Impact of TRIPs Agreement on Life-forms / Living Organisms

Manzoor Elahi Laskar LLM 2nd Year, Roll No. 21, IPL Abstract The paper discusses upon the implication of TRIPs agreement relating to life forms in USA, EPO, India and Japan. It also sets the grounds on which patent are granted across these jurisdictions on life forms and the reasons for not granting patents for the same. TRIPs and IPR in living organisms (US, Europe & Asia) Biotechnology  Introduction:- The system of patenting was developed for machines, apparatus and so. However, with the advancement of biotechnological industry, it is being forced onto living things. Biotechnology has given us the power to manipulate genes, proteins and organisms. It has the potential to revolutionise the way that diseases are diagnosed and treated, our food is produced, our energy is generated and how we deal with our waste. Biotechnology concerns living organisms, such as plants, animals and micro-organisms, as well as non- biological material. Biological inventions ordinarily fall into three categories. They are the process for creation or modification of living organisms and biological materials; the result of such processes; and the use of such results. WIPO, Background Reading Material on Intellectual Property, Geneva, 1988, p.375 For the most part, patentability of biotechnological inventions is judged no differently to any other invention and so must be novel, non-obvious and capable of industrial use, although some specific technologies in this field are excluded from patentability in some countries. In addition, the exploitation of certain biotechnological inventions may be regulated by legislation beyond patent legislation. TRIPS on Life forms:- The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) was established in 1994 as one of the pillars of the global trade regime which is enforced through the World Trade Organisation (WTO). TRIPs Agreement defines minimum standards of protection for Intellectual Property Rights (IPRs) in more than 171 WTO member states. Section Five of the Agreement is devoted to patents and states that inventions in all fields of technology should be patentable. The TRIPS Agreement requires Member countries to make patents available for any inventions, whether products or processes, in all fields of technology without discrimination, subject to the normal tests of novelty, inventiveness and industrial applicability. It is also required that patents be available and patent rights enjoyable without discrimination as to the place of invention and whether products are imported or locally produced. Article 27.1 There are three permissible exceptions to the basic rule on patentability. One is for inventions contrary to public order or morality; this explicitly includes inventions dangerous to human, animal or plant life or health or seriously prejudicial to the environment. The use of this exception is subject to the condition that the commercial exploitation of the invention must also be prevented and this prevention must be necessary for the protection of order public or morality. Article 27.2 The second exception is that Members may exclude from patentability diagnostic, therapeutic and surgical methods for the treatment of humans or animals. Article 27.3(a) The third is that Members may exclude plants and animals other than micro-organisms and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, any country excluding plant varieties from patent protection must provide an effective sui generis system of protection. Moreover, the whole provision is subject to review four years after entry into force of the Agreement. Article 27.3(b) This includes life forms, which is highly controversial. Under Article 27.3(b) of the TRIPs, WTO member states must provide patent protection over micro-organisms and microbiological processes, such as those used in biotechnology. Countries are free to exclude plants and animals from their patent laws. However, all nations must provide intellectual property titles over plant varieties, either through patents or through an 'effective sui generis system'. The Agreement allows Member countries not to patent higher organisms, whether plants or animals, and "essentially biological processes for the production of plants and animals". However, Members must generally provide patent protection for micro-organisms and for "non-biological and micro-biological processes". Countries have to protect plant varieties by patents, by an effective sui generis system or by any combination thereof. Micro-organisms: Under Article 27.3(b), micro-organisms are mandatorily patentable. Micro-organisms are commonly defined as any microscopic organism, including bacteria, viruses, unicellular algae and protozoans, and microscopic fungi. They are considered to be a category of life different from the kingdoms of plants and animals. Non-biological and micro-biological processes includes the transformation of cells or tissue with recombinant DNA or the process of genetic engineering. Plant and Animals: In Article 27.3(b), Members are provided the option to exclude plants and animals from being protected by IPR. However, there is a single exception. Members are obliged to provide protection for one particular classification, i.e. plant varieties, either by patents as laid down by the TRIPS Agreement, by an effective sui generis system, or by any combination thereof. Cells and tissues from higher plants and animals are the subject of microbiology, but they are not micro-organisms. Under the concept of “essentially biological” processes, classical plant breeding methods would be excluded from patentability but genetic engineering methods would be patentable. Patentability of life forms in USA (Legal Framework, Disputes and Cases) Plant Patent Act, 1930 35 U.S.C. §161 which is the most recent amendment Plant Patent Act 1954 (Amendment), Sept. 3, 1954, provided that plant seedlings, discovered, propagated asexually, and proved to have new characteristics distinct from other known plants are patentable. to the U.S. plant patent statute states: “Whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefor, subject to the conditions and requirements of this title.” The provisions of this title relating to patents for inventions shall apply to patents for plants, except as otherwise provided. In re Beineke 10/919,574, 10/919,902 involves an attempt to obtain a plant patent for improved varieties of oak trees. Inventor Beineke is the proprietor of a forestry company which holds plant patents on a number of tree varieties important in forestry. Beineke discovered two white oak trees, each more than 100 years old, which showed superior properties growing in some one’s front yard. He took acorns from the trees and grew them. Whereupon he discovered