UNIVERSITY OF TURIN MASTER OF LAW (L.L.M) IN INTELLECTUAL PROPERTY CLASS NOTES ON

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1 UNIVERSITY OF TURIN MASTER OF LAW (L.L.M) IN INTELLECTUAL PROPERTY CLASS NOTES ON BIOTECHNOLOGY PATENTS AND PATENT DOCUMENTS SEARCH (Week 4) Lectures by Professor Carlos Correa & Mr.Andrew Czajkowski Notes taken by:- Abdulrezak Oumer Mercy Kyomugasho Honório Cumbi Sep 30, 11 Torino, Italy

2 Acronyms CBD ECLA EPO GM IPC SMEs TISCs TRIPs UPOV USPC - Convention on Biological Diversity - European Classification - European Patent Office - Genetically Modified - International Patent Classification -Small and Medium Enterprises -Technology and Innovation Support Centers -Trade Related Aspects of Intellectual Property Rights -Union internationale pour la Protection des Obtentions Végétales -United State Patent Classification USPTO -United State Patent and Trademark Office WIPO WTO -World Intellectual Property Organization -World Trade Organization WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 2

3 TABLE OF CONTENTS 1. Historical Background of Biotechnology 2. Biotechnology Patents 3. Intellectual Property and The Intellectual Legal Regime Of Access To Genetic Resource: 4. Article 27 of the TRIPs Agreement 5. The Convention On Biological Diversity 6. The Nagoya Protocol 7. The Draft Decision by developing countries 8. IPR Enforcement 9. Dispute Settlement Under Trips 10. University Inventions/SPLT 11. The Importance and the Role of Patent Information 12. Conclusions 13. Facts and Figures WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 3

4 Historical Background of Biotechnology: Biotechnology is a field of technology that involves the purposeful utilization of living organism, or biological system, to produce food and medicine; or the use of microorganism to produce industrial product. While biotechnology has developed rapidly in recent years, the main beneficial applications of biotechnology for agriculture and for human health have been identified for a long time. For example, the isolation of adrenalin over a century ago from the human suprarenal gland was an important advance. In 1901, the American Journal of Physiology reported that the most important contribution to our knowledge of the active principle of the suprarenal gland. The application of technology to agriculture has helped contribute to enormous increases in yield and quality of the produce. This has been through selective breeding and improved technologies for fertilization and pest and weed management. The subject matter of patents: The first patent (U.S Patent 135,245) was granted in 1873 for improvement in Brewing beer and Ale Pasteurization in the name of Louis Pasteur s. In his invention, Pasteur claimed that types of microbes could be separated from each other by proper techniques, and could be shown to differ in nutritional requirements and in their susceptibility to antiseptics. The Impact of his Invention was that Spoilage of perishable products could be prevented by destroying the microbes already present in these products and by protecting the sterilized material against subsequent contamination. Pasteur applied this theory to the preservation of beverages and foodstuffs, introducing the technique of heat treatment now known as pasteurization.pasteur s pasteurisation process killed germs and prevented the spread of disease. Hence finding a cure for a disease affecting silk worms. He also found cures for anthrax and rabies. Intellectual property protection for plants: The intellectual property protection of biotechnology-related subject matter is undergoing significant change and several countries have revised their legislation and/or patent practice as a result of challenges from industry and members of the public. Plant-related subject matter can be protected using plant variety protection, utility patents or, in the USA, by plant patent. Although easier to obtain than a utility patent, plant variety protection does not provide the same scope of protection. Protecting a plant using a utility patent is permitted only in countries that allow the patenting of higher life forms and requires a higher degree of experimental support than is required for plant variety protection, although the scope of protection is being steadily reduced. Intellectual property rights may be applied to genetic resources including microorganism, plants and animals. These may be protected as utility patents, trade secrets, plant varieties and other sui generis systems of protections for plants. Since 1930, plant patents have been available from the U.S Patent and Trademark Office (USPTO) to protect novel asexually reproduced plant varieties including fruits. Plant breeders rights similar to the U.S plant variety protection are available in other countries that are members of the International Union for the Protection of New Varieties of Plants (Union internationale pour la protection des obtentions végétales) UPOV. Other legislations that deal with plant varieties include The Plant Varieties Protection of Netherlands 1942 & Germany 1953 and The Paris convention, Lisbon (1958). Plant patents: A plant patent is granted by the Government to an inventor (or the inventor's heirs or assigns) who has invented or discovered and asexually reproduced a distinct and new variety of plant, other than a tuber propagated plant or a plant found in an uncultivated state. The grant, which lasts for years from the WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 4

