Intellectual Property Rights (IPR) PDF

INTELLECTUAL PROPERTY RIGHTS(IPR) What are IPRs? Intellectual Property Rights (IPRs) are legal rights, which result from the intellectual invention, innovation, and discovery in the industrial, scientific, literary, and artistic fields. These rights entitle an individual or group to the moral...

INTELLECTUAL PROPERTY RIGHTS(IPR) What are IPRs? Intellectual Property Rights (IPRs) are legal rights, which result from the intellectual invention, innovation, and discovery in the industrial, scientific, literary, and artistic fields. These rights entitle an individual or group to the moral and economic rights of creators in their creation. Types: Patent- It is a set of exclusive rights granted by a sovereign state to an inventor for a limited period of time in exchange for detailed public disclosure of an invention. Copyright- It is a legal right created by the law of a country that grants the creator of an original work exclusive right for its use and distribution. It includes literary & artistic works such as novels, poems, plays, films, musical works, drawing, painting, photography, sculpture, architectural designs Trademark- It is a recognizable sign, design, or expression which identifies products or services of a particular source from those of others. Trademarks used to identify services are usually called service marks. Industrial design right- It is an intellectual property right that protects the visual design of objects that are not purely utilitarian. An industrial design consists of the creation of a shape, configuration or composition of pattern or color, or combination of pattern and color in three- dimensional form containing aesthetic value. An industrial design can be a two- or three- dimensional pattern used to produce a product, industrial commodity or handicraft. Trade secret- It is a formula, practice, process, design, instrument, pattern, commercial method, or compilation of information which is not generally known or reasonably ascertainable by others, and by which a business can obtain an economic advantage over competitors or customers Geographical Indication (GI)- It is a name or sign used on certain products which corresponds to a specific geographical location or origin (e.g. a town, region, or country). The use of a geographical indication may act as a certification that the product possesses certain qualities, is made according to traditional methods or enjoys a certain reputation, due to its geographical origin. A recent example is of the Indian variety of Basmati rice getting GI tag. From the above points, it is clear that IPR is a very sensitive issue in terms of businesses’ different kinds and international relations as well.  IPRs in the pharmaceutical sector: Some sectors are very sensitive in terms of IPRs like pharmaceuticals. Let’s explore briefly IPR issues in the pharmaceutical sector. We hear of two kinds of drugs- generic and brand name drugs: Generic drugs are those whose patent has expired or does not exist and which can be produced by any registered manufacturer without the need of taking permission from any authority and also without any payment of royalty. Brand name drugs are those which are patented and cannot be produced without the consent of the patent holder. A royalty is to be paid for the production of these drugs. But what happens if a company holds a patent for an essential drug and there is an emergency in which the drug needs to be provided at a low cost for the vast populace? In this case, Compulsory Licensing comes to the rescue. What is Compulsory Licensing?  A compulsory license provides that the owner of a patent or copyright-licenses the use of their rights against payment. This payment is either set by law or determined through some form of arbitration  In essence, under a compulsory license, an individual or company seeking to use another’s intellectual property can do so without seeking the rights holder’s consent, and pays the rights holder a set fee for the license  This is an exception to the general rule under intellectual property laws that the intellectual property owner enjoys exclusive rights that it may license – or decline to license – to others Does there have to be an emergency? Not necessarily. This is a common misunderstanding. The TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement does not specifically list the reasons that might be used to justify compulsory licensing. However, the Doha Declaration on TRIPS and Public Health confirms that countries are free to determine the grounds for granting compulsory licenses. In March 2012, India granted its first compulsory license ever. The license was granted to Indian generic drug manufacturer Natco Pharma Ltd for Sorafenib tosylate, a cancer drug patented by Bayer. What is TRIPS?  