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Related post: II. Background A. Topamax Cost Evolution of India�s Pharmaceutical Industry The development of the Indian pharmaceutical industry was shaped by the introduction of the Patents Act of 1970. Before the enactment of the Patents Act, the Indian pharmaceutical market was dominated by western multinational corporations that controlled over 75 percent of the market, primarily through imported drugs.2 Almost all of the pharmaceutical products under patent in India at the time were held by foreign companies and domestic drug prices were among the highest in the world (Chaudhuri 2005).3 The situation changed substantially Purchase Topamax Online with the passage of the 1970 Patents Act. An important feature of the Act was the special provision relating to drugs (as well as agricultural chemicals and food products) that could be patented only for a new method or process of manufacture and not the product itself.4 This meant that a slight modification in the synthesis of a molecule was patentable and allowed several firms to produce essentially the same product. Furthermore, the Act provided only seven years of process patent protection for pharmaceuticals, about half of the average fifteen years required to develop and test a new drug. The complete elimination of product patent 2 Many western multinational corporations like Merck, Pfizer, and Bayer entered the Indian market in 1950s not to initiate manufacturing but to distribute and sell imported products. See Chaudhuri (2005) for a historical account of the Indian pharmaceutical industry. 3 The process of drug manufacturing has two interlinked components: bulk drug production that is production of active ingredients present in the drugs and second, formulation production, Buy Topamax No Rx that is processing of bulk drugs into finished dosage forms such as tablets, capsules, ointments. India was dependent on imports of a majority of the essential bulk drugs. Manufacturing by western multinational corporations was primarily restricted to processing of imported bulk drugs into formulations and not necessarily the production of bulk drugs itself. 4 The Indian Patents Act (1970), which replaced the inherited British colonial law regarding intellectual property rights, specifically excluded pharmaceutical product patents and only admitted process patents for a period of seven years. 4 protection, the provision that only one process could be patented by an applicant and the shorter protection period of just seven years, all encouraged generic drug development in India. The result was more than three decades of reverse engineering of 'on patent' products, and a flourishing domestic generics market.5 Most foreign pharmaceutical manufacturers abandoned the Topamax Online Price Indian market altogether due to the absence of legal mechanisms to protect their patented products and local firms were quick to respond to the favorable provisions created by the 1970 Patents Act. Over the last forty years the Indian pharmaceutical industry grew rapidly to the point where its annual revenues are currently valued at $21.8 billion and is the third largest in the world in terms of production volume (behind U.S. and Japan). The structure of the industry also evolved. In 1970, the industry was dominated by multinational subsidiaries; by 2001, Indian-owned firms were not just the leading players in the industry, many had also become major exporters (Chaudhuri, Goldberg, and Jia 2006).6 India�s entry into the World Trade Organization (WTO) in 1994 necessitated significant changes in its patent regime. Under the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS), member states of the WTO were required to implement minimum levels of intellectual property protection. 7 These include providing for product and process patents in all fields of technology, including pharmaceuticals, with a minimum patent term of 20 years.8 Although TRIPS came into force on 1 January 1995, developing countries such as India were granted a transition period of five years to implement the provisions of TRIPS. In addition, if a country did not provide product patent protection in any field when TRIPS came into force (such as in the case of agro- chemicals, food and drugs in India), then an Topamax Mg additional five years were granted. The provision was designed to give developing countries time to adapt their patent systems and patent offices Buy Topamax With No Prescription to the post-TRIPs world. During this 10 year transition period (from 1 January 1995 Topamax Cost Buy to 1 January 2005) to implement the new policy, India introduced a 5 The two stated objectives of the 1970 act were: the development of an indigenous pharmaceuticals industry; and the provision of low-cost access to medicines for Indian consumers. Consistent with Purchase Topamax these objectives, and with the broader leftward tilt in policy, a number of other measures were introduced�drug price controls, restrictions on capacity expansion, limits on multinational equity shares that kept pharmaceutical prices low, and Topamax Cost Australia encouraged the development of the Indian pharmaceutical industry (Chaudhuri, Goldberg, and Jia 2006). 6 Moreover, Indian companies account for over 70 percent of drugs sold in the country, making India one of the few countries in the world achieving self-sufficiency in drugs, and an Topamax Online Cheap important supplier of certain product segments that treat diseases prevalent Topamax Cost Canada in less regulated markets of Africa, Asia and Latin America, most notably vaccines and ARVs. 7 TRIPS aims Order Topamax at establishing strong minimum standards for intellectual property rights. Apart from patents, intellectual property includes copyrights, trademarks, geographical indications, industrial designs, integrated circuits, trade secrets. The protection of IPRs is binding and legally enforceable. TRIPs has three broad components, the first (Parts I and II, Articles 1-40) set out the goals, objectives and standards of IPRs. The second component (Parts III, IV, Topamax Coupon Online and V, Articles 41�61) deals Topamax Cost Uk with the mechanisms of enforcement of Topamax Cost Without Insurance IPRs. The third component (Parts VI and VII, Articles 65�73) focuses on the specific needs of developing countries, such as transitional arrangements, technology transfers and technical cooperation, and institutional arrangements for monitoring and review. The text of TRIPS is available at: www.wto.org. 8 Least developed countries (LDCs) are not required to implement patents for pharmaceuticals until 2016. 5 facility ('mailbox') to receive and hold patent applications in the field of pharmaceuticals (and agricultural chemicals), which were examined beginning 1 January 2005. Thus, product patent protection in all fields, including pharmaceuticals, began in India from January 1, 2005.9 B. Important Provisions Topamax Cost Us Relating to TRIPS Compliance Due to the absence of product patent protection in pharmaceuticals under the Patent Act of Buy Topamax 1970, the Indian generic companies could reverse engineer to produce and market in India any new drug developed abroad. For example, copies of global brands like Pfizer's top-selling cholesterol drug Lipitor (active ingredient-Atrovastatin) and Eli Lilly�s popular anti-depressant drug Prozac (active ingredient-Fluoxetine) were manufactured and sold in India by generic producers within two years of being introduced in the United States. The absence of any restriction on the entry of firms resulted in a competitive market structure with low prices. Policymakers anticipated that with the introduction of full product patent protection in pharmaceuticals from 1 January, 2005, as the generic companies are prevented from introducing new drugs, the decrease in competition would result in higher prices and Buy Topamax Australia thus lower utilization of pharmaceutical treatments. TRIPS, however, provides opportunities to developing countries to tackle such consequences of product patent protection. For instance, countries are permitted some flexibility in determining what an invention is and in deciding their own standards of patentability.10 Indeed, the two important instruments available with the Indian government to regulate prices are (i) to use the flexibilities provided under TRIPs and (ii) price controls. For instance, the Patents Amendment Act of 2005 (the TRIPS consistent Indian patent law) limits recourse to ancillary patents on chemical variants, alternative formulations, delivery systems, and relatively minor aspects of the drug unless these incremental innovations demonstrate an increased level of effectiveness (as stated Buy Topamax Online in section 3(d) of the Act).11 This type of provision Cheap Topamax finds no parallel in any other 9
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