5 date of filing the application, protects the inventor's right to exclude others from asexually reproducing, selling, or using the plant so reproduced. Plant Protection: A plant can be protected under the Patent law as long as it meets the criteria of novelty, inventive step and industrial applicability. Legal protection for plants varies from one country to another. Patents may cover cells and sub-cellular parts, including genes, plants and plant varieties depending of national laws. However, Plant patents have caused concerns with regard to the scope of their protection, its impact on the use of seed and access to germ plasm for further research and breeding. Accordingly plants can be modified to cope with the climate change by enhancing their resistance to environments stresses such as heat, cold etc. Intellectual property protection of plant biotechnology inventions: UPOV Conventions of 1978 and 1991 and are similar, in that they provide protection to a plant variety that is distinct from existing known varieties, and that is uniform, stable and novel. However, there are several significant changes in the 1991 Act. For example, the definition of propagating material has been tightened and provisions relating to farmers rights (or privilege) the rights that permit a farmer to replant seed for personal use have been defined. Although plant variety protection meeting the standard set out under UPOV is accepted in 50 countries, such protection has not been uniformly accepted and many countries with strong histories of farmers privilege have yet to accede to the convention A rigorous debate also continues over the effect of plant variety protection and associate Material Transfer Agreements, on sharing and developing new germ plasm. UPOV 1978 provides an exclusive right to produce and offer for sale propagating materials of a plant variety but not the harvested end product, for example a fruit. Furthermore, the right pertains only to a commercial end product and not to non-commercial uses. As a result, replanting seed is implicitly allowed under UPOV 1978, leading to farmers privilege. Also provided in the 1978 convention was a breeders exemption permitting the use of protected varieties as a germ plasm source to develop new plant varieties. A plant variety is 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;" (UPOV) A plant variety can be protected under the Plant Varieties law. A plant variety shall be granted protection if it is: new, distinct, uniform and stable WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 5

6 Expansion of patent protection of biological materials: In 1980 the US Supreme Court decision in Diamond V. Charkrabarty (44 U.S. 303, 1980) held that regular utility patents could be granted for inventions involving living organisms. This decision specifically addressed the patentability of newly created microorganism that could break down crude in a manner that might be useful to control oil spills. Subsequent U.S.P.T.O and supreme court decisions confirmed that plants and animals including those created by conventional breeding, and particular sequences of genetic material or DNA such as genes, markers and promoters ( which control the expression of genes in cells) could be protected by utility patents. Here the issue to be resolved remains whether the patentability of isolated gene and function amount to an invention within the definition of Patent or a discovery? Owing to the fact the Patents are only for inventions and not discoveries. In light of these developments, some issues raised by the grant of patents in the area of plants include the distinction between invention and discovery and inventive step. It has been argued that there is a thin line between invention and discovery. The basic question normally is whether isolated genes and other biological materials may be deemed invented and hence eligible for patent protection. It is noted that some countries however do not consider that an invention exists where certain natural substance, such as a gene has been isolated and its utility identified. The scope of patent rights: Gene patents A gene patent is a patent on a specific isolated gene sequence, its chemical composition, the processes for obtaining or using it, or a combination of such claims. Gene patents are a part of the broader category of biological patents. In terms of genetics, inventors must,(1) identify novel genetic sequences, (2) specify the sequence's product, (3) specify how the product functions in nature i.e., its use and (4) enable one skilled in the field to use the sequence for its stated purpose One of the most contentious issues relating to gene patents in general, has been the setting of their appropriate scope. Critics argue that the scope of a gene patent should be limited to the particular function that the inventor describes in the patent application. The issue is whether gene patents should be given Absolute protection or use bound protection. Absolute protection is where the gene is protected for all possible functions, whereas use bound protection is where protection is for only the disclosed function. Reference was made the Myriads patents over BRCA1 and BRCA2 genes which were found to lead the body to produce tumor suppressing proteins. (Genes themselves do not have a direct function on the body; rather, they produce proteins that do the work necessary to carry on life.) When present, these proteins reduce the chances that an individual will develop cancer. When there is a mutation in one of these genes, however, the body cannot produce the protein, thus increasing the risk of contracting breast or ovarian cancer. Based on this knowledge, Myriad and others applied for and obtained patents over the genes and associated diagnostic test. This patent attracted a lot of criticism where by some critics claim that what Myriad did was simply to identify the function and sequence of two preexisting genes. Critics argue that the scope of a gene patent should be limited to the particular function that the inventor describes in the patent application. This, they claimed, was a discovery and not an invention as any human intervention was required for the genes WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 6