that the resulting saplings also showed the same superior properties. He demonstrated that both the parent trees and the seedlings could be asexually reproduced so he applied for two plant patents, one for each tree and its progeny. The Patent Examiner rejected the applications because the oak trees had been discovered in an uncultivated state. Inventor Beinke filed a request for continued examination and submitted declarations to demonstrate that the trees were growing in a cultivated lawn and, thus, were not in an uncultivated state. The Examiner again rejected the applications and these rejections were appealed to the Board which again sustained the rejections. These rejections were then appealed to the Federal Circuit resulting in the case cited above. The court concluded that the original oak trees discovered by Beineke did not meet the requirements of either the original 1930 Act (which did not include found plants) or the 1954 Act (because the adult oak trees were not newly found seedlings). The underlying thread of reasoning is that the trees did not result from human intervention and thus were clearly products of nature. Bowman v. Monsanto Co. 07-CV-0283 is a United States Supreme Court patent decision in which the Court unanimously affirmed the Federal Circuit and held that patent exhaustion does not permit a farmer to reproduce patented seeds through planting and harvesting without the patent owner's permission. The facts of the case is that in 2007, Monsanto sued Indiana farmer Vernon Hugh Bowman for patent infringement. Monsanto alleged that infringement began in 1999 when Bowman, believing that a loophole existed under patent exhaustion, purchased mixed soybean seeds from a grain elevator and planted them for his second planting that year. Bowman purchased these seeds from the same elevator where he and neighbours sold their crops, many of which were transgenic, and the elevator sold soybeans as commodities, not as seeds for planting. He tested the new seeds, and found that as he had expected, some were resistant to glyphosate, a herbicide marketed under the trade name Roundup. He replanted seeds from the original second harvest in subsequent years for his second seasonal planting, supplementing them with more soybeans he bought at the elevator. He informed Monsanto of his activities. Monsanto stated that he was infringing their patents because the soybeans he bought from the elevator were new products that he purchased for use as seeds without a license from Monsanto; Bowman stated that he had not infringed due to patent exhaustion on the first sale of seed to whatever farmers had produced the crops that he bought from the elevator, on the grounds that for seed, all future generations are embodied in the first generation that was originally sold. Bowman had previously purchased and planted Monsanto seeds under a contract promising not to save seeds from the resulting crop. In 2009, the district court ruled in favour of Monsanto; on appeal, the Federal Circuit upheld the verdict. Bowman appealed to the United States Supreme Court, which granted review, then unanimously affirmed the Federal Circuit on May 13, 2013. Thus, the US Supreme Court has ruled unanimously that farmers cannot freely use patented genetically modified soybeans to harvest progeny seeds for subsequent replanting. This outcome is contrary to the doctrine of exhaustion of patent rights under which, once a patented product is sold with the authority of the patentee, its resale is generally not subject to restriction. Thus, in the case of a plant patent, the grant shall include the right to exclude others from asexually reproducing the plant, and from using, offering for sale, or selling the plant so reproduced, or any of its parts, throughout the United States, or from importing the plant so reproduced, or any parts thereof, into the United States. 35 USC § 163 Plant Varieties Protection Act, 1970 The PVPA confers a limited period of legal control to breeders of sexually reproduced or tuber propagated plant varieties. In order to be eligible for a certificate under the PVPA, a plant variety must satisfy four requirements. First, it must be new, in the sense that propagating or harvested material has not been sold or otherwise disposed of for purposes of exploitation for more than one year in the United States, or more than four years in any foreign jurisdiction (or six years in the case of a tree or vine). Second, the variety must be distinct -- that is, clearly distinguishable from any other publicly known variety. Distinctness may be based on one or more identifiable morphological, physiological, or other characteristics, including commercially valuable characteristics affecting activities such as milling and baking (in the case of wheat). Third, the variety must be uniform, in the sense that any variations are describable, predictable, and commercially acceptable. Finally, the variety must be stable, in the sense that the variety, when reproduced, will remain unchanged with regard to its essential and distinctive characteristics within a reasonable degree of commercial reliability. A plant variety certificate gives the breeder the right to exclude others from selling the variety, or offering it for sale, or reproducing it, or importing it, or exporting it, or using it in producing (as distinguished from developing) a hybrid or different variety. The term of protection runs 20 years from the certificate's date of issue, or 25 years in the case of a tree or vine. The PVPA contains three exemptions that significantly limit the scope of the plant breeder's exclusive right. First, the PVPA's provision safeguarding the "public interest in wide usage" allows the United States Department of Agriculture to declare an otherwise protected variety open on the basis of equitable remuneration to the owner, upon a finding that no more than two years of compulsory licensing of a protected variety is necessary in order to insure an adequate supply of fiber, food, or feed and that the owner is unwilling or unable to meet public demand at a price which may reasonably be deemed fair. Second, the PVPA's "research exemption" declares that the use and reproduction of a protected variety for plant breeding or other bona fide research shall not constitute infringement. The PVPA's third exemption permits a farmer to save seed from protected varieties and to use such saved seed in the production of a crop without infringement. Patent Act, 1952 Section 101 of the U.S. patent law states that “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title”. U.S.C Title 35 Naturally occurring things are not patentable. For e.g. naturally occurring microorganisms are not patentable but genetically engineered microorganisms, animals, plants are patentable as it is