TRIPS AGREEMENT AND ITS IMPACT ON INTELLECTUAL PROPERTY RIGHTS
The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) brought about a very important change in international standards relating to intellectual property rights, because of its far-reaching implications, particularly with respect to developing countries, the agreement has been one of the most controversial components of the WTO system. Strong disagreements on the scope and content of the Agreement emerged during the Uruguay Round negotiations, both between developed and developing countries and among developed countries themselves. Implementations of the Agreement and its review under the “built-in agenda” have also been contentious with regard to many aspects. The agreement with its intellectual property rights trade linkage and strict protection standard setting creates competing interests for developing and least developed countries. Although adopted in the realm of trade liberalization, the IPRs trade tie appears to monopolize free trade and rent payments for IPR owning developed countries when the agreements strict protection is accorded to IPRs and duration of such protection is extended<href=”#_ftn1″ name=”_ftnref1″ title=””>.The agreement causes further tension when it introduces a uniform and mandatory protection regime for all WTO members, developed, developing, least developed countries alike. The uniformity in normative protection seems to undervalue countries that have different standing in terms of economic development. It also disregards developing and least developed countries comparative advantage of reverse engineering in IPRS products when it restricts technology transfer. Bangladesh which is an LDC and has one-thirds of its population living below the poverty line, faces such TRIPS implications and challenges since it depends mostly on agriculture for livelihoods, generics of drugs for health, foreign patented products for reverse engineering and technology transfer for economic development.<href=”#_ftn2″ name=”_ftnref2″ title=””>
1.2 Objectives and Organization of The Study
The present research is an attempt to evaluate TRIPs Agreement in the context of Bangladesh. It tries to find out implications and Challenges for Bangladesh. Although the Agreement tells about seven Kinds of IPRs, this paper tries to focus on the issues which have tremendous effect on and raised widespread concern in Bangladesh as it is an LDC. To be precise, the paper tries to find answer to the aforementioned questions raised by TRIPS. While doing so, it also tries to make reference to and share the experiences of some countries where TRIPS provisions are already in force.
The research work is Qualitative research<href=”#_ftn3″ name=”_ftnref3″ title=””>. It has to use facts and information to make a critical evaluation. The methodology of the present research work includes review of related literature, examination of policy document, articles and law books of renowned writers, law based journals, newspaper reports relating to the Trips Agreement. The data and information used was collected from websites. In case of need other related works would also be carried out.
1.4 Meaning of the terms used in the title of the thesis:
TRIPS Agreements: Trade-Related Aspects of Intellectual Property Rights came into effect on 1 January 1995, is to date the most comprehensive multilateral agreement on intellectual property. The areas of intellectual property that it covers are: copyright and related rights (i.e. the rights of performers, producers of sound recordings and broadcasting organizations); trademarks including service marks; geographical indications including appellations of origin; industrial designs; patents including the protection of new varieties of plants; the layout-designs of integrated circuits; and undisclosed information including trade secrets and test data.<href=”#_ftn4″ name=”_ftnref4″ title=””>
The three main features of the Agreement are:
Standards: In respect of each of the main areas of intellectual property covered by the TRIPS Agreement, the Agreement sets out the minimum standards of protection to be provided by each Member. Each of the main elements of protection is defined, namely the subject-matter to be protected, the rights to be conferred and permissible exceptions to those rights, and the minimum duration of protection. The Agreement sets these standards by requiring, first, that the substantive obligations of the main conventions of the WIPO, the Paris Convention for the Protection of Industrial Property (Paris Convention) and the Berne Convention for the Protection of Literary and Artistic Works (Berne Convention) in their most recent versions must be complied with. With the exception of the provisions of the Berne Convention on moral rights, all the main substantive provisions of these conventions are incorporated by reference and thus become obligations under the TRIPS Agreement between TRIPS Member countries. The relevant provisions are to be found in Articles 2.1 and 9.1 of the TRIPS Agreement, which relate, respectively, to the Paris Convention and to the Berne Convention. Secondly, the TRIPS Agreement adds a substantial number of additional obligations on matters where the pre-existing conventions are silent or were seen as being inadequate. The TRIPS Agreement is thus sometimes referred to as a Berne and Paris-plus agreement.
Enforcement: The second main set of provisions deals with domestic procedures and remedies for the enforcement of intellectual property rights. The Agreement lays down certain general principles applicable to all IPR enforcement procedures. In addition, it contains provisions on civil and administrative procedures and remedies, provisional measures, special requirements related to border measures and criminal procedures, which specify, in a certain amount of detail, the procedures and remedies that must be available so that right holders can effectively enforce their rights.
