement.
Subject matter requirements
Limited number of protected genera or species. Not all plant varieties must be protected under the 1978 Act. Rather, article 4 provides that member states are to progressively extend protection to an increasing number of genera or species, beginning with five on the date the treaty enters into force for that state and ending with twenty-four within eight years. In addition, member states are free to limit the Act's application within a particular genus or species to varieties with a particular manner of reproduction or multiplication, or a certain end-use.
Novelty. To avoid protection for plant varieties that have already been exploited or are a matter of common knowledge, a new variety in which a breeder seeks protection must not have been sold on the market for more than a specified period of years prior to the date of application for protection. The 1978 Act specifies the maximum number of years during which such pre-application sales have occurred, with different periods of time set for different types of plants as well as for sales within the territory of the applicant state versus the territory of other states. (art. 6(1)(b))
Eligibility Requirements
When a variety fulfils these four criteria, it is listed in a national register or catalogue which publicly discloses that the variety is protected.
Distinctness
The 1978 Act states that a protectable plant variety must be "clearly distinguishable in one or more important characteristics from any other variety whose existence is a matter of common knowledge at the time when protection is applied for." (art. 6(1)(a)). Although the treaty itself does not further define distinctness, the Guidelines for the Conduct of Tests for Distinctness, Homogeneity and Stability (UPOV Guidelines) use both qualitative and quantitative plant characteristics, including such visible attributes as leaf shape, stem length and color, to determine if the difference between varieties is "clear and consistent."
As explained below in the analysis of the UPOV 1991 Act, the concept of distinctness is critical to determining the scope of a breeder's right in plants that are closely related but not identical to a protected variety.
Homogeneity
Under the 1978 UPOV Act, a variety has to be "sufficiently homogeneous, having regard to the particular features of its sexual reproduction or vegetative propagation." (art. 6(1)(c)). The UPOV Guidelines further clarify that to be considered homogeneous; the variation shown by a variety must be "as limited as necessary to permit accurate description and assessment of distinctness and to ensure stability." The homogeneity requirement has been criticized by commentators as discouraging variability in plant varieties that are often useful for sound agricultural practices and as denying protection to breeders of cultivated landraces that exhibit diversity traits.
Stability
The stability requirement is a temporal one, requiring the breeder to show that the essential characteristics of its variety are homogeneous or uniform over time, even after repeated reproduction or propagation. (art. 6(1)(d)) In practice, what has been shown to be homogeneous is usually considered to be stable as well. For this reason, the stability requirement has engendered the same sort of critiques as the uniformity requirement in its preclusion of protection for cultivated landraces and other traditional plant varieties.
Breeders' exclusive rights
Under article 5 of the 1978 Act, any person seeking to engage in the following three acts, with respect to a protected variety's reproductive or vegetative propagating material, must obtain the prior authorization of the breeder: production for purposes of commercial marketing, the offering for sale and marketing.[42]
The 1978 Act does not, however, require member states to extend these exclusive rights to harvested material or other marketed products.
National Treatment and Reciprocity
Member states must grant the three exclusive rights referred to in the preceding paragraph in the same manner to both national breeders and to breeders who reside in or are nationals of other 1978 Act member states.[43] However, where a state extends legal protection to a specific genus or species, or where it provides more extensive exclusive rights to breeders than the rights required under the treaty, reciprocity is permitted. Thus, a state providing these additional rights may restrict protection to breeders from those member states that apply the Act to the same genus or species, or that provide such additional exclusive rights to their own nationals. (arts. 3 and 5(4))[44]
Term of protection
The 1978 Act requires a minimum term of protection of fifteen years, with the exception of vines, forest trees, fruit trees and ornamental trees, which are protected for no less than eighteen years.
Breeders' exemption
This exemption in article 5(3) precludes member states from granting to breeders of protected varieties the right to authorize or refrain from authorizing other breeders seeking to use the protected variety to create new varieties or to market those new varieties. States are permitted to grant breeders such an authorization right only if the repeated use of the protected variety is necessary for the commercial production of the new variety. According to the International Association of Plant Breeders and the International Seed Federation, this breeders' exemption "is essential for continued progress from plant breeding.[45]
Farmers' privilege
The focus of the 1978 Act on commercial exploitation of protected plant varieties has been interpreted to allow the use of seeds and propagating material for non-commercial purposes without the breeder's prior authorization.[46]
In national plant variety protection laws, this implicit non-commercial exception most frequently benefits farmers who purchase the seeds of protected varieties. The scope of this so-called farmers' privilege varies widely, however. Some nations only permit farmers to plant seeds saved from prior purchases to be used on their own land holdings, while others allow them not only to replant but also to sell limited quantities of seeds for reproductive purposes, a practice often referred to as brown bagging.
The 1991 UPOV Act
The limited scope of the 1978 Act led a number of member states of the UPOV to adopt a revised Act with enhanced rights for plant breeders. The major revisions of the 1991 Act are discussed below:
Subject matter requirements
Unlike its predecessor, the 1991 Act requires states to protect at least fifteen plant genera or species upon ratifying or acceding to the Act, and to extend protection to all plant varieties within ten years. (art. 3(2)) It also contains a definition of a plant "variety" as a "plant grouping within a single botanical taxon of the lowest known rank" which can be "defined by the expression of the characteristics resulting from a given genotype or combination of genotypes; distinguished from any other plant grouping by the expression of at least one of the said characteristics; and considered as a unit with regard to its suitability for being propagated unchanged." (Art. 1(vi))
No definition of "variety" appears in the 1978 Act, which indicates that member states to that earlier treaty have greater discretion in defining the characteristics of plant groupings that qualify for protection.
Breeders' exclusive rights in protected material
Extensive additions to the 1978 Act were made with respect to the exclusive rights enjoyed by breeders in protected material of plant varieties.
Enumerated Exclusive Rights in Propagating Material
The breeder's prior authorization must be obtained for the use of reproductive or vegetative propagating material of the variety for:
National Treatment Required
Whatever the particular exclusive rights member states adopt in their plant variety protection laws, those rights must also be provided to the nationals of other 1991 Act member states. Unlike the 1978 Act, granting rights only on condition of reciprocity is not permitted. (art. 4)
For example, if a 1991 Act member chooses to grant more expansive exclusive rights to breeders than the exclusive rights required by the 1991 Act, it must grant those rights to breeders from all other 1991 Act member states. The state cannot choose to grant such expansive rights to only those 1991 Act states that also provide the same level of rights protection to the first state's nationals.
Terms of protection:
The 1991 Act extends the term of protection to 20 years, and requires a 25-year term for tree and vine varieties.
International Legal Framework
The WTO Doha Round of trade negotiations
On 14 November 2001, trade ministers from the WTO's than 142 Members meeting in Doha, Qatar agreed upon the text of several official declarations to serve as the framework for a new round of trade negotiations. These declarations do not expressly address the issue of plant variety protection. They do, however, suggest that the WTO will conduct an expansive review of the relationship between IPRs in plants and competing policy objectives as it considers whether and in what ways to revise the current text of the TRIPs Agreement.
The sources of this change are twofold. First, in November 2001 the WTO membership agreed to a new round of multi-year trade negotiations which will include a review of the plant-related IPR obligations in the TRIPs Agreement. Second, in the same month, the FAO Conference adopted a new International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR).
For governments considering the propriety and scope of IPR protection for plant varieties and plant breeders, both of these events merit significant attention. Within the WTO, states will revisit TRIPs article 27.3(b) and will consider whether to broaden or narrow it and whether to harmonize diverse and sometimes conflicting international and national approaches.
Trade Tensions Between Industrialized and Developing Nations
After the widely publicized failure of the WTO meetings held in Seattle, Washington in December 1999, industrialized countries were eager to commence a new round of trade negotiations to address the many issues that had arisen since the conclusion of the Uruguay Round of trade talks in 1994.
Developing nations, however, had become resistant to many aspects of the international trading system and would consider negotiating new trade obligations only if they received substantial concessions to achieve their interests. According to one recent commentary, during the last two years "developing countries in general were more coordinated and outspoken, and better informed than in the past" (CIDSE, 2002, p. 2), and thus were in a more favourable position to bargain for these concessions. This coordination has continued during the Doha Round, as reflected, for example, in the creation of the "Group of 21" (or "G21") developing country governments with common negotiating positions.
International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR)
On 3 November 2001, a conference of 120 government delegates concluded seven years of negotiations and adopted the text of a binding international agreement on access to plant genetic resources.
The ITPGR's principal aim is to facilitate the exchange of seeds and other germplasm to be used for research, breeding and crop development. The treaty promotes this exchange by establishing a "multilateral system" to which member states and their nationals will be granted facilitated access. In essence, the multilateral system is a communal seed treasury composed of 35 food and 29 feed crops now held by governments (both in situ on public lands and ex situ in national seed banks) and by the CGIAR in its extensive ex situ seed collections. In exchange for access to this common seed pool, those who create commercial products that incorporate plant genetic resources received from the multilateral system must pay a percentage of their profits into a fund to be administered by the treaty's Governing Body.
