


{"id":7150,"date":"2026-07-24T17:26:35","date_gmt":"2026-07-24T11:56:35","guid":{"rendered":"https:\/\/lawsikho.com\/blog\/?p=7150"},"modified":"2026-07-25T03:03:08","modified_gmt":"2026-07-24T21:33:08","slug":"compulsory-licensing-of-patents-under-section-84","status":"publish","type":"post","link":"https:\/\/lawsikho.com\/blog\/compulsory-licensing-of-patents-under-section-84\/","title":{"rendered":"Compulsory Licensing Of Patents Under Section 84"},"content":{"rendered":"\n<p>Compulsory licensing of patents under Section 84 of the Patents Act, 1970 lets any interested person apply, three years after a patent is granted, for a licence to work the invention without the patentee&#8217;s consent. It rests on three statutory grounds: the reasonable requirements of the public are not being met, the invention is not available at a reasonably affordable price, or it is not worked in the territory of India. India has granted exactly one such licence in its history, for the anti-cancer drug Nexavar in 2012, and two later applications were rejected. That single grant, and those two refusals, still define how every Section 84 dispute is argued today.<\/p>\n<p>This article sets out the three grounds, the step-by-step Section 84 procedure, the terms that follow a grant, the landmark case trilogy, and how the section compares with Sections 92 and 92A.<\/p>\n<p>The route is used almost entirely by generic manufacturers, and almost entirely in pharmaceuticals. The 2012 Nexavar order collapsed the price of a month&#8217;s cancer therapy from roughly Rs 2,84,428 to roughly Rs 8,880, and that figure still anchors the debate over what an &#8220;affordable&#8221; price means in Indian patent law.<\/p>\n<p>The threshold, though, is harder to clear than the headline suggests. Of the three landmark applications filed under this provision, only one succeeded, and the two failures turned on procedure and evidence rather than on public health. That grant-versus-rejection contrast is the lens this piece uses throughout.<\/p>\n<p>Compulsory licensing of patents under Section 84 of the Patents Act, 1970 lets any interested person apply, three years after a patent is granted, for a licence to work the invention without the patentee&#8217;s consent. It is granted on three grounds: the public&#8217;s reasonable requirements are unmet, the invention is not available at a reasonably affordable price, or it is not worked in India.<\/p>\n\n<hr>\n\n<nav class=\"ls-toc\" aria-label=\"Table of contents\">\n<h2>Table of Contents<\/h2>\n<ol class=\"ls-toc-list\">\n<li><a href=\"#h2-1\">Compulsory licensing of patents under Section 84 and why the law allows it<\/a>\n<ul>\n<li><a href=\"#h3-1-1\">How the Nexavar order made Section 84 real<\/a><\/li>\n<li><a href=\"#h3-1-2\">From the 1970 Act to product patents in 2005<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#h2-2\">What must an applicant prove under the three grounds of Section 84(1)?<\/a>\n<ul>\n<li><a href=\"#h3-2-1\">When are the public&#8217;s reasonable requirements treated as unmet?<\/a><\/li>\n<li><a href=\"#h3-2-2\">How is &#8220;reasonably affordable price&#8221; measured?<\/a><\/li>\n<li><a href=\"#h3-2-3\">What does &#8220;not worked in the territory of India&#8221; mean?<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#h2-3\">Who can apply for a compulsory license under Section 84, and after how long?<\/a>\n<ul>\n<li><a href=\"#h3-3-1\">Does a compulsory license apply to every patent, or only pharmaceuticals?<\/a><\/li>\n<li><a href=\"#h3-3-2\">Must you try for a voluntary licence first, and for how long?<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#h2-4\">How do you apply for a compulsory license under Section 84, step by step?<\/a>\n<ul>\n<li><a href=\"#h3-4-1\">How is a prima facie case under Section 87 established, and how is it lost?<\/a><\/li>\n<li><a href=\"#h3-4-2\">The voluntary-licence-effort trap<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#h2-5\">What happens to the patent and the parties after a compulsory license is granted?<\/a>\n<ul>\n<li><a href=\"#h3-5-1\">How is the royalty rate set, and does the patentee still earn?<\/a><\/li>\n<li><a href=\"#h3-5-2\">Can the licence be exclusive, assigned, or exported, and can the patent be revoked for non-working?<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#h2-6\">How does Section 84 differ from Section 92 and Section 92A?<\/a>\n<ul>\n<li><a href=\"#h3-6-1\">When does Section 92 or Section 92A apply instead of Section 84?<\/a><\/li>\n<li><a href=\"#h3-6-2\">How does compulsory licensing differ from government use or acquisition under Section 100?<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#h2-7\">Is compulsory licensing allowed under TRIPS, and why has India granted none since 2012?<\/a>\n<ul>\n<li><a href=\"#h3-7-1\">Did COVID-19 change anything?<\/a><\/li>\n<li><a href=\"#h3-7-2\">Why the machinery sits idle<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#h2-8\">Frequently asked questions on compulsory licensing under Section 84<\/a>\n<\/li>\n<li><a href=\"#h2-9\">References<\/a>\n<\/li>\n<\/ol>\n<\/nav>\n\n<hr>\n\n<a id=\"h2-1\"><\/a><\/p>\n<h2>Compulsory licensing of patents under Section 84 and why the law allows it<\/h2>\n<p>Compulsory licensing under <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15954&#038;sectionno=84&#038;orderno=86\" target=\"_blank\" rel=\"noopener\">Section 84 of the Patents Act, 1970<\/a> is a statutory override of a patent&#8217;s exclusivity, allowing a third party to work the invention in the public interest without the patentee&#8217;s agreement. A patent gives its holder a 20-year monopoly to make, use, and sell the invention. Compulsory licensing of patents under Section 84 is the point at which the law decides that monopoly has been misused, and lets someone else step in.<\/p>\n<p>Why would a legal system that spends so much effort granting monopolies then hand one away? Because the patent bargain was never unconditional. The inventor gets exclusivity in exchange for disclosing the invention and making it genuinely available to the public. When the patentee sits on the monopoly, prices the product out of reach, or refuses to supply the Indian market, the public interest ground of the bargain fails, and Section 84 supplies the remedy.<\/p>\n<p>The provision is best understood as an anti-abuse tool, not a reward for the applicant. A compulsory licence does not cancel or revoke the patent. The patent stays on the register, the patentee keeps the title, and the licensee simply gets a non-exclusive right to work the invention on terms the Controller sets. This is the single most common misconception about the section, and it matters: an applicant is asking to share the market, not to destroy the patent.<\/p>\n<a id=\"h3-1-1\"><\/a>\n<h3>How the Nexavar order made Section 84 real<\/h3>\n<p>The provision existed on paper from 1972, but it stayed theoretical until the March 2012 compulsory-licence order over Nexavar, later challenged and upheld in <a href=\"https:\/\/indiankanoon.org\/doc\/28519340\/\" target=\"_blank\" rel=\"noopener\">Bayer Corporation v. Union of India, (2014) 60 PTC 277 (Bom)<\/a>. A domestic generic manufacturer applied for a compulsory licence to make sorafenib tosylate, a kidney and liver cancer drug the patentee sold as Nexavar. The Controller of Patents granted the licence, and the numbers are what made it a landmark.<\/p>\n<p>The patentee had priced a month&#8217;s therapy at roughly Rs 2,84,428. The compulsory licensee was permitted to sell the same month&#8217;s supply at roughly Rs 8,880, close to 3% of the originator&#8217;s price. In exchange, the licensee had to pay the patentee a 6% royalty on net sales and supply the drug free to at least 600 needy patients each year. So the patentee did not walk away with nothing: it lost exclusivity, but kept a running royalty.<\/p>\n<p>The patentee opposed the grant at every level. It argued that supplying the drug through imports counted as working the patent, and that its patient-assistance programme met public demand. The Controller, the Intellectual Property Appellate Board on appeal, and later the Bombay High Court on a writ challenge all disagreed and upheld the licence.<\/p>\n<p>What experienced practitioners take from this sequence is that the Nexavar order was not an outlier decision reversed on appeal. It was tested three times and survived, which is exactly why it still frames every Section 84 argument.<\/p>\n<p>A question practitioners still hear from clients is whether Bayer &#8220;lost&#8221; the patent in this case. It did not. The patent remained valid and in force for its full term, and the patentee continued to receive royalties on the generic sales. The right that was overridden was exclusivity, not ownership.