Dispute settlement: The Agreement makes disputes between WTO Members about the respect of the TRIPS obligations subject to the WTO’s dispute settlement procedures.
In addition the Agreement provides for certain basic principles, such as national and most-favored-nation treatment, and some general rules to ensure that procedural difficulties in acquiring or maintaining IPRs do not nullify the substantive benefits that should flow from the Agreement. The obligations under the Agreement will apply equally to all Member countries, but developing countries will have a longer period to phase them in. Special transition arrangements operate in the situation where a developing country does not presently provide product patent protection in the area of pharmaceuticals.
The TRIPS Agreement is a minimum standards agreement, which allows Members to provide more extensive protection of intellectual property if they so wish. Members are left free to determine the appropriate method of implementing the provisions of the Agreement within their own legal system and practice.
Implication: Something that is inferred (deduced or entailed or implied, the reasoning involved in drawing a conclusion or making a logical judgment on the basis of circumstantial evidence and prior conclusions rather than on the basis of direct observation, a relation implicated by virtue of involvement or close connection (especially an incriminating involvement).<href=”#_ftn5″ name=”_ftnref5″ title=””>
Challenge; to object or except to; to perform objections to a person, right, or instrument, to question formally the legality or legal qualifications of: to invite into competition; to formerly call into question the capability of a person for a particular function, or the existence of a right claimed, or the sufficiency or validity of an instrument; to call or put in a question; to put into dispute; to render doubtful.<href=”#_ftn6″ name=”_ftnref6″ title=””>
Bangladesh: Bangladesh is a unitary, independent, sovereign Republic to be known as the People’s Republic of Bangladesh. Dhaka is the capital of Bangladesh. Today Bangladesh is a secular, democratic republic state, though it is not widely recognized in the political arena. Bangladesh is a unitary state and parliamentary democracy. Direct Directs elections in which all citizens, aged 18 or over, can vote are held every five years for the unicameral parliament known as JatiyaSangsad.
The executive power of the Republic shall be exercised by the authority of the Prime Minister. The President is the head of the state but mainly a ceremonial post elected by the parliament. The country is a member of the United Nations, OIC, SAARC, BIMSTEC, D-8 etc.
2.1IPRs Laws of Bangladesh
The enforceable IPRs which are currently enforceable in Bangladesh are the Patents and Design Act, 1911<href=”#_ftn7″ name=”_ftnref7″ title=””>, the Trademarks Act,1940<href=”#_ftn8″ name=”_ftnref8″ title=””> and the Copyright Act,2000 as amended in 2005<href=”#_ftn9″ name=”_ftnref9″ title=””>. These laws are older than its membership in international IPRs regime as these are the colonial inheritance, enacted in British India. The British laws have changed several times in order to cater for the needs and developmental objectives and keep pace with the revision of the Paris Convention and Berne convention. Bangladesh is yet to amend the colonial law to keep pace with the national circumstances comprising low research and development, huge poor population, poor infrastructure and low economic stability and development.
2.2 Bangladesh under WIPO Regime<href=”#_ftn10″ name=”_ftnref10″ title=””>:
The Patent and Design Act 1911 was enacted in line with the Paris Convention originally adopted on 20 March 1883. Between the date of enactment of the Patents Designs Act and the adoption of the TRIPs Agreement 1994, the concepts of patents and Designs have come across massive development through adoption of a large number of international conventions and decision of the courts throughout the world. They recommended enactment of uniform laws on intellectual property including patents and designs. For Bangladesh as member of the Paris Convention, the current Act requires to be updated in order to validate certain revisions and amendments made to the Paris Convention as regards independence of patents obtained for the same invention in different countries, mention of the inventor in the patent, protection of industrial designs in all the member countries or prevention of unfair competition through effective use of compulsory licensing parallel importation etc.
The Trademarks Act 1940 was enacted as an instrument off protection of the industrial property as formulated in the Paris Convention. Over the years the definition and scope of trademarks have undergone gradual international development and application and the Convention has also contained some revisions. These revised or amended provisions f the Convention are not covered in the present Act. Some of them include refusal or cancellation of registration or use of well-known marks in another country in the other member countries.
The Copyright Act 2000 as amended in 2005 and substituted the Copyright Ordinance 1962 is updated in many respects as required by the Berne Convention. In accordance with the Convention, the old statute required to incorporate compulsory licensing as regards translation and reproduction of copyrighted materials keeping in consideration of the educational needs of Bangladesh and its developing country status.