7 to possess this function. Others said that the process of sequencing genes has now become so routine that that act alone can no longer be considered to be inventive, others argued that the problem with Myriad s patents is that they cover all possible functions even those unknown at the time of application of the genes and covered virtually all forms of diagnostic testing, even those not contemplated by the inventors, thus the scope of the patent claims was too broad and should have been restricted to a specific, known function. The European directive on biotechnological inventions (98/44/EC) Article 3(1) provides for inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a products consisting of or containing biological material or a process by means of which biological material is produced, processed or used. Article 3(2) provides for biological material which is isolated from its natural environment or produced by means of a technical process may be subject of an invention even if it previously occurred in nature. This indicates that biological material is patentable. DNA related patents: Gene patents may claim the isolated natural sequences of genes, the use of a natural sequence for purposes such as diagnostic testing, or a natural sequence that has been altered by adding a promoter or other changes to make it more useful. Others gene patents may be promoters, enhancers, transit peptides, individual exons, cloning vectors, expression vectors, amino acid sequences (proteins), nucleic acid probes, isolated host cells transformed with expression vectors and modified plants. Therefore, Patents on genes have only been granted on isolated gene sequences with known functions, and these patents cannot be applied to the naturally occurring genes in humans or any other naturally occurring organism. Genetically Modified plants: Genetically modified plants are plants whose DNA is modified using genetic engineering techniques. In most cases the aim is to introduce a new trait to the plant which does not occur naturally in this species. Examples include resistance to certain pests, diseases or environmental conditions, or the production of a certain nutrient or pharmaceutical agent. The exclusion of plant varieties from patenting doesn t apply to plant types in general that are modified by patentable biotechnical processes. The process to obtain a hybrid involves a new combinations of traditional plant breeding techniques that results in plants and seeds. Implications of plant protection: Plant Patents Plant patents may, prevent farmers from saving and re-using seeds from their harvests, when protected under patents and if there is need for reuse they may be required to pay. Under Patent protection, improved plant/variety obtained through research or experimentation on Plant Varieties Under the plant variety protection, the use of protected varieties for further breeding (research) may lead to new varieties to be independently commercialized. Here, improved plant/variety obtained through research or experimentation on invention can be WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 7

8 invention cannot be independently commercialized. independently commercialized. A compulsory license is normally required in the interface between patents and plant variety protection. This is because breeder cannot commercialize a plant variety without infringing a patent and on the other hand a patentee cannot commercialize an invention without infringing a PVP. The extension of protection to derivatives: This is another implication of plant patents. The issue here is whether derivatives are subject to a patent over a trait. This issue was envisaged in the Monsanto case and Argentina. In this case Monsanto patent holder claimed a breach of patent by Argentina Soy exporters because of the presence of his DNA sequence in the said beans. Monsanto has not registered his patent in Argentina and it was evident that for many years, all farmers in Argentina used the said technology. Monsanto wanted to be paid for the technology and even tried to enforce intellectual property rights against Argentina exports to the European markets. The European commission found there was no infringement. Though Monsanto s gene had been discovered to be present in the meal, it was established under the Directive 98/44/EC of the European Parliament that for a gene to be enforceable, the gene needs to be functional in the infringing product. The ECJ decided that the Biotech Directive does not provide protection for soybean meal despite the presence of the gene as you can t plant soybean meal and grow a soy plant. Other implications of plant patent include the protection of technologies in the state of art, the misappropriation of genetic resources and traditional knowledge. New developments: There have been new developments in the area of plant patents. This is seen from the patent applications relating to native traits and conventional breeding methods. For example, EP on Broccoli and EP , on Tomatoes. In EP , a method for production of Brassica Oleracea which comprises of crossing wild Brassica Oleracea species with Brassica Oleracea lines and selecting hybrids with levels of 4- methylsulfinybutyl glucosinolates, or 3-methylfinypropyl glucosinolates or both, elevated above that initially found Brassica Oleracea breeding lines. In EP , is a method for breeding tomatoes having reduced water content and product of the method. The following policies can be applied on plant patents: The exclusion of plants (whether the genetically modified or not) and biological processes; The clear distinction between discovery and invention; The rigorous examination of novelty and inventive step; The use bound protection (only the function of the gene specified in the claim); Research exemptions and commercialization of new variety; The interface patent-pvp: Compulsory. WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 8