manmade. Anything under the sun that is made by man is patentable. As early as 1948, in Funk Brothers Seed Co. v. Kalo Inoculat Co. 333 U.S. 127 (1948), the Supreme Court held that an inoculant comprising a plurality of selected mutually noninhibitive strains of root-nodule bacteria was not patent eligible. It was ruled that the discovery of properties of the bacteria is “no more than the discovery of some of the handiwork of nature”; and the aggregation of the selected strains into one product is “hardly more than an advance in the packaging of the inoculants”. From 1970s till early 1980s, the Supreme Court made several decisions regarding the issue of patent eligibility. In this period, a landmark case in the field of biotechnology is Diamond v. Chakrabarty 447 U.S. 303 (1980). In contrast to Funk Brothers Seed Co. v. Kalo Inoculat Co., in this case, the Supreme Court considered that an oil-eating bacterium comprising at least two stable energy-generating plasmids “qualifies as patentable subject matter” since it is “a non-naturally occurring manufacture of composition of matter” On 20 March, the US Supreme Court cut back on the types of inventions that can be patented in America. The court held in Mayo Collaborative Services v. Prometheus Labs Inc. 101 USPQ2d 1961 (2012), that one cannot patent an invention which merely applies known technology to natural phenomena. Justice Stephen Breyer stated that this process was un-patentable because it claimed a monopoly on a law of nature – the relationship between the amount of thio purine metabolites in a person and the likelihood that the thiopurine drug dosage is ineffective or harmful. Although some technological measures were needed to ascertain the amount of metabolites in a patient’s blood, these measures “were well known” by scientists and did not suffice to make the invention patentable. In 1988, the United States Patent and Trademark Office (USPTO) granted U.S. Patent to Harvard College claiming “a transgenic non-human mammal whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal” The claim explicitly excluded humans, apparently reflecting moral and legal concerns about patents on human beings, and about modification of the human genome. Remarkably, there were no US courts called to decide on the validity of this patent. Two separate patents were issued to Harvard College covering methods for providing a cell culture from a transgenic non-human animal and testing methods using transgenic mice expressing an oncogene. Following are the statics of the number of Biotechnology Patents issued yearly and the number of Biotechnology Patents issued per year by technological groups before USPTO. From the figures above mentioned, it can be analysed that the number of biotechnological patents have increased since 1990 due to the broadening patent protection in biotechnological inventions and increased growth in biotechnological industry. Patentability of life forms in Europe In regards to the European Patent system, the laws are little different. Article 52 (1) states that “European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step”. Hence in Europe all inventions that are novel, not obvious and having industrial utility are patentable with certain exceptions and exclusions which are specified. Inventions which would be contrary to the “public order” or “morality” are not patentable. Plant or animal varieties or essentially biological processes for the production of plants or animals are not patentable. Methods for treatment of human or animal body by surgery or therapy and diagnostic methods are not patentable. Discoveries, scientific theories, mathematical methods, aesthetic creations, presentation of information, programs for computers, schemes, rules and methods for performing mental acts, playing games or doing business all these are not considered as inventions and hence cannot be patentable. According to Article 53 EPC 2000, the following inventions are not eligible for European patents: inventions the commercial exploitation of which would be contrary to “public order” or morality; plant or animal varieties; essentially biological processes for the production of plants or animals; methods for the treatment of the human or animal body by surgery or therapy; and diagnostic methods practiced on the human or animal body. It can be seen that the excluded subject matters are substantially consistent with those set forth in TRIPS. In 1998, the European Union codified its patenting mechanism for transgenic plant and animal varieties by passing the EC Directive 98/44/EC on patenting of biotechnological inventions. On 16th June, 1999 the Administrative Council inserted a new Chapter VI entitled ‘Biotechnological inventions’ in Part II of the EPC Implementing Regulations. The new provisions entered into force on 1 September 1999 and implemented the requirements of the EU Biotechnology Directive in European patent law. The EPO has introduced four new rules, Rules 23b to 23e. Rule 23b sets out general matters and defines the meaning of biotechnological inventions, biological material, plant variety, and microbiological process. Rule 23c states patentable biotechnological inventions, including material isolated from their environment, even if known in nature. This particularly applies to genes that are isolated from their natural environment by means of technical processes and made available for industrial production. Rule 23d sets out what is not patentable. This includes processes for cloning human beings, processes for modifying the genetic identity of human beings, using human embryos for commercial purposes and modifying the genetic identity of animals such as may cause them suffering without substantial medical benefit. The list is to be seen as giving concrete form to the concepts of ‘public order’ and ‘morality’. Rule 23e indicates what is and is not patentable with respect to the human body. The human body and its elements cannot be patented. However, elements of the body, when isolated from the body, may be patented. Thus, European rules and regulations are stricter when compared to U.S rules and regulations. The following are the implications of the EU Biotechnology Directive and EPC Implementing Regulations on European Patent Law. Inventions the commercial exploitation of which would be contrary to “ordre public” or morality. Four types of such inventions are exemplified, namely: processes for cloning human beings; processes for modifying the germ line genetic identity of human beings; use of human embryos for industrial or commercial purposes; and processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes. Article 6.2 Although use of human embryos for industrial or commercial purposes are not patent eligible, induced pluripotent stem cells (iPSC) may be