3.1 Implications and Challenges for Bangladesh in Agriculture
The TRIPS Agreement includes three items related to agriculture: geographical indications (Arts. 22-24); patent protection of agricultural chemical products (Arts. 70.8 and 70.9); and plant variety protection (Art.27.3(b)). The issues raised by Art.27.3(b) are of particular concern. The obligation of WTO Members to adopt protection to plant varieties, either by patents or by an effective sui generis system, or by any combination thereof, has important implications for the development of the agricultural economies and trade of developing countries.
Intellectual property rights (IPRs) in agriculture makes agriculture a commodity for trade and transforms it from common heritage to private property on making its use restrictive. As a consequence, for securing investment of private individuals, IPRs in agriculture cause hardships to the mass people in developing and in particular least developed countries with making agricultural products high priced in the disguise of patent monopoly, making people pushed up and dependent on engineered seeds and other agricultural inputs. Nevertheless, the World Trade Organization (WTO) Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement) recognizes some exceptions and flexibilities to the general rule of trade, which include the discretion to redefine patentable invention, choosing between patents and plant breeders‘ rights (PBRs), and providing for compulsory licensing.
To be patentable, an invention must be new, involve a formal inventive step and have industrial application. Patenting of new plant varieties is also permissible. In that sense, medicinal plants, indigenous knowledge, ideas or innovations evolving naturally or products and technologies arising out of resources identified, developed, and used by indigenous people from time immemorial are not patentable but if they are collected, refined or produced as knowledge in modern laboratories with a view to earning profits in the open market they become patentable. This process often termed as bio-prospecting or bio-piracy involves the expense of those who cultivate knowledge to protect their heritage from appropriation and over-exploitation but it does not care for authorization from or compensation to these indigenous people. It forces them to pay high prices for the finished product. It is a cause for great concern for biodiversity-rich developing countries.<href=”#_ftn11″ name=”_ftnref11″ title=””>
Patenting of such products and their commercial exploitation by MNCs appear to be a huge concern for biodiversity. Though it is a source of massive profits, it has been causing damage to the biodiversity by preventing the production or reproduction of indigenous products and food supply chains. As a result, it has been economically injuring the livelihood of small producers and obstructing the poor people from using their own traditional resources and knowledge to cater their human rights to health and nutrition.
MNCs are producing seeds using ‘terminator’ technology’<href=”#_ftn12″ name=”_ftnref12″ title=””> which do not germinate second time and farmers are forced to pay royalties each time they plant these engineered varieties of seeds. It causes adverse effects on their livelihood
|3.2 Int. organizations oppose patents on life formsInternational organizations called for developing countries and least developed countries (LDCs) to reject patents on life forms when meeting their obligations under Section 27(3)(b) of the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The call was made by Action Aid Bangladesh, Consumers Internationa (CI) and SAWTEE.
Article 27 (3) (b) of the TRIPS Agreement requires member countries to legislate for the protection of new plant varieties. It requires Mandatory patent protection for micro-organisms, non-biological and microbiological processes. However, it allows member countries to exempt from patenting plants and animals, as well as “essentially biological processes for the production of plants and animals”. Where patent protection is not mandatory for plant varieties, some other effective sui generis (one of a kind or specific) system of intellectual property rights protection or a combination of patent and sui generis system must be provided. Under the current text, developing countries and LDCs have an option to enact sui generis legislation for the protection of new plant varieties but they have no option but to provide for patent protection for micro-organisms, on-biological and microbiological processes.
Such patents protection for life forms includes seeds, plant tissues, plant genes, plant genetic sequences, and so on. Patents allow holders the exclusive right to exploit their inventions for up to 20 years. In the area of plant genetic resources, this is extremely critical as it allows corporations, which hold these patent rights monopoly control over the seeds of new varieties. Already, seventy four percent (74%) of biotechnology patents are held by six TNCs Monsanto, Dupont, Syngenta, Dow, Aventis and Grupo Pulsar. Between them, these six corporations hold 1011 patents on food crops, including important staples such as maize, rice, sorghum and soybean.
Patenting represents another step towards the corporatization of the food chain, forcing farmers to purchase both seeds and chemical inputs, and will accelerate the trend towards monoculture, reduce genetic diversity, expand the spread of genetically engineered foods and crops, and strain local ecosystems. Commercial seed accounts for a third of the total value of the seed industry. The other two-thirds are equally shared between farm-saved seed and seed from public institutions. Although more than a third of the value of the seed trade is earned from the OECD countries, African and Asian demand for seed has also been rising.
