EVERGREENING OF PATENTS: REVIVAL OF COLONISATION AND MONOPOLY.

...................................................................................................................... Introduction:Concept of evergreening An attempt to “stockpile” the patent protection by original manufacturers by obtaining several patents on multiple forms of the same product can be termed as “ever greening”. 1 As per “the Age”, “ever greening refers to a variety of legal, business and technological strategies to extend the term of patent protection of those which are about to expire for a longer periods of times than provided under legal framework”. 2 Ever greening is not a formal concept of patent law rather it is a social idea to refer various ways in which the patent owners use the law and all related regulatory processes so as to gain monopolistic control over the given product which is known as “intellectual monopoly privileges”. 3 It is generally used by the drug industry to develop “bullet proof patent portfolios” so as to block a possible entry into the domain of innovator, or to protect their “IMP” 4 upon highly-profitable drugs which are considered as “blockbuster drugs”. 5 There is a lot of ‘hue and cry’ for the much talked “evergreen resolution” 6


ISSN: 2320-5407
Int. J. Adv. Res. 7 (6), 747-758 749 present in the drug. These drugs are not given fancy brand names by different pharmaceutical companies and patented in the market, rather they are sold under their manufacturer's name. Generic drugs may look or taste different from brand name drugs, but have same chemical composition as their. This makes them identical in efficacy, potency, route of administration, strength and dosage. Generic drugs are cheaper than their branded equivalents as they are not patented or advertised and involve the cost of manufacturing only, hence they often prove to be a better choice. 18 Most nations have a requirement for generic drug manufacturers that they need to prove that their formulation exhibits bioequivalence to the innovator product. 19 Hence it can be said to avoid the purchase of high-priced drugs and also to escape the colonisation and monopolistic practices of giant pharmaceutical companies, many pharmaceutical companies have taken a step ahead to manufacture generic drugs so that people can have access to such affordable medicines which also possess same curative quality as that of in the high-priced patented drugs manufactured by such giant pharmaceuticals companies and also in those drug modifications which the companies also got patented via evergreening of patents obtained in the "parent drug".

Evergreening And Trips
The TRIPS Agreement provides for the negative monopoly over competitors or rivals from using patented invention without consent of the patent holder for a term of 20 years irrespective of the field of technology. 20 TRIPS provides that patent shall be available for any inventions, whether product or processes, in all fields of technology without discrimination, subject to 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. 21 TRIPS Agreement recognises that members have the right to use/adopt measures to protect public health so long as they are consistent with TRIPS. Therefore the implementation of IP laws should be based on "pro-public health" and "pro-access" principles. 22 Doha Declaration is an affirmation of the flexibilities provided under the TRIPS Agreement. But the language of the Doha Declaration laid emphasis on the importance of implementing and interpreting the TRIPS Agreement in a way that supports public health. 23 There arise several questions regarding adherence to the TRIPS Agreement in pharmaceutical sector especially by developing and least developed countries concerning public health. N. Lalitha poses such questions as follows: 1. Would the TRIPS Agreement and product patent regime affect access to medicines for the public? 2. What are the options available for the countries that face health crises? 24 Doha Declaration has simplified access to medicines by simplifying "compulsory licensing" clause. The Declaration responds to the concerns of developing countries about the obstacles they faced when seeking to implement measures to promote access to affordable medicines in the interest of public health in general, without limitations to certain diseases. The Doha Declaration refers to several aspects of TRIPS, including the right to grant compulsory licenses and the freedom to determine the grounds upon which licenses are granted, the right to determine what constitutes a national emergency and circumstances of extreme urgency, and the freedom to establish the regime of exhaustion of intellectual property rights. 