allowable. Moreover, the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. Article 5.1 Plant or animal varieties. Although plant or animal varieties are not patentable, however, if the technical feasibility of an invention concerning a plant or animal is not confined to a particular plant or animal variety, such an invention shall be patentable. Therefore, a claim wherein specific plant varieties are not individually claimed is not excluded from patentability even though it may embrace plant varieties. In this regard example may be cited of NovartisII T1054/96,Plants/NOVARTIS where in the Enlarged Board of Appeal held that the genetically created herbicide resistance would not create a plant variety as this resistance could also be transferred to other varieties. Thus, the technical feasibility of the invention was not only confined to one plant variety. Therefore, the invention would not be excluded from patentability, regardless of the fact that the claim might also embrace a plant variety. Furthermore, the board clarified that although a patent cannot be obtained for a plant variety, it may well be obtained for a method to produce such variety. This would apply even in the light that products produced by a protected process are also covered by patent protection according to Art. 64. However, if an invention consists only in genetically modifying a particular plant variety, and if a new plant variety is bred, it will still be excluded from patentability even if the genetic modification is the result not of an essentially biological process but of a biotechnological process. Article 4.32 Also, the decision of Harvard Onco-mouse T 19/90 confirmed that a transgenic non-human mammalian animal does not fall within the scope of animal varieties under Article 53 EPC. The first European patent on a transgenic animal was granted in 1992 for a transgenic mouse that was susceptible to carcinogens due to an introduced oncogene. The case did not only break records with regard to its extraordinary consumption of time and human resources, it also contains important clarifications as to the patentability of animals. Bearing in mind that for animals – unlike plant varieties – no other industrial property right was available, the Board of Appeal held that Art. 53 (b) has to be narrowly construed and only applied to certain categories of animals but not to animals as such. Furthermore, the Board considered Art. 53 (a) EPC and concluded that it was necessary to carefully weighing up the suffering of the animal and the risk to the environment on the one hand and the invention’s usefulness to mankind on the other. Another slightly different balancing test has been adopted by the Directive and later introduced in the implementation rules of the EPC in order to specify the morality clause of the EPC and the national patent laws. According to rule 23 (d) EPC processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such process, are excluded from patentability. Thus, genetic modification of test animals for other than medical purposes, e.g. for the development of new cosmetics, are excluded from patentability if the modification causes suffering to the animal. The exclusion does not only comprise the animal but also the method of modification, thereby avoiding patenting of the animal through the backdoor of method claims. Inventions directed to the human body and its elements. Inventions as such are categorized into two forms: natural form and isolated form. On one hand, the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. Article 5.1, Biotech Directive; Rule 29.1 EPC On the other hand, an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. As confirmed by the EC Directive plant and animal varieties are not patentable. Plant varieties are currently protected under the Plant Varieties Act 1997. Both the 1997 Act and a separate European Community regime (Council Regulation (EC) No. 2100/94) are based on the 1991 UPOV Convention. Essential Biological Process. Essentially biological processes for the production of plants and animals, which are not micro-biological or other technical processes are excluded from patentability. Whether or not a (non-microbiological) process is to be considered as “essentially biological” has to be judged on the basis of the essence of the invention taking into account the totality of human intervention and its impact on the result achieved. However, the necessity for human intervention alone is not a sufficient criterion for an invention not being “essentially biological”. Human intervention may only mean that the process is not a purely biological process, without contributing anything beyond the trivial level. Moreover, it is simply not a matter of whether such intervention is of a quantitative or qualitative character. The Enlarged Board of Appeal found that claims to any non-microbiological processes for the sexual crossing of the whole genomes of plants are to be considered as being excluded as being "essentially biological" Furthermore, claims to a breeding process do not escape the exclusion merely by the addition of a further step of a technical nature which serves to enable or assist the performance of the steps of sexual crossing or subsequently selecting the offspring. This is because such steps do not move the process beyond what is considered to be an “essentially biological process”. A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being “essentially biological” within the meaning of Article 53(b) EPC. Therefore, in order to be patentable at least one additional technical step must be performed within the steps of sexual crossing and selection, which for instance ‘by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing’, although each case will be assessed on its own merits. Micro-organism. The European Union has defined “'biological material" instead of "micro-organism", as under Article 2.1 (a) of the EU Biotechnology Directive. “Biological material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system". European Board of Appeal held that a micro-organism would include bacteria, yeast, fungi, algae, protozoa, plasmids and viruses, but also animal or plant cells and generally all unicellular entities with dimensions beneath the limits of human vision. Plant Genetic Systems application (T356/93) Article 53(b) of the European Patent Convention (EPC) provides that European patents shall not be granted in respect of ‘plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof’. Article 3 of this EU Biotechnology Directive, provides that inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. Moreover, Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature. Claims to micro-organisms per se have been allowed on the grounds that they are products of microbiological processes. This