Transnational seed companies have been consolidating and acquiring seed companies in developing and least developed countries to increase their market share. Governments in developing countries and LDCs must ensure that the farmers and public sector researchers continue to have access to plant genetic resources for breeding and the success of their efforts remain in the public domain. Privatisation of this knowledge through intellectual property laws will cut off access to further research and development and inhibit the free exchange of seed varieties amongst farmers, disrupting traditional practices that form the basis of on-farm diversity and thus food security for the majority of the world’s farmers.
Threat to the food security
Action Aid believes that patents on seeds and crops are a threat to the food security and livelihoods of small farmers. According to Action Aid, farming is the main livelihood for seventy-five per cent (75%) of the world’s population living in rural areas and 1.4 billion farmers save seed from year to year around the world. “We want a more responsive and balanced international trade regime that adequately addresses the food rights of poor people in developing and least developed countries at national and household levels. There should be no patents on seed, food and crops. The three organisations also call on governments of developing and least developed countries to reject the plant breeders’ rights model advocated by the International Union for the Protection of New Plant Varieties (UPOV).
UPOV seeks to grant patent type protection for plant varieties. Established by the International Convention for the Protection of New Varieties of Plants, the convention was adopted in Paris in 1961 and was revised in 1972, 1978 and 1991.
Fifty-one countries are members of UPOV. Most are European and American countries; the only Asian members are China, Japan and South Korea. In Africa, only Kenya and South Africa are members. UPOV is more appropriately designed for large-scale industrialized agriculture, where farmers are a small percentage of the population, farming is commercial, seeds are bought from corporate suppliers and products are sold through commodity markets. In developing countries, millions depend on farming for food, employment and economic security. Consumer International (CI) cautioned governments of developing countries from adopting the UPOV model of sui generis plant variety laws and urged them to resist bi-lateral pressure to do so. “The UPOV model restricts the rights of farmers to save, use, sell, and exchange seeds, thereby inhibiting new seed development. Adopting the UPOV model will increase costs to farmers, create a dependency where previously there was none, and force farmers to pay for what was previously free. Eventually consumers will pay the price of higher food bills and reduced choice”, said Dr. SothiRachagan, Regional Director of CI’s Asia Pacific Office.
Pressure on LDC
Developing countries and LDCs, including Bangladesh, are being pressured to enact UPOV style sui generis legislation and many are caving into the UPOV as well as domestic industry lobby. The EU-Bangladesh Trade and Aid Agreement of 1999 requires Bangladesh to “make every effort” to join UPOV. In addition, bilateral pressure has been applied to achieve TRIPS ‘plus’ commitments (i.e. beyond what is required under TRIPS) in plant variety protection (PVP) legislation. As a least- developed country (LDC), Bangladesh is not required to implement TRIPS until 2006. Bangladesh is not the only country under pressure to enact UPOV style legislation. The US-Vietnam trade agreement obliges Vietnam to be a member of UPOV. A similar US Trade Agreement with Cambodia obliges it to accede to UPOV. There are at least 23 cases of bilateral or regional treaties between developed and developing countries that are TRIPS plus, affecting 150 countries in the South. SAWTEE rejects patents on life forms and emphasises that legislation recognizing farmers’ rights must be enacted at local, provincial and federal levels, paying due attention to the vulnerability and threat of marginalization faced by mountain farmers.
Call for harmonization
Countries at low levels of human and technological capacity cannot benefit significantly from TRIPS. The experience of developed countries shows that strong patents follow industrial development, not lead it. All three organizations recommended that governments of developing countries and LDCs conduct studies on the local implications of intellectual property protection on plants and other life forms before commencing to enact legislation. A broad-based consultative process must follow before legislation is eventually enacted. Governments must actively sponsor public sector research and development, including collaboration between scientists and farmers to ensure that local plant genetic resources are identified, conserved and improved. Governments must achieve a balance between providing incentives for the development of new plant varieties and the rights of farmers to save, use, exchange and sell seeds through an appropriate sui generis system. Action Aid Bangladesh, Consumers International and SAWTEE also called for harmonisation of Section 27(3)(b) of TRIPS with global agreements to protect biodiversity i.e. the Convention on Biological Diversity and the International Treaty on Plant Genetic Resources for Food and Agriculture. The three organisations called on governments of developing and least developed countries to: Adopt a sui generis PVP law to protect farmers and community rights; Reject patents on life forms; Call for the review of Section 27(3)(b) of TRIPS to adopt this position; oppose the UPOV model of PVP law; refrain from becoming a member of UPOV; and ratify the Convention on Biological Diversity and International Treaty on Plant Genetic Resources for Food and Agriculture.<href=”#_ftn13″ name=”_ftnref13″ title=””>
Implications and Challenges for Bangladesh in Pharmaceuticals
4.1Legal position of Bangladesh
The way in which the Patents and Designs Act, 1911 defines invention, it seems that there is no bar to patent pharmaceutical inventions in Bangladesh. Let us examine the definition of invention given in the Act in order to justify the statement made above. Clause (8) of Section 2 of the Act defines ‘invention’ as any manner of new manufacture and the term includes an improvement and an alleged invention. Clause (10) of the same section provides that the term ‘section’ provides that the term ‘manufacture’ includes any art, process or manner of producing, preparing or making an article, and also any article prepared or produced by manufacture. If we read both the definitions together we would find that the words ‘new manufacture’ include pharmaceutical inventions. Since there is no provision regarding patentable invention and exclusion from patentability, therefore, it is very difficult to come to a straight forward conclusion that any particular invention is not patentable in Bangladesh.