<\/p>\n<a id=\"h3-1-2\"><\/a>\n<h3>From the 1970 Act to product patents in 2005<\/h3>\n<p>The compulsory licensing machinery is older than India&#8217;s product-patent regime, and that history explains why it exists. The Patents Act, 1970 was built around process patents, deliberately excluding product patents on medicines and food so that Indian firms could reverse-engineer and manufacture affordable generics. Strong working and compulsory-licensing provisions were part of the same design: patents were tolerated only so far as they served domestic industry and public access.<\/p>\n<p>That regime changed in 2005. To comply with the TRIPS Agreement, India amended the Act to introduce product patents on pharmaceuticals for the first time. This handed originator companies genuine 20-year monopolies on new molecules, and it removed the reverse-engineering escape route that the generic industry had relied on for three decades.<\/p>\n<p>Compulsory licensing was retained, and even expanded, precisely as the safety valve for this new pressure. When product patents arrived, the risk that a life-saving drug could be monopolised and priced out of reach became real, and Section 84 (together with the export route added as Section 92A) was the counterweight Parliament kept in place. Understanding this lineage is what separates a surface reading of the section from a working one: the provision is not an accident of drafting, it is the deliberate public-health hinge of a compromise India struck to join the global patent system.<\/p>\n<p>Voluntary and compulsory licences sit at opposite ends of the same spectrum, and the difference is worth fixing before going further.<\/p>\n<table>\n<thead>\n<tr>\n<th>Feature<\/th>\n<th>Voluntary licence<\/th>\n<th>Compulsory licence (Section 84)<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Who initiates<\/td>\n<td>The patentee, by choice<\/td>\n<td>Any interested person, by application to the Controller<\/td>\n<\/tr>\n<tr>\n<td>Consent of patentee<\/td>\n<td>Required<\/td>\n<td>Not required<\/td>\n<\/tr>\n<tr>\n<td>Terms and royalty<\/td>\n<td>Negotiated freely between the parties<\/td>\n<td>Fixed by the Controller under Section 90<\/td>\n<\/tr>\n<tr>\n<td>Exclusivity<\/td>\n<td>Can be exclusive or non-exclusive<\/td>\n<td>Always non-exclusive and non-assignable<\/td>\n<\/tr>\n<tr>\n<td>Trigger<\/td>\n<td>Commercial agreement<\/td>\n<td>Statutory ground plus three-year wait<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n<p>\n\n<figure class=\"ls-infographic-wrap\" style=\"margin:2rem 0;\">\n<div class=\"ls-ig-nexavar\" style=\"margin:2rem 0;max-width:800px;\">\n<style>\n.ls-ig-nexavar *, .ls-ig-nexavar *::before, .ls-ig-nexavar *::after { margin: 0; padding: 0; box-sizing: border-box; }\n.ls-ig-nexavar { font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, sans-serif; color: #212121; background: #ffffff; border-radius: 8px; overflow: hidden; box-shadow: 0 2px 12px rgba(0,0,0,0.10); }\n.ls-ig-nexavar .ig-title-bar { background: #1a237e; padding: 20px 24px; }\n.ls-ig-nexavar .ig-title-bar h2 { color: #ffffff; font-size: 20px; font-weight: 700; line-height: 1.3; }\n.ls-ig-nexavar .ig-title-bar p { color: #c5cae9; font-size: 13px; margin-top: 5px; }\n.ls-ig-nexavar .ig-body { padding: 24px; }\n.ls-ig-nexavar .ba-grid { display: grid; grid-template-columns: 1fr 1fr; gap: 16px; margin-bottom: 8px; }\n.ls-ig-nexavar .ba-card { border: 1px solid #e0e0e0; border-radius: 8px; overflow: hidden; }\n.ls-ig-nexavar .ba-head { padding: 10px 14px; font-size: 13px; font-weight: 700; color: #ffffff; text-transform: uppercase; letter-spacing: 0.5px; }\n.ls-ig-nexavar .ba-before .ba-head { background: #b0182a; }\n.ls-ig-nexavar .ba-after .ba-head { background: #2e7d32; }\n.ls-ig-nexavar .ba-inner { padding: 16px 14px; }\n.ls-ig-nexavar .ba-amount { font-size: 30px; font-weight: 800; line-height: 1.05; }\n.ls-ig-nexavar .ba-before .ba-amount { color: #b0182a; }\n.ls-ig-nexavar .ba-after .ba-amount { color: #2e7d32; }\n.ls-ig-nexavar .ba-label { font-size: 12px; color: #757575; margin-top: 6px; line-height: 1.4; }\n.ls-ig-nexavar .ba-track { height: 12px; border-radius: 6px; background: #f0f0f0; margin-top: 14px; overflow: hidden; }\n.ls-ig-nexavar .ba-fill { height: 100%; border-radius: 6px; }\n.ls-ig-nexavar .ba-before .ba-fill { width: 100%; background: #b0182a; }\n.ls-ig-nexavar .ba-after .ba-fill { width: 3%; background: #2e7d32; }\n.ls-ig-nexavar .drop-banner { text-align: center; background: #fff3e0; border: 1px solid #ffcc80; border-radius: 8px; padding: 14px; margin: 6px 0 18px; }\n.ls-ig-nexavar .drop-banner .big { font-size: 26px; font-weight: 800; color: #e65100; }\n.ls-ig-nexavar .drop-banner .cap { font-size: 13px; color: #5d4037; margin-top: 2px; }\n.ls-ig-nexavar .stat-grid { display: grid; grid-template-columns: 1fr 1fr; gap: 14px; }\n.ls-ig-nexavar .stat-card { background: #f5f5f5; border-left: 4px solid #ff6f00; border-radius: 6px; padding: 14px 16px; }\n.ls-ig-nexavar .stat-num { font-size: 24px; font-weight: 800; color: #1a237e; line-height: 1; }\n.ls-ig-nexavar .stat-desc { font-size: 13px; color: #424242; margin-top: 6px; line-height: 1.45; }\n.ls-ig-nexavar .ig-footer { margin-top: 20px; padding-top: 14px; border-top: 1px solid #e0e0e0; display: flex; justify-content: space-between; align-items: center; gap: 12px; }\n.ls-ig-nexavar .ig-source { font-size: 11px; color: #9e9e9e; font-style: italic; max-width: 580px; line-height: 1.4; }\n.ls-ig-nexavar .ig-brand { font-size: 13px; font-weight: 700; color: #1a237e; letter-spacing: 0.5px; white-space: nowrap; }\n@media (max-width: 600px) {\n  .ls-ig-nexavar .ig-title-bar h2 { font-size: 17px; }\n  .ls-ig-nexavar .ig-body { padding: 16px; }\n  .ls-ig-nexavar .ba-grid { grid-template-columns: 1fr; }\n  .ls-ig-nexavar .stat-grid { grid-template-columns: 1fr; }\n  .ls-ig-nexavar .ba-amount { font-size: 26px; }\n  .ls-ig-nexavar .ig-footer { flex-direction: column; align-items: flex-start; }\n}\n<\/style>\n  <div class=\"ig-title-bar\">\n    <h2>The Nexavar Price Collapse<\/h2>\n    <p>India&#8217;s first compulsory licence under Section 84 (Sorafenib, 2012) &mdash; monthly cost of therapy<\/p>\n  <\/div>\n  <div class=\"ig-body\">\n    <div class=\"ba-grid\">\n      <div class=\"ba-card ba-before\">\n        <div class=\"ba-head\">Before &mdash; originator price<\/div>\n        <div class=\"ba-inner\">\n          <div class=\"ba-amount\">Rs 2,84,428<\/div>\n          <div class=\"ba-label\">per month of therapy, patentee&#8217;s price<\/div>\n          <div class=\"ba-track\"><div class=\"ba-fill\"><\/div><\/div>\n        <\/div>\n      <\/div>\n      <div class=\"ba-card ba-after\">\n        <div class=\"ba-head\">After &mdash; compulsory licensee<\/div>\n        <div class=\"ba-inner\">\n          <div class=\"ba-amount\">Rs 8,880<\/div>\n          <div class=\"ba-label\">per month of therapy, licensee&#8217;s price<\/div>\n          <div class=\"ba-track\"><div class=\"ba-fill\"><\/div><\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n    <div class=\"drop-banner\">\n      <div class=\"big\">&#8776; 97% lower<\/div>\n      <div class=\"cap\">The compulsory-licence price was roughly 3% of the originator&#8217;s price<\/div>\n    <\/div>\n    <div class=\"stat-grid\">\n      <div class=\"stat-card\">\n        <div class=\"stat-num\">6%<\/div>\n        <div class=\"stat-desc\">Royalty on net sales payable to the patentee, as set by the Controller&#8217;s order<\/div>\n      <\/div>\n      <div class=\"stat-card\">\n        <div class=\"stat-num\">600+<\/div>\n        <div class=\"stat-desc\">Needy patients per year to receive the drug free, as a condition of the licence<\/div>\n      <\/div>\n    <\/div>\n  <\/div>\n  <div class=\"ig-footer\">\n    <div class=\"ig-source\">Source: Controller of Patents order, March 2012; upheld by IPAB (2013) and the Bombay High Court (15 July 2014).<\/div>\n    <div class=\"ig-brand\">LawSikho<\/div>\n  <\/div>\n<\/div>\n<\/figure>\n\n<a id=\"h2-2\"><\/a><\/p>\n<h2>What must an applicant prove under the three grounds of Section 84(1)?<\/h2>\n<p>An applicant must establish at least one of the three grounds set out in <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15954&#038;sectionno=84&#038;orderno=86\" target=\"_blank\" rel=\"noopener\">Section 84 of the Patents Act, 1970<\/a>. The grounds are listed in Section 84(1), and any one of them, if proved, is enough to support a grant. In practice, strong applications plead all three and give the Controller independent reasons to grant, because a case that rests on a single contested ground is fragile.<\/p>\n<p>The three grounds are these: that the reasonable requirements of the public with respect to the patented invention have not been satisfied; that the patented invention is not available to the public at a reasonably affordable price; and that the patented invention is not worked in the territory of India. Each ground has its own evidentiary demands, and each has been fought over in the case law.<\/p>\n<p>The most instructive lesson on this provision comes not from the grant but from a refusal. In Lee Pharma Ltd. v. AstraZeneca AB (Controller of Patents, C.L.A. No. 1 of 2015, order dated 19 January 2016), a generic manufacturer applied for a compulsory licence over the anti-diabetic drug saxagliptin, and the Controller rejected it in January 2016.