Governments interested in retaining discretion would be advised to monitor and participate in these negotiations, with a view to harmonizing their international obligations, thereby avoiding the necessity of turning to international tribunals to settle their disputes.[47]
India's Plant Variety Protection Regime
For decades, Indian policy on plant varieties and seeds was based on the principle of common heritage of mankind. Post-independence, Indian Government adopted a system wherein plant breeding activities were largely confined to the public sector post-independence to address national food security issues.1 This policy to a large extent succeeded when at the end of the 1970s, India achieved the milestone from being an importer of food-grains to achieving self-sufficiency in food.
Indian initiative for the protection of Plant Varieties and Farmers Right (PPVFRA)
The Protection of Plant Varieties and Farmers' Rights Act, 2001 is primarily considered as an upshot of the pressures from India's membership in the WTO by the developed countries, as well as entry of overseas corporations into the Indian market. Exercising the flexibility given under the TRIPS Agreement with regard to the defense for Plant Varieties Protection.
India chose a sui generis structure to protect plant varieties with a view to balancing the interests of both Breeders rights and farmers rights without succumbing to the pressures of developed countries to became a member to UPOV Convention or to enact a law for Plant Varieties Protection based on UPOV model. Since India is also a member of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) which has got substantial provisions on farmers' rights and contains a chapter on it makes it obligatory on the member state to provide for its safeguard through national legislative process.[48]
Under the PPVFRA, a variety is eligible for protection provided it is novel, distinct, uniform, and stable.11 However, it is contended that while making these criteria for the protection of a new variety, the requirement for novelty almost similar to the UPOV 1991 Act which also contains the same criteria for the protection of a new plant variety. Further varieties not "sold or otherwise disposed of' in India more than a year prior to filing, or outside India for more than four or six years, depending on the type of plant, can pass the novelty test under the PPVFRA.[49]
Protecting Biodiversity
The PPVFRA has laid weight on conventional and traditional farming practices to protect biodiversity. Traditional Farmers are encouraged under PPVFRA to conserve and improve inherited land resources and for doing that they will be recognized and rewarded from the Gene Fund.[50]
Benefit Sharing
The concept of benefit sharing refers to the perception of sharing a fraction of the benefits accruing to a breeder of a new variety with qualifying pretenders who could be indigenous groups, individuals, farmers or communities. The concept of benefit sharing is very close to the community rights concept as elaborated in the above part. PPVFRA provides that before registering any new variety, the Plant authority should call claims for benefit sharing.
Farmers or persons or groups can respond based on two criteria:
India is one of the 12 mega-biodiversity centres in the world. It has a wide diversity of ecological habitats like forests, grasslands, wetlands, coastal and marine ecosystems. Based on the available data, India ranks tenth in the world and fourth in Asia in plant diversity."92 Like many other developing countries, India is at a crossroads with regard to the development of a new legal regime concerning the management of its vast biological resources and related knowledge. There are general links between biodiversity conservation and agro-biodiversity conservation specifically mentioned in the Plant Variety Act.
There are also general links between farmer's knowledge and the more general question of traditional knowledge concerning plant genetic resources. More specifically, the specific nature of the Biodiversity Act makes it an Act which is intrinsically linked to the Plant Variety Act. In pursuance of this, the Indian Parliament enacted the Biological Diversity Act 2002 in order to implement and give effect to the CBD.
The patenting of Neem and Turmeric by foreign firms initiated a public unrest not only in India, but also abroad, thus compelling the government to enact legislation to protect and regulate access to genetic resources and traditional knowledge.
The BD Act prescribed an institutional framework in order to implement the three CBD objectives of conservation, sustainable use, and equitable sharing of benefits arising out of the use of biological resources and related knowledge. It institutes a National Biodiversity Authority and State Biodiversity Authorities as nodal bodies to oversee the conservation, use and sharing of the benefits from the use of biological resources.
Seeds Bill 2004
In 2004, the Indian government brought a bill for regulating the quality of seeds for sale, import and export and to facilitate production and supply of seeds. The Seeds bill is primarily concerned with regulation, production and supply of seeds and is not a law on plant breeder rights (PBRs). It is important to note that the draft of the Seeds bill has been revised three times i.e., 2004, 2008, 2010 largely to put up the concerns expressed by various stakeholders including the farming community, civil society and parliamentarians, and the latest 2011 version of this Bill is still pending in the Upper House (Rajya Sabha) of the Parliament.
A careful scrutiny of the Seeds bill reveals that in the garb of regulating the quality of seeds, the bill introduces provisions which are either in direct conflict with the PPVFRA and reduces its efficacy by undermining the rights given to farmers under the PPVFRA whereby it takes away the various features recognized and protected under the PPVFRA. The features of the Seeds bill that undermine or conflict with the PPVFR Act raise the issue of indirectly diluting the PPVFRA and making it more UPOV compliant which is detrimental to the small and marginal farmers of India.
Protection Of Traditional Knowledge in India
Biodiversity and associated traditional knowledge are two capital resources of India. 'In 2000 the Council for Scientific and Industrial Research in India found out that almost 80% of the 4896 references to individual plant based medicinal patents in the United States Patents Office that year related to just seven medicinal plants of Indian origin. Three years later, there were almost 15,000 patents on such medicines spread over the United States, UK, and other registers of patent offices.
In 2005 this number had grown to 35,000, which clearly demonstrates the interest of developed world in the knowledge of the developing countries. (Menon, 2007). The need for protection of India's traditional knowledge stems from its obligations towards it indigenous and local communities the traditional knowledge holders whose rights are at stake, and also the need for legal compliance with international regimes and emerging norms. India's response has so far included both defensive and positive protection.
Introducing the Traditional Knowledge Digital Library (TKDL) as a form of prior art is an effort towards defensive protection of Indian traditional knowledge. India has sought to incorporate Access and Benefit Sharing provisions of CBD through its Biological Diversity Act 2002 and has enacted the Protection of Plant Varieties and Farmers' Rights Act 2001 as envisaged under the TRIPS.
Besides, several NGOs, civil society organizations and governmental institutions are working towards documentation of traditional knowledge at the local level. The question that one seeks to answer in the chapter, are, if domestic efforts are sufficient in an age of trade liberalization and whether there is a need to first provide for a legally binding mechanism at the international level.
Traditional Medicine System
Traditional medicine system in India prevails at two levels-the classical and folk system. Indian Systems of Medicine(lSM) having a central place in the official Indian healthcare system are derived from traditional knowledge based on codified systems such as Ayurveda, Siddha and Unani medicines is referred to as the classical system of medicine.
These are characterized by institutionally trained practitioners, a body of texts originating since ancient times, and highly developed theories to support the practices. These traditional medicine systems encompass knowledge of life, health and diseases of all living forms, not only human but also of plants and animals.
There exists an estimated 10-30 million manuscripts in Sanskrit alone, many of them relating to medicine .(Balasubramaniam,2003:40) In addition, innumerable manuscripts exist with individuals and families of vaidyas or traditional healers. Thus not all traditional knowledge is in the public domain.
Traditional knowledge of Agro -biodiversity
India like other developing countries is notable for agriculture as the major or only source of income for majority of its population, and for its wealth of genetic diversity present in the form of large number of farmer selected varieties. 'With more than 60% of the population employed in agriculture, seed supply in India fundamentally relies on decentralized local systems of seed production. These systems operate on the basis of the free diffusion of the best seed available within the community, with local farmers ensuring that the local community is supplied with planting material' (Sahai,2003:166).
The traditional ethics and cultural lore followed by these farming communities over long years value a public rather thari exclusive ownership on propagating material of all plants. Exchange of seed was and is essential to crop improvement, and the farmers selected the best seeds in the region with which to plant their field the next season. 'As one of the 12 mega diverse regions of the world, India has over 45,000 wild species of plants and 77,000 wild species of animals recorded' .(Tiwari,2006:49-62)These together constitute 6.5%ofthe world's wildlife.
The range of domesticated biodiversity in the country is also impressive. At least 166 species of crops and 320 species of wild relatives of crops are known to have originated in India. The diversity of crops within each of these species is very high. In case of rice, 50,000-60,000 are reported to have been grown in India in the recent past. Indian varieties and parental lines have been used in many countries (Tiwari,I998:91-107) 'For example Indian sugarcane varieties such as the Coimbatore (Co) varieties like Co 213, 281,290,312,313 and 475 have been were extensively used as parents of choice in economic breeding programmmes of many countries specially lava(Indonesia); Louisiana and Hawaii(USA) , Queensland (Australia) and West Indies.
Similar is the case with rice, wheat, chickpea, maize, sorghum etc. Thus there are numerous such Indian sources already in use internationally' (Siddiq, 1996:38-40) For instance Intan, Mas, and Peta, the most popular varieties of Indonesia are the cross of the Indian variety latisail with the Chinese variety Cina. 'It has been estimated that at least 10% ofIndia's recorded wild flora are on the threatened list.