4.2Provisions of the TRIPS
The TRIPS Agreement requires member countries to make patents available for any invention, 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 .<href=”#_ftn14″ name=”_ftnref14″ title=””>There are three permissible exceptions to the basic rule on patentability. One is for inventions contrary to ordre public 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 ordre public or morality.<href=”#_ftn15″ name=”_ftnref15″ title=””>
The second exception is that Members may exclude from patentability diagnostic, therapeutic and surgical methods for the treatment of humans or animals.<href=”#_ftn16″ name=”_ftnref16″ title=””>
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. Plant varieties, however, must be protectable by patents or by a special system (such as the breeder’s rights provided in the conventions of UPOVthe International Union for the Protection of New Varieties of Plants). Moreover, the whole provision is subject to review four years after entry into force of the Agreement (Agreement Article 27.3(b)).
The agreement says patent protection must be available for inventions for at least 20 years. Patent protection must be available for both products and processes, in almost all fields of technology. Governments can refuse to issue a patent for an invention if its commercial exploitation is prohibited for reasons of public order or morality. They can also exclude diagnostic, therapeutic and surgical methods, plants and animals (other than microorganisms), and biological processes for the production of plants or animals (other than microbiological processes).
The agreement describes the minimum rights that a patent owner must enjoy. But it also allows certain exceptions. A patent owner could abuse his rights, for example by failing to supply the product on the market. To deal with the possibility, the agreement says governments can issue “compulsory licenses”, allowing a competitor to produce the product or use the process under licence. But this can only be done under certain conditions aimed at safeguarding the legitimate interests of the patent-holder.
If a patent is issued for a production process, then the rights must extend to the product directly obtained from the process. Under certain conditions alleged infringers may be ordered by a court to prove that they have not used the patented process.
A much-talked issue of the present time is ensuring patent protection for pharmaceutical products to provide
In the Declaration of the 4th Ministerial Conference in Doha, the Ministers emphasized on the implementation and interpretation of the TRIPS Agreement in a way that supports public health by promoting both access to existing medicines and creation of new medicines. The ministers referred the matter to a separate declaration. The separate declaration on TRIPS and Public Health was to address concerns on the possible implications of the TRIPS Agreement for the access to medicine.
At present, pharmaceutical industry is a fast- products to more than 70 countries. The exemption that flourishing sector in Bangladesh resulting in exporting Bangladesh and other Least Developed Countries (LDCs) is enjoying from granting pharmaceutical patent up to 2016 has topped among the catalysts behind such boom. Withdrawal of such waiver shall require patent to be granted in pharmaceuticals to witness higher price, narrow market demand and poor public health. But, there are rays of hope!
The wording of Para 7 of Doha Declaration 2001 and article 66(1) of Trade-Related aspects of Intellectual Property Rights (TRIPS) agreement offers us bases for hope. They speak of ‘Duly Motivated Request’ to get such further extensions after 2016. Finding grounds which may really motivate an international forum to offer such extensions for LDCs requires specific research. This is an attempt to find out the grounds which will really matter in such negotiation.
Doha Declaration and public health: Special treatment to public health was implicit in the Doha Declaration 2001. Paragraph-7 of the Declaration runs as follows: “….we also agree that LDCs will not be obliged, with respect to pharmaceutical products, to implement or to apply sections 5 and 7 of TRIPS agreement or to enforce rights provided for under these sections until January, 1, 2016, without prejudice to the rights of LDCs to seek other extensions of the transition periods as provided in art.66 (1) of TRIPS .” Hence, by dint of para-7 of Doha Declaration LDCs are free from granting patent on product and undisclosed information (sec 5 & 7 of TRIPS) in pharmaceutical sector.