<\/p>\n<p>The applicant asserted all three grounds but failed to quantify them. It did not establish the actual public demand for the drug, could not show how much of that demand went unmet, and offered no reliable comparison to prove the price was unaffordable. The refusal is a checklist of what an applicant must actually prove, written in the negative.<\/p>\n<p>What does this mean for anyone filing under the section? Asserting a ground is not proving it. The burden sits squarely on the applicant, and the Controller expects numbers: demand figures, supply figures, price comparisons, and a working record. Vague public-interest rhetoric loses.<\/p>\n<a id=\"h3-2-1\"><\/a>\n<h3>When are the public&#8217;s reasonable requirements treated as unmet?<\/h3>\n<p>The reasonable requirements of the public are treated as unmet when the patentee&#8217;s supply fails to meet demand on reasonable terms, and Section 84(7) spells out the circumstances that count. These include a refusal to grant licences on reasonable terms that prejudices existing trade or industry, a failure to supply the market adequately, and conduct that prevents the commercial working of the invention in India to its fullest reasonable extent.<\/p>\n<p>The core test is comparative: what is the real demand for the invention, and how much of it is the patentee actually satisfying? In the Nexavar dispute, the Controller found that the patentee supplied only a tiny fraction of the patients who needed the drug, which meant the public&#8217;s reasonable requirements were plainly unmet. The gap between demand and supply was too wide to explain away.<\/p>\n<p>Here is where applicants stumble. Proving this ground requires hard demand data, ideally epidemiological figures on patient numbers, set against the patentee&#8217;s documented sales. An applicant who leads with the argument that a drug is expensive, without first establishing how many patients need it and are not getting it, has skipped the foundational step.<\/p>\n<a id=\"h3-2-2\"><\/a>\n<h3>How is &#8220;reasonably affordable price&#8221; measured?<\/h3>\n<p>Reasonably affordable price is measured chiefly from the standpoint of the public, not the patentee&#8217;s costs, and the comparison is usually between the originator&#8217;s price and a realistic generic price. This is the ground that produces the vivid numbers, because price is quantifiable in a way that &#8220;public interest&#8221; is not.<\/p>\n<p>The Nexavar figures are the worked example every practitioner reaches for. A month of the originator&#8217;s therapy cost roughly Rs 2,84,428, an amount beyond almost every Indian patient without insurance. The generic version, once licensed, cost roughly Rs 8,880 for the same month. When the Controller set the originator&#8217;s price against what a domestic manufacturer could charge and still profit, the conclusion that the drug was not reasonably affordable followed almost automatically.<\/p>\n<p>The practical reality is that a price-unaffordability case is only as good as its comparator. An applicant needs to show the price a properly run generic operation would charge, and demonstrate that the gap between that price and the originator&#8217;s is what puts the drug out of the public&#8217;s reach. A bare assertion that a patented product is &#8220;too costly&#8221; carries no weight without that benchmark.<\/p>\n<a id=\"h3-2-3\"><\/a>\n<h3>What does &#8220;not worked in the territory of India&#8221; mean?<\/h3>\n<p>&#8220;Not worked in the territory of India&#8221; means the patentee is not making the invention available to the Indian market on a commercial scale within the country, and the long-running debate is whether importing the product counts as working it. The patentee in the Nexavar case argued that supplying the market through imports satisfied the working requirement. The Controller took a narrower view, treating manufacture in India as central to what &#8220;worked in the territory&#8221; was designed to encourage.<\/p>\n<p>This ground connects directly to the statement of working that every patentee must file, known as Form 27. The statement of working is where a patentee records, year by year, whether and to what extent the patent is being worked in India, including quantities and value. That filing is the evidentiary backbone of this third ground: an applicant builds the &#8220;not worked&#8221; case largely out of the patentee&#8217;s own working statements, or out of the gaps in them.<\/p>\n<p>Fair warning: the working-statement obligation is not optional, and it is not pharma-only. Every patentee across every field of technology is required to file the statement, and a failure to file, or a false statement, carries penal consequences under the Act. Many patentees treat Form 27 as a formality, and that casual approach is exactly what hands a compulsory-licence applicant the material to argue the invention is not being worked.<\/p>\n<p>\n\n<figure class=\"ls-infographic-wrap\" style=\"margin:2rem 0;\">\n<div class=\"ls-ig-trilogy\" style=\"margin:2rem 0;max-width:800px;\">\n<style>\n.ls-ig-trilogy *, .ls-ig-trilogy *::before, .ls-ig-trilogy *::after { margin: 0; padding: 0; box-sizing: border-box; }\n.ls-ig-trilogy { font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, sans-serif; color: #212121; border: 1px solid #e0e0e0; border-radius: 8px; overflow: hidden; }\n.ls-ig-trilogy .title-bar { background: #1a237e; color: #ffffff; padding: 20px 24px; text-align: center; }\n.ls-ig-trilogy .title-bar .h { font-size: 20px; font-weight: 700; line-height: 1.3; }\n.ls-ig-trilogy .title-bar .sub { font-size: 13px; font-weight: 400; margin-top: 6px; opacity: 0.9; }\n.ls-ig-trilogy .content { padding: 20px 24px; }\n.ls-ig-trilogy table { width: 100%; border-collapse: collapse; font-size: 13.5px; }\n.ls-ig-trilogy thead th { background: #ff6f00; color: #ffffff; text-align: left; padding: 12px 12px; font-size: 13.5px; font-weight: 700; vertical-align: top; }\n.ls-ig-trilogy thead th:first-child { background: #1a237e; }\n.ls-ig-trilogy tbody td { padding: 12px 12px; border-bottom: 1px solid #e0e0e0; line-height: 1.5; vertical-align: top; }\n.ls-ig-trilogy tbody tr:nth-child(even) { background: #f5f5f5; }\n.ls-ig-trilogy tbody td:first-child { font-weight: 700; color: #1a237e; }\n.ls-ig-trilogy .badge { display: inline-block; font-size: 12px; font-weight: 700; color: #ffffff; border-radius: 4px; padding: 3px 10px; white-space: nowrap; letter-spacing: 0.4px; }\n.ls-ig-trilogy .badge.grant { background: #2e7d32; }\n.ls-ig-trilogy .badge.reject { background: #b0182a; }\n.ls-ig-trilogy .source { font-size: 11px; color: #9e9e9e; font-style: italic; padding: 0 24px 4px; }\n.ls-ig-trilogy .branding { text-align: right; padding: 12px 24px; font-size: 12px; color: #9e9e9e; border-top: 1px solid #e0e0e0; }\n@media (max-width: 640px) {\n  .ls-ig-trilogy .title-bar .h { font-size: 17px; }\n  .ls-ig-trilogy .content { padding: 12px; }\n  .ls-ig-trilogy table, .ls-ig-trilogy thead, .ls-ig-trilogy tbody, .ls-ig-trilogy th, .ls-ig-trilogy td, .ls-ig-trilogy tr { display: block; }\n  .ls-ig-trilogy thead { display: none; }\n  .ls-ig-trilogy tbody tr { border: 1px solid #e0e0e0; border-radius: 6px; margin-bottom: 12px; padding: 6px 0; background: #ffffff; }\n  .ls-ig-trilogy tbody tr:nth-child(even) { background: #ffffff; }\n  .ls-ig-trilogy tbody td { border-bottom: 1px dashed #e0e0e0; }\n  .ls-ig-trilogy tbody td:last-child { border-bottom: none; }\n  .ls-ig-trilogy tbody td:first-child { background: #f5f5f5; }\n  .ls-ig-trilogy tbody td::before { content: attr(data-label); display: block; font-size: 11px; text-transform: uppercase; letter-spacing: 0.5px; color: #9e9e9e; margin-bottom: 3px; font-weight: 700; }\n  .ls-ig-trilogy tbody td:first-child::before { content: \"\"; display: none; }\n}\n<\/style>\n  <div class=\"title-bar\">\n    <div class=\"h\">The Section 84 Case Trilogy: Why One Was Granted, Two Were Refused<\/div>\n    <div class=\"sub\">India&#8217;s only compulsory licence, and the two applications that failed<\/div>\n  <\/div>\n  <div class=\"content\">\n    <table>\n      <thead>\n        <tr>\n          <th>Application<\/th>\n          <th>Drug<\/th>\n          <th>Outcome<\/th>\n          <th>Reason<\/th>\n        <\/tr>\n      <\/thead>\n      <tbody>\n        <tr>\n          <td data-label=\"Application\">Natco v. Bayer (2012)<\/td>\n          <td data-label=\"Drug\">Sorafenib (Nexavar)<\/td>\n          <td data-label=\"Outcome\"><span class=\"badge grant\">GRANTED<\/span><\/td>\n          <td data-label=\"Reason\">All three grounds met &mdash; price unaffordable and the patent not worked in India<\/td>\n        <\/tr>\n        <tr>\n          <td data-label=\"Application\">BDR v. BMS (2013)<\/td>\n          <td data-label=\"Drug\">Dasatinib (Sprycel)<\/td>\n          <td data-label=\"Outcome\"><span class=\"badge reject\">REJECTED<\/span><\/td>\n          <td data-label=\"Reason\">No genuine voluntary-licence effort; no prima facie case made out under Section 87<\/td>\n        <\/tr>\n        <tr>\n          <td data-label=\"Application\">Lee Pharma v. AstraZeneca (2016)<\/td>\n          <td data-label=\"Drug\">Saxagliptin<\/td>\n          <td data-label=\"Outcome\"><span class=\"badge reject\">REJECTED<\/span><\/td>\n          <td data-label=\"Reason\">Failed to evidence any of the three grounds under Section 84(1)<\/td>\n        <\/tr>\n      <\/tbody>\n    <\/table>\n  <\/div>\n  <div class=\"source\">Source: Natco v. Bayer (Controller, 2012); BDR v. BMS (C.L.A. No. 1 of 2013); Lee Pharma v. AstraZeneca (C.L.A. No. 1 of 2015, decided Jan 2016).