Patent on Turmeric
The patent on healing properties of turmeric is a case of undue appropriation of traditional knowledge in foreign jurisdiction. Seen as a deficiency of the local patent system , in this case, the United States, with regard to prior art in foreign countries, the patent on the healing properties of turmeric, has received widespread attention in India and abroad.
Suman K Das and Hari Har P Cohly , two researchers based at the University of Mississipi Medical Centre in Jackson , Mississipi , applied for a United States patent on the use of turmeric in wound healing. More specifically, the application related to the use of turmeric to augment the healing process of chronic and acute wounds. The inventors claimed to have found "that the use of turmeric at the site of an injury by topical application and! or oral intake of turmeric will promote healing of wounds"
The patent application acknowledged that turmeric has been used for long time in India as a traditional medicine for the treatment of various sprains and inflammatory conditions. The patent was granted in 1995 on the basis of limited searches of prior art which did not indicate the claims were part of the public domain.
The case came to be noticed by some people about a patent that had been granted on properties of turmeric which were widely known in India and which were in public domain for centuries. "Since the patent was granted in United States, the only possible way to object to the patent was to take legal action in the United States.
As there was no specific individual or group affected by the patent, the Council of Scientific and Industrial Research(CSIR) in India challenged the patent to have it revoked on the ground that the alleged invention was actually a part of public domain knowledge in India. The patent was re-examined, all claims were cancelled and the patent expired on 28 March I 999.
Neem Related Patents
The case study of neem is an example of indirect appropriation of traditional knowledge by way of patents which are granted in other jurisdictions on traditional knowledge derived process or products. In India and the neighboring countries of the subcontinent, neem has applicability in agriculture as well as households.
For centuries farmers have used neem leaves as pesticides. In recent times, properties of neem have received attention prompting large scale research for production of commercially viable products. The natural formulation of pesticides produced from neem has a short shelf life.
The commercially produced ones have longer shelf lives. Among the many patents applied for, one patent, claiming a method for long term storage of the active pesticidal ingredient (azadirachitin) became the centre of vigorous debates. In 1992 USPTO issued a patent to W R grace which covers a method of creating a stabilized azadirachtin solution itself.[52]
Patents Related to Basmati Rice
In 1997 United States rice breeding firm Rice Tec Inc was awarded a patent (US 566 3484) relating to plants and seeds, seeking a monopoly over various rice lines including some having characteristics similar to basmati lines. This happened at a time when the world over, Basmati was a term used to refer to a variety of rice from the Punjab provinces of India.
Thus, Rice Tec Company's 1997 patent claim for Basmati rice described it as "an instant invention of a novel rice line" even though all Rice Tec did was to use Indian basmati rice to derive a Basmati strain. It was only after severe protests in India, led by various NGOS, and as a result of worldwide citizen campaign against Rice Tec Basmati patents, on August14 2001, the USPTO struck down large sections of the Basmati patent. Since Basmati Rice is an indication of a rice variety grown in a geographical region with specific climatic, soil and atmospheric conditions, Geographical Indications (GI) as means to protect similar products gained prominence in India.
Conclusion
Finally, India has had a much longer experience with patents systems than some European countries because of its colonial past. The Patent Act of 1970 brought about significant changes. It excluded patentability of life forms and specifically the patenting of methods of agriculture and horticulture (Section 3, Patents Act, 1970)
The Act specifically mentioned that the general principles governing the use of patents were that: patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented Act 1970)
The Act was different from the western model as it sought to control monopoly on one hand and provide for the health and food needs of India on the other. In the 1990s the national policy developments in the field of patents were influenced by international developments such as the adoption of TRIPS Agreement. Subsequently, the Patent Amendment Act 2002, also provided for changes in lieu of protection of traditional knowledge.
References:
A patent can be understood as an IPR relating to inventions and is the grant of exclusive right, for a limited period, provided by the Government to the patentee, in exchange for full disclosure of his invention, for excluding others, from making, using, selling, importing the patented product or process producing that product for those purposes.
It also identifies the international institutions and intergovernmental organizations that regulate intellectual property rights in plant varieties and plant genetic resources generally and describes the core obligations outlined in international intellectual property agreements.
Introduction
A life form is an entity or being that is living or alive. A life form can be anything from a virus or a plant to a human being. Traditionally, patents have applied solely to inventions, granted as a reward for ingenuity and to encourage innovation. Naturally occurring substances, like DNA, were exempt from such laws. Now the issue is should living things be patented?
The existing study describes and analyses the various international legal regimes governing intellectual property rights in the protection of life forms and plant varieties and sets forth regulatory options for national governments to protect plant varieties while achieving other public policy objectives relating to plant genetic resources. It identifies different sets of policy options for governments based upon the specific constellation of treaty commitments they have undertaken.
Central issues
The international community realized this around the early 1990's and fallout of this realization came out in the form of Trade Related Aspects of Intellectual Property Rights (TRIPs) agreement in 1994 and its enforcement on 1st January 1995. A patent is an exclusive right granted to the inventor or creator of a useful or improved article or a new process of making an article for a specified period. India is a member of the World Trade Organization (WTO) and a signatory to the WTO agreement on TRIPs.[1]
According to the TRIPs agreement, [2]India has amended its patent legislation which is governed by the Patent Act, 1970 on three occasions. The case of Diamond v/s Chakrabarty in 1980 led to the general trend of patenting inventions on living matter. In India, the position was made clear after the 2002 amendment to the Indian Patents Act. The amended act stated that life forms can be patented provided they satisfy the other requirements.
The improvements in the Indian patent regime have resulted in a significant upthrust in the promulgation and enforcement of patents in India. Now, India can boast of one of the best patent law regimes in the world.[3]
The relevant TRIPS provisions under review, says India, have three dimensions. Firstly, whether and what form of exclusion from patentability should apply to plants and animals per se (patenting of life forms). Secondly, the review could consider the effect of protection granted to micro-organisms and non-biological and microbiological processes (scope and definition of microorganisms).[4]
Thirdly, whether and what form of protection of plant varieties through sui generis systems is an effective form of protection (effectiveness of plant variety protection). Patenting of life forms, according to India, may have at least two dimensions. Firstly, there is the ethical question of the extent of private ownership that could be extended to life forms.
The second relates to the use of the IPRs concept, as understood in the industrialized world, and its appropriateness in the face of the larger dimension of rights on knowledge, their ownership, use, transfer and dissemination. International IPR regimes recognize formal systems of knowledge only, India maintains. Informal systems, e.g. the shrutis and smritis in the Indian tradition and grandmothers' potions all over the world get scant recognition.[5]
To create systems that fail to address this issue can have severe adverse consequences on mankind, some say even leading to our extinction, the Indian paper warns. India says there is clearly a case for re-examining the need to grant patents on life forms anywhere in the world.
Till such systems are in place, it may be advisable to:
- Exclude patent on all life forms; if this is not possible, then;
- Exclude patents based on traditional/indigenous knowledge and essentially derived products and processes from such knowledge; or at least:
- Insist on disclosure of the country of origin of the biological resource and associated knowledge, and obtain consent of the country providing the resource and knowledge, to ensure equitable sharing of benefits.[6]
Patent protection in India brings unique considerations for life sciences industry because of the typical statutory exclusions on certain aspects of innovations, for which no patent protection is available. Apart from the regular three leg test of novelty, inventive step and industrial applicability, Indian patent laws have specifically listed certain subject matters, which despite passing the three leg test, may not be protected.
Some of the relevant subject matters related to life sciences industry that are excluded from patent protection in India are, inventions that could be contrary public order or morality or which cause serious prejudice to human, animal or plant life or health or to the environment - clause 3(b); inventions that are mere discovery of living or non-living substance occurring in nature- clause 3(c); inventions that are mere discovery of a new form of a known substance and does not have enhanced efficacy or the mere discovery of any new property or new use of a known substance or mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant - clause 3(d); inventions that are directed to a substance obtained by a mere admixture or a process for producing such substance - clause 3(e); inventions directed to methods of agriculture or horticulture - clause 3(h); inventions that are a process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or animals- clause 3(i);inventions that are directed to plants and animals in whole or any part thereof other than micro-organisms or essentially biological processes - clause 3(j); and inventions that are related to aggregation or duplication of the traditional knowledge - clause 3(p).[7]
India also provides a sui generis law to protect inventions/ innovations related with the development of plant varieties, which are commercially exploited by production and sale of seeds or plant material. However, protection under the Protection of Plant Varieties and Farmers' Rights Act is available only for notified varieties and any plant variety that is not in the notified list cannot be protected.[8]
In India considerable efforts at different levels have been made to strike a balance regarding legislative requirements and the interest of industry, particularly in IP for effectively securing the gains of huge investment of resources in developing the inventions/innovations.[9] The past decade has witnessed considerable improvements in Indian industrial policies and IP practices by adopting different procedural and policy measures, which have created conducive environment for the growth of industry and IP protection. India is undoubtedly advancing rapidly towards a strongly supported Industrial regime with strong IP environment.[10]
Genetic engineering techniques are currently being used to produce a wide range of new products, which the biotechnology industry believes will benefit all citizens. Most research involves plants and animals although some effort is now being put on genetically engineered microbes, such as nitrogen fixing bacteria, frost suppressive bacteria, and some microbial soil amendments.
