The Indian Patent Office rejected Gilead Sciences’ patent application for Sofosbuvir, a new hepatitis C treatment, by a decision dated 13 January 2015. The drug is marketed under the brand name Sovaldi. Gilead had priced the drug at US$84,000 per treatment course, or approximately US$1,000 per pill, in the United States, and had received regulatory approval in the US in 2013.<\/p>\n
Patent application 6087\/DELNP\/2005 for Sofosbuvir was opposed by the Indian generic company Natco Pharma; by Medicines, Access & Knowledge, a non-profit initiative; and by the Delhi Network of Positive People (DNP+). The opponents contended that the drug did not fulfil the patentability criteria under sec. 3(d) of the Patents Act, 1970.<\/p>\n
The Indian Patent Office rejected the application on grounds similar to those applied in its rejection of the patent for Novartis’ cancer drug Glivec, namely sec. 3(d). The patent office was of the opinion that, although the modifications described in the application rendered Sofosbuvir novel and inventive, the drug failed to demonstrate enhanced therapeutic efficacy over the closest prior art compound D1 (patent WO2001\/92282). The patent office held that a structurally and functionally similar molecule, even if novel, must demonstrate enhanced therapeutic efficacy over the prior art compound before it can receive patent protection under sec. 3(d).<\/p>\n
The pricing of Sofosbuvir had been widely contested. A study published by Liverpool University estimated that a three-month treatment course could be manufactured for approximately US$101. Gilead had entered into voluntary licensing agreements with seven Indian generic manufacturers to produce the drug for sale in 91 countries including India and had offered to sell the branded drug in India at a reduced price of US$900 (approximately Rs 54,000) for 84 days.<\/p>\n
The patent rejection opened the market to generic manufacturers not bound by the voluntary licensing agreement. Companies operating under the licence would, however, remain bound by the terms of their agreements even in the absence of patent protection.<\/p>\n
Gilead challenged the rejection order before the Delhi High Court. The hearing was scheduled for January 30, 2015, and the Court sought the government’s views on whether the matter should be remanded to the patent office for reconsideration or decided by the Court.<\/p>\n
Separately, on the same day as the rejection order, India became the first Asian country to grant regulatory approval to Sofosbuvir, recognising the urgent need to make the drug available to patients.<\/p>\n
This article is for general information and does not constitute legal advice. Readers should consult a qualified attorney before acting on any matter discussed here.<\/p>\n","protected":false},"excerpt":{"rendered":"
Gilead\u2019s patent for Sofosbuvir was rejected by the Indian Patent Office on grounds of insufficient therapeutic efficacy. This landmark decision enables wider access to affordable generic Hepatitis C treatments in India.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"iawp_total_views":34,"footnotes":""},"categories":[6,14],"tags":[1821,6948,6949,42,5824,61,520,6947],"class_list":["post-18124","post","type-post","status-publish","format-standard","hentry","category-intellectual-property","category-patents","tag-generic-drugs","tag-gilead-sciences","tag-hepatitis-c","tag-indian-patent-office","tag-patent-rejection","tag-pharmaceutical-patents","tag-section-3d","tag-sofosbuvir"],"_links":{"self":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/18124","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/comments?post=18124"}],"version-history":[{"count":4,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/18124\/revisions"}],"predecessor-version":[{"id":149719,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/18124\/revisions\/149719"}],"wp:attachment":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/media?parent=18124"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/categories?post=18124"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/tags?post=18124"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}