25 So as to understand the flexibility provided by TRIPS regarding public health and then affirmation of Doha Declaration on the TRIPS, we need to look into the provision pertaining to that flexibility and such provision is Art. 27 which reads as: patents shall be available for any inventions whether products or processes in all fields of technology provided they are new, involve an inventive step and are capable of industrial application-and shall be available and patent rights shall be enjoyable without discrimination as to the place of invention, field of technology and whether products are imported or locally produced". The text of TRIPS Article 27.1 can be divided into two components. The first 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 18 Ibid. 19  are capable of industrial application." 26 This section lays out the basic premise that patents must be available for "all fields of technology" subject to the three basic requirements of novelty, utility, and non-obviousness. No other requirements are named, giving rise to a possible negative inference that no other patentability requirements are permitted. 27 The second component states "patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced." 28 This component is known as the "non-discrimination clause" of TRIPS because it appears on its face to contemplate non-discrimination among different fields of technology. 29 Hence, we can say that TRIPS and Doha Declaration both provide for the basic parameters and object of "patent law" that is "openness" and "accessibility" among which affordability is more important and the flexibilities provided by it are concerned for this aspect only and also for public health. Under the TRIPS Agreement companies enjoy monopoly for a fixed period of time. Pharmaceutical organisations pour their resources in the development of a pharmaceutical which is subjected to various uncertainties. Maximizing such certainty that a research based manufacturer can obtain, enforce, defend and make full legitimate use of his IP rights is very essential or else the promise of pharmaceutical innovation can be lost. 30 However this in no way implies that evergreening of patents should be promoted. Hence what is required is to strike a balance between innovations and affordability. 31

Evergreening and indian patents act, 2005: prevailing controversy Development of indian patent law
Having given the brief description of how the concept of evergreening has been taken into consideration under the TRIPS Agreement, the deliberation should move forward to discuss the national law regime of India regarding "patents" and its compliance with the provisions of TRIPS Agreement and also the amendments made in "Indian Patent Law" so as to comply completely with the standardised provisions incorporated under the TRIPS Agreement. In this regard the development of Indian Patent Law needs to be discussed. After the enactment of the Patents Act, 1970 several changes have been introduced in the legislation via three major amendments of 1999, 2002 and 2005 respectively. The requirement to grant exclusive marketing rights to medicines or drugs as an alternative to product patent protection during the transition period 33 was the main reason to amend the Patent Act and hence 1999 Amendment introduced Chapter IVA relating to exclusive marketing rights for medicines and drugs during the transition period. The chapter pertaining to "EMRs" was omitted in the 2005 Amendment Act after the expiry of transition period given to India. After the Amendment in 1999, numerous changes were made to the Indian Patent Act in 2002 through the Patents (Amendment) Act of 2002. 34 The transition period given to India under the TRIPS Agreement ended in December 2004 and the Indian Parliament passed the Patents (Amendment) Act, 2005 in order to bring the Indian Patent Law in conformity with the Agreement on TRIPS Agreement. In addition to provisions directed to the TRIPS Agreement, the amendment also modified and incorporated other provisions in the Act. 35 The most important is the 2005 Amendment which came into force with retrospective effect from January 1, 2005. But it was also added that Ss. 37(a)(ii) and (b), 41, 42, 47, 59-63 and 74 shall come into force on such date as the Central Government may appoint by notification in the Official Gazette. 36 The most important change made via this amendment is that "section-3(d) of the Act was substituted by a new clause, which provided that discovery of a new form, property or use of a known substance was not patentable unless it results in "enhanced efficacy".

Section-3(D) Of The Patents Act, 1970
Section 3(d) stipulates "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant, is not patentable". 37 The provision has posed two conditions falling into ambit of which will make the subject-matter non-patentable. They are as follows: 1. Mere discovery of a new form of known substances, and 2. Mere Discovery of Any New Use of Known Substance.