<\/div>\n  <div class=\"branding\">LawSikho<\/div>\n<\/div>\n<\/figure>\n\n<a id=\"h2-3\"><\/a><\/p>\n<h2>Who can apply for a compulsory license under Section 84, and after how long?<\/h2>\n<p>Any person interested may apply for a compulsory licence under <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15954&#038;sectionno=84&#038;orderno=86\" target=\"_blank\" rel=\"noopener\">Section 84 of the Patents Act, 1970<\/a>, but only after three years have passed from the date the patent was granted. The applicant does not need to be an existing licensee, and does not need the patentee&#8217;s permission to file. The three-year clock is a hard statutory bar, not a guideline, and it runs from the date of grant rather than the date of the patent application.<\/p>\n<p>An &#8220;interested person&#8221; is read broadly. It includes anyone engaged in, or promoting, research in the same field, and in practice it is almost always a manufacturer that wants to produce the patented product. The manufacturer does not have to already be in the market; a genuine, demonstrated intention and capacity to work the invention is enough to give it standing to apply.<\/p>\n<p>Why a three-year wait at all? The period gives the patentee a fair runway to establish the invention in the Indian market, build supply, and set a sustainable price before the state will consider overriding the monopoly. It reflects a policy judgment that a patentee deserves a reasonable chance to work the patent voluntarily before compulsion becomes available.<\/p>\n<a id=\"h3-3-1\"><\/a>\n<h3>Does a compulsory license apply to every patent, or only pharmaceuticals?<\/h3>\n<p>A compulsory licence can be sought over any patent in any field of technology, not only pharmaceuticals. Nothing in Section 84 limits it to medicines. In principle, a patent on a manufacturing process, an agrochemical, a piece of telecom hardware, or a green-energy technology is equally open to a compulsory-licence application if the grounds are met.<\/p>\n<p>In practice, though, every Indian application to date has been in pharmaceuticals, and the reason is structural. Medicines combine three features that make the grounds easy to argue: life-or-death demand, extreme price sensitivity, and a well-organised generic industry ready to manufacture. Few other sectors line up all three, which is why the machinery, though general, has only ever been fired in pharma.<\/p>\n<p>The gap between the theory and the practice is itself worth noting. The provision&#8217;s breadth means the working-statement and pricing debates it generates ripple across every patent-holding industry, even though the courtroom action stays in medicines. To see how the &#8220;three years after grant&#8221; clock begins in the first place, it helps to understand <a href=\"https:\/\/lawsikho.com\/blog\/guide-to-filing-a-pct-application\/\" target=\"_blank\" rel=\"noopener\">how a patent is filed and granted internationally<\/a>, because the grant date, not the filing date, starts the countdown.<\/p>\n<a id=\"h3-3-2\"><\/a>\n<h3>Must you try for a voluntary licence first, and for how long?<\/h3>\n<p>Yes, an applicant must first make a genuine effort to obtain a voluntary licence from the patentee on reasonable terms, and must allow a reasonable period, treated as six months, for that effort to succeed before applying under Section 84. This pre-condition is easy to overlook and fatal to ignore. The applicant has to approach the patentee, propose reasonable terms, and give the negotiation a real chance before the compulsory route opens.<\/p>\n<p>The six-month period is not a waiting game to run down the clock. It has to be a bona fide attempt, meaning a real proposal on genuine commercial terms, not a token letter sent to create a paper record. The distinction between a genuine effort and a going-through-the-motions effort is precisely where one landmark application collapsed, which the next section examines in detail.<\/p>\n<p>A common question is whether the patentee&#8217;s silence or refusal counts as satisfying this step. It does: if the patentee refuses reasonable terms or fails to respond within the reasonable period, the applicant has met the pre-condition and can proceed. What the applicant cannot do is skip the approach altogether and argue that negotiation would have been futile.<\/p>\n<a id=\"h2-4\"><\/a>\n<h2>How do you apply for a compulsory license under Section 84, step by step?<\/h2>\n<p>The applicant files Form 17 with the Controller after the three-year wait and a prior six-month voluntary-licence effort, and the Controller then tests the application for a prima facie case before it can proceed. The procedure under <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15954&#038;sectionno=84&#038;orderno=86\" target=\"_blank\" rel=\"noopener\">Section 84 of the Patents Act, 1970<\/a> is sequential, and each stage is a gate the applicant has to pass. Miss a step, and the application fails on procedure before the merits are ever reached.<\/p>\n<p>The full route runs as follows:<\/p>\n<ol>\n<li>Wait three years from the date the patent was granted.<\/li>\n<li>Make a bona fide request to the patentee for a voluntary licence on reasonable terms, and allow a reasonable period (six months) for a response.<\/li>\n<li>File Form 17 with the Controller of Patents, setting out the grounds relied on and the terms the applicant proposes.<\/li>\n<li>The Controller examines the application for a prima facie case under <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15957&#038;sectionno=87&#038;orderno=89\" target=\"_blank\" rel=\"noopener\">Section 87 of the Patents Act, 1970<\/a>.<\/li>\n<li>If a prima facie case is made out, the application is published, and the patentee may file a notice of opposition and be heard.<\/li>\n<li>The Controller settles the terms and the royalty under <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15960&#038;sectionno=90&#038;orderno=92\" target=\"_blank\" rel=\"noopener\">Section 90 of the Patents Act, 1970<\/a>, including price and supply conditions.<\/li>\n<li>The compulsory licence is granted or refused.<\/li>\n<\/ol>\n<p>The Controller of Patents is the decision-maker at every stage, not a court. The Controller decides whether a prima facie case exists, conducts the hearing, weighs the evidence, and fixes the terms of any licence granted. Only after the Controller&#8217;s order does the dispute move to the appellate forum and, on a writ, to the High Court, as the Nexavar sequence showed.<\/p>\n<a id=\"h3-4-1\"><\/a>\n<h3>How is a prima facie case under Section 87 established, and how is it lost?<\/h3>\n<p>A prima facie case under Section 87 is a threshold showing that, on the applicant&#8217;s own material, at least one of the three grounds is plausibly made out, and it is the filter that decides whether an application even proceeds to a hearing. If the Controller is not satisfied that a prima facie case exists, the application is refused at the gate. No opposition, no hearing on the merits, no examination of pricing or demand.<\/p>\n<p>This is exactly how one application died. In BDR Pharmaceuticals International Pvt. Ltd. v. Bristol-Myers Squibb Co. (Controller of Patents, C.L.A. No. 1 of 2013, order dated 29 October 2013), a generic manufacturer applied for a compulsory licence over the leukaemia drug dasatinib, sold as Sprycel, and the Controller rejected it in October 2013 for want of a prima facie case.<\/p>\n<p>The fatal defect was not the public-health merits, which were never reached. It was that the applicant had not made a genuine effort to secure a voluntary licence first. The applicant had sent the patentee a request but had not engaged with the patentee&#8217;s queries or pursued the negotiation in good faith, so the statutory pre-condition was unmet, and without it there could be no prima facie case.<\/p>\n<p>The lesson experienced counsel draw is blunt. The prima facie stage is not won on the strength of the public-interest story; it is won or lost on whether the applicant did the procedural groundwork. An application with an overwhelming affordability case can still be thrown out at the threshold if the voluntary-licence step was skipped or faked.<\/p>\n<p>The grant-versus-rejection contrast across the three landmark applications makes the pattern obvious.