{"id":34067,"date":"2023-03-24T04:20:58","date_gmt":"2023-03-23T22:50:58","guid":{"rendered":"https:\/\/vajiramandravi.com\/current-affairs\/?p=34067"},"modified":"2025-04-20T08:37:54","modified_gmt":"2025-04-20T03:07:54","slug":"patent-monopolyevergreening-india-rejects-johnson-johnsons-attempt-to-extend-monopoly-on-lifesaving","status":"publish","type":"post","link":"https:\/\/vajiramandravi.com\/current-affairs\/patent-monopolyevergreening-india-rejects-johnson-johnsons-attempt-to-extend-monopoly-on-lifesaving\/","title":{"rendered":"Patent Monopoly\/Evergreening: India rejects Johnson &#038; Johnson\u2019s attempt to extend monopoly on lifesaving TB drug"},"content":{"rendered":"<h3><strong>What\u2019s in today\u2019s article?<\/strong><\/h3>\n<ul>\n<li><strong>Why in News?<\/strong><\/li>\n<li><strong>What is the Evergreening of Patents?<\/strong><\/li>\n<li><strong>Why is Patent Monopoly\/Evergreening Granted?<\/strong><\/li>\n<li><strong>What is the Supreme Court\u2019s Verdict in this Regard?<\/strong><\/li>\n<li><strong>News Summary Regarding Indian Patent Office\u2019s Recent Decision<\/strong><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2><strong>Why in News?<\/strong><\/h2>\n<ul>\n<li>The Indian Patent Office rejected U.S. pharmaceutical giant Johnson &amp; Johnson\u2019s (J&amp;J) attempt to extend its monopoly on the manufacturing of the anti-tuberculosis drug Bedaquiline in India beyond July 2023.<\/li>\n<li>This will pave the way for generic drug manufacturers (Lupin and Macleods) to produce Bedaquiline tablets, thus ensuring cheaper (currently priced at $400 per six-month course) and wider access to the drug.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2><strong>What is the Evergreening of Patents?<\/strong><\/h2>\n<ul>\n<li>The evergreening of patents is a practice of <strong>tweaking drugs in order to extend their patent<\/strong> term and thus their profitability.<\/li>\n<li>The Indian <strong>Patents Act<\/strong> <strong>1970 <\/strong>introduced many provisions [Sections 3(d), 53(4) and 107A] to prevent the mischievous practice of \u201c<u>evergreening<\/u>\u201d of patents.<\/li>\n<li>This is to <strong>aid millions of people who can&#8217;t afford the expensive<\/strong> modified drugs, as well as the development of the domestic<strong> generic drug market<\/strong>.<\/li>\n<li>However, evergreening patents on drugs (diabetes, cancers, cardiovascular diseases, etc) <strong>continue to be granted to pharmaceutical innovator companies by the Indian Patent Office <\/strong>and enforced through courts.<\/li>\n<\/ul>\n<p><strong>\u00a0<\/strong><\/p>\n<h2><strong>Why is Patent Monopoly\/Evergreening Granted?<\/strong><\/h2>\n<ul>\n<li>The economic assumption behind the <strong>Patent Bargain <\/strong>(private risk is rewarded and incentivised in return for a limited private monopoly right) is to have a <strong>trickle-down impact<\/strong> that benefits the general population.<\/li>\n<li>Therefore, patent monopolies are granted to innovators in the hope that <strong>they disclose something new, inventive and of industrial value to the public<\/strong>.<\/li>\n<li>However, <strong>the Patent Bargain becomes a Faustian bargain<\/strong> (in which a person abandons his or her moral principles to obtain benefits),\n<ul>\n<li><strong>Undermining competition in the market<\/strong> and<\/li>\n<li>Enables patentees to extract more from the society than permitted.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<figure class=\"media\">\n<div data-oembed-url=\"https:\/\/www.youtube.com\/watch?v=bdzUMaxZt3g\">\n<div><iframe src=\"https:\/\/www.youtube.com\/embed\/bdzUMaxZt3g\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/div>\n<\/div>\n<\/figure>\n<p><strong>\u00a0<\/strong><\/p>\n<h2><strong>What is the Supreme Court\u2019s Verdict in this Regard?<\/strong><\/h2>\n<ul>\n<li>In <u>Novartis AG v. Union of India &amp; Others<\/u> (2013), the apex court held that the legislative intent is to<strong> prevent evergreening of a patent monopoly<\/strong> that in no way enhances the drug\u2019s therapeutic efficacy.<\/li>\n<li>However, the SC\u2019s verdict has <strong>not yielded any positive outcomes<\/strong> both from the Patent Office and subordinate courts, rather it delayed entry of generic versions, <strong>adversely affecting the availability of affordable medicines<\/strong>.