Genetically Modified Organisms
A genetically modified organism (GMO) is an organism whose genetic material has been altered using techniques in genetics generally known as recombinant DNA (rDNA) technology. DNA technology is the ability to combine DNA molecules from different sources into the one molecule in a test tube. Thus, the abilities or the phenotype of the organism, or the proteins it produces, can be modified through the modification of its genes. The term generally does not cover organisms whose genetic makeup has been altered by conventional cross breeding or by "mutagenesis" breeding as these methods predate the discovery of the recombinant DNA techniques.
Genetically Modified Animals
Like bacteria and plants, animals can be genetically modified by viral infection. The genome of an animal embryo can be modified by the addition of synthetic chromosomes, targeted removal of certain genes, or addition of genes. The embryo can then be implanted into a mother to develop.
However, the genetic Modification occurs only in those cells that become infected, and in most cases these cells are eventually eliminated by the immune system. In some cases it is possible to use the gene transferring ability of viruses for gene therapy, i.e. to correct diseases caused by a defective gene by supplying a normal copy of the gene.[11]
Genetic Engineering and Plants
Herbicide tolerant plants won't die when sprayed with broad spectrum Herbicides, thereby allowing the herbicide to be used more Insect and disease resistant plants contain toxins and other factors produced by other organisms, including bacteria, scorpions and other venomous organisms. The toxins enable the plant to resist pests. Delayed ripening allows food to be shipped farther. For example, genetic engineering allows the regulation of ripening in the trademarked FLAVR SAVR tomato.
Environmental tolerance enables plants to become more drought resistant, freeze tolerant, and so on. This allows the geographic range of crops such as corn and soyabeans to expand, potentially intensifying monoculture cropping and transforming local economies.[12]
Genetic engineering and animals
Essential nutrients may no longer be required in animal feed if animals are engineered to no longer need these nutrients. Faster development may result from engineering animals that eat more or digest more efficiently so that they can grow larger and/or be slaughtered earlier. However, growing fast creates problems for the animal; some of these animals may be more prone to disease and stress. Environmental tolerance is a factor being engineered in certain animals that currently cannot tolerate cold or heat or wetness or dryness.
Human Genetic Engineering
Serious ethical issues arise even more starkly in the case of attempts to patent human genetic material or information. Human genetic engineering deals with the controlled modification of the human genome.[13]
Human genetic engineering means changing the genes in a living human cell. If a person had a lung disease caused by defective genes in the lung cells, he might be cured if there was a way to fix those genes. Scientists change the genes in living cells by putting the desired "new" gene into a little virus-like organism which is allowed to get into your cells and which inserts the new gene into the cell along ith the "old" genes.
Human Genome and IPR
In 1953, two scientists, one from the United States and the other from Britain, Dr. J.D. Watson and Dr. F.H.C. Crick, published in 'Nature' magazine an essay that was to revolutionise our understandings of the basic forms of life. Not just human life, but all forms of life. They provided a model for understanding the process of the transfer of genetic information between generations of the same organism.
The early, primitive discoveries came together and were explained by Watson and Crick. They proposed that the basic determinates of living matter were to be found in DNA, in a structure described as the double helix. DNA was the molecule which carried the genetic code that would unlock the truth known instinctively by farmers and described in a primitive but accurate way by Mendel. From that moment to this, the search has been undertaken to explore the DNA and to unlock its remaining secrets.[14]
Patenting In Biotechnology
Patenting in Biotechnology is a crucial issue because it involves life forms. This, in the world Context, apart from being hit by moral and ethical issues, has been criticized heavily on the basis of mere modifications on substances occurring in nature and its subsequent modification by human intervention.[15] The world has reached a stage where it can justify Biotechnology Patents and the debates and discussions on whether patenting on life forms should be granted as such.
"Broadly defined, biotechnology may be considered as the production of useful products from living micro-organisms and cell cultures, and as such it has been with us since the first nameless biotechnologist discovered that fermentation did interesting things to grape juice.[16]
Today biotechnology is most closely identified with work involving changes to the genetic make-up of an organism, the so-called genetic engineering. As a result of this engineering, new and improved drugs have been constructed. These include human insulin, interferon, vaccines, and treatments for a host of human afflictions such as septic shock, anemia, diabetes, AIDS, cancer, hepatitis, and heart attack.[17]
Biotechnology is also the area of human endeavour which has simultaneously produced controversy and modified higher life forms like the Harvard and Dupont mice, and, modified not so high life forms such as microorganisms for use in environmental areas such as oil spill cleanup technology.[18]
Therefore, the subject matter ranges from DNA sequences, microorganisms, genetically modified organisms, Plant variety and Animal Variety because they are produced using Biotechnology. Bio-matter is a term broad enough in scope to capture all "products" related to biotechnology. Compounds and organisms per se are what constitute bio-matter.[19] Within this category, there are two main groups of "products": living and non-living.
Examples of Non-living Bio-matter include, amino acids, peptides, proteins, fats and fatty acids, and nucleic acids. These kinds of compounds are better recognized when referred to by their more commonly known names of antibodies, hormones, enzymes, antibiotics, steroids, cholesterol, HLDL, VLDL, and DNA molecules. Although complex, they are all really just chemical compounds5. Also, under this head, somewhere between living and non-living, we have the Viruses.[20]
Bio-diversity of India will be an advantage for Biotech companies. Vast reservoir of scientific human resource with reasonable cost, wealth of R&D institutions, centers of academic excellence in Biosciences Vibrant Pharmaceutical Industry and fast developing clinical capabilities collectively point to promising biotech sector. Over 300 companies and 241 institutions use some form of biotechnology in agricultural, medical or environmental applications.
Diamond v. Chakrabarty[21]
To begin with, a panel of thirteen judges of the Court of Justice of the European Communities heard The Netherlands v European Parliament29. In response to a challenge to the validity of the European Biotechnology Directive30, the court commented: The biotechnological industry began to develop seriously after a decision by the US Supreme Court in 1980 that 'a live, human-made micro-organism is patentable subject matter' (Diamond v Chakrabarty).[22]
That case concerned an invention of a human-made, genetically engineered bacterium capable of breaking down crude oil. The Supreme Court held (by a 5:4 majority) that the micro-organism constituted a 'manufacture' or 'composition of matter' within the meaning of the Patent Act 1952 (The wording derived unchanged from the first Patent Act 1793, authored by Thomas Jefferson.). The court noted that the committee reports accompanying the 1952 Act indicated that Congress intended statutory subject matter to 'include anything under the sun that is made by man.[23]
Opinion of Judges in the Judgment
It was stated in the case that, A live, human-made microorganism is patentable. Respondent's micro-organism constitutes a "manufacture" or "composition of matter" within that statute.
In choosing such expansive terms as "manufacture" and "composition of matter," modified by the comprehensive "any," Congress contemplated that the patent laws should be given wide scope, and the relevant legislative history also supports a broad construction. While laws of nature, physical phenomena, and abstract ideas are not patentable, respondent's claim is not to a hitherto unknown natural phenomenon, but to a non-naturally occurring manufacture or Composition of matter - a product of human ingenuity "having a distinctive name, character [and] use.
The passage of the 1930 Plant Patent Act, which afforded patent protection to certain asexually reproduced plants, and the 1970 Plant Variety Protection Act, which authorized protection for certain sexually reproduced plants but excluded bacteria from its protection, does not evidence congressional understanding that the terms "manufacture" or "composition of matter" in do not include living things.[24]
The Indian Patent Act of 1970 did not earlier permit the granting of patents on life forms and related technologies. These and other substances in the areas of agriculture, horticulture, and curing or enhancing human animal or plant life were not patentable "on the grounds of law, morality, and health". In the case of food, medicine, drugs, and chemicals, only process
patents were allowed, since it is believed that the grant of product patents will inhibit the discovery of more efficient an economical processes for the manufacture of the same product.
Experts have hailed these aspects of the Act as amongst the most socially progressive in the world.[25]
The problem is that the phrase "plants and animals other than microorganisms" does not cover parts of animals and plants, nor does it include altered plants and animals and therefore allows the patenting of biological organisms. Also the worlds "other than microorganisms" prevent the exclusion of microorganisms from patentability and make patenting of microorganisms compulsory.
Since microorganisms are living organisms, making their patenting compulsory is the beginning of a journey down the slippery slope that leads to the patenting of all life. The best example of this slippery slope can be seen in the history of United States patent law where the granting of patents to microorganisms signaled the taking of a first step to granting patents to so-called higher life forms.
In 1971, General Electric and one of its employees Ananda Mohan Chakrabarty applied for US patent on a genetically engineered pseudomonas bacterium. Taking plasmids from three kinds of bacteria, he transplanted them into the fourth. As he explained, "I simply shuffled genes, changing bacteria that already existed".