applies even when they are merely isolated from their natural surroundings, their isolation, culture, characterization and the finding of a utility turning what would be a discovery into an invention. Claims to genetically modified micro-organisms derived from readily available known micro-organisms where the invention resides in the gene introduced, may be claimed more generally. Claims to mutants and variants of a specified deposited micro-organism are allowed provided they possess the same inventive property as the deposited micro-organism. If however the invention resides in the discovery that a known end product can be made using a different micro-organism not previously known to make it, then the process claim must be limited to the use of the actual micro-organism discovered. The protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall extend to any biological material derived from that biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics. The protection conferred by a patent on a process that enables a biological material to be produced possessing specific characteristics as a result of the invention shall extend to biological material directly obtained through that process and to any other biological material derived from the directly obtained biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics. Article 8 of the EU Biotechnology Directive Patentability of life forms in Asia (India and Japan) INDIA – Legal Framework, Disputes and Cases PATENT ACT, 1970 In India, not everything under the Sun is patentable in contrary to US Patent system. Section 3 of the Patent Act, 1970 provides a list of inventions which cannot be patented in India. So for any invention to be patented; it must first fulfil the basic requirements of patentability, i.e., it should be nobel, useful and have industrial applicability and should not fall under the purview of Section 3. As per Section 3(c) of the Act, the products such as microorganisms, nucleic acid sequences, proteins, enzymes, compounds, etc., which are directly isolated from nature are not patentable subject matter. It is mandated that microorganisms which are naturally occurring are not patentable. It is implied also that only modified microorganisms are patentable subject matter under the Act. Claims relating to basic biological processes of growing plants, germination of seeds, of development stages of plants and animals are not patentable. Section 3(d) of the Act provides that any minor modifications in the already existing substance in the prior art are not patentable unless the improved property or efficacy of the modified substance is established. With respect to biotechnology patent applications, section 3(d) is applicable to those inventions relating to a three-dimensional or crystal structure of a polypeptide unless it is proved that such polypeptide differs significantly in properties with regards to therapeutic efficacy. Further, Section 3(e) establishes that a composition comprising a combination of substances naturally occurring in nature is not patentable subject matter unless the synergistic effect of the components is established. According to Section 3(h) of the Act, a method of agriculture (a method of spraying insecticide for controlling pests) or horticulture is not considered as patentable subject matter. Conventional methods performed on actual open fields should be construed as method of agriculture/horticulture. Section 3(i) of the Act emphasizes that any method of treatment including diagnostic procedures or method of drug administration either to humans or animals are not patentable. The grant of patents relating to microorganisms depends upon the regulations regarding the requirements for the deposition of microorganisms in recognized International Depository Authorities (IDA) formed under Article-7 of the Budapest Treaty and accessibility of that microorganism from the depositories. As per section 10(4) (d) (ii) of the Indian Patent Act, 1970 , the microorganism if not being described fully and is not available to public the said microorganism is to be deposited before the IDA under the Budapest Treaty before filing of application in India. All the characteristics of the microorganisms and details of depositary institutions along with accession number shall be mentioned in specification for correctly identifying the same. Section 10(5) of the Act, provides that the claim(s) shall be clear and succinct and shall be fairly based on the matter disclosed in the specification. Also, the claim(s) of a complete specification shall relate to a single invention, or to a group of inventions linked so as to form a single inventive concept. Apart from setting the basic minimum standard for patentability, TRIPs obliges member states to patent micro-organisms (Article-27 (3) (b)). However, the term microorganism lacks a precise scientific definition because of which there are inherent anomalies in patenting these life forms. Though the TRIPs agreement mandates patent protection for micro-organisms, it does not define micro-organisms; thus there is no standard definition for member nations to follow. TRIPs facilitate the provision for the member country to adopt a sui generis (adoption of national laws and regulation) system to protect the GEMs and invented biological material. It is not clear whether, the term would include only genetically modified organisms or naturally occurring substances also. The Calcutta High Court decision in Dimminaco AG v. Controller of Patents and Designs, 2002 2002 IPLR relating to patentability of biotechnological process with living end product is another milestone decision in Indian context. Dimminaco A.G., a Swiss company applied for patenting the process for preparation of a live vaccine for Bursitis, an infectious poultry disease and the invention involved a live (attenuated) vaccine to combat the disease. The Controller of Patents refused to allow the application on the ground that the vaccine involved processing of certain microbial substances; this was only a natural process devoid of any manufacturing activities and hence not patentable. This was in consonance with the prevailing practice that grants patents only to non-living and tangible inventions, even though the Patent Act imposed no such limitation. However, on appeal, the Calcutta High Court diverted from the above position. It rejected the contention of the controller that a patent is given only for a process that results either in an article, substance, or manufacture and a vaccine with a living organism is not an article, substance, or manufacture. Law does not bar processes where the end-product is living. No statutory bar in the Act to accept a manner of manufacture as patentable even if the end product contains a living organism. Justice Ashok