<\/p>\n<table>\n<thead>\n<tr>\n<th>Application<\/th>\n<th>Drug<\/th>\n<th>Outcome<\/th>\n<th>Decisive reason<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Natco v. Bayer (2012)<\/td>\n<td>Sorafenib (Nexavar)<\/td>\n<td>Granted<\/td>\n<td>All three grounds evidenced; drug unaffordable and not worked in India<\/td>\n<\/tr>\n<tr>\n<td>BDR v. BMS (2013)<\/td>\n<td>Dasatinib (Sprycel)<\/td>\n<td>Rejected<\/td>\n<td>No genuine voluntary-licence effort; no prima facie case under Section 87<\/td>\n<\/tr>\n<tr>\n<td>Lee Pharma v. AstraZeneca (2016)<\/td>\n<td>Saxagliptin<\/td>\n<td>Rejected<\/td>\n<td>Failed to evidence any of the three Section 84(1) grounds<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<a id=\"h3-4-2\"><\/a>\n<h3>The voluntary-licence-effort trap<\/h3>\n<p>Because one application failed purely on the negotiation record, the practical gatekeeper to Section 84 is now documentary proof of a clean voluntary-licence effort, not the public-health merits. This is a second-order consequence most readers miss. The statute lists three substantive grounds about demand, price, and working, yet the decisive battleground has quietly shifted to a procedural pre-condition that the grounds do not even mention.<\/p>\n<p>The downstream effect is a niche but high-value litigation skill. An applicant who can build and document a bona fide six-month negotiation, with reasonable terms genuinely proposed and the patentee&#8217;s responses (or silence) carefully recorded, clears the gate that sank one of the three landmark filings. Conversely, a patentee&#8217;s counsel who can pick apart the sincerity of that negotiation record has a way to defeat an application without ever contesting the affordability figures.<\/p>\n<p>Where does this leave a prospective applicant? The uncomfortable truth is that the strongest public-health case in the world is worthless if the negotiation file is thin. Building that file, correctly and contemporaneously, is now the first real task in any Section 84 matter, and it is where the cases are increasingly decided.<\/p>\n\n\n<p>\n\n<figure class=\"ls-infographic-wrap\" style=\"margin:2rem 0;\">\n<div class=\"ls-ig-procedure\" style=\"margin:2rem 0;max-width:800px;\">\n<style>\n.ls-ig-procedure *, .ls-ig-procedure *::before, .ls-ig-procedure *::after { margin: 0; padding: 0; box-sizing: border-box; }\n.ls-ig-procedure {\n  font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, sans-serif;\n  color: #212121; background: #ffffff; border-radius: 8px; overflow: hidden;\n  box-shadow: 0 2px 12px rgba(0,0,0,0.10);\n}\n.ls-ig-procedure .ig-title-bar { background: #1a237e; padding: 20px 24px; }\n.ls-ig-procedure .ig-title-bar h2 { color: #ffffff; font-size: 20px; font-weight: 700; line-height: 1.3; }\n.ls-ig-procedure .ig-title-bar p { color: #c5cae9; font-size: 13px; margin-top: 5px; }\n.ls-ig-procedure .ig-body { padding: 22px 24px; }\n.ls-ig-procedure .step { display: flex; align-items: flex-start; gap: 14px; padding: 14px 16px; background: #f5f5f5; border-left: 4px solid #ff6f00; border-radius: 6px; }\n.ls-ig-procedure .step-num { flex-shrink: 0; width: 38px; height: 38px; border-radius: 50%; background: #ff6f00; color: #ffffff; font-weight: 700; font-size: 17px; display: flex; align-items: center; justify-content: center; }\n.ls-ig-procedure .step-text { flex: 1; }\n.ls-ig-procedure .step-title { font-weight: 700; font-size: 15px; color: #1a237e; margin-bottom: 4px; }\n.ls-ig-procedure .step-detail { font-size: 13px; line-height: 1.55; color: #424242; }\n.ls-ig-procedure .step-detail .tag { display: inline-block; font-size: 11px; font-weight: 700; color: #e65100; background: #fff3e0; border-radius: 4px; padding: 1px 7px; margin-left: 4px; white-space: nowrap; }\n.ls-ig-procedure .arrow { text-align: center; color: #ff6f00; font-size: 18px; line-height: 1; padding: 3px 0; }\n.ls-ig-procedure .ig-footer { margin-top: 4px; padding: 14px 24px; border-top: 1px solid #e0e0e0; display: flex; justify-content: space-between; align-items: center; gap: 12px; }\n.ls-ig-procedure .ig-source { font-size: 11px; color: #9e9e9e; font-style: italic; max-width: 600px; line-height: 1.4; }\n.ls-ig-procedure .ig-brand { font-size: 13px; font-weight: 700; color: #1a237e; letter-spacing: 0.5px; white-space: nowrap; }\n@media (max-width: 600px) {\n  .ls-ig-procedure .ig-title-bar h2 { font-size: 17px; }\n  .ls-ig-procedure .ig-body { padding: 16px; }\n  .ls-ig-procedure .step-num { width: 32px; height: 32px; font-size: 15px; }\n  .ls-ig-procedure .ig-footer { flex-direction: column; align-items: flex-start; }\n}\n<\/style>\n  <div class=\"ig-title-bar\">\n    <h2>Section 84 Compulsory Licence: The Procedure Step by Step<\/h2>\n    <p>How an interested person applies to the Controller under the Patents Act, 1970<\/p>\n  <\/div>\n  <div class=\"ig-body\">\n    <div class=\"step\">\n      <div class=\"step-num\">1<\/div>\n      <div class=\"step-text\">\n        <div class=\"step-title\">Wait three years from grant<\/div>\n        <div class=\"step-detail\">No application can be filed until three years have passed from the date the patent was granted<span class=\"tag\">s. 84(1)<\/span><\/div>\n      <\/div>\n    <\/div>\n    <div class=\"arrow\">&#9660;<\/div>\n    <div class=\"step\">\n      <div class=\"step-num\">2<\/div>\n      <div class=\"step-text\">\n        <div class=\"step-title\">Attempt a voluntary licence first<\/div>\n        <div class=\"step-detail\">Make a bona fide request for a voluntary licence on reasonable terms and wait a reasonable period, usually up to six months, before the Controller will act<span class=\"tag\">s. 84(6)<\/span><\/div>\n      <\/div>\n    <\/div>\n    <div class=\"arrow\">&#9660;<\/div>\n    <div class=\"step\">\n      <div class=\"step-num\">3<\/div>\n      <div class=\"step-text\">\n        <div class=\"step-title\">File Form 17 with the Controller<\/div>\n        <div class=\"step-detail\">Submit the compulsory-licence application stating the ground relied on and the terms and royalty proposed by the applicant.<\/div>\n      <\/div>\n    <\/div>\n    <div class=\"arrow\">&#9660;<\/div>\n    <div class=\"step\">\n      <div class=\"step-num\">4<\/div>\n      <div class=\"step-text\">\n        <div class=\"step-title\">Controller tests for a prima facie case<\/div>\n        <div class=\"step-detail\">The application proceeds only if the Controller is satisfied that a prima facie case has been made out<span class=\"tag\">s. 87<\/span><\/div>\n      <\/div>\n    <\/div>\n    <div class=\"arrow\">&#9660;<\/div>\n    <div class=\"step\">\n      <div class=\"step-num\">5<\/div>\n      <div class=\"step-text\">\n        <div class=\"step-title\">Publication, opposition and hearing<\/div>\n        <div class=\"step-detail\">The application is published; the patentee may oppose it, and a hearing is held before any terms are settled.<\/div>\n      <\/div>\n    <\/div>\n    <div class=\"arrow\">&#9660;<\/div>\n    <div class=\"step\">\n      <div class=\"step-num\">6<\/div>\n      <div class=\"step-text\">\n        <div class=\"step-title\">Controller settles the terms and royalty<\/div>\n        <div class=\"step-detail\">Terms are fixed so the patent is worked to the fullest extent, the licensee earns a reasonable profit and the patentee gets adequate remuneration<span class=\"tag\">s. 90<\/span><\/div>\n      <\/div>\n    <\/div>\n    <div class=\"arrow\">&#9660;<\/div>\n    <div class=\"step\">\n      <div class=\"step-num\">7<\/div>\n      <div class=\"step-text\">\n        <div class=\"step-title\">Compulsory licence granted or refused<\/div>\n        <div class=\"step-detail\">The Controller grants a non-exclusive, non-assignable licence, or refuses the application. The patent itself stays valid throughout.<\/div>\n      <\/div>\n    <\/div>\n  <\/div>\n  <div class=\"ig-footer\">\n    <div class=\"ig-source\">Source: Patents Act, 1970, ss. 84, 87, 90; Patents Rules, 2003 (Form 17).<\/div>\n    <div class=\"ig-brand\">LawSikho<\/div>\n  <\/div>\n<\/div>\n<\/figure>\n\n<a id=\"h2-5\"><\/a><\/p>\n<h2>What happens to the patent and the parties after a compulsory license is granted?<\/h2>\n<p>After a grant, the patent stays in force, but the patentee must now share the market with a licensee on terms the Controller fixes under <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15960&#038;sectionno=90&#038;orderno=92\" target=\"_blank\" rel=\"noopener\">Section 90 of the Patents Act, 1970<\/a>. Nothing about the patent&#8217;s validity or term changes. The patentee remains the owner, the patent runs its full 20 years, and the only thing lost is exclusivity. This is the answer to the most persistent misconception about the section, and it bears repeating because so many readers assume a compulsory licence extinguishes the patent.