The John Moore Case
In 1976, a leukemia patient, John Moore had surgery at the University of California to remove a cancerous spleen. The University was later granted a patent for a cell line called Mo, removed from the spleen, which could be used for producing valuable proteins. The long-term commercial value of the cell line has been estimated at over $1 billion. Permission had not been sought of John Moore for the use of his body parts.[26]
Moore demanded the return of the cells and control over his body parts. In 1984, he filed a lawsuit claiming that his blood cells were misappropriated while he was undergoing treatment for leukemia at the University of California, Los Angeles Medical Center. During his treatment, Moore's doctor developed a cell line which proved valuable in fighting bacteria and cancer. The UCLA Board of Regents filed a patent claim on this cell line and commercially developed valuable antibacterial and cancer-fighting pharmaceuticals.
Moore claimed that he was entitled to share in profits derived from commercial uses of these cells and any other products resulting from research on any of his biological materials. In a significant 1990 California Supreme Court decision, the court established that a donor does not have a "property right" in the tissues removed from his or her body.[27]
The court further reasoned that to favour John Moore's claim would "...hinder research by restricting access to the necessity raw materials," thereby interfering with the progress of science.[28]
Protection of the Indigenous Communities
Genetic manipulation raises serious ethical and moral concerns with regard to the sanctity of life. For indigenous peoples, any violation of the natural law and the natural order of life is
Abhorrently wrong. Scientists are genetically manipulating existing life forms, altering the course of natural evolution, and creating new life forms. Genes are living organisms which reproduce, migrate and mutate. The full impact of genetically manipulated life forms cannot possibly be anticipated.
Indigenous people must engage in community education and discussion about the full scope of this project and the potential dangers of genetic manipulation. It is imperative that indigenous communities become fully aware of the implications of this project, and learn whether any genetic sampling is being conducted or is proposed to take place in their areas.
Protection of Life Forms
The distribution of property rights over biological resources has been a. longstanding concern in international law. Indeed one of the cardinal principles of international law since decolonisation has been the permanent sovereignty of states over their Natural resources.[29]
Law in the area of life patenting has been developing in the west for the last two decades, keeping pace with the developments in biotechnology. According to Iver P Cooper "Biotechnology is a new word for an old idea, the idea of a technology based on the use of other living things". The advancements in this area proved that genetic constitution of living beings can be altered.
This resulted in the emergence of genetic engineering as a scientific revolution which promises even the creation of new life. The subject matters of biotechnological inventions are micro-organisms, hybrid plants, genetically engineered animals, Gene therapy, genetically engineered vaccines and new antibody technology, Recombinant DNA technology popularly known as genetic engineering, used for developing disease resistant plants, herbicide resistant crops human genes and cell lines. The high commercial potential of genetic researches made this branch of science a focal point of trade and investment.[30]
The new biotechnological approach implies that crops. as such are not the raw materials, but rather the compound in them starch, protein, fats and oils etc. As such, producers of such commodities, farmers, fishermen and big multinational companies will all be competing with each other for selling their commodities in the international market - a competition between unimaginable unequal.
Based on this policy the US Patent office granted the first patent on an animal the Harvard On comouse the patent was for transgenic non-human mammal. The mouse disclosed in this patent was bearing activated ontogenesis in its genome as a-result of which it had an increased susceptibility to cancer . Even though this patent is generally referred to as the Harvard Oncomouse patent, the claims allowed under the patent were of considerable breadth and not limited to mice.[31]
Patenting of living beings in U.S. is no more confined to microorganisms. In 1995 the scientists at the University of Utah succeeded in. finding BRCA, the breast cancer gene. They got it patented in US and the small biotech company which they started, to commercially exploit the invention, turned to be a market gain. Subsequently, W. French Anderson of the national Institute of Health (NIH) of US obtained a broad patent on human gene therapy in 1995. Mammals, human genes and cell lines, nothing is left out now from the purview of patents in US.[32]
India being a member of the WTO was required to provide product patents on microorganism before Jan 1st, 2004, which has already been done vide the patent (Amendment) Act, 2002 as is evidenced by the following amended portion of S3 of the patent Act, 1970 (as amended 2002). Exclusion clause implies inclusion in "invention". Thus any process for the medicinal, surgical, curative, prophylactic ... or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products (in the case of plants) is not excluded from patentability and thus patentable.[33]
Indian Judicial Initiative
Calcutta High Court on 15th January 2002 has given a landmark decision allowing claim for grant of patent to genetically engineered microorganism called infectious bursitis vaccine. The appellant had filed a patent application for an inventive process of preparing infectious bursitis vaccine.
The application was rejected by the Patent Authorities on the ground that:
- The process of preparing a vaccine having living entity cannot be considered as manufacture.
- The above mentioned process is 1 not an invention according to Sec. 2(1) of the Patent Act. 1970. A process to be covered under invention must result in a substance and a vaccine with a living organism cannot be considered as a substance.[34]
Contention of the appellant was that preparation of infectious bursitis vaccine is an invention because:
- The process involves inventive steps and the invented vaccine protect poultry against infectious Bursitis.
- There is no bar in present Indian law against patenting of end product, the manufacture of which involve live virus.
- The patent claimed in the present case is only for process for preparation of vaccine itself.
Taking into consideration the arguments of both sides, The High Court held as under:
- Controller erred himself in law by holding that merely because end product contains live virus, process involved is not an invention.
- The claim of patent should have. been considered by Controller on principles of Sec. 3 of the Patent Act. No objection was raised by examiners under Sec. 3 Applying the vincibility test the vaccme was treated as substance. The Court directed Controller to reconsider the application for grant of patent to appellant. It is submitted that this judgment has opened new opportunities for obtaining patents in India on microorganism related inventions which were hitherto not granted.
The Protection of Plant Varieties and Farmers' Rights Act was passed by the Indian Government in 2001. After India became signatory to the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPs) in 1994, a legislation was required to be formulated. Article 27.3 (b) of this agreement requires the member countries to provide for protection of plant varieties either by a patent or by an effective sui generis system or by any combination thereof.
Thus, the member countries had the choice to frame legislations that suit their own system and India exercised this option. The existing Indian Patent Act, 1970 excluded agriculture and horticultural methods of production from patentability. The sui generis system for protection of plant varieties was developed integrating the rights of breeders, farmers and village communities, and taking care of the concerns for equitable Sharing of benefits. We attempt here to critically analyse the provisions of legislations for their effective implementation.
Plant Variety Protection.[35]
Plant variety protection, also called a "plant breeder's right," is a form of intellectual property right granted to the breeder of a new plant variety in relation to certain facts concerning the exploitation of the protected variety which require the prior authorization of the breeder. As in the case of patents, trademarks and industrial designs, prior examination and granting by the relevant authority is required to establish the breeder's right.
However, to understand more completely what a plant variety is, the UPOV Convention (Article 1(vi)) defines it as: "a plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a breeder's right are fully met, can be defined by the expression of the characteristics resulting from a given genotype or combination of genotypes, distinguished from any other plant grouping by the expression of at least one of the said characteristics and considered as a unit with regard to its suitability for being propagated unchanged."
The UPOV Convention
The UPOV Convention (Article 1(iv)) defines a breeder as: "The person who bred, or discovered and developed, a variety, the person who is the employer of the aforementioned person or who has commissioned the latter's work, where the laws of the relevant Contracting Party so provide, or the successor in title of the first or second aforementioned person, as the case may be." The breeder might be, for example, an amateur gardener, a plants man, a farmer or a scientist. The plant breeding techniques used can range from traditional crossing and selection through to new techniques, such as genetic engineering".
The UPOV Convention (Article 3) requires the grant of protection for the varieties of all plant genera and species in order to give breeders more encouragement to work with new species with the appropriate legal certainty.
The development of new plant varieties is protectable in most countries as a species of intellectual property right (IPR) derived from the International Convention for the Protection of New Varieties of Plants (UPOV). Countries which are members of the World Trade Organization (WTO) are obliged by Article 27.3(b) of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) to 'provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof'.[36]
The TRIPS Agreement does not specify which 'sui generis system' will meet its requirements, but most of the 153 members of the WTO have promulgated domestic legislation based upon the 1991 version of UPOV.[37]
The International Union for the Protection of New Varieties of Plants, known as "UPOV," is an intergovernmental organization with legal personality and which has its headquarters in Geneva, Switzerland. UPOV was established by the International Convention for the Protection of New Varieties of Plants (hereinafter referred to as the UPOV Convention), which was adopted in Paris in 1961. This was the point at which there was recognition of the intellectual property rights of plant breeders in their varieties on an international basis.
International IPR Agreements Regulating Plant Varieties and Plant Breeders' Rights
The two major treaty systems that regulate different international IPR agreements that protect plant varieties and plant breeders' rights are as discussed as follows. The UPOV treaties adopt a sui generis system of protection (that is, a system that is unique, or of its own kind) especially tailored to the needs of plant breeders.
The TRIPs Agreement requires WTO Members to protect new plant varieties using patent rights, a sui generis system or some combination thereof. TRIPs provides states with this flexibility and because the treaty has an uncertain relationship to the previously adopted UPOV conventions, national governments face a wide array of options in choosing the intellectual property regime applicable to plant varieties. This section of the study outlines the requirements imposed by these two treaty systems, and Part III of the study then identifies and analyses these options.