Kumar Ganguly observed “if the end is the commercial and vendible entity; and for that presence of living virus or micro-organism in the end product cannot be a bar to its patentability”. The Calcutta High Court held that, the Indian statute on patents does not put any restraints on patentability of micro-organisms developed in a controlled environment in the laboratories. The Court also held that the process for creating a vaccine leads to a vendible product even if the end product contains live material. The court said that if the invention results in the production of some vendible items or improves or restores formal conditions of vendible item. Therefore since the claim process for patent leads to a vendible product, it is certainly a substance after going through the process of manufacture. The court concluded that a new and useful art or process is an invention, and where the end product is a new article, the process leading to its manufacture is an invention. This decision on the Calcutta High Court was in line with the position in US, most of the European countries as well as Japan, since most processes in the biotechnology field will be patentable, irrespective of whether resultant product is living or non-living. After the Dimminaco decision, the Indian law kept pace with the needs of flourishing biotechnology industry. Section 3(j) renders ‘plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals’ not patentable. Thus, in the light of above mentioned Sections, simply isolating a gene from a living thing amounts to ‘discovery’ and not ‘invention’ and hence not patentable. That is to say, under the current Patent regime naturally occurring DNA sequences cannot be patented as such. They can only be patented when after isolating the sequence they are purified and chemically modified resulting into a sequence that is new, inventive and has industrial application. Nevertheless, artificially developed genetically engineered microorganisms, vaccines and recombinant DNA are all considered to be patentable. Thus, when a genetically engineered gene, DNA, or amino acid sequence is novel and holds an inventive step thereby ensuring its industrial application, the patents can be claimed. It should be noted that rDNA, plasmids and process of forming the same are allowed to be patentable if substantive inventive steps are employed. One such example of gene patents in India, as seen in Indian Patent No. 243373 (279/MUM/2004) assigned to Sichuan Biotechnology Research Center, discloses artificial gene sequence for encoding recombinant super compound interferon with enhanced activity. Further, unidentified functions of gene/DNA sequences and without any industrial application cannot be construed to be patentable. PLANT VARIETY PROTECTION AND FARMER’S RIGHT ACT, 2001:- India has ratified the TRIPS agreement and to give effect to this agreement, The Protection of Plant Varieties and Farmers Rights Act, 2001 (PPV&FRA) was enacted. The main aim of this Act is to establish an effective system for the protection of plant varieties and, the rights of the breeders and to encourage the development of new varieties of plants. Any variety that fulfills within the distinct, uniform and stable criteria and that is "new" (in the market) is eligible for this kind of protection, and there is no need to demonstrate an inventive step or industrial application, as required under a patent regime. Novel: if at the date of filing an application for registration for protection, the propagating or harvested material of such variety has not been sold or otherwise disposed of in India earlier than one year or outside India, in the case of trees or vines earlier than six years, or in any other case earlier than four years, before the date of filing such application. Distinct: A variety is said to be distinct if it is clearly distinguishable by atleast one essential characteristic from any other variety whose existence is a matter of common knowledge in any country at the time of filing an application. Uniform: A variety is said to be uniform, if subject to the variation that may be expected from the particular features of its propagation it is sufficiently uniform in its essential characteristics. Stable: A variety is said to be stable if its essential characteristics remain unchanged after repeated propagation or, in the case of a particular cycle of propagation, at the end of each such cycle. Rights of Plant Breeder’s: Breeders’ rights over the varieties they have developed are more than adequately protected by the draft legislation. On registration, the breeder has rights of commercialization for the registered variety either in his/her own person or through anyone he designates. These rights include the right to produce, sell, market, distribute, import or export a variety, in short, full control over formal marketing. The strong protection granted to a plant breeder over his/her variety is seen in the section dealing with infringement of breeders’ rights where punishment in the form of substantial fines and jail terms has been prescribed for those who infringe the rights of the registered breeder. Rights of Researcher: Researchers’ right allows scientists and breeders to have free access to registered varieties for research. The registered variety can also be used for the purpose of creating other, new varieties. Farmer’s Right: The Act recognizes the farmer not just as a cultivator but also as a conserver of the agricultural gene pool and a breeder who has bred several successful varieties. The Act makes provisions for such farmer’s varieties to be registered, with the help of NGOs so that they are protected against being scavenged by formal sector breeders. This formulation allows the farmer to sell seed in the way he has always done, with the restriction that this seed cannot be branded with the breeder’s registered name. In this way, both farmers’ and breeders’ rights are protected. JAPAN - Legal Framework, Disputes and Cases Japan grants patents to plants and animals (other than human beings). Japanese Patent Office (“JPO”) requirements for patenting living matter are similar to the requirements of both the USPTO and the EPO. In Japan, a biotechnological invention must be non-naturally occurring matter. However, the JPO maintains that “processes in the fields of medicine, diagnosis, therapy, and pharmacology in which the human body is an indispensable element” fall outside the scope of patentable living matter. In 1997, the Japanese Patent Office (JPO) published its ‘Implementing Guidelines for Inventions in Specific Fields’. Japan grants patents to living organisms (other than human beings). JPO provides guidelines for the patentability of biological inventions in relation to the Japan Patent Act (1959). This guideline is divided