Besides granting exemption from pharmaceutical patent up to 2016, para-7 leaves room for further extension in the clause “….without prejudice to the right of the LDCs to seek other extensions of the transition periods as provided in article 66(1) of the TRIPS agreement.” According to article 66(1) of the TRIPS agreement LDCs are entitled to get exemption for 10 years from the date of application from complying with articles 3,4,5(dealing with patent) considering their economic, financial, and administrative constraints and for creating a viable technological base. In such case the council for TRIPS shall accord such extension upon ‘Duly Motivated Request’. So, in pursuance of article 66(1) of TRIPS agreement it is possible to extend the exemption period for pharmaceutical patent after 2016 if the request is one which is persuasive supported by facts.
Finding convincing grounds: Finding the grounds which can really motivate the council for TRIPS for granting such extension needs specific research as to status of Bangladesh in pharmaceuticals, manufacturing ability of drugs without reverse-engineering, percentage of persons pursuing self-medication due to poverty etc. However, following grounds may hold good in this regard:
4.4Impacts of patenting drug formula
Therefore, from the analysis of the legal provisions mentioned above it can be concluded that by providing patent protection to the drug formulas of the multinational companies the patent office of Bangladesh failed to utilize the waiver given by the WTO ministerial conference, the highest-level decision-making body of the organization. We cannot straight way come to a conclusion that the patent office deliberately ignored the waiver of the Ministerial conference. We have already seen the legal provision of Bangladesh is in favor of patenting pharmaceutical products. The patent office is legally bound to grant patent on a valid application.
When patent protection is provided for a pharmaceutical product or a drug formula in such a case local manufacturers cannot use the method of reverse engineering in order to manufacture the product commercially or use the drug formula for commercial purpose. At best the local manufacturers can use such products or formula to invent a better product or formula by using reverse engineering. Since Bangladesh is an LDC it is not in a position to provide its local manufactures the technological or logistic support to conduct research on the patented products or formula of the multinational companies in order to produce better product or formula and in this way reap the benefit of patenting pharmaceutical products or drug formula.
The existing practice of using reverse engineering of the pharmaceutical products or drug formula would be definitely challenged by the multinational companies for the reverse engineering of their patented product and formula. The local manufacturers would loose the legal battle and will be compelled to withdraw their products or formula from national and international market and have to pay a huge compensation to the multinational company concerned. When the local manufacturers would require to use the patented product or formula of a multinational company they must get licence from the company by paying huge foreign currency. Due to this the price of the essential drugs may shoot up to several times than the existing price.
Since the Doha Declaration extended the time for providing patent protection to the pharmaceutical products by the LDCs till 1 January 2016, the exclusive rights for a new pharmaceutical product i.e. making, using, offering for sale, selling and importing for these purpose and for a new drug formula i.e. for use of the formula and the product obtained directly from the formula need not be provided by the LDCs. Therefore, Bangladesh is not required to provide exclusive rights to a multinational company for its new pharmaceutical product or a new drug formula. But once patent protection is given by the patent office for such a product or formula then the government is bound to provide and ensure the exclusive rights of such a company.
We cannot outright say that the local patent officials are ignorant about the consequences of the patent rights and the new development in the TRIPS Agreement due to the grant of patent for the drug formulas of the multinational companies as mentioned in the news. But we can emphasise the need of awareness of the patent officials about the latest development in the TRIPS Agreement and WTO’s latest development and the WIPO’s programmes regarding patent law.
At this point of time we cannot make such comment that government has failed to reap the full benefit of the TRIPS Agreement regarding the relaxation given by the TRIPS and the Doha declaration for providing patent protection to the pharmaceutical products. But right now government must act positively to reap the full benefit of the TRIPS and the Doha Declaration regarding protection of right to public health and access to medicine.
4.5 Required role of government
In order to stop patenting pharmaceutical products and drug formula by multinational companies the government must take step to amend the Patents and Designs Act, 1911 within the shortest possible time in order to exclude pharmaceutical products and drug formula or process by providing express provision regarding patentable subject matter in the Act which will expressly exclude that pharmaceutical products and process or drug formula from patenting till 1 January 2016. This is the easiest and convenient way of reaping benefit of the TRIPS and the Doha Declaration. Government may grant compulsory licenses for patented pharmaceutical products, process or drug formulas or provide provision for parallel import of such patented product, process or formula.