The UPOV Convention established for members of the Union a legal framework with the following key features: [38]
- common agreement on essential notions: variety and breeder
- genera and species to be protected;
- rules for national treatment and priority, which establish relations between members of the Union and provide for the legal mechanism for nationals and residents of a member to benefit from protection in the territories of other members;
- the conditions for the grant of protection: novelty, distinctness, uniformity and stability and a suitable variety denomination;
- a minimum scope of protection;
- a minimum duration of protection;
- clear delimitation of the grounds to nullify or cancel the breeder's right.
Plant Variety Protection and the TRIPS Agreement
The TRIPs Agreement
TRIPs as a spur to plant variety protection, TRIPs' influence on plant variety protection stems from the following sources:
- Its link to other international trade agreements
- Its widespread adherence by states in both the industrialized and developing world;
- Its novel enforcement, review and dispute settlement provisions;
- The requirement in TRIPs article 27.3(b) that its signatories must provide protection for plant varieties "either by patents or by an effective sui generis system or by any combination thereof"; and
- A formal review of article 27.3(b) which was scheduled to be held in 1999.
The following paragraphs briefly address each of these five issues. Subsequent sections devote more detailed treatment to the protection of plant varieties with patents and to the elements necessary to create an Effective sui generis system.
Although the UPOV Acts have provided IPR protection for plant varieties for more than forty years, their significance has recently been overshadowed by a different intellectual property treaty, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs or the TRIPs Agreement).
Adopted in 1994 as a treaty administered by the WTO,[39] TRIPs is the first and only IPR treaty that seeks to establish universal, minimum standards of protection across the major fields of intellectual property, including patents, copyrights, trademarks, industrial designs, integrated circuits and trade secrets.
Although the TRIPs Agreement devotes only minimal attention to plant breeders' rights or plant variety protection and does not even mention the UPOV Acts, its adoption has done more to encourage the legal protection of plant varieties than any other international agreement.
Under the TRIPS Agreement, all developing countries other than those categorized as least developed countries ("LDCs") had to provide intellectual property rights protection for plant varieties by January 1, 2000. LDCs have until January 1, 2005, to meet the same obligation.[40]
The relationship of TRIPs to the WTO and the international trading system
Unlike all prior intellectual property treaties, TRIPs is not a free-standing agreement concerned solely with IPRs. Rather, TRIPs is linked to a larger family of trade-related agreements concerning subjects such as trade in goods and services, agriculture, textiles and health-related restrictions on imports.
All of these agreements were adopted within the WTO during the Uruguay Round of trade negotiations held between 1988 and 1994. As such, TRIPs was part of a global "package deal."
Industrialized nations secured a commitment from developing nations to provide minimum standards of effective legal protection to intellectual property products, and in exchange developing nations received a commitment from industrialized countries to open their domestic markets to goods and other products manufactured in the developing world.[41]
The enforcement, review and dispute settlement provisions of TRIPs
In addition to its widespread adherence, the influence of the TRIPs Agreement can be traced to its unique provisions relating to the enforcement of IPRs within national laws, the review of those national laws by the TRIPs Council and the mechanism for settlement of disputes between states leading to rulings backed up by the threat of trade sanctions.
The UPOV Acts
The first UPOV Act was drafted in 1961, principally by industrialized governments seeking to provide protections for plant breeders in their own and overseas markets. The UPOV was later revised in Acts adopted in 1972, 1978 and 1991. As of July 2004, 55 states were parties to UPOV - 29 to the 1978 Act, 24 to the 1991 Act and 2 to the 1972 Act. (States Parties to the UPOV, Status on 30 June 2004).
As a result, this study will focus on the two most recent UPOV Acts. Many of the accessions to these Acts are quite recent, with a number of developing states and countries in transition to a market economy acceding in the 1990s. The 1991 Act entered into force on 24 April 1998 and on that same date the 1978 Act was closed to future accessions except by a few states already in the process of adhering to it.
Countries generally give domestic effect to the UPOV Act to which they are a party in one of two ways. In "automatic incorporation" states, courts and administrative agencies directly apply and enforce the Act, although implementing legislation is often needed to authorize administrative agencies to process applications to protect new plant varieties. In "legislative incorporation" states, by contrast, the UPOV Act does not become enforceable in domestic law until the state enacts a national plant variety protection law that conforms to the Act's requirements.
The 1978 UPOV Act
The 1978 UPOV Act adopts most of the international IPR obligations set out in Part I above, including a definition of the applicable subject matter and protected material, eligibility requirements, exclusive rights, national treatment, reciprocity, terms of protection and exceptions and limitations to exclusive rights. It does not, however, contain any provisions on MFN treatment or enforcement.
Subject matter requirements
Limited number of protected genera or species. Not all plant varieties must be protected under the 1978 Act. Rather, article 4 provides that member states are to progressively extend protection to an increasing number of genera or species, beginning with five on the date the treaty enters into force for that state and ending with twenty-four within eight years. In addition, member states are free to limit the Act's application within a particular genus or species to varieties with a particular manner of reproduction or multiplication, or a certain end-use.
Novelty. To avoid protection for plant varieties that have already been exploited or are a matter of common knowledge, a new variety in which a breeder seeks protection must not have been sold on the market for more than a specified period of years prior to the date of application for protection. The 1978 Act specifies the maximum number of years during which such pre-application sales have occurred, with different periods of time set for different types of plants as well as for sales within the territory of the applicant state versus the territory of other states. (art. 6(1)(b))
Eligibility Requirements
When a variety fulfils these four criteria, it is listed in a national register or catalogue which publicly discloses that the variety is protected.
Distinctness
The 1978 Act states that a protectable plant variety must be "clearly distinguishable in one or more important characteristics from any other variety whose existence is a matter of common knowledge at the time when protection is applied for." (art. 6(1)(a)). Although the treaty itself does not further define distinctness, the Guidelines for the Conduct of Tests for Distinctness, Homogeneity and Stability (UPOV Guidelines) use both qualitative and quantitative plant characteristics, including such visible attributes as leaf shape, stem length and color, to determine if the difference between varieties is "clear and consistent."
As explained below in the analysis of the UPOV 1991 Act, the concept of distinctness is critical to determining the scope of a breeder's right in plants that are closely related but not identical to a protected variety.
Homogeneity
Under the 1978 UPOV Act, a variety has to be "sufficiently homogeneous, having regard to the particular features of its sexual reproduction or vegetative propagation." (art. 6(1)(c)). The UPOV Guidelines further clarify that to be considered homogeneous; the variation shown by a variety must be "as limited as necessary to permit accurate description and assessment of distinctness and to ensure stability." The homogeneity requirement has been criticized by commentators as discouraging variability in plant varieties that are often useful for sound agricultural practices and as denying protection to breeders of cultivated landraces that exhibit diversity traits.
Stability
The stability requirement is a temporal one, requiring the breeder to show that the essential characteristics of its variety are homogeneous or uniform over time, even after repeated reproduction or propagation. (art. 6(1)(d)) In practice, what has been shown to be homogeneous is usually considered to be stable as well. For this reason, the stability requirement has engendered the same sort of critiques as the uniformity requirement in its preclusion of protection for cultivated landraces and other traditional plant varieties.
Breeders' exclusive rights
Under article 5 of the 1978 Act, any person seeking to engage in the following three acts, with respect to a protected variety's reproductive or vegetative propagating material, must obtain the prior authorization of the breeder: production for purposes of commercial marketing, the offering for sale and marketing.[42]
The 1978 Act does not, however, require member states to extend these exclusive rights to harvested material or other marketed products.
National Treatment and Reciprocity
Member states must grant the three exclusive rights referred to in the preceding paragraph in the same manner to both national breeders and to breeders who reside in or are nationals of other 1978 Act member states.[43] However, where a state extends legal protection to a specific genus or species, or where it provides more extensive exclusive rights to breeders than the rights required under the treaty, reciprocity is permitted. Thus, a state providing these additional rights may restrict protection to breeders from those member states that apply the Act to the same genus or species, or that provide such additional exclusive rights to their own nationals. (arts. 3 and 5(4))[44]
Term of protection
The 1978 Act requires a minimum term of protection of fifteen years, with the exception of vines, forest trees, fruit trees and ornamental trees, which are protected for no less than eighteen years.
Breeders' exemption
This exemption in article 5(3) precludes member states from granting to breeders of protected varieties the right to authorize or refrain from authorizing other breeders seeking to use the protected variety to create new varieties or to market those new varieties. States are permitted to grant breeders such an authorization right only if the repeated use of the protected variety is necessary for the commercial production of the new variety. According to the International Association of Plant Breeders and the International Seed Federation, this breeders' exemption "is essential for continued progress from plant breeding.[45]
Farmers' privilege
The focus of the 1978 Act on commercial exploitation of protected plant varieties has been interpreted to allow the use of seeds and propagating material for non-commercial purposes without the breeder's prior authorization.[46]
In national plant variety protection laws, this implicit non-commercial exception most frequently benefits farmers who purchase the seeds of protected varieties. The scope of this so-called farmers' privilege varies widely, however. Some nations only permit farmers to plant seeds saved from prior purchases to be used on their own land holdings, while others allow them not only to replant but also to sell limited quantities of seeds for reproductive purposes, a practice often referred to as brown bagging.