<\/p>\n<p>The licensee, for its part, receives a defined and limited right. It can work the invention to the extent the Controller allows, on the price, royalty, and supply conditions the order specifies, and no further. The relationship is regulated by the terms of the order rather than by a freely negotiated contract, which is what distinguishes it from ordinary licensing. Readers moving from patents into the wider field will find it useful to compare this with <a href=\"https:\/\/lawsikho.com\/blog\/all-about-ownership-and-trasnfer-of-ip\/\" target=\"_blank\" rel=\"noopener\">how IP rights are licensed and transferred<\/a> by agreement, where the parties, not the Controller, set the terms.<\/p>\n<a id=\"h3-5-1\"><\/a>\n<h3>How is the royalty rate set, and does the patentee still earn?<\/h3>\n<p>The royalty is set by the Controller under Section 90, and yes, the patentee continues to earn from the invention even after losing exclusivity. Section 90 directs the Controller to secure that the invention is worked to the fullest extent reasonably practicable and at a reasonable profit to the licensee, while also securing that the patentee receives adequate remuneration having regard to the nature of the invention.<\/p>\n<p>The Nexavar order is the benchmark. The Controller fixed the royalty at 6% of the licensee&#8217;s net sales, payable to the patentee, alongside the price cap and the free-supply condition for 600 patients a year. So the patentee did not lose its revenue stream; it lost the ability to set a monopoly price. The 6% figure has become the informal reference point that later commentary and applications measure against, though the Controller retains discretion to set a different rate on different facts.<\/p>\n<p>A question clients raise is whether a compulsory licence hands the licensee the patentee&#8217;s clinical data, manufacturing know-how, or trade secrets. It does not. The licence covers the patented invention as disclosed in the patent specification, and the licensee must develop its own manufacturing process and generate its own regulatory data. Compulsory licensing overrides the patent monopoly, not the patentee&#8217;s confidential information.<\/p>\n<p>The Nexavar terms were challenged and upheld all the way up. The appellate board and then the Bombay High Court both declined to interfere with the grant or the terms, which is why the order carries the weight it does.<\/p>\n<a id=\"h3-5-2\"><\/a>\n<h3>Can the licence be exclusive, assigned, or exported, and can the patent be revoked for non-working?<\/h3>\n<p>A compulsory licence is always non-exclusive and non-assignable, is primarily meant to supply the Indian market, and cannot be freely transferred or exported. Section 90 makes the non-exclusive and non-assignable character mandatory: the licensee cannot demand sole rights, and cannot sell the licence on to a third party. The patentee remains free to grant other voluntary or compulsory licences, and to keep working the invention itself.<\/p>\n<p>The market orientation also matters. A Section 84 licence is granted predominantly to supply the domestic market, which is why a separate provision, Section 92A, exists specifically for the export of patented pharmaceuticals to countries that cannot manufacture their own. The concept of &#8220;working&#8221; the patent runs through all of this, and the courts have examined it in related litigation.<\/p>\n<p>In <a href=\"https:\/\/indiankanoon.org\/doc\/56241748\/\" target=\"_blank\" rel=\"noopener\">Bayer Intellectual Property GmbH v. Alembic Pharmaceuticals Ltd. (2017)<\/a>, the Delhi High Court considered a generic manufacturer&#8217;s activity, including export, during the patent term, which feeds the wider debate over what genuinely counts as working an invention in India. For the underlying obligation itself, this overview of <a href=\"https:\/\/blog.ipleaders.in\/an-overview-of-patentees-rights-and-duties\/\" target=\"_blank\" rel=\"noopener\">a patentee&#8217;s duty to work the invention<\/a> sets out the working requirement that the &#8220;not worked in India&#8221; ground depends on.<\/p>\n<p>There is also a sting in the tail for patentees. Under <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15955&#038;sectionno=85&#038;orderno=87\" target=\"_blank\" rel=\"noopener\">Section 85 of the Patents Act, 1970<\/a>, if the patented invention has still not been worked, or the reasonable requirements of the public are still unmet, even two years after a compulsory licence was granted, the Controller or the Central Government may move to revoke the patent altogether. The Controller&#8217;s broader powers to settle these matters sit in <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15958&#038;sectionno=88&#038;orderno=90\" target=\"_blank\" rel=\"noopener\">Section 88 of the Patents Act, 1970<\/a>, and the general purposes the section serves, including the public-interest objectives, are set out in <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15959&#038;sectionno=89&#038;orderno=91\" target=\"_blank\" rel=\"noopener\">Section 89<\/a>. So a compulsory licence is not always the end of the story: it can be the first step toward revocation if the underlying problem persists.<\/p>\n<p>Can a compulsory licence itself be terminated? Yes, on application by the patentee, the Controller may terminate it if and when the circumstances that justified the grant have ceased to exist and are unlikely to recur, which protects the patentee against a licence outliving its public-interest justification.<\/p>\n\n<a id=\"h2-6\"><\/a>\n<h2>How does Section 84 differ from Section 92 and Section 92A?<\/h2>\n<p><a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15954&#038;sectionno=84&#038;orderno=86\" target=\"_blank\" rel=\"noopener\">Section 84 of the Patents Act, 1970<\/a> is the ordinary route driven by a private applicant after three years, <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15962&#038;sectionno=92&#038;orderno=94\" target=\"_blank\" rel=\"noopener\">Section 92<\/a> is the government-triggered emergency route with no waiting period, and <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15963&#038;sectionno=92A&#038;orderno=95\" target=\"_blank\" rel=\"noopener\">Section 92A<\/a> is the export route for pharmaceuticals. All three sit within the same compulsory-licensing chapter of the Patents Act, 1970, but they are aimed at different problems and switched on by different actors. Confusing them is one of the most common errors in exam answers and client advice alike.<\/p>\n<a id=\"h3-6-1\"><\/a>\n<h3>When does Section 92 or Section 92A apply instead of Section 84?<\/h3>\n<p>Section 92 applies when the Central Government notifies a national emergency, extreme urgency, or public non-commercial use, while Section 92A applies only to the export of patented medicines to a country that cannot manufacture them.<\/p>\n<p>Section 92 is the emergency lever. It lets the Central Government, by notification, declare that a compulsory licence should be available in circumstances of national emergency, extreme urgency, or public non-commercial use. There is no three-year wait, and no private application is needed to start it: the government pulls the trigger, and manufacturers can then apply for licences under the notified terms. It is designed for public-health crises, not ordinary commercial disputes.<\/p>\n<p>Section 92A is narrower still. It permits a compulsory licence purely for the manufacture and export of patented pharmaceutical products to a country with insufficient or no manufacturing capacity, where that country has itself allowed importation or issued a compulsory licence. It is India&#8217;s implementation of the international mechanism that lets producer countries supply medicines to countries that cannot make their own.<\/p>\n<table>\n<thead>\n<tr>\n<th>Feature<\/th>\n<th>Section 84 (ordinary route)<\/th>\n<th>Section 92 (emergency route)<\/th>\n<th>Section 92A (export route)<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Who initiates<\/td>\n<td>Any interested person, by application<\/td>\n<td>Central Government, by notification<\/td>\n<td>A manufacturer, to supply an eligible importing country<\/td>\n<\/tr>\n<tr>\n<td>Trigger<\/td>\n<td>Three years after grant plus one of three grounds<\/td>\n<td>National emergency, extreme urgency, or public non-commercial use<\/td>\n<td>Export of patented pharma to a country lacking manufacturing capacity<\/td>\n<\/tr>\n<tr>\n<td>Waiting period<\/td>\n<td>Three years from grant<\/td>\n<td>None<\/td>\n<td>None<\/td>\n<\/tr>\n<tr>\n<td>Primary purpose<\/td>\n<td>Domestic access and anti-abuse<\/td>\n<td>Crisis response<\/td>\n<td>Cross-border pharmaceutical supply<\/td>\n<\/tr>\n<tr>\n<td>Illustrative use<\/td>\n<td>Nexavar (2012)<\/td>\n<td>Public-health emergencies<\/td>\n<td>Doha-mechanism pharmaceutical exports<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Which route fits a genuine pandemic, then? Section 92 does, because it removes the three-year wait and lets the government act at speed. That distinction, ordinary route versus emergency route, is the one worth carrying into any discussion of compulsory licensing under Section 84.