9 TRIPS flexibility: Patentability standards: The standard for intellectual property rights is outlined in the global intellectual property treaty agreement of Trade-Related Aspects of Intellectual Property Rights (TRIPS).Member countries that have signed this agreement must ensure that the requirements stated in TRIPS are met in their own legislation. TRIPS states that patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Although seemingly simple and consistent with the requirements for obtaining a patent in most developed countries, this statement is at the heart of most of the controversy relating to biotechnology patenting. An additional paragraph in TRIPS permits several grounds for exclusion in granting patent protection, including exclusion on moral grounds; or diagnostic, therapeutic and surgical methods for the treatment of humans or animals, life forms other than microorganisms and processes for the production of plants or animals. However, these exclusions are optional and vary from country to country. For example, the European Patent Convention (EPC) provides limited moral grounds for exclusion.yet no such grounds are defined in the Patent Acts in Canada, Australia, the USA or Japan. TRIPS also states that if protection of plants is not available by patent, then member countries need to provide protection in some other way A standard method for such alternative protection is plant variety protection, as set out under Union International pour la Protection des Obtentions Végétales, known more simply as UPOV. Article 27.1 of the TRIPS agreement stipulates that, patents shall be available for any inventions, whether products or processes, in the field of technology, provided they are new, involve an inventive step and are capable of industrial application. Therefore, this provision obligates members to protect inventions provided they meet the requirements of novelty, inventive step (or non-obviousness) and industrial applicability (or utility). It should be noted however, that the term invention is not interpreted in TRIPS. The US Law provides for flexibility about novelty which provides that a person shall be entitled to a patent unless the invention was patented or described in a printed publication in the US or a foreign country or public use or sale in US, more than one year prior to the date of the application. Inventive step: This is a legal requirement for patentability. This implies that the invention should not be obvious to a person with ordinary skill in the art. However the challenge has always been how to determine the person with ordinary skill, or how ordinary the skills should be. In the case of Jeus Douglas EN Cuno Engineering Copr, 314 U.S. 84, 51 U.S.P.Q.1, 1941, was held that for a new device to be patentable, it must reveal a flash of creative genius. Examples of inventions that have been patented include the sealed crustless sandwitch (US 6,004,596/1999), the method of excising a cat (US 5,443,036), Business method patents and patents in pharmaceuticals among others. Patenting strategies: The strategies for patenting include, blanketing, flooding, fencing, surrounding and combination into patent networks. The role of the Patent Office: The patent office plays an important role in the society. It should therefore function as a steward of the public interest, not as a servant of patent applications. The PTO must therefore protect the public against the issuance of invalid patents that add unnecessary costs and may confer market power. WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 9

10 Other developments in the field of Bio-diversity: The Convention On Biological Diversity (CBD) and the TRIPS Agreement: The objectives of this Convention, are the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding. The objectives of the TRIPs Agreement are to set minimum standards of intellectual property protection within WTO members and to ensure that states make available to the rights holders judicial and or administrative procedures to enforce their intellectual property rights. The interaction between the rights referred to in the CBD and the TRIPs agreement has implications on biotechnology, plant varieties, environmental technology relating to conservation and sustainable use, information relating to conservation and sustainable use, traditional knowledge and benefit sharing. Disclosure requirements: It has been argued that Article 27 of the TRIPs Agreement should incorporate requirement in the CBD concerning access from the government of the country providing a genetic resource used in an invention, prior informed consent, benefit sharing, protection of traditional knowledge would be respected by patent applicants and would prevent abusive patenting of existing traditional knowledge by parties other than the holders of traditional knowledge. The Nagoya protocol: The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity is a supplementary agreement to the Convention on Biological Diversity. It provides a transparent legal framework for the effective implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilization of genetic resources. This protocol is important in the field of genetic resources and will create greater legal certainty and transparency for both providers and users of genetic resources by, establishing more predictable conditions for access to genetic resources, helping to ensure benefit-sharing when genetic resources leave the contracting party providing the genetic resources, by helping to ensure benefit-sharing, the Nagoya Protocol creates incentives to conserve and sustainably use genetic resources, and therefore enhances the contribution of biodiversity to development and human well-being. The draft decision to enhance mutual supportiveness between the TRIPS agreement and the conventions on biological diversity: This is a communication from Brazil, China, Colombia, Ecuador, India, Indonesia, Peru, Thailand, The ACP Group and the African Group. The draft decision proposes to add a new Article 29bis on "Disclosure of Origin of Genetic Resources and/or Associated Traditional Knowledge" in the WTO Trade-related Aspects of Intellectual Property Rights (TRIPS) Agreement. The proposed TRIPS Agreement addition by the developing countries appears to build on the Nagoya Protocol momentum. Intellectual property Rights Enforcement The TRIPS Agreement under Part 111 provides for the enforcement of intellectual property rights. This is seen as a major innovation in international intellectual property law. WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 10