The 1991 UPOV Act
The limited scope of the 1978 Act led a number of member states of the UPOV to adopt a revised Act with enhanced rights for plant breeders. The major revisions of the 1991 Act are discussed below:
Subject matter requirements
Unlike its predecessor, the 1991 Act requires states to protect at least fifteen plant genera or species upon ratifying or acceding to the Act, and to extend protection to all plant varieties within ten years. (art. 3(2)) It also contains a definition of a plant "variety" as a "plant grouping within a single botanical taxon of the lowest known rank" which can be "defined by the expression of the characteristics resulting from a given genotype or combination of genotypes; distinguished from any other plant grouping by the expression of at least one of the said characteristics; and considered as a unit with regard to its suitability for being propagated unchanged." (Art. 1(vi))
No definition of "variety" appears in the 1978 Act, which indicates that member states to that earlier treaty have greater discretion in defining the characteristics of plant groupings that qualify for protection.
Breeders' exclusive rights in protected material
Extensive additions to the 1978 Act were made with respect to the exclusive rights enjoyed by breeders in protected material of plant varieties.
Enumerated Exclusive Rights in Propagating Material
The breeder's prior authorization must be obtained for the use of reproductive or vegetative propagating material of the variety for:
- production or reproduction
- conditioning for the purpose of propagation,
- offering for sale,
- selling or marketing,
- exporting,
- importing and
- stocking for any of these purposes.
National Treatment Required
Whatever the particular exclusive rights member states adopt in their plant variety protection laws, those rights must also be provided to the nationals of other 1991 Act member states. Unlike the 1978 Act, granting rights only on condition of reciprocity is not permitted. (art. 4)
For example, if a 1991 Act member chooses to grant more expansive exclusive rights to breeders than the exclusive rights required by the 1991 Act, it must grant those rights to breeders from all other 1991 Act member states. The state cannot choose to grant such expansive rights to only those 1991 Act states that also provide the same level of rights protection to the first state's nationals.
Terms of protection:
The 1991 Act extends the term of protection to 20 years, and requires a 25-year term for tree and vine varieties.
International Legal Framework
The WTO Doha Round of trade negotiations
On 14 November 2001, trade ministers from the WTO's than 142 Members meeting in Doha, Qatar agreed upon the text of several official declarations to serve as the framework for a new round of trade negotiations. These declarations do not expressly address the issue of plant variety protection. They do, however, suggest that the WTO will conduct an expansive review of the relationship between IPRs in plants and competing policy objectives as it considers whether and in what ways to revise the current text of the TRIPs Agreement.
The sources of this change are twofold. First, in November 2001 the WTO membership agreed to a new round of multi-year trade negotiations which will include a review of the plant-related IPR obligations in the TRIPs Agreement. Second, in the same month, the FAO Conference adopted a new International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR).
For governments considering the propriety and scope of IPR protection for plant varieties and plant breeders, both of these events merit significant attention. Within the WTO, states will revisit TRIPs article 27.3(b) and will consider whether to broaden or narrow it and whether to harmonize diverse and sometimes conflicting international and national approaches.
Trade Tensions Between Industrialized and Developing Nations
After the widely publicized failure of the WTO meetings held in Seattle, Washington in December 1999, industrialized countries were eager to commence a new round of trade negotiations to address the many issues that had arisen since the conclusion of the Uruguay Round of trade talks in 1994.
Developing nations, however, had become resistant to many aspects of the international trading system and would consider negotiating new trade obligations only if they received substantial concessions to achieve their interests. According to one recent commentary, during the last two years "developing countries in general were more coordinated and outspoken, and better informed than in the past" (CIDSE, 2002, p. 2), and thus were in a more favourable position to bargain for these concessions. This coordination has continued during the Doha Round, as reflected, for example, in the creation of the "Group of 21" (or "G21") developing country governments with common negotiating positions.
International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR)
On 3 November 2001, a conference of 120 government delegates concluded seven years of negotiations and adopted the text of a binding international agreement on access to plant genetic resources.
The ITPGR's principal aim is to facilitate the exchange of seeds and other germplasm to be used for research, breeding and crop development. The treaty promotes this exchange by establishing a "multilateral system" to which member states and their nationals will be granted facilitated access. In essence, the multilateral system is a communal seed treasury composed of 35 food and 29 feed crops now held by governments (both in situ on public lands and ex situ in national seed banks) and by the CGIAR in its extensive ex situ seed collections. In exchange for access to this common seed pool, those who create commercial products that incorporate plant genetic resources received from the multilateral system must pay a percentage of their profits into a fund to be administered by the treaty's Governing Body.
Governments interested in retaining discretion would be advised to monitor and participate in these negotiations, with a view to harmonizing their international obligations, thereby avoiding the necessity of turning to international tribunals to settle their disputes.[47]
India's Plant Variety Protection Regime
For decades, Indian policy on plant varieties and seeds was based on the principle of common heritage of mankind. Post-independence, Indian Government adopted a system wherein plant breeding activities were largely confined to the public sector post-independence to address national food security issues.1 This policy to a large extent succeeded when at the end of the 1970s, India achieved the milestone from being an importer of food-grains to achieving self-sufficiency in food.
Indian initiative for the protection of Plant Varieties and Farmers Right (PPVFRA)
The Protection of Plant Varieties and Farmers' Rights Act, 2001 is primarily considered as an upshot of the pressures from India's membership in the WTO by the developed countries, as well as entry of overseas corporations into the Indian market. Exercising the flexibility given under the TRIPS Agreement with regard to the defense for Plant Varieties Protection.
India chose a sui generis structure to protect plant varieties with a view to balancing the interests of both Breeders rights and farmers rights without succumbing to the pressures of developed countries to became a member to UPOV Convention or to enact a law for Plant Varieties Protection based on UPOV model. Since India is also a member of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) which has got substantial provisions on farmers' rights and contains a chapter on it makes it obligatory on the member state to provide for its safeguard through national legislative process.[48]
Under the PPVFRA, a variety is eligible for protection provided it is novel, distinct, uniform, and stable.11 However, it is contended that while making these criteria for the protection of a new variety, the requirement for novelty almost similar to the UPOV 1991 Act which also contains the same criteria for the protection of a new plant variety. Further varieties not "sold or otherwise disposed of' in India more than a year prior to filing, or outside India for more than four or six years, depending on the type of plant, can pass the novelty test under the PPVFRA.[49]
Protecting Biodiversity
The PPVFRA has laid weight on conventional and traditional farming practices to protect biodiversity. Traditional Farmers are encouraged under PPVFRA to conserve and improve inherited land resources and for doing that they will be recognized and rewarded from the Gene Fund.[50]
Benefit Sharing
The concept of benefit sharing refers to the perception of sharing a fraction of the benefits accruing to a breeder of a new variety with qualifying pretenders who could be indigenous groups, individuals, farmers or communities. The concept of benefit sharing is very close to the community rights concept as elaborated in the above part. PPVFRA provides that before registering any new variety, the Plant authority should call claims for benefit sharing.
Farmers or persons or groups can respond based on two criteria:
- The extent and/or nature of use of genetic material in the development of the new variety, and
- The commercial utility and demand in the market of the new variety. Only
citizens of India or firms or organizations formed or recognized in India
are eligible to claim benefits. However some critics claim that the benefit
sharing provision is disconnected from the farmers, and onerous to
implement. Critics assert that farmers may not be observant in applying for
benefits considering social, economic, and other conditions of the local
communities. Subsequently, critics assert that the communities will be left
uncompensated for breeders' misappropriations and the actual benefit will
not be passed on to the actual claimers.[51]
India is one of the 12 mega-biodiversity centres in the world. It has a wide diversity of ecological habitats like forests, grasslands, wetlands, coastal and marine ecosystems. Based on the available data, India ranks tenth in the world and fourth in Asia in plant diversity."92 Like many other developing countries, India is at a crossroads with regard to the development of a new legal regime concerning the management of its vast biological resources and related knowledge. There are general links between biodiversity conservation and agro-biodiversity conservation specifically mentioned in the Plant Variety Act.
There are also general links between farmer's knowledge and the more general question of traditional knowledge concerning plant genetic resources. More specifically, the specific nature of the Biodiversity Act makes it an Act which is intrinsically linked to the Plant Variety Act. In pursuance of this, the Indian Parliament enacted the Biological Diversity Act 2002 in order to implement and give effect to the CBD.
The patenting of Neem and Turmeric by foreign firms initiated a public unrest not only in India, but also abroad, thus compelling the government to enact legislation to protect and regulate access to genetic resources and traditional knowledge.
The BD Act prescribed an institutional framework in order to implement the three CBD objectives of conservation, sustainable use, and equitable sharing of benefits arising out of the use of biological resources and related knowledge. It institutes a National Biodiversity Authority and State Biodiversity Authorities as nodal bodies to oversee the conservation, use and sharing of the benefits from the use of biological resources.