The main objective of this section is to prevent several pharmaceutical companies from obtaining patents on old medicines which are just a mere increment or trivial improvement of the known substances and also a refusal to the 33 India was given transition time until 2005, under the Agreement on Trade Related Aspects of Intellectual Property rights (TRIPS) to provide for the grant of product and process patents to all inventions including drugs and medicines, The TRIPS Agreement, 1994, Art. 70 Para 9. 34  752 patent on discovery of new form or new use of old drugs. 38 Hence, section-3(d) introduces pharmaceutical product patents in India for the first time. The Patent (amendment) Act 2005 defines what invention is and makes it clear that any existing knowledge or thing cannot be patented. The provision defines that a 'novelty' standard -which, along with 'non-obviousness' or 'inventive step' and industrial applicability, are the three prerequisites for 'patentability'. "Discovery" essentially refers to finding out something which already existed in nature but was unknown or unrecognised. Therefore, discoveries are excluded from patent protection under section 3 of the Indian Patent Act 1970. 39 The provision under section 3(d) has been approved by WHO Public Health, Innovation and Intellectual Property Rights Report, 2006, that countries can adopt legislation and examination guidelines requiring a level of inventiveness that would prevent ever-greening patents from being granted. 40 Section 3 (d) aims to prevent ever greening, a process by which a company introduces minor modifications in the patented product and then gets a new patent for its product on the strength of the alterations. By applying for secondary patents over related or derivative technologies, prior to the date of expiry of original patent, these companies seek to extend the life of patent by additional 20 year periods for different attributes of the same drug. The changes made may add little therapeutic or clinical value to the original patented product, but the patents granted for them ensure that the patent holders do not lose out market shares to the generic versions of its patented drug. Thus, company can enjoy lengthy monopoly over the drugs and profit from their R&D investment. 41 The practice of ever greening has anti-competitive effects as it enables the pharmaceutical MNCs to eliminate competition from the generic manufacturers and charge exorbitant prices for their patented drugs over a prolonged period of time. This in turn is detrimental to public interest since many essential drugs become inaccessible to the general public on account of prohibitive pricing. It was India's concern for public health issues that compelled her to exclude from patentability 'incremental innovation" or modifications on existing drug molecules unless they satisfied the enhanced efficacy requirement under Section 3(d). Prior to India's membership in the WTO, India had developed a highly successful generic pharmaceutical industry producing cheaper versions of patented drugs. This became possible on account of its patent regime which allowed protection only on the process and not the product. After the introduction of patent protection for products, it was feared that such a move would jeopardize the position of Indian generic drug manufacturers in the global pharmaceutical market. Moreover, there was growing apprehension that the sharp rise in the price of life-saving drugs which would take them beyond the reach of common man. By incorporating the enhanced efficacy requirement in Section 3(d), it sought to allay the fear regarding patent evergreening through incremental innovation, and at the same time implemented its obligations under TRIPS. 42

Criticisms Against Section-3(D) Of Patents Act, 1970
Having deliberated over the provisions contained under section-3 (d), the other face of the coin is that the incorporation of section 3 (d) was widely criticized also in the terms that: 1. It does not comply with the TRIPS Agreement 2. The "enhanced efficacy" was not envisaged under Art. 27.1 of the TRIPS 3. It falls beyond the flexibilities in TRIPS since it limits patentability to only "new chemical entities and excludes "new forms of known substances lacking enhanced efficacy".
To answer the questions we need to look into the relevant provisions of TRIPS. Art. 27.1 provides that "patent shall be available for any inventions, in all fields of technology, provided that they are new, involves an inventive step and are capable of industrial application". The language of this provision is very broad as it does not define any of the terms hence it allows the member countries to design their patent laws as per their convenience so long as they satisfy the broad patentability criteria. Another aspect of concern is that of flexibility regarding public health and in this regard Art. 8 of TRIPS is of vital importance which provides that "Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public 38  Art. 7 of TRIPS states "The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to balance of rights and obligations". 44 Art. 27.2 of TRIPS states "Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law". 45 Hence it can be said that though TRIPS does not provide any definition to the terms "invention", "inventive step" and "industrial application" and it left this to member countries to accordingly define the limits of patentability criteria as per their socio-economic need. So, it can be said that there is nothing which prevents section 3 d of Indian Patents Act, 1970 to adopt the criteria of "enhanced efficacy" which can be considered as higher level of defining inventiveness of "new form of known substances" hence it can be said that Indian Patent Act has heightened the non-obviousness criteria provided by TRIPS in full compliance of it and hence can very well be considered as "TRIPS PLUS" and not in contravention of TRIPS. 46 More importantly, Article 8 gives considerable leeway to the developing countries to design a patent system which is conducive to the protection of environment and public health. Article 27.2 enhances the scope of this flexibility by permitting member nations to exclude certain inventions from patentability for protecting public interest. 