TRIPS is an international agreement administered by the World Trade Organization (WTO), which sets down minimum standards for many forms of intellectual property (IP) regulations as applied to the nationals of other WTO Members  It was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994  TRIPS requires WTO members to provide copyright rights, covering content producers including performers, producers of sound recordings and broadcasting organizations, geographical indications, including appellations of origin, industrial designs, integrated circuit layout-designs, patents, new plant varieties, trademarks, trade dress, and undisclosed or confidential information  The agreement also specifies enforcement procedures, remedies, and dispute resolution procedures Now, back to the topic… India is a huge market for generic drugs and hence it is very obvious that there must emerge issues out of patents for pharmaceuticals. One such case came up in 1998- Novartis v. Union of India & Others It was a landmark decision by a two-judge bench of the Supreme Court, on the issue of whether Novartis could patent Glivec in India. It was the culmination of seven-year-long litigation fought by Novartis. The Supreme Court upheld the Indian patent office’s rejection of the patent application. Ground of rejection? Novartis claimed a patent for the changed form of Glivec on the basis of the increased bio- availability in the body of the patient by making changes in the chemical composition of its original anti-cancer drug Imatinib Mesylate. This changed form of the drug could not withstand the ‘enhanced therapeutic efficacy’ test enshrined under Section 3(d) of the Indian Patents Act and therefore it was rejected. Recently, Gilead got patent for its Hepatitis C drug Solved. An application for the same patent was first rejected in January 2015 as lacking inventiveness and novelty. The decision, however, is seen as a major blow to the access to drug movement Now let’s turn towards the latest developments in the IPRs in India. New IPR Policy Govt of India recently released a new National Intellectual Property Rights (IPR) Policy which is in compliance with WTO’s agreement on TRIPS Why a new policy?  Global drug brands led by US companies have been pushing for changes to India’s intellectual property rules for quite some time now. They have often complained about India’s price controls and marketing restrictions  Also, an IPR policy is important for the government to formulate incentives in the form of tax concessions to encourage research and development (R&D)  It is also critical to strengthen the Make In India, Startup and Digital India schemes  The IPR policy comes at a time when India and other emerging countries faces fresh challenges from the developed world and mega regional trade agreements such as the Trans-Pacific Partnership (TPP). Seven objectives: 1. IPR Awareness: To create public awareness about the economic, social and cultural benefits of IPRs among all sections of society 2. Generation of IPRs: To stimulate the generation of IPRs 3. Legal and Legislative Framework: To have strong and effective IPR laws, which balance the interests of rights owners with larger public interest 4. Administration and Management: To modernize and strengthen service-oriented IPR administration 5. Commercialization of IPRs: Get value for IPRs through commercialization 6. Enforcement and Adjudication: To strengthen the enforcement and adjudicatory mechanisms for combating IPR infringements 7. Human Capital Development: To strengthen and expand human resources, institutions and capacities for teaching, training, research and skill building in IPRs Benefits:  The new policy will try to safeguard the interests of rights owners with the wider public interest, while combating infringements of intellectual property rights  By 2017, the window for trademark registration will be brought down to one month. This will help in clearing over 237,000 pending applications in India’s four patent offices  It also seeks to promote R&D through tax benefits available under various laws and simplification of procedures for availing of direct and indirect tax benefits  Unlike earlier where copyright was accorded to only books and publications, the recast regime will cover films, music and industrial drawings  A host of laws will also be streamlined — on semi-conductors, designs, geographical indications, trademarks and patents  The policy also puts a premium on enhancing access to healthcare, food security and environmental protection  Policy will provide both domestic and foreign investors a stable IPR framework in the country  This will promote a holistic and conducive ecosystem to catalyse the full potential of intellectual property for India’s growth and socio-cultural development while protecting public interest  It is expected to lay the future roadmap for intellectual property in India, besides putting in place an institutional mechanism for implementation, monitoring and review  The idea is to incorporate global best practices in the Indian context and adapt to the same Challenges:  According to the policy, India will retain the right to issue so-called compulsory licenses to its drug firms, under “emergency” conditions  