Seeds Bill 2004
In 2004, the Indian government brought a bill for regulating the quality of seeds for sale, import and export and to facilitate production and supply of seeds. The Seeds bill is primarily concerned with regulation, production and supply of seeds and is not a law on plant breeder rights (PBRs). It is important to note that the draft of the Seeds bill has been revised three times i.e., 2004, 2008, 2010 largely to put up the concerns expressed by various stakeholders including the farming community, civil society and parliamentarians, and the latest 2011 version of this Bill is still pending in the Upper House (Rajya Sabha) of the Parliament.
A careful scrutiny of the Seeds bill reveals that in the garb of regulating the quality of seeds, the bill introduces provisions which are either in direct conflict with the PPVFRA and reduces its efficacy by undermining the rights given to farmers under the PPVFRA whereby it takes away the various features recognized and protected under the PPVFRA. The features of the Seeds bill that undermine or conflict with the PPVFR Act raise the issue of indirectly diluting the PPVFRA and making it more UPOV compliant which is detrimental to the small and marginal farmers of India.
Protection Of Traditional Knowledge in India
Biodiversity and associated traditional knowledge are two capital resources of India. 'In 2000 the Council for Scientific and Industrial Research in India found out that almost 80% of the 4896 references to individual plant based medicinal patents in the United States Patents Office that year related to just seven medicinal plants of Indian origin. Three years later, there were almost 15,000 patents on such medicines spread over the United States, UK, and other registers of patent offices.
In 2005 this number had grown to 35,000, which clearly demonstrates the interest of developed world in the knowledge of the developing countries. (Menon, 2007). The need for protection of India's traditional knowledge stems from its obligations towards it indigenous and local communities the traditional knowledge holders whose rights are at stake, and also the need for legal compliance with international regimes and emerging norms. India's response has so far included both defensive and positive protection.
Introducing the Traditional Knowledge Digital Library (TKDL) as a form of prior art is an effort towards defensive protection of Indian traditional knowledge. India has sought to incorporate Access and Benefit Sharing provisions of CBD through its Biological Diversity Act 2002 and has enacted the Protection of Plant Varieties and Farmers' Rights Act 2001 as envisaged under the TRIPS.
Besides, several NGOs, civil society organizations and governmental institutions are working towards documentation of traditional knowledge at the local level. The question that one seeks to answer in the chapter, are, if domestic efforts are sufficient in an age of trade liberalization and whether there is a need to first provide for a legally binding mechanism at the international level.
Traditional Medicine System
Traditional medicine system in India prevails at two levels-the classical and folk system. Indian Systems of Medicine(lSM) having a central place in the official Indian healthcare system are derived from traditional knowledge based on codified systems such as Ayurveda, Siddha and Unani medicines is referred to as the classical system of medicine.
These are characterized by institutionally trained practitioners, a body of texts originating since ancient times, and highly developed theories to support the practices. These traditional medicine systems encompass knowledge of life, health and diseases of all living forms, not only human but also of plants and animals.
There exists an estimated 10-30 million manuscripts in Sanskrit alone, many of them relating to medicine .(Balasubramaniam,2003:40) In addition, innumerable manuscripts exist with individuals and families of vaidyas or traditional healers. Thus not all traditional knowledge is in the public domain.
Traditional knowledge of Agro -biodiversity
India like other developing countries is notable for agriculture as the major or only source of income for majority of its population, and for its wealth of genetic diversity present in the form of large number of farmer selected varieties. 'With more than 60% of the population employed in agriculture, seed supply in India fundamentally relies on decentralized local systems of seed production. These systems operate on the basis of the free diffusion of the best seed available within the community, with local farmers ensuring that the local community is supplied with planting material' (Sahai,2003:166).
The traditional ethics and cultural lore followed by these farming communities over long years value a public rather thari exclusive ownership on propagating material of all plants. Exchange of seed was and is essential to crop improvement, and the farmers selected the best seeds in the region with which to plant their field the next season. 'As one of the 12 mega diverse regions of the world, India has over 45,000 wild species of plants and 77,000 wild species of animals recorded' .(Tiwari,2006:49-62)These together constitute 6.5%ofthe world's wildlife.
The range of domesticated biodiversity in the country is also impressive. At least 166 species of crops and 320 species of wild relatives of crops are known to have originated in India. The diversity of crops within each of these species is very high. In case of rice, 50,000-60,000 are reported to have been grown in India in the recent past. Indian varieties and parental lines have been used in many countries (Tiwari,I998:91-107) 'For example Indian sugarcane varieties such as the Coimbatore (Co) varieties like Co 213, 281,290,312,313 and 475 have been were extensively used as parents of choice in economic breeding programmmes of many countries specially lava(Indonesia); Louisiana and Hawaii(USA) , Queensland (Australia) and West Indies.
Similar is the case with rice, wheat, chickpea, maize, sorghum etc. Thus there are numerous such Indian sources already in use internationally' (Siddiq, 1996:38-40) For instance Intan, Mas, and Peta, the most popular varieties of Indonesia are the cross of the Indian variety latisail with the Chinese variety Cina. 'It has been estimated that at least 10% ofIndia's recorded wild flora are on the threatened list.
Patent on Turmeric
The patent on healing properties of turmeric is a case of undue appropriation of traditional knowledge in foreign jurisdiction. Seen as a deficiency of the local patent system , in this case, the United States, with regard to prior art in foreign countries, the patent on the healing properties of turmeric, has received widespread attention in India and abroad.
Suman K Das and Hari Har P Cohly , two researchers based at the University of Mississipi Medical Centre in Jackson , Mississipi , applied for a United States patent on the use of turmeric in wound healing. More specifically, the application related to the use of turmeric to augment the healing process of chronic and acute wounds. The inventors claimed to have found "that the use of turmeric at the site of an injury by topical application and! or oral intake of turmeric will promote healing of wounds"
The patent application acknowledged that turmeric has been used for long time in India as a traditional medicine for the treatment of various sprains and inflammatory conditions. The patent was granted in 1995 on the basis of limited searches of prior art which did not indicate the claims were part of the public domain.
The case came to be noticed by some people about a patent that had been granted on properties of turmeric which were widely known in India and which were in public domain for centuries. "Since the patent was granted in United States, the only possible way to object to the patent was to take legal action in the United States.
As there was no specific individual or group affected by the patent, the Council of Scientific and Industrial Research(CSIR) in India challenged the patent to have it revoked on the ground that the alleged invention was actually a part of public domain knowledge in India. The patent was re-examined, all claims were cancelled and the patent expired on 28 March I 999.
Neem Related Patents
The case study of neem is an example of indirect appropriation of traditional knowledge by way of patents which are granted in other jurisdictions on traditional knowledge derived process or products. In India and the neighboring countries of the subcontinent, neem has applicability in agriculture as well as households.
For centuries farmers have used neem leaves as pesticides. In recent times, properties of neem have received attention prompting large scale research for production of commercially viable products. The natural formulation of pesticides produced from neem has a short shelf life.
The commercially produced ones have longer shelf lives. Among the many patents applied for, one patent, claiming a method for long term storage of the active pesticidal ingredient (azadirachitin) became the centre of vigorous debates. In 1992 USPTO issued a patent to W R grace which covers a method of creating a stabilized azadirachtin solution itself.[52]
Patents Related to Basmati Rice
In 1997 United States rice breeding firm Rice Tec Inc was awarded a patent (US 566 3484) relating to plants and seeds, seeking a monopoly over various rice lines including some having characteristics similar to basmati lines. This happened at a time when the world over, Basmati was a term used to refer to a variety of rice from the Punjab provinces of India.
Thus, Rice Tec Company's 1997 patent claim for Basmati rice described it as "an instant invention of a novel rice line" even though all Rice Tec did was to use Indian basmati rice to derive a Basmati strain. It was only after severe protests in India, led by various NGOS, and as a result of worldwide citizen campaign against Rice Tec Basmati patents, on August14 2001, the USPTO struck down large sections of the Basmati patent. Since Basmati Rice is an indication of a rice variety grown in a geographical region with specific climatic, soil and atmospheric conditions, Geographical Indications (GI) as means to protect similar products gained prominence in India.
Conclusion
Finally, India has had a much longer experience with patents systems than some European countries because of its colonial past. The Patent Act of 1970 brought about significant changes. It excluded patentability of life forms and specifically the patenting of methods of agriculture and horticulture (Section 3, Patents Act, 1970)
The Act specifically mentioned that the general principles governing the use of patents were that: patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented Act 1970)
The Act was different from the western model as it sought to control monopoly on one hand and provide for the health and food needs of India on the other. In the 1990s the national policy developments in the field of patents were influenced by international developments such as the adoption of TRIPS Agreement. Subsequently, the Patent Amendment Act 2002, also provided for changes in lieu of protection of traditional knowledge.
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- Mohammad Rasikh Wasiq
- Sayed Arsalan Sadat Nasseri
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