into four main sections: 1. Genetic engineering 2. Microbes 3. Plants 4. Animals Inventions relating to genetic engineering include those of a gene, a vector, a recombinant vector, a transformant, a fused cell, a recombinant protein, and a monoclonal antibody. Inventions relating to microbes include micro-organisms per se as well as those relating to the use of micro-organisms. In Japan, micro-organism means yeast, molds, mushrooms, bacteria, actinomycetes, unicellular algae, viruses, protozoa, etc. and further includes undifferentiated animal or plant cells as well as animal or plant tissue cultures. The JPO requires that the invention be a non-natural occurring substance; that the invention has substantial human intervention; that the claim language is limited to claims and; that the human body is not an essential element. The Japanese patent system limits the scope of patentable subject matter to exclude processes in the field of medicine, diagnosis, therapy, and pharmacology. Medical related activities are not explicitly excluded from patentable subject matter under the Japanese Patent Law (JPL). However, methods for treating the human body by surgery or therapy and diagnostic methods have been excluded from patentability as they are inventions which are not industrially applicable. This non-patentability applies only when the claims are directed to a method. If an invention relating to a medical method is claimed as a medical device (i.e., product) to be used for the medical method, it may be patented. As a result, an inventor cannot receive Japanese patent protection for biotechnology inventions of products falling within these areas where the human body is an essential element. Further, the Japanese patent statute contains a morality provision. Article 32 excludes the patentability of inventions that are “liable to contravene public order, morality or public health. Under Japanese Patent Law, human biological materials are patentable subject matter unless they are mere discoveries of products of nature. If biological materials have been artificially isolated from their surroundings, then they are “creations” and are considered statutory patentable subject matter. JPO Guidelines, Part II, Chapter 1, 1.1. The human body at its various stages of formation and development, including germ cells, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute a patentable invention. The patentability standards with regard to plants and animals are same with that of US Patent Law and EPO. However, an alternative registration system for plant varieties also exits that is maintained by the Ministry of Agriculture, Forestry and Fisheries. Rules for the recognition of plant varieties as IP are outlined in the Seed and Seedling Law (1999), which went under full amendment from the original Seed and Seedling Law issued in 1947. The period of protection and conditions for eligibility is identical or similar to those for the Australian PBR. All inventions in this category must fulfil the three standard criteria for patentability, which are industrial utility, novelty and inventive step. The novelty and inventive step criteria emphasises the importance to explain the ‘unexpected and useful result’ that was found through the invention, because many biological inventions use known nucleic acid or protein sequences, substances, methods and organisms. In terms of plant and animal inventions, non-differentiated cells and tissue are regarded as ‘microbes’ and therefore criteria for such inventions should refer to those for microbes. Animal inventions list an additional criterion of public order and morality (Japan Patent Act sect. 32), which excludes creation of human beings. There is another guideline on inventions that concern methods of medical practice on human beings through surgery, general treatment, or diagnosis. These methodological inventions do not meet the ‘industrial utility’ criterion, therefore cannot be patented. Methods to treat animals other than human beings are patentable, however it must be clearly stated as such. On the other hand, medical devices or instruments and medicines are regarded as an ‘invention of an object’ and not a ‘method of medical practice’, therefore are patentable matter. ‘Swiss-style’ claims are included as patentable matter in the medicines category. In Japan any new, non-obvious and industrially applicable invention can be patentable. Any invention that is liable to contravene public order, morality or public health is not patentable. Mere discoveries, laws of nature, inventions which are contrary to the laws of nature are not patentable. Methods for treatment of human body by surgery or therapy and diagnostic methods are considered to be industrially inapplicable. Software is considered to be patentable when information processing by the software is concretely realized by using hardware resources. Biological subject matters are patentable if the utility is described. Trade agreement There are several regional trade agreements which relates to intellectual property and provides for both substantive and procedural obligations on member states. They are: ANDEAN COMMUNITY, G-3 FREE TRADE AGREEMENT, NAFTA, MERCOSUR, SIECA, ASEAN and OAPI (African Intellectual Property Organization). NAFTA is Free trade Agreement between Canada, Mexico and the US. It also contains similar provision as to patentability of life forms as there in TRIPs Agreement. In Article 1709, it provides that patents should be available for any inventions, whether products or processes, in all fields of technology, provided that such inventions are new, result from an inventive step and are capable of industrial application. For purposes of this Article, a Party may deem the terms "inventive step" and "capable of industrial application" to be synonymous with the terms "non-obvious" and "useful", respectively. Moreover, a Party may exclude from patentability inventions if preventing in its territory the commercial exploitation of the inventions is necessary to protect order public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to nature or the environment, provided that the exclusion is not based solely on the ground that the Party prohibits commercial exploitation in its territory of the subject matter of the patent. A Party may also exclude from patentability: (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals; (b) plants and animals other than microorganisms; and (c) essentially biological processes for the production of plants or animals, other than non-biological and microbiological processes for such production. In case of plants, each Party shall provide for the protection of plant varieties through patents, or an effective scheme of sui generis protection, or both. In case of plant breeder’s right, this agreement