11 Article 41.1 of the TRIPS Agreement provides that Members shall ensure that enforcement procedures as specified in this Part are available under their law so as to permit effective action against any act of infringement of intellectual property rights covered by this Agreement, including expeditious remedies to prevent infringements and remedies which constitute a deterrent to further infringements. These procedures shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse. Article 41.2 provides that Procedures concerning the enforcement of intellectual property rights shall be fair and equitable. Interpretation of the treaty: The interpretation shall be in good faith in accordance with the ordinary meaning to the given terms in light of its objects and purpose. Enforcement mechanisms measures: Temporary injunctions: Article 50 provides that judicial authorities shall have the authority to order prompt and effective measures to prevent infringement of any intellectual property.in the USA provisional injunctions can be availed if there is likelihood of prevailing if the validity of the patent is challenged, if there is irreparable harm, if reasonable likelihood that infringement exists etc. It is important to note that preliminary injunctions in patent litigation are not common. For example in a study done in France from 1984 to 04, out of 6000 requests for preliminary injunctions filed, only 19 have been granted. (Source: Institut National de la Propriete Industriele). This is an indicator that it is not easy to obtain preliminary injunctions in patent litigation. Permanent injunctions: Article 44.1 provides that the judicial authorities shall have the authority to order a party to desist from an infringement, inter alia to prevent the entry into the channels of commerce in their jurisdiction of imported goods that involve the infringement of an intellectual property right, immediately after customs clearance of such goods. Members are not obliged to accord such authority in respect of protected subject matter acquired or ordered by a person prior to knowing or having reasonable grounds to know that dealing in such subject matter would entail the infringement of an intellectual property right. Disposing of infringing goods: Article 46 provides that the judicial authorities shall also have the authority to order that materials and implements the predominant use of which has been in the creation of the infringing goods be, without compensation of any sort, disposed of outside the channels of commerce in such a manner as to minimize the risks of further infringements. Damages: Article 45.1 provides that the judicial authorities shall have the authority to order the infringer to pay the right holder damages adequate to compensate for the injury the right holder has suffered because of an infringement of that person s intellectual property right by an infringer who knowingly, or with reasonable grounds to know, engaged in infringing activity. Boarder measures: Article 51 provides that members shall, in conformity with the provisions set out below, adopt procedures to enable a right holder, who has valid grounds for suspecting that the importation of counterfeit trademark or pirated copyright goods 1 may take place, to lodge an application in writing with competent authorities, administrative or judicial, for the suspension by the customs authorities of the release into free circulation of such goods. WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 11

12 Further Article 4 of the EC Regulation No. 1383/03 provides for customs actions against goods suspected of infringing intellectual property rights. However Article 44.2 notwithstanding the provisions of this part, Members are not obliged to accord such authority in respect of protected subject matter acquired or ordered by a person prior to knowing or having reasonable grounds to know that dealing in such subject matter would entail the infringement of an intellectual property right. This implies that Nations are given authority to some extent to allow infringement to continue upon compensation by the infringing party and this is normally achieved through compulsory licenses. Therefore if the infringement is not harmful to health and the environment for example, the parties can negotiate on the terms. For example in the case of ebay INC. et al v MERCEXCHANGE, the US Supreme Court held that, the decision whether to grant or deny injunctive relief rest within the equitable discretion of the district courts. The same was upheld in the case of Amado v. Microsoft (Febrero 26, 08). In 08, for the first time in its history, The European Patent Office reported a refusal rate of over 50% of pending applications. This implies that the EPO is becoming more strict. Counterfeiting and piracy: Under the TRIPS Agreement (Article 61), Members shall provide for criminal procedures and penalties to be applied at least in cases of willful trademark counterfeiting or copyright piracy on a commercial scale. This has been extended to exports and goods in transit (GATT). Other special anti-counterfeiting legislation has also been put in place for example the Anti- counterfeiting Trade Agreement (ACTA) Counterfeiting in medicine: This has also been noted to be a global problem. Counterfeiting medicines have not only bees seen as an abuse for intellectual property rights but also a health risk. The approach that has been given to fight this is through drug regulations in order to determine whether the said counterfeited medicine are fit for human consumption and or whether they have any medicinal values which aspect cannot be resolved by intellectual property regulations. Potential Positive economic effects of counterfeiting and piracy: It has is argued that counterfeiting and piracy have positive economic effects. It is established that most consumer may knowingly purchase a counterfeit or pirated product because it is less expensive than a genuine good product which is unavailable. For example consumers in the US and other countries purchase counterfeit copies of high-priced luxury branded fashion goods at low prices, although they may be aware that they are not genuine. Consumers may also purchase movies that have not yet been released in theaters and re unavailable in legitimate form. Lower priced counterfeit goods may also exert competitive pressure to lower prices for legitimate goods, which may benefit consumers. Some authors have argued that companies may experience high revenue returns because their products or brand awareness has spread through counterfeiting. Enforcement costs: It is important to note that federal governments incur a lot high costs in seizing, storing and disposing of counterfeit and pirated goods and this has been increasingly burdensome. For example CBP reported that it spent about $41.9 million to destroy seized property between fiscal years 07 and 09. The new scenario on enforcement: WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 12

