{"id":31451,"date":"2018-10-27T14:08:38","date_gmt":"2018-10-27T08:38:38","guid":{"rendered":"https:\/\/blog.forumias.com\/?p=31451"},"modified":"2018-10-27T14:08:38","modified_gmt":"2018-10-27T08:38:38","slug":"biologics-patents-and-drug-prices","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/biologics-patents-and-drug-prices\/","title":{"rendered":"Biologics, patents and drug prices\u00a0"},"content":{"rendered":"<p><a href=\"http:\/\/www.thehindu.com\/todays-paper\/tp-opinion\/biologics-patents-and-drug-prices\/article22684123.ece\"><b>Biologics, patents and drug prices<\/b><\/a><b>\u00a0<\/b><\/p>\n<p><b>Context:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The global sales of the world\u2019s best-selling prescription drug, <\/span><b>Humira, continue to grow even after the expiry of the patent over its main ingredient, Adalimumab,<\/b><span style=\"font-weight: 400;\"> a biologic used for the treatment of arthritis.<\/span><\/li>\n<\/ul>\n<p><b>Background:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">By 2020, AbbVie Inc, makers of Humira, expects its sales to touch $21 billion \u2014 a figure that will surpass India\u2019s pharmaceutical exports for that year.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">In 2015 faced with <\/span><b>imminent expiry of the patent for Humira\u2019s main ingredient, AbbVi<\/b><span style=\"font-weight: 400;\"> reassured investors that \u00a0\u201cBroad U.S. Humira Patent Estate\u201d <\/span><b>a list of 75 secondary patents in the U.S. for new indications, new methods of treatment, new formulations,<\/b><span style=\"font-weight: 400;\"> and the like \u00a0would take care of the problem.<\/span><\/li>\n<\/ul>\n<p><b>The issue:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Patents offer their owners market <\/span><b>exclusivity for a limited period of time<\/b><span style=\"font-weight: 400;\">.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">For medicines, this exclusivity should <\/span><b>last as long as the primary patent<\/b><span style=\"font-weight: 400;\"> which relates to the active pharmaceutical ingredient (API) of the medicine which is in effect, typically 20 years.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The end of patent exclusivity is referred to as a patent cliff, because <\/span><b>drug prices fall steeply afterwards \u2014 by as much as 80% owing to generic competition.<\/b><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">But the threat of this fall in profits drives pharmaceutical companies to <\/span><b>find new ways to postpone their exclusivity by filing secondary patents<\/b><span style=\"font-weight: 400;\"> for derivatives and variants of the API.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The secondary patents <\/span><b>prop up before the expiry of a primary patent thereby stretching the exclusivity beyond 20 years, a practice that is called \u201cevergreening\u201d.<\/b><\/li>\n<\/ul>\n<p><b>Secondary patents:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The <\/span><b>Humira patent estate<\/b><span style=\"font-weight: 400;\"> now comprises secondary patents.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Over the years, <\/span><b>AbbVie has increased the price of Humira in the U.S.<\/b><span style=\"font-weight: 400;\"> by 100%, while steadily filing a large number of secondary patents.<\/span><\/li>\n<li style=\"font-weight: 400;\"><b>India, however, does not,<\/b><span style=\"font-weight: 400;\"> which means that while Humira costs $1,300 (Rs. 85,000) in the U.S., the same treatment costs only $200 (Rs. 13,500) in India,<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The <\/span><b>rejection of a secondary patent for Novartis\u2019 Glivec,<\/b><span style=\"font-weight: 400;\"> a crucial leukaemia cure, was famously upheld by the <\/span><b>Supreme Court of India in 2013,<\/b><span style=\"font-weight: 400;\"> while the same was granted in the U.S.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Consequently, the cost of a monthly dose of the medicine in the <\/span><b>U.S. was Rs. 1.6 lakh,<\/b><span style=\"font-weight: 400;\"> while the cost of the generic was <\/span><b>Rs. 11,100 in India.<\/b><\/li>\n<\/ul>\n<p><b>Good patent law:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Study sheds new light on how Indian patent law helps thwart <\/span><b>evergreening practices by pharmaceutical companies.<\/b><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Secondary patents for several blockbuster medicines have been rejected by the IPO dramatically <\/span><b>expanding access to medicines for important health problems<\/b><span style=\"font-weight: 400;\"> such as cancer, AIDS, asthma and cardiovascular diseases.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">None of this would have been possible without some <\/span><b>remarkable innovations in Indian patent law.<\/b><\/li>\n<\/ul>\n<p><b>Provisions:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><b>As per Section 2(1)(ja) of the Patents Act, <\/b><span style=\"font-weight: 400;\">the product in question must feature a technical advance over what came before that\u2019s not obvious to a skilled person.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Because secondary patents for pharmaceuticals are often sought for trivial variants, they typically <\/span><b>fail to qualify as an invention.<\/b><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Further, when a medicine is merely a variant of a known substance, <\/span><b>Section 3(d)<\/b><span style=\"font-weight: 400;\"> necessitates a demonstration of improvement in its therapeutic efficacy.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The provision also <\/span><b>bars patents for new uses and new properties of known substances.<\/b><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">This additional requirement is unique to Indian law, and along with <\/span><b>Section 2(1)(ja),<\/b><span style=\"font-weight: 400;\"> ensures that bad patents stay out of the system.<\/span><\/li>\n<li style=\"font-weight: 400;\"><b>Section 3(e)<\/b><span style=\"font-weight: 400;\"> ensures that patents for combinations of known substances are allowed only if there is synergistic effect, while <\/span><b>Section 3(i)<\/b><span style=\"font-weight: 400;\"> ensures that no exclusivity can be claimed over methods of treatment.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Together, <\/span><b>Sections 3(d), 3(e) and 3(i)<\/b><span style=\"font-weight: 400;\"> have been instrumental in rejecting close to 1,000 secondary patents for pharmaceuticals we studied.<\/span><\/li>\n<\/ul>\n<p><b>Biologics:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">These provisions also extend to <\/span><b>biologics, <\/b><span style=\"font-weight: 400;\">the new big players in the therapeutics marketplace.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Thanks to the provisions in the patent law, <\/span><b>Humira enjoys no patent protection in India,<\/b><span style=\"font-weight: 400;\"> since AbbVie restricted their Indian filings to only cover their secondary patents.<\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Biologics, patents and drug prices\u00a0 Context: The global sales of the world\u2019s best-selling prescription drug, Humira, continue to grow even after the expiry of the patent over its main ingredient, Adalimumab, a biologic used for the treatment of arthritis. Background: By 2020, AbbVie Inc, makers of Humira, expects its sales to touch $21 billion \u2014&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/biologics-patents-and-drug-prices\/\">Continue reading <span class=\"screen-reader-text\">Biologics, patents and drug prices\u00a0<\/span><\/a><\/p>\n","protected":false},"author":61,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"categories":[555],"tags":[],"class_list":["post-31451","post","type-post","status-publish","format-standard","hentry","category-test-1","entry"],"jetpack_featured_media_url":"","views":{"total":11,"cached_at":""},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/31451","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/users\/61"}],"replies":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/comments?post=31451"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/31451\/revisions"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=31451"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=31451"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=31451"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}