47 It has been said that in fact none of the member nations has utilised the flexibilities provided by TRIPS but section 3d of Indian Patents Act, 1970 is one of those few provisions of patent legislations which has actually utilised the flexibilities provided by the TRIPS as the Doha Declaration also states that "we agree that TRIPS Agreement does not and should not prevent Members from taking measures to protect public health" 48 Thus we can see that Doha Declaration also envisages in it some sort of flexibilities for developing countries to deviate from the normal patentability criteria so as to ensure public health of their citizens. 49 While reading literatures pertaining to this paper I came across to a very interesting fact that though section 3d of Indian Patents Act, 1970 found no parallel of it in any other patent legislation of any other country but interestingly it has been copied from a European Directive 50 dealing with drug safety regulation which defines "generic medicinal products" as a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. Shamnad Basheer then contests that "If the intention behind this provision is to heighten the obviousness standard and weed out frivolous and fairly obvious patents, this seems a rather illogical result, as a new use for a new form is certainly more inventive than a mere showing of an increase in known efficacy. 52 But conclusively it can be said that section 3d made an effort to find a balance between grant of patents and accessibility and affordability of low priced generic drugs by patients and consumers by not allowing the practice of "ever greening" which could potentially delay low priced generic drugs from reaching to low income consumers and patients. 53 And since WTO Dispute Settlement Body (DSB) would consider that section 3d of Patents Act, 1970 has used flexibilities of TRIPS validly and hence it should be taken as a proposal to clarify TRIPS while addressing the concerns about "ever greening". 54 And hence it can be contested that Section-3d of the Indian Patents Act, 1970 is an anti-ever greening provision which by incorporating "enhanced efficacy" criteria has in one hand heightened the non-obviousness criteria of patentability complying with the basic requirements of patentability provided under the TRIPS and on the other hand has sought a balance between grant of patents and affordability of low priced generic drugs and hence a balance can be seen between public health and intellectual property rights. The controversy regarding section-3d hence seen to be resolved and it can very well be said that it can be a proposed universal solution of the problem of "ever greening of patents" which can be considered as a means of colonisation and monopolistic control by giant MNCs in pharmaceutical sector, which is the next part of this paper to be dealt with.

Meaning Of Colonisation And Its Effect
Colonization or colonisation is an ongoing process of control by which a central system of power dominates the surrounding land and its components. The term is derived from the latin word colere, which means to "inhabit". The history of colonisation can be traced long back to times of maritime nations such as city-states of Greece and Phoenicia, they used to establish colonies to farm and also with the intent of regulating and expanding trade throughout the Mediterranean and Middle East. The Vikings of Scandinavia also carried out a large scale colonisation, they also established colonies to began trading. While reading literature pertaining to colonisation I came across an emerging concept of "hypothetical colonisation" which interlinks different fields with the concept of colonisation such as "ocean colonisation", "space colonisation" etc. 55 And hence the paper is also dealing with another type of hypothetical colonisation which is "market colonisation" pursued by giant MNCs in pharmaceutical sector via process of "ever greening of patents". The advent of colonialism in India produced major upheavals in the economy causing disruptions in production, trade and agriculture. Before being colonised by British, India was a major supplier of manufactured goods to the world market and after colonisation she became a source of raw materials and agricultural products and consumer of manufactured goods largely for the benefit of industrialising England. At the same time new groups entered the trade and business sometimes in alliance with existing communities and in some cases by forcing them out. 56 In industrialised nations, historic colonialism is rarely equated with "economic globalisation". Yet as MNCs assert rights over nation-state sovereignty, globalisation increasingly looks like a highly-evolved form of colonialism, resubordinating the economies of newly industrialised countries, as well as labour markets of developed nations. 57 Colonialism means "the policy or practice of a wealthy or powerful nations maintaining or extending its control over other countries, especially in establishing settlements or exploiting resources". 58 As per Collins English Dictionary, colonialism means "the policy and practice of power in extending control over weaker peoples or areas". 59 While dealing with the concept of colonialism, "neo-colonialism" is another worth mentioning concept which means "control of its former colonies by economic pressures". 60 Colonialism, colonisation, imperialism and neo-colonialism all these terms refer towards control of stronger over the weaker and this control can be in any manner and in any sphere. Conventionally, these terms have always been talked in the political sense but an attempt has been made to link these concepts with one of the concept relating to Intellectual Property rights which is the concept of "ever greening of patents" wherein the huge MNCs try to control the economy of newly industrialised companies by getting their patent protection renewed over the products manufactured by them just by making small modifications and hence this process leads to the price inflation of such products which cannot be easily afforded by the low-income consumers. The next part of the paper talks about this very interconnection that how these multinational companies are colonising the economy of newly settled or small companies by using this concept of "ever greening" which is in a way not only affecting the right to trade and commerce of small enterprises in the concerned spheres but also adversely affecting the rights of consumers to have access to those products and in case of pharmaceutical product affecting the rights of patients to have access to generic version or cheaper drugs.