Also, the government has indicated that there is no urgent need to change patent laws that are already fully World Trade Organization-compliant. So India has resisted pressure from the US and other Western countries to amend its patent laws  The policy also specifically does not open up Section 3(d) of the Patents Act, which sets the standard for what is considered an invention in India, for reinterpretation Examples Turmeric Patent Case Two US-based Indians Suman K. Das and Hari Har P. Cohly were granted a US Patent 5, 40,504 on 28 March 1995 on Use of turmeric in wound healing. The patent was assigned to the University of Mississippi Medical Center, USA. This patent claimed the administration of an effective amount of turmeric through local and oral routes to enhance the wound healing process, as a novel finding. Any patent, before it is granted, has to fulfill the basic requirements of novelty, non-obviousness, and utility. Thus, if the claims have been covered by relevant published art, then the patent becomes invalid. Council of Scientific and Industrial Research (CSIR) could locate 32 references (some of them being more than one hundred years old and in Sanskrit, Urdu, and Hindi), which showed that this finding was well known in India prior to the filing of this patent. The following points are interesting to note: 1. The turmeric case was a landmark case in that this was the first time that a patent based on the traditional knowledge of a developing country was challenged successfully and The United States Patent and Trademark Office (USPTO) USPTO revoked the patent. This eventually opened up the path to the creation of Traditional Knowledge Digital Library, Traditional Knowledge Resource Clarification, and finally inclusion of traditional knowledge in the International Patent Clarification System. 2. Amidst the loud protests against ‘biopiracy’ and ’theft’ of India’s biodiversity and traditional knowledge by foreign nationals, it is interesting to note here that the patentees were Indians (Das and Cohly), the re-examination in USPTO was done by an Indian (Kumar) and the re- examination was sought by an Indian institution (CSIR). World Intellectual Property Organization (WIPO) has been sensitive to these concerns. At a conference held in October 1998, under the aegis of the WIPO an agenda for the future of IPR in the field of traditional medicines was prepared, which prioritized activities in this area, namely, development of standards for the availability, scope and use of IPRs on traditional medicine in Asian countries, systematic documentation of traditional medicine for protection purposes, regional and inter-regional information exchange and compilation of the requisite databases, etc. This agenda needs to be moved forward. The case of Amazon Rainforest Plant Patent Many traditional healers and religious leaders from the indigenous tribes of the Amazon used to collect a plant named Baniste-riopsis caapi is a South American liana of the family Malpighiaceae, and process it to produce a ceremonial drink - ‘ayahausca’, also called ‘yage’. They used ayahausca in religious and healing ceremonies. According to tradition, ayahausca was prepared and administered only under the guidance of traditional healers. A Plant Patent No. 5,751, issued to Loren Miller on 17 June 1986 by USPTO claimed rights over a supposed variety of B. caapi, which Miller dubbed ‘Da Vine’. The challenge to this patent was made by the Center for International Environment Law (CIEL), on behalf of the Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA) and the Coalition for Amazonian Peoples and Their Environment (Amazon Coalition). COICA is a coordinating body of more than 400 tribes. Although the patent claimed to have identified a variety of the species with new and distinctive physical features, particularly the colour of the flower. But according to Prof. William A. Anderson of the University of Michigan, a leading expert on the plant family to which B. caapi belonged, the features described as ‘prior art’ were already there in the records of major herbaria. Further, this plant grew naturally throughout the Amazon basin. By law, plant patents cannot be awarded to plants ‘found in an uncultivated state’. On reexamination, USPTO revoked this patent on 3 November 1999. However, the inventor was able to convince the USPTO on 17 April 2001, the original claims were reconfirmed, and the patent rights restored to the innovator. Neem Oil Cases The US has been taking undue advantage of the low level of patent awareness and laxity in enforcement of law. The Neem tree is used in India in the areas of medicine, toiletries, contraception, timber, fuel and agriculture. Its uses have been developed over many centuries but never patented. Since the mid 1980s, US corporations have taken out over a dozen patents on Neem- based materials, When the US Patents Office (USPTO) granted patent for ‘Neem oil’ for antiseptic use, the Council of Scientific and Industrial Research (CSIR) urged for