<\/p>\n<a id=\"h3-6-2\"><\/a>\n<h3>How does compulsory licensing differ from government use or acquisition under Section 100?<\/h3>\n<p>Compulsory licensing differs from government use because Section 100 lets the government itself use a patented invention for its own purposes, whereas Section 84 lets a private party work it for the market. Under <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15967&#038;sectionno=100&#038;orderno=103\" target=\"_blank\" rel=\"noopener\">Section 100 of the Patents Act, 1970<\/a>, the Central Government and anyone authorised by it may use a patented invention for the purposes of the government, on terms agreed or, failing agreement, settled by the High Court. The beneficiary is the state, not a commercial licensee competing in the open market.<\/p>\n<p>The practical distinctions are worth holding onto. A Section 84 licence is applied for by a manufacturer that wants to sell to the public; government use under Section 100 is deployed by the state for public functions such as government procurement of a medicine or a defence-related technology. There is also acquisition, a separate and more drastic step, where the government takes over the patent itself rather than merely using the invention. Compulsory licensing is the least invasive of these tools: the patent survives, the owner keeps it, and only exclusivity is shared.<\/p>\n<p>\n\n<figure class=\"ls-infographic-wrap\" style=\"margin:2rem 0;\">\n<div class=\"ls-ig-routes\" style=\"margin:2rem 0;max-width:800px;\">\n<style>\n.ls-ig-routes *, .ls-ig-routes *::before, .ls-ig-routes *::after { margin: 0; padding: 0; box-sizing: border-box; }\n.ls-ig-routes { font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, sans-serif; color: #212121; border: 1px solid #e0e0e0; border-radius: 8px; overflow: hidden; }\n.ls-ig-routes .title-bar { background: #1a237e; color: #ffffff; padding: 20px 24px; text-align: center; }\n.ls-ig-routes .title-bar .h { font-size: 20px; font-weight: 700; line-height: 1.3; }\n.ls-ig-routes .title-bar .sub { font-size: 13px; font-weight: 400; margin-top: 6px; opacity: 0.9; }\n.ls-ig-routes .content { padding: 20px 24px; }\n.ls-ig-routes table { width: 100%; border-collapse: collapse; font-size: 13.5px; }\n.ls-ig-routes thead th { background: #ff6f00; color: #ffffff; text-align: left; padding: 12px 12px; font-size: 13.5px; font-weight: 700; vertical-align: top; }\n.ls-ig-routes thead th:first-child { background: #1a237e; }\n.ls-ig-routes tbody td { padding: 12px 12px; border-bottom: 1px solid #e0e0e0; line-height: 1.5; vertical-align: top; }\n.ls-ig-routes tbody tr:nth-child(even) { background: #f5f5f5; }\n.ls-ig-routes tbody td:first-child { font-weight: 700; color: #1a237e; }\n.ls-ig-routes .source { font-size: 11px; color: #9e9e9e; font-style: italic; padding: 0 24px 4px; }\n.ls-ig-routes .branding { text-align: right; padding: 12px 24px; font-size: 12px; color: #9e9e9e; border-top: 1px solid #e0e0e0; }\n@media (max-width: 640px) {\n  .ls-ig-routes .title-bar .h { font-size: 17px; }\n  .ls-ig-routes .content { padding: 12px; }\n  .ls-ig-routes table, .ls-ig-routes thead, .ls-ig-routes tbody, .ls-ig-routes th, .ls-ig-routes td, .ls-ig-routes tr { display: block; }\n  .ls-ig-routes thead { display: none; }\n  .ls-ig-routes tbody tr { border: 1px solid #e0e0e0; border-radius: 6px; margin-bottom: 12px; padding: 6px 0; background: #ffffff; }\n  .ls-ig-routes tbody tr:nth-child(even) { background: #ffffff; }\n  .ls-ig-routes tbody td { border-bottom: 1px dashed #e0e0e0; }\n  .ls-ig-routes tbody td:last-child { border-bottom: none; }\n  .ls-ig-routes tbody td:first-child { background: #f5f5f5; }\n  .ls-ig-routes tbody td::before { content: attr(data-label); display: block; font-size: 11px; text-transform: uppercase; letter-spacing: 0.5px; color: #9e9e9e; margin-bottom: 3px; font-weight: 700; }\n  .ls-ig-routes tbody td:first-child::before { content: \"\"; display: none; }\n}\n<\/style>\n  <div class=\"title-bar\">\n    <div class=\"h\">Section 84 vs Section 92 vs Section 92A<\/div>\n    <div class=\"sub\">Three compulsory licensing routes under the Patents Act, 1970<\/div>\n  <\/div>\n  <div class=\"content\">\n    <table>\n      <thead>\n        <tr>\n          <th>Feature<\/th>\n          <th>Section 84<br>(ordinary route)<\/th>\n          <th>Section 92<br>(emergency route)<\/th>\n          <th>Section 92A<br>(export route)<\/th>\n        <\/tr>\n      <\/thead>\n      <tbody>\n        <tr>\n          <td data-label=\"Feature\">Who initiates<\/td>\n          <td data-label=\"Section 84\">Any interested person, by application<\/td>\n          <td data-label=\"Section 92\">Central Government, by notification<\/td>\n          <td data-label=\"Section 92A\">Any manufacturer, for an eligible importing country<\/td>\n        <\/tr>\n        <tr>\n          <td data-label=\"Feature\">Trigger<\/td>\n          <td data-label=\"Section 84\">Three years after grant plus one of three statutory grounds<\/td>\n          <td data-label=\"Section 92\">National emergency, extreme urgency or public non-commercial use<\/td>\n          <td data-label=\"Section 92A\">Export of patented pharma products to a country with insufficient manufacturing capacity<\/td>\n        <\/tr>\n        <tr>\n          <td data-label=\"Feature\">Waiting period<\/td>\n          <td data-label=\"Section 84\">Three years from grant<\/td>\n          <td data-label=\"Section 92\">None<\/td>\n          <td data-label=\"Section 92A\">None<\/td>\n        <\/tr>\n        <tr>\n          <td data-label=\"Feature\">Typical use<\/td>\n          <td data-label=\"Section 84\">Nexavar (2012)<\/td>\n          <td data-label=\"Section 92\">Public-health emergencies<\/td>\n          <td data-label=\"Section 92A\">Doha paragraph-6 pharmaceutical exports<\/td>\n        <\/tr>\n      <\/tbody>\n    <\/table>\n  <\/div>\n  <div class=\"source\">Source: Patents Act, 1970, ss. 84, 92, 92A.<\/div>\n  <div class=\"branding\">LawSikho<\/div>\n<\/div>\n<\/figure>\n\n<a id=\"h2-7\"><\/a><\/p>\n<h2>Is compulsory licensing allowed under TRIPS, and why has India granted none since 2012?<\/h2>\n<p>Yes, compulsory licensing is expressly permitted by Article 31 of the TRIPS Agreement and reaffirmed by the 2001 Doha Declaration, yet India has issued no compulsory licence under <a href=\"https:\/\/www.indiacode.nic.in\/show-data?abv=CEN&#038;statehandle=123456789\/1362&#038;actid=AC_CEN_11_61_00002_197039_1517807321764&#038;sectionId=15954&#038;sectionno=84&#038;orderno=86\" target=\"_blank\" rel=\"noopener\">Section 84 of the Patents Act, 1970<\/a> since the 2012 Nexavar grant. Far from being a rogue departure from international patent law, India&#8217;s regime tracks a flexibility that the World Trade Organization&#8217;s own rules build in. Article 31 allows member states to authorise use of a patent without the holder&#8217;s consent, subject to conditions, and the Doha Declaration confirmed that each member is free to determine the grounds on which such licences are granted.<\/p>\n<p>India&#8217;s Section 84 grounds map closely onto the Article 31 conditions, which is why the Nexavar grant survived the argument that it breached international obligations. The table below sets the two frameworks side by side.<\/p>\n<table>\n<thead>\n<tr>\n<th>India&#8217;s Section 84 approach<\/th>\n<th>TRIPS Article 31 condition<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Prior effort to obtain a voluntary licence on reasonable terms (six months)<\/td>\n<td>Prior negotiation with the right holder, waivable in emergencies<\/td>\n<\/tr>\n<tr>\n<td>Non-exclusive, non-assignable licence<\/td>\n<td>Use must be non-exclusive and non-assignable<\/td>\n<\/tr>\n<tr>\n<td>Predominantly to supply the Indian market<\/td>\n<td>Predominantly for the supply of the domestic market<\/td>\n<\/tr>\n<tr>\n<td>Adequate remuneration (royalty) fixed by the Controller<\/td>\n<td>Right holder paid adequate remuneration for the authorisation<\/td>\n<\/tr>\n<tr>\n<td>Grant reviewable and terminable by the Controller<\/td>\n<td>Legal validity and remuneration subject to review<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>So the machinery is lawful under international law and demonstrably works, having produced a grant upheld through appeal. The puzzle is not legality. It is why a fully functional tool has sat idle for more than a decade.<\/p>\n<a id=\"h3-7-1\"><\/a>\n<h3>Did COVID-19 change anything?<\/h3>\n<p>COVID-19 revived the global debate over compulsory licensing but produced no domestic compulsory licence in India. India, together with South Africa, led a proposal at the World Trade Organization for a waiver of certain TRIPS obligations on COVID-19 vaccines and treatments, and the WTO adopted a limited decision on the issue at its Ministerial Conference in 2022. The debate reached the highest levels of trade diplomacy.