Evergreening Of Patents: Reason Of Colonisation And Monopoly
As the concepts of "ever greening" and "colonisation or colonialism" have been deliberated in quite detail, the basic idea which can be gathered about these concepts is that the term "ever greening" refers to the renewal over the patent production before its expiry just by introducing trivial modifications over the patented products. And the term "colonisation or colonialism" refers to the strategy of control of stronger over the weaker ones. Hence we can very well say that ever greening of patents is nothing but a main cause behind the colonisation and the increasing monopoly by huge giant MNCs pharmaceutical countries as they continuously practice this practice of getting their patented products or drugs renewed by making trivial modifications in their composition which results in the inflation of prices of drugs and medicines as they have to extract all the expenditure which they had bear while research and development and also to secure the finance for further research regarding modifications to be made in the patented products such as drugs or medicines. The process of ever greening is a double-edged sword because it hampers interest of two classes of the society such as the newly emerged pharmaceutical companies dealing in the manufacturing of generic medicines because by getting their patented product's protection renewed MNCs in that field trying to bring "market colonialism" in which they try to control the economy of these newly emerging companies in pharmaceutical sector who are trying to bring some generic version of high-priced drugs or medicines which could not be afforded by low-income consumers or patients by increasing their monopolistic tendency of getting their patent renewed just by making small modifications in the patented products and secondly, the affordability aspect of the patients because due to evergreening of patent over the drugs and medicines, there is a rise in the price of those secondarily patented drugs and medicines which could not be afforded by the low-income consumers or patients. But today, India still has a thriving domestic generic drug industry that competes directly with brand-name drug manufacturers from the U.S. and Europe. Indeed, India and Japan are the only two countries where generic drug manufacturers dominate over multinational corporations." The domestic industry is itself divided between several large companies (such as Ranbaxy, Cipla, and Dr. Reddy's Laboratories), which engage in some original research and development in addition to generic drug production, and hundreds of smaller companies, which exclusively reverse engineer and manufacture generics.' Both segments rely heavily on export markets. 61 Hence, the fragmented Indian pharmaceutical industry has led to a wide disparity of interests with respect to patent protection. Not only do multinational drug companies want enhanced patent protection, but some domestic companies-primarily those who have significant research and development operations-also want a stronger patent regime.' 62 Other domestic companies, however, fervently oppose patent law reform, fearing that it would lead to patent-based monopolies and destroy their imitation-based business models. 63 On the basis of above analysis, it can very well be said that ever greening is nothing but a means of increasing "market colonisation" and the enhanced monopolistic patent regime. patients to have access to the medicines which they require for their concerned treatment because ever greening always leads to inflation of prices of drugs or medicines. As a suggestion the author wants to mention that the "enhanced efficacy" standard should also be adopted by other national patent law legislations so to ensure that ever greening may not only be eradicated from India but it could be combated globally so as to harmonise the balance between the IPRs and affordability on the part of the consumers.