{"id":1054,"date":"2012-10-07T15:53:47","date_gmt":"2012-10-07T15:53:47","guid":{"rendered":"http:\/\/ncjolt.org\/?p=1054"},"modified":"2020-06-04T20:54:06","modified_gmt":"2020-06-04T20:54:06","slug":"closing-the-pharmacy-of-the-third-world-indias-battle-with-the-international-pharmaceutical-industry","status":"publish","type":"post","link":"https:\/\/journals.law.unc.edu\/ncjolt\/blogs\/closing-the-pharmacy-of-the-third-world-indias-battle-with-the-international-pharmaceutical-industry\/","title":{"rendered":"Closing the Pharmacy of the Third World? : India\u2019s Battle with the International Pharmaceutical Industry"},"content":{"rendered":"

Friday, October 5, 2012 by Lauren Powers
\nIndia, considered by many to be the \u201cPharmacy of the Third World<\/a>,\u201d has built a reputation for manufacturing cheaper generic versions of expensive branded pharmaceuticals. \u00a0Following the amendment of its patent laws in 2005<\/a>, India has been forced by multinational pharmaceutical companies to reconsider the strictness of these laws, and Novartis AG v. Indian Patent Office<\/em><\/a> <\/em>serves as the first case based on the new laws heard in the Indian Supreme Court. Because this suit is a case of first impression for the Indian Supreme Court, it possesses the potential to drastically alter international patent law, which would have a particularly large effect on India and other developing countries.\u00a0 Since the origins of the suit in a regional High Court, critics of the current Indian patent regime have argued over whether it should be amended, but proponents and critics of the patent laws have predicted consequences<\/a> in stark contrasts of each other. If India does not make a decision in this case, it should prepare the courts for an onslaught of similar litigation in the coming years.\u00a0 India would benefit most from balancing domestic and international interests in generic drugs following the wake of Novartis AG v. Indian Patent Office<\/em> in the fall of 2012 and other potential future cases like it.<\/p>\n

India would benefit most from balancing domestic and international interests in generic drugs following the wake of Novartis AG v. Indian Patent Office<\/em> in the fall of 2012 and other potential future cases like it.<\/p><\/blockquote>\n

Indian patent officials claim that they drafted the controversial portions of the amendments to the India Patents Act with the intention of preventing \u201cevergreening<\/a>,\u201d a process that occurs when pharmaceutical companies file new patents on miniscule changes in their pharmaceuticals that produce no real alteration in efficacy in order to extend the lives of their patents.\u00a0 Understandably, India claims to have drafted the amendments to prevent evergreening by pharmaceutical companies trying to extend the lives of their patents, but a reasonable argument can be made that the law also inhibits incremental innovation<\/a>, the process by which pharmaceutical companies legitimately attempt to increase the effectiveness of patented drugs.
\nInitially, the regional Madras Patent Office rejected Novartis AG\u2019s Glivec patent application because the examiner<\/a> postulated that the form of Glivec proposed should be considered prior art because of Novartis AG\u2019s previously granted international patents for the free base imatinib form of Glivec. Additionally, he believed that the new beta crystalline form of imatinib mesylate did not meet the \u201cenhanced efficacy<\/a>\u201d requirement found in \u00a73(d) of the amendments based upon a 30% increase in bioavailability from the free base version of the drug.
\nIndia should clarify its \u201cenhanced efficacy\u201d requirement in \u00a73(d) of its 2005 amendment of the Patents Act in order to avoid any wastes of resources for both the Indian Patent Office and inventors seeking Indian patents.\u00a0 Firstly, no other WTO country has included this rigid of an efficacy requirement or its equivalent into its patent laws. While the WTO does not require India to abide by the laws or guidelines of any other WTO nations, India should reasonably consider modifying its laws to better meld with other internationally established laws in order to permit less room for argument from inventors and particularly from the multinational pharmaceutical companies.\u00a0 Secondly, given the unpredictable nature of chemistry and pharmaceutical production, the Patent Controller\u2019s rejection of a 30% increase in bioavailability does not seem to adhere to India\u2019s own requirement for a demonstration of enhanced efficacy. Therefore, Novartis AG had to significantly alter Glivec in order to produce a 30% increase in bioavailability, so it appears reasonable for Novartis AG to consider this alteration to constitute \u201cenhanced efficacy\u201d under \u00a73(d).\u00a0 Therefore, Novartis AG has reasonably argued that, as it currently stands, \u00a73(d) of the Indian Patents Act lacks enforceability due to ambiguity<\/a>.
\nBy examining the public outcry based on India\u2019s current predicament regarding its patent law system, it appears that India cannot remain idle and figure out solutions to challenges to its patent system as they arise.\u00a0 While the majority of India\u2019s domestic generic pharmaceutical industry would prefer for the laws to remain in their current embodiments, this approach does not ultimately benefit India\u2019s economy or the international protection of intellectual property rights as they related to pharmaceuticals.\u00a0 Ultimately, if the Indian Supreme Court determines that a reworking \u00a73(d) of the 2005 amendment to the India Patents Act and permitting Novartis AG to receive a patent on Glivec has become necessary this Fall, these actions will not create the myriad problems that opponents of the change anticipate, particularly if India adopts laws that assuage the consternation of both sides of the argument by encouraging incremental innovation while simultaneously stimulating its booming generic pharmaceutical industry.<\/p>\n","protected":false},"excerpt":{"rendered":"

Friday, October 5, 2012 by Lauren Powers India, considered by many to be the \u201cPharmacy of the Third World,\u201d has built a reputation for manufacturing cheaper generic versions of expensive branded pharmaceuticals. \u00a0Following the amendment of its patent laws in 2005, India has been forced by multinational pharmaceutical companies to reconsider the strictness of these …<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[51],"tags":[],"_links":{"self":[{"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/posts\/1054"}],"collection":[{"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/comments?post=1054"}],"version-history":[{"count":1,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/posts\/1054\/revisions"}],"predecessor-version":[{"id":7683,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/posts\/1054\/revisions\/7683"}],"wp:attachment":[{"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/media?parent=1054"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/categories?post=1054"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/tags?post=1054"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}