follows UPOV Convention model, where in under its free trade agreement with Mexico, it compels that plant breeders be protected for varieties in all plant genera and species and grant protection, in accordance with such substantive provisions of UPOV Convention. Analysis:- This study provides an overview of the legal provisions regarding patent-eligible subject matter in view of recent cases. Under the “umbrella” of TRIPS, the provisions are harmonized to some extent, but the specific doctrines are still distinct in individual patent law. Compared with Europe, Japan and India, currently, patent-eligible subject matters are more extensive in the U.S.A. Inventions contrary to public interest or morality are not patent eligible in Europe, Japan and India, which corresponds to the provision in Article 27.2 TRIPS. Embryonic stem cells of human beings are considered as inventions contrary to “public order” or “morality” and explicitly excluded from patent eligibility in Europe and India. In contrast, there is no such morality concern under the U.S. patent law currently, which was described as “Patent First, Ask Questions Later”. Corresponding to the provisions in Article 27.3 TRIPS, methods for the treatment or diagnosis of diseases are not patent eligible in Europe, Japan and India, although the specific criteria are not completely identical. In Europe and India, such methods practiced on a human or animal body are not patent eligible; in contrast, such methods practiced on a non-human animal body may be patent eligible in Japan. Corresponding to the provisions in Article 27.3 TRIPS, plant and animal varieties are excluded from patent-eligible subject matters in Europe and India. However, in Europe, if the technical feasibility of an invention concerning a plant or animal is not confined to a particular plant or animal variety, such an invention shall be patentable. As of now, isolated genes are patent eligible under the four jurisdictions. Even though the debate regarding gene patents has been on-going and there is concern about the prospect of gene inventions, it appears that the filing of patent applications was not adversely affected in the U.S. in 2012. The amount of DNA patent applications in 2012 (9941) slightly increased compared with that in 2011 (9894). Considering the importance of biotechnology industry in the U.S., it is expected that isolated genes would continue to be patent eligible. Conclusion: Japan and India has always been, and still is, lagging behind the US and Europe in terms of life science related patents. In relation to Japan, firstly, the percentage of life science related patents registered in Japan was approximately 2% (just over 2000 patents) of the total number of patents filed in 2003. In contrast to the high percentage of total domestic applications (87% in 2003), that of patents in the life science field was below 40%, the rest being dominated by US applications. International applications from Japan both via the Paris Convention route and PCT are relatively less compared to those from US and Europe. This can create a huge disadvantage in life science related inventions, since the industrial application of such inventions are usually beneficial to any society. One reason for the difference in the number of patents in the life science field generated between the industrial trilateral is due to differences in the support system towards research institutions. Whereas most biotechnological patents in Japan and Europe are being generated by large chemical, pharmaceutical and food companies, there is a large proportion of universities in the US that contribute to the number of biotechnological patents. Because these inventions require intensive research, pure research-based institutions and universities will have better opportunities at inventing. The US was among the first to establish the supportive platform by the introduction of the Bayh-Dole Act in 1980, which provides incentive for researchers to conduct good-quality research funded by the government and eventually hold the patent rights within the research institution. Japan was late to introduce industrial policies that would promote innovative research by research institutions, however have so far introduced six such policies: the law for promotion of university-industry technology transfer (1998), special measures law for industrial revitalization (Japanese Bayh-Dole Act, 1999), basic strategy towards creation of the biotechnological industry (1999), new developmental strategy for the renewal of Japan (2000), outline for biotechnological strategies (2002), and basic act for intellectual property (2002). In relation to India, under the present TRIPS framework, irrespective of the fact that it is a MNC or an Indian company, the edge exists for only those companies which are innovative in their product profiles and who are continuously innovating and introducing new products. The focus needs to be changed from export oriented activity to a global marketing. This involves establishing strategic marketing alliances in developed markets that will provide access to distribution networks and enable Indian pharmaceutical companies to operate as profit sharing partners. This also involves adopting vertical integration in a planned manner into the distribution and using chain, starting from developing markets and moving up to developed markets. More emphasis should be given on rapid development of processes, which are innovative. Cost effective R&D for the development of low cost bulk drugs, formulation and discovery research as well as clinical studies for the worldwide markets need to be carried out. Government can use affordability as the low threshold for drug pricing, based on annual per capita spending of its citizen, on health care. Patenting of tropical bio-diversity should be emphasized so as to prevent patenting of Neem, Turmeric, Basmati and other components of indigenous system of medicine by outsiders. This will help ensure IPR protection to herbal and botanicals to MNC exploitation and also revenue earnings for Indian companies dealing in them. Many Indian pharmaceutical companies have already geared up for facing the reality of product patent. Several new developments have already taken place in their R&D and strategic efforts. The strength of the industry is in developing cost-effective technologies in the shortest possible time for drug intermediates and bulk actives without compromising on quality. Accordingly, generic drug manufacturing is going to be the main growth driver for the future. India is set to capture a large portion of this market by leveraging its inherent strengths in technology, R&D facilities and trained human capital. * * * * * * * * * TRIPs and IPR in living organisms (US, Europe & Asia) Assignment No.3 pg. 2