But such solution is a temporary one. The government also can strengthen its patent officials by providing them better training on WTO, TRIPS Agreement and WIPO’s role on protecting the interest of LDCs. The government should take appropriate step to be treated as most favored nation by the developed countries as per article 4 of the TRIPS Agreement. The government may take step to modernize its WTO cell of the Ministry of Trade and Commerce and open a special wing at the Ministry of Law, Justice and Parliamentary Affairs to oversee the legal consequences of the TRIPS Agreement and WTO Ministerial Conferences on Bangladesh. Such an effort would give Bangladesh a better footing to protect and exploit benefit from such ministerial conferences and any negotiations on WTO Agreement. Bangladesh should exploit the provision of article 66 (2) of the TRIPS Agreement to get better technology by way of technology transfer from the developed countries to create a sound and viable technology base.
More specifically Bangladesh can argue the following:
1. Bangladesh can argue that its pharmaceutical industry is passing infancy period compared with that of USA, Switzerland, France, Japan, and Germany. In the list of 10 top pharmaceutical companies of the world by revenue as of March 2010, Switzerland had two companies (Roche, Novartis), France one (Sanofi), Germany one (Bayer Healthcare). In 2008 among the largest 48 companies of the world in terms of revenue Japan had 10 companies. These countries provided pharmaceutical patent when their pharmaceutical industries attained maturity. Switzerland introduced pharmaceutical patent in 1977, France in 1960, Germany in 1968, Japan 1976. In terms of volume India’s pharmaceutical industry ranks 3rd in the world. Still India provides only product patent from 2005. Carlos M. Correa (2002), a Professor of University of Buenos Aires writes that, “it is the relaxation Indian patent law after 1970, which enabled India witness such a boom in pharmaceutical industry”. On the other hand, according to Bangladesh healthcare and pharmaceutical report Q1-2011 Bangladesh ranks 67th globally. To be at par with those countries Bangladesh needs more time after 2016.
2. The number of people accustomed to self-medication due to inability to visit doctor can play a decisive role in this regard. According to a survey in 2005 titled “Exploring Health Seeking Behavior of Disadvantaged Population in Rural Bangladesh” it has been found that about 30%-40% people rely on self-medication. People, here, pursue self- medication or OTC medicine mainly to avoid doctors’ fee. If patent is granted in pharmaceuticals the prices of medicine will go higher and exacerbate the present healthcare system. So, it can be validly argued that Bangladesh should have the exemption for another period of 15-20 years after 2016.
3. Bangladesh can propagate that “public health” should not be viewed as a matter of trade yielding high return. It is a problem area which warrants both national and international efforts. Suppose, patent protection on AIDS vaccines raises the price very high making a number of patients unable to afford it and die consequently. Would the world community still remain silent allowing companies receive high return? The world conscience is supposed to respond and ensure supply of vaccines or at least negotiate with the traders to reduce the price. The method of compulsory license in national laws allowing generic producers to produce patented products might be well exercised on priority basis. Doha Declaration, TRIPS agreement, national laws-all speak of special protection to public health. So, restriction in trade, patent and high return is implicit in national and international IP laws. Restriction in this case is deemed to have been incorporated to ensure affordable healthcare system throughout the world. Hence, Bangladesh can claim the exemption on pharmaceutical patent to continue after 2016 until its healthcare becomes affordable to everybody.
4. As Doha Declaration was the creator of privileges for LDCs in pharmaceutical patent, they can very validly call for extension of duration mentioned by convening a review of the declaration.
Equality should be ensured among the equals. Equality among the unequal is itself a great inequality. As Bangladesh and other LDCs are not on a firm basis regarding public health, they need the exemption to be extended for another 15-20 years after 2016. It is going to be a hard earned one if not impossible. So, Bangladesh and other LDCs should be well equipped for such negotiation.
Trips and Human Rights
Rights affected by the TRIPS Agreement include the right to an adequate standard of living, the right to work, the right to food, the right to health and the right to life (unavailability of food can lead to illness and death).These rights are set out in a range of legally-binding treaties including the International Cov- enant on Civil and Political Rights (ICCPR), the International Covenant on Economic, Social and Cultural Rights (ICESCR) and the Convention on the Rights of the Child (CRC). The ICESCR also requires that States “take steps individually and through international assistance and co- operation (…) to the maximum of […] available resources” towards realization of the rights set out in the Covenant. Moreover, the Committee on Economic, Social and Cultural Rights emphasized in its third General Comment that the ICESCR’s requirement that a state party take steps ‘to the maximum of available resources’ refers both to the resources available within a state and those available through international co-operation and assistance.