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2><strong>News Summary Regarding Indian Patent Office\u2019s Recent Decision:<\/strong><\/h2>\n<p><img decoding=\"async\" src=\"https:\/\/vajiramandravi-test.s3.us-east-1.amazonaws.com\/media\/content\/ckeditor\/2023\/03\/26\/image-20230326153345-1.png\" alt=\"\" \/><\/p>\n<p>Image Caption: India rejects evergreening of Bedaquiline<\/p>\n<ul>\n<li><strong>Bedaquiline <\/strong>is a crucial drug in the treatment of <strong>multi-drug resistant TB patients<\/strong> for whom the first-line drug treatment (using Isoniazid, Rifampicin, Pyrazinamide and Ethambutol) has stopped working.<\/li>\n<li>According to the latest estimates, over 55,000 patients who had developed multi-drug resistant TB could have benefited from access to Bedaquiline in 2019.<\/li>\n<li>Therefore, <strong>it is high time that alternate manufacturers start supplying Bedaquiline<\/strong> at lower prices, especially as TB programmes around the world plan to scale-up the all-oral, shorter, six-month drug-resistant TB regimen.<\/li>\n<li>Since 2007, J&amp;J has indulged in \u2018evergreening\u2019 by making multiple claims in its applications for patent extensions.<\/li>\n<li>When the company <strong>filed for evergreening of its patent on fumarate salt<\/strong> (a formulation of Bedaquiline), the practice was challenged by two TB survivors in 2019.<\/li>\n<li>The Indian Patent Office, in the order passed, stated that the invention claimed was obvious and <strong>does not involve any inventive step <\/strong>(under Section 3(e) of the Patents Act), and is therefore non-patentable.<\/li>\n<li><strong>Section 3(d) of the Patents Act<\/strong> states that salt forms and derivatives of known substances are not patentable.<\/li>\n<li>Hence, the applicant cannot claim a patent on these methods and compositions of salt forms that have been <strong>known in the scientific world for more than three decades.<\/strong><\/li>\n<li>However, J&amp;J will continue to hold the patent on Bedaquiline in other major markets such as South Africa, meaning that Indian generic manufacturers will be unable to export the drug there.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<hr \/>\n<h3><strong>Q1) What is multi-drug resistant TB?<\/strong><\/h3>\n<p>Multidrug-resistant TB is caused by TB bacteria that are resistant to at least isoniazid and rifampin, the two most potent TB drugs. Such patients are treated with Bedaquiline tablets.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<h3><strong>Q2) What is Section 3(d) of the Indian Patents Act?<\/strong><\/h3>\n<p>It bars the patenting of a \u201cmere use of a known method\u201d unless such known method results in a new product or employs at least one new reactant.<\/p>\n<p>&nbsp;<\/p>\n<hr \/>\n<p><strong>Source:\u00a0<\/strong><a href=\"https:\/\/www.thehindu.com\/sci-tech\/health\/india-rejects-johnson-johnsons-attempt-to-extend-monopoly-on-lifesaving-tb-drug\/article66654219.ece\" target=\"_blank\" rel=\"nofollow noopener\"><u>India rejects Johnson &amp; Johnson\u2019s attempt to extend monopoly on lifesaving TB drug<\/u><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The evergreening of patents is a practice of tweaking drugs in order to extend their patent term and thus their profitability<\/p>\n","protected":false},"author":5,"featured_media":34068,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[18],"tags":[],"class_list":{"0":"post-34067","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-upsc-mains-current-affairs","8":"no-featured-image-padding"},"acf":[],"_links":{"self":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/34067","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/comments?post=34067"}],"version-history":[{"count":0,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/34067\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/media\/34068"}],"wp:attachment":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/media?parent=34067"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/categories?post=34067"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/tags?post=34067"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}