13 There have been domestic and international actions in enforcement of intellectual property rights and some demands have also been made by developing countries on the same. The European Union Approach: In the EU, the Customs Regulations No. 1383/03, the Enforcement Directive 04/48/EC and the Draft European Directive on Criminal measures aimed at ensuring the enforcement of intellectual Property Rights have been applied to deal with the internal market. EU s actions in foreign countries include the Strategy for the Enforcement of Intellectual Property Rights in Third World Countries (05). This provides a long-term line of action for the Commission with the goal of achieving a significant reduction of the level of IPR violations in third countries. In the USA, the domestic measures taken include The Stop Counterfeiting in Manufactured Goods Act (06) and The Intellectual Property Protection Act of 07. The USA enforcement strategies: These are the Strategy Targeting Organized Piracy (STOP) initiative and the National Intellectual Property Law Enforcement Coordination Council (NIPLECC). It is also imperative to note the US agencies involved in the enforcement strategy and these include, The Department of commerce-international Trade Administration (ITA), the US State Department, The US Customs and Border Protection (CBP), The USTR and the US Patent and Trademark Office. The Global Actions: The global enforcement actions include the World Trade Organisation submissions to the TRIPS council by USA, Japan and EU, and The Group 8 s statement on Combating IPR Piracy and Counterfeiting and G8 Intellectual Property Experts Group. Bilateral/ Regional actions: These include the Free Trade Agreement and the Economic partnership agreements. Strengthening enforcement: There is need to strengthen enforcement through harmonisation of laws and procedures, creation of special units/tasks forces in national administration, criminalisation of any commercial scale IP violation and ex-official action. Dispute Settlement under Trips: The TRIPS Agreement under Part V provides for a dispute resolution mechanism. The aim of the dispute settlement mechanism is to secure a positive solution to a dispute. A solution mutually acceptable to the parties to a dispute and consistent with the covered agreements is clearly to be preferred. In the absence of a mutually agreed solution, the first objection of the dispute settlement mechanism is usually to secure the withdrawal of the measures concerned. Dispute resolution can proceed relatively quickly, within less than a year and a half. The WTO summarizes the time lines as follows: 60 days Consultations, mediation, etc. 45 days Panel set up and panelists appointed 6 months Final panel report to parties 3 weeks Final panel report to WTO members 60 days Dispute Settlement Body adopts report (if no appeal) Total = One year (without appeal) days Appeals report 30 days Dispute Settlement Body adopts appeals report Total= 1 year, 3 mos. (with appeal). WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 13

14 WTO structure: All WTO members may participate in all councils, committees, etc, except Appellate Body, Dispute Settlement panels, Textiles Monitoring Body, and plurilateral committees The Role of Universities and innovation: The traditional role of universities was education basic research and science. However in the past 2-3 decades new functions were taken over and these are knowledge and technology transfer to industry, commercialization of knowledge, more active role in national and regional innovation systems, development of new products and processes and improvement. WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 14

15 In most countries, a growing attention is paid to the economic utilization of publicly funded research. This holds particularly true for high-technology and knowledge based sectors where scientific inputs are of key importance in the innovation process. Universities are key elements in the subsystem of knowledge generation and diffusion. Research and Development organizations and universities are at specific locations and are knowledge spillovers are spatially bounded. Universities adopt knowledge and disseminate and distribute accordingly. This knowledge becomes more important for generating new knowledge and innovations. Universities hold a key function in this respect being inserted in global knowledge communities and networks conferences, workshops, research collaborations, co-publication, co-patenting etc. University industry linkages have clearly become more frequent in past years. Universities have become important knowledge sources and innovation partners for industry. This has lead to increasing variety of relationships: R&D contracts, R&D collaborations, innovation partnerships, joint use of facilities, informal knowledge exchange. University has therefore become important actors in innovation systems. However the Key challenge is the protection of the research outputs. Protection of research out puts: Protection of research outputs and innovation are increasingly becoming important activities for universities all over the world. This realization has re-enforced investment in research, innovations and commercialization of products of research for public good as well as contribute to economic development. Protection of research will help researchers to maximize benefits and returns from their public investment in research. Universities are likely to reduce on lost opportunities arising from failure to protect innovations and research out puts by inventors and institutions. Copyright protection in universities: The issue here is of ownership of works done by professors and researchers. The Bayh- Dole Act (1980) allows for the transfer of exclusive control over federal government funded inventions to Universities and companies operating with federal contracts for further development and commercialization. Universities and companies are permitted to exclusively license the inventions to other parties. It should however be noted that the Federal government retains March-in rights to license the invention to a third party, without the consent of the patent holder or original license, where it determines the invention is not being made available to the public on a reasonable basis. Employee s inventions: Most companies rely on their innovations to succeed and many of the more successful companies go to great lengths to engender a culture of innovation. But what happens to employee inventions? And who owns these inventions? The general rule is that an invention made by an employee shall, as between him and his employer, be taken to belong to his employer and all other purposes if it was made in the course of the normal duties of the employee or in the course of duties falling outside his normal duties, but specifically assigned to him, and the circumstances in either case were such that an invention might reasonably be expected to result from the carrying out of his duties; or if the invention was made in the course of the duties of the employee and, at the time of making the invention, because of the nature of his duties and the particular WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 15