In Asia, the majority of people depend on the agricultural sector for employment and a source of income, guaranteeing the right to an adequate standard of living and the right to work. In Bangladesh alone, 72% of the population lives in rural areas and the agricultural sector provides employment to about 60% of the country’s total labour force. This situation is true for many other Asian countries. Agricultural trade liberalization, promoted under the AoA, threatens the strong base of farmer-oriented agriculture in favor of industrialized and mechanized agriculture largely carried out and controlled by transnational commodity producers and traders from developed countries. The consequence is often a de facto discrimination against the poorest and most vulnerable sectors of society, contrary to human rights. TRIPS – also affects human rights in agriculture, because it makes it mandatory for countries to provide patent protection for micro-organisms, non-biological and micro-biological processes as well as providing protection for plant varieties either by patents, or by an “effective sui generis system.” The fear of such a system of patent protection on genetic resources for food and agriculture is that it could raise the cost of seed and agricultural inputs making them unaffordable for small-scale farmers in developing countries. Another problem is that TRIPS allows patenting of the shared knowledge of indigenous communities.
In effect, the TRIPS Agreement protects the rights of corporations, such as the biotechnology industry. To date, six multinationals control around 70% of the patents held on staple food crops.
This could have serious implications for farmers’ rights to save, use, re-use, exchange and sell seeds if it means, as it could, that farmers would have to pay patent duties to save, use or ex- change seeds in the way they have done for centuries. Seed companies are already active in the seed markets of Bangladesh . Under TRIPS, the Government of Bangladesh is obliged to protect the intellectual property rights of the seeds marketed by those companies. The patenting of seeds coupled with technologies such as “terminator” technology could have drastic effects on the human rights of farmers. They will have to depend on spcial types of seeds, which increase farmers’ cost of farming. As a consequence of this, farmers’ right to food in agriculture-prone Bangladesh is likely to get affected.(MahfuzUllah, Intellectual property Rights and Bangladesh ,Dhaka centre for sustainable Development,2002).
Under the existing Patents and Design Act it offers patents to pharmaceutical process. To implement full-fledged TRIPs obligations, it shall have to patent protection to pharmaceutical product. In the consequence, it will not be able to continue copying reverse engineering in producing generics of life saving drugs. To produce them the companies have to get licenses from foreign patentees which will increase the cost of pharmaceuticals. This will affect 33 percent of the poor people who live below the poverty line and they will not be able to get access to drugs, which is a concern for human rights of this people as it will directly affect their right to health or life.
We should recognize that there are fundamental differences among the WTO members in relation to the role of intellectual property and, in particular, on how it can affect the realization of basic human rights as well as the development prospects of developing countries. Decisions on TRIPS matters should be adopted having in view the objectives and principles set forth in Articles 7 and 8 of the TRIPS Agreement. The adoption of the Doha Declaration has represented an important step in recognizing the ?exibilities permitted by the TRIPS Agreement, and the right of Members to adopt measures to protect public health. The Declaration not only has political value, but legal effects, equivalent to those of an authoritative interpretation under WTO rules. Bangladesh should come forward to take advantages of flexibility prudently and judicially. It should try to enact law balancing the needs of the people and trips agreement. Trips Finally, due attention should be given to the fact that one of the principal objectives of the GATT/WTO system is to expand the production of and trade in goods and services by reducing barriers to trade and ensuring the realization of competitive opportunities on a non-discriminatory basis. The TRIPS provisions should therefore be interpreted bearing in mind that it is the promotion rather than the restriction of competition that is the foundation of the international trade system.
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<href=”#_ftnref1″ name=”_ftn1″ title=””>Jagadishbhagwati, “From Seattle to Hongkong” (December 2005: WTO special Edition) 84(7) Foreign Affairs 2012
<href=”#_ftnref2″ name=”_ftn2″ title=””>Mohammad Towhidul Islam, The Trips Agreement in Bangladesh: Implications and Challenges, Dhaka University Journal,Part F,vol.18/2
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<href=”#_ftnref6″ name=”_ftn6″ title=””>Black, Henry Champel, Black’s law Dictionary, 5th edition,page-209.
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<href=”#_ftnref10″ name=”_ftn10″ title=””> Mohammad Towhidul Islam, The Trips Agreement in Bangladesh: Implications and Challenges, Dhaka University Journal,Part F,vol.18/2
<href=”#_ftnref11″ name=”_ftn11″ title=””>Mohammad Towhidul Islam,Trips Agreement: Concern for DCs and LDCs, www.daily star.net/law
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<href=”#_ftnref14″ name=”_ftn14″ title=””>Article 27.1).of TRIPS Agreement
<href=”#_ftnref15″ name=”_ftn15″ title=””>(Article 27.2).of TRIPS Agreement
<href=”#_ftnref16″ name=”_ftn16″ title=””> Article 27.3(a) of ibid