re-examination of the case, but without success. In this way, collective local knowledge developed by Indian researchers and indigenous communities has been expropriated by outsiders who have added very little to the process. There is a problem on the grant of such patents linked to the indigenous knowledge of the developing world that needs to be addressed jointly by the developing and the developed world. We need to understand that there is a distinction between the patents that are granted based on modem research and patents, which can be categorized as traditional knowledge-based patents. A recent study by an Indian expert group examined randomly selected 762 US patents, which were granted under A61K35/78 and other IPC classes, having a direct relationship with medicinal plants in terms of their full text. Out of these patents, 374 patents were found to be based on traditional knowledge not that all of them were wrong. The Governments in the Third World as well as members of public are rightly concerned about the grant of patents for non-original inventions in the traditional knowledge systems of the developing world. At international level there is significant level of support for opposing the grant of patents on non-original inventions. For example, more than a dozen organizations from around the world got together to oppose the EPO Neem patent and the entire process took five years. Such a process of opposition is, understandably expensive and time consuming. The issue of ‘protection’ of traditional knowledge needs to be looked at from two perspectives, the ‘protection’ may be granted to exclude the unauthorized use by third parties of the protected information. On the other hand, the ‘protection’ also means to preserve traditional knowledge from uses that may erode it or negatively affect the life or culture of the communities that have developed and applied it. Further, the protection also promotes self respect and self- determination. While recognizing the market-based nature of IPRs, other non-market-based rights could be useful in developing models for a right to protect traditional knowledge, innovations and practices. To date, debate on IPRs and biodiversity has focused on patents and plant breeders’ rights. Provisions under undisclosed information or trade secrets could be invoked to protect traditional knowledge not available in the public domain. Geographical indications and trademarks, or sui generis analogies, could also be the alternative tools for indigenous and local communities seeking to gain economic benefits from their traditional knowledge. The potential value of geographical indications and trademarks is in protecting plants and germplasms that are specific and unique to geographical regions. They could protect and reward traditions while allowing innovation. New experiments are beginning to emerge on benefit-sharing models for indigenous innovation. An experience in India is worth sharing. It relates to a medicine that is based on the active ingredient in a plant, Trichopus zeylanicus, found in the tropical forests of southwestern India and collected by the Kani tribal people. Scientists at the Tropical Botanic Garden and Research Institute (TBGRI) in Kerala learned of the plant, which is claimed to bolster the immune system and provide additional energy, while on an expedition with the Kani in 1987. These scientists isolated and tested the ingredient and incorporated it into a compound, which they christened ‘Jeevan’, the giver of life. The tonic is now being manufactured by a major Ayurvedic drug company in Kerala. TBGRI agreed to share the license fee and royalty with the tribal community on a fifty-fifty basis and formed a registered trust with an understanding that the interest accrued from this amount alone can be used for the welfare activities of the Kani tribe. It is significant to note that while the issue of material transfer and benefit sharing was discussed and debated after Convention on Biological Diversity (CBD), India has already pioneered one of the first models. Developing countries need a systematic documentation of traditional medicine for protection purposes, regional and inter-regional information exchange and compilation of the requisite databases etc. To mitigate this problem, the Indian Government has taken steps to create a Traditional Knowledge Digital Library (TKDL) on traditional medicinal plants and systems, which will also lead to a Traditional Knowledge Resource Classification (TKRC). Linking this to internationally accepted International Patent Classification (IPC) System will mean building the bridge between the knowledge contained in an old Sanskrit Shloka and the computer screen of a patent examiner in Washington. This will eliminate the problem of the grant of wrong patents since the Indian rights to that knowledge will be known to the examiner. It is right time that India must evolve a viable and effective mechanism to protect the biodiversity, bio-information and creativity of indigenous communities.