16 responsibilities arising from the nature of his duties he had a special obligation to further the interests of the employer's undertaking. Inventions made during the course of duty or service sometimes called service inventions. The may be absolute or relative. On the other hand if the invention by the employee is made during his/her free time (free inventions) ownership doesn t belong to the employer. In the USA, employees are not required by law to assign their inventions to their employers. Employers can gain through agreements. The employer may also claim ownership rights, the employee may retain them or there may be some combination of the two. Disclosure: The employee must notify his/her employer of all inventions created during the course of the employment that are relevant to the company business, or any tasks or assignments and all that were created using the company s resources. In this case the employer has the right to assess the invention and decide whether or not it will assert any claims of ownership. Pre-invention assignments: Here the employee relinquishes to the employer ownership rights over all inventions created during the course of employment. The employer obtains complete control over the copyright, patent and licensing of everything created by its employees. It also gives the employer the right to use the invention as it sees fit, with or without input from the employee. University s patenting strategies: Universities are advised to draft patent applications, decide when to apply for patents taking into consideration of the time for filing PCT applications, how a patent shall be maintained and enforced taking into consideration of payment of maintenance fees, and the licensing conditions. WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 16

17 PART II - The Importance and the Role of Patent Information Patent information comprises technical, legal, business-relevant and public policy-relevant information which can be used to stimulate further creativity and innovation. The rapid growth in the use of the patent system, and in the diversity of users, has led to an explosion of raw data on patenting activities in areas of interest to public policymakers. Analytical tools are becoming more widely available, which opens up enormous potential for clearer, more accessible and representative information to support policy processes. By focusing on a particular technology, patent landscapes contribute to highlighting essential technologies, know-how, processes and methods that are necessary to meet the basic development needs of developing countries, particularly with regards to improving the environment, life, health of human beings, animals, plants and food security. WIPO has already cooperated with other intergovernmental organizations, such as the World Health Organization (WHO), the Food and Agriculture Organization (FAO), and the United Nations Framework Convention on Climate Change (UNFCCC), in drafting Patent Landscaping Reports (a sample of a Patent Landscaping Report is a Study prepared by WIPO for WHO with regards to the avian flu virus and further information may be found in the WIPO Press Release PR/07/529), as well as contributing to such landscapes produced by private non-profit research institutes, such as CAMBIA. General knowledge and techniques in searching patent information, including the extraction of relevant information from patent databases such as Patentscope to prepare Patent Landscaping Reports, is not readily known and is, therefore, fundamentally important to understand the role.. As a specialized agency of the United Nations WIPO is dedicated to developing a balanced and accessible international property system, which rewards creativity, stimulates innovation and contributes to economic development while safeguarding the public interest. The patent system encourages innovation and consequently economic growth by: Rewarding investments made in developing a new invention (protection) Publishing and making known technical information of a new invention (disclosure) The Differences between Protection & Disclosure (patent information) The patent protection is territorial in nature and the scope of protection is limited by claims in a certain period of time, generally most of countries apply year from the filling date. The privilege of the patent owner is that given a protection, they have a right to prevent others from carrying out the invention (manufacturing or making). The patent information once published is global and include all information contained in patent documents. This information remains permanently available even if the patent lapse, so no one can prevent others to learn from the invention. The patent documents provide various types of information in a high standardized format, over 70 million patent documents have been published to date. The access of the patent document is a tool to increase the number of new patent application. Essential parts of the patent document: Bibliographic data: is a legal status, with commercial purpose, where you find the owner of the patent, if it is valid or not, so that you can ask for licensing. WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 17

18 Description (specification): Describes how the invention works (addresses a particular technical problem), provides background information on this problem and indicates other know solutions to the problem. Claims: define the scope of protection sought by the applicant, this is the important part in a patent in terms of infringement, the court look at the claims to find out whether the patent is being infringed or not. The patent information are now available online in digital format, search services and tools have made the exploitation of this information simpler and more cost-effective and many search services and tools are available for free. Uses and users of the patent information Uses: Legal: avoid patent infringement, determine the patentability of your inventions, draft strong patent applications, determine the validity of existing patents and which technologies to the public domain. Technical: Develop a new solutions to technical challenges faced in the country, or adapt existing technologies to suit local conditions, target research resources more effective ( avoid reinventing the wheel ), technical information must be sufficiently clear and comprehensive to be carried out by a typical expert in the field of technology. Business and policy: Track research activities of competitors, identify opportunity for licensing and joint ventures, review trends in specific areas of technology. Users: Individual inventors Small and medium enterprises (SMEs) Industry Research institutions Academia Patent attorneys And many others Search Tools and Strategies Is a set of key words that enable to search a patent documents kin a given Database and combine the results of the classification with additional features of the searched technology using keywords. The search may be done using: application number, publication number, priority number, application date or filing date, publication date, priority date, inventor s names, company s names, patent classification (IPC entries, ECLA entries, F/FI Terms , USPC entries, Others). Now a hard work is being taken to establish a new Cooperative Patent classification- CPC with more details than the IPC. In some cases it is used combination of fields and criteria for search such as keywords and phrases, operators, Boolean operators (AND, OR, ANDNOT, XOR), proximity operator (NEAR), range operator (TO), wildcard operators (?, *, $). WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 18

19 Using patent classification for searching, in particular the International Patent Classification Patent classification is a system for classifying technical subject matter, specially adopted for needs of patent documentation and applied to patent documents worldwide. It is available in most databases for search; it is also an efficient tool to retrieving pertinent patent documents. Databases PATENTSCOPE ESPACENET JPO IPDL USPTO PatFT/AppFT TISCs- Technology and Innovation Support Center (Project) The objective of this project is to provide support in addressing the digital divide and knowledge gap, foster the development of appropriate, effective and sustainable technology and innovation support services for national stakeholders in developing countries. TISCs is adapted to local needs and conditions, delivers desired benefits to stakeholders and the country, can ultimately be maintained using locally available resources. TISCs: Benefit Allow users to benefit effectively from increased accessibility offered by internet searches through direct personal assistance, to strengthen the local technological base by building up local know-how, to increase technology transfer, e.g. by investing the possibilities of licensing, joint venture, to assist local users to create, protect, own and manage their intellectual property rights. Access to specialized patent information: ardi-wipo HINARI-WHO AGORA-FAO OARE-UNEP Conclusions: Throughout the decades, biotechnology has emerged as research area which requires the understanding of the biological intricacies of nature. Much of the scientific knowledge has been imparted to transfer beneficial genetic traits from one species to another to enhance or protect an organism. In the field of medicine, these tasks have ranged from the production of proteins, such as insulin, to selective targeting and binding of specific cell types. Since the discovery in the year 1800 that the human body is composed of cells and proteins that are susceptible to infection but can also combat pathogenic microbes, the perceived battlefield has challenged our imagination to develop biopharmaceuticals biologically based therapeutic products. WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page 19

20 As we enter the information age, the presence of excessive amount of biologic and genetic data, coupled with exponential growth in computing power, mean that the rate of developing novel biopharmaceuticals is not at all limited by the ability to identify targets and clone macromolecules. But after post GATT period, this research area has faced a lot of restrictions by the government to follow the patent protection of these biologically engineered products of plant or human cell origin. Thus, biotechnology which is usually defined as any technique that uses living organisms or substances from organisms to make or modify a product, to improve plants or animals or to develop microorganisms for specific uses, is facing serious constraints like lack of skilled human resources, funds to bear the cost of these projects, the sophisticated infrastructure and facilities and stringent government laws. However, drawing an appropriate boundary between patentable natural phenomena and patentable inventions is crucial in preventing the patent laws from unduly restricting access to fundamental scientific discoveries. Some would argue that, particularly in the U.S., patents are being issued that purport to claim a novel product or process but that, in effect, encompasses any practical application of a fundamental biological principle. In view of the mounting concern, it seems likely that Congress and/or the courts will address the issue, and perhaps substantially shift the boundary. Facts and Figures Percentage of dedicated biotechnology firms by application, latest available year Agricultu re Food and beverage Natural resource Environme nt Industrial processin g Bioinform atics Othe r Total N/A 2.0 N/A SOURCE OECD, Biotechnology Statistics Database, May 11. Year Firm type Biotechnology firms Biotechnology firms Dedicated biotech R&D firms Biotechnology firms WIPO/ILO/ICT-Turin-LLM-IP Kyomugasho Mercy, Abdulrezak Oumer and Honório Cumbi - Page