<\/p>\n<p>And yet, at home, the Section 84 machinery was never fired for any COVID-19 product. No compulsory licence was issued for a vaccine, a treatment, or a diagnostic during the pandemic, despite the emergency that Section 92 was in principle designed for. A common community question is whether compulsory licensing could be used for pandemic drugs and vaccines at all. Legally it could, through Section 92&#8217;s emergency route more than Section 84&#8217;s ordinary one, but India chose other levers, including voluntary licensing arrangements and domestic manufacturing scale-up, instead.<\/p>\n<p>The contrast with some other developing countries is instructive. Nations such as Brazil and Thailand have used or threatened compulsory licensing for HIV and other essential medicines as a negotiating and access tool. India, which built the legal architecture and produced the landmark grant, has been comparatively restrained in deploying it since 2012. For the broader international framework these debates sit within, this guide to <a href=\"https:\/\/lawsikho.com\/blog\/how-to-protect-your-intellectual-property-using-wipo-tools\/\" target=\"_blank\" rel=\"noopener\">international IP protection systems<\/a> maps the treaties and institutions in play.<\/p>\n<a id=\"h3-7-2\"><\/a>\n<h3>Why the machinery sits idle<\/h3>\n<p>The machinery sits idle largely for reasons of investment climate and trade pressure rather than law, and the consequences ripple in directions most observers miss. Granting a compulsory licence signals to foreign patent holders that their monopolies are vulnerable, and successive governments have weighed that signal against the benefit of any single grant. The restraint is strategic and reputational, not a gap in the statute.<\/p>\n<p>The second-order effects are where this gets genuinely interesting for practice. Because the compulsory-licence route now carries this chilling reputation, generic manufacturers increasingly reach for other tools instead: pre-grant and post-grant oppositions, and challenges under Section 3(d) of the Act, which blocks patents on trivial modifications of known substances. The demand for legal skill has shifted accordingly, away from compulsory-licence drafting and toward opposition and validity work. There is also an emerging investment-treaty question, still largely academic, of whether a compulsory licence could expose India to an investor-state claim under a bilateral investment treaty.<\/p>\n<p>Looking ahead, early signals suggest the pressure on this machinery will build rather than fade. Practitioners expect tighter enforcement of the Form 27 working-statement obligation, which supplies the evidence for the &#8220;not worked in India&#8221; ground, and continued global debate over compulsory licensing for high-cost oncology, diabetes, and future pandemic products. India&#8217;s dormant tool is likely to be tested again; the only real question is which therapeutic area forces the issue.<\/p>\n\n\n<a id=\"h2-8\"><\/a>\n<h2>Frequently asked questions on compulsory licensing under Section 84<\/h2>\n<p><strong>1. What is compulsory licensing of patents under Section 84?<\/strong>\nIt is a statutory mechanism that lets any interested person apply, three years after a patent is granted, to work the invention without the patentee&#8217;s consent, on public-interest grounds. The Controller of Patents grants the licence on terms it fixes. The patent itself stays valid and in force; only the patentee&#8217;s exclusivity is overridden.<\/p>\n<p><strong>2. What are the three grounds for a compulsory license under Section 84(1)?<\/strong>\nThe three grounds are that the reasonable requirements of the public with respect to the invention are not satisfied, that the invention is not available to the public at a reasonably affordable price, and that the invention is not worked in the territory of India. Any one ground, if proved, supports a grant. Strong applications plead and evidence all three.<\/p>\n<p><strong>3. Who can apply for a compulsory license in India?<\/strong>\nAny person interested may apply, which in practice means a manufacturer that wants to make the patented product. The applicant does not need to be an existing licensee or to have the patentee&#8217;s permission. A genuine intention and capacity to work the invention is enough to establish standing.<\/p>\n<p><strong>4. After how many years can a compulsory license be applied for?<\/strong>\nAn application can be filed only after three years from the date the patent was granted. The clock runs from the date of grant, not the date of the patent application. The wait gives the patentee a reasonable chance to work the invention in the Indian market first.<\/p>\n<p><strong>5. Does a compulsory license mean the patent is cancelled?<\/strong>\nNo. This is the most common misconception. The patent remains valid, stays on the register, and runs its full term; the patentee keeps ownership and continues to earn a royalty. What the licensee gets is a non-exclusive right to work the invention alongside the patentee, not the patent itself.<\/p>\n<p><strong>6. Must an applicant first try for a voluntary license before Section 84?<\/strong>\nYes. The applicant must make a genuine, bona fide effort to obtain a voluntary licence from the patentee on reasonable terms before applying. Skipping this step is fatal, as one landmark application discovered. A token letter that is not a real negotiation does not satisfy the requirement.<\/p>\n<p><strong>7. How long is the voluntary-license negotiation period?<\/strong>\nA reasonable period, treated as six months, must be allowed for the voluntary-licence effort before a compulsory-licence application can be filed. If the patentee refuses reasonable terms or does not respond within that period, the pre-condition is met. The effort must be genuine, not a formality to run down the clock.<\/p>\n<p><strong>8. How is the royalty rate decided in a compulsory license?<\/strong>\nThe Controller fixes the royalty under Section 90, balancing a reasonable profit for the licensee against adequate remuneration for the patentee. In the Nexavar matter the rate was set at 6% of the licensee&#8217;s net sales. The Controller retains discretion to set a different rate on different facts.<\/p>\n<p><strong>9. What is Section 92 compulsory licensing?<\/strong>\nSection 92 is the emergency route. It lets the Central Government, by notification, make compulsory licences available in situations of national emergency, extreme urgency, or public non-commercial use, with no three-year wait. It is aimed at public-health crises rather than ordinary commercial disputes.<\/p>\n<p><strong>10. What is Section 92A?<\/strong>\nSection 92A permits a compulsory licence solely for the manufacture and export of patented pharmaceutical products to a country that has insufficient or no manufacturing capacity of its own. It implements the international mechanism that allows producer countries to supply medicines to countries that cannot make them. It is an export-only route, distinct from the domestic Section 84.<\/p>\n<p><strong>11. Why has India granted only one compulsory license since 2012?<\/strong>\nThe restraint is strategic rather than legal. Granting a compulsory licence signals to foreign patent holders that their monopolies are vulnerable, inviting trade friction and unsettling investors, and no government since 2012 has judged a single drug worth that cost. The machinery works and is lawful; it has simply been left largely unused.<\/p>\n<p><strong>12. Is compulsory licensing legal under international law and TRIPS?<\/strong>\nYes. Article 31 of the TRIPS Agreement expressly permits members to authorise use of a patent without the holder&#8217;s consent, subject to conditions, and the 2001 Doha Declaration confirmed each member&#8217;s freedom to set its own grounds. India&#8217;s Section 84 conditions map closely onto the Article 31 requirements. The Nexavar grant survived the argument that it breached international obligations.<\/p>\n<p><strong>13. What is the difference between voluntary and compulsory licensing?<\/strong>\nA voluntary licence is granted by the patentee by choice, on freely negotiated terms. A compulsory licence is granted by the Controller without the patentee&#8217;s consent, on terms the Controller fixes, and is always non-exclusive and non-assignable. One flows from agreement; the other from statute and a public-interest ground.<\/p>\n<p><strong>14. Has any compulsory license been granted in India after the Nexavar case?<\/strong>\nNo. The 2012 Nexavar grant remains the only compulsory licence India has ever issued under Section 84. Two later applications, for the drugs dasatinib and saxagliptin, were both rejected, one on procedure and one on evidence. No grant has followed since.<\/p>\n<p><strong>15. Is it mandatory to file a statement of working of patents?<\/strong>\nYes. Every patentee must file a statement of working, Form 27, recording whether and to what extent the patent is being worked in India. The obligation applies to all patents in every field, not only pharmaceuticals. A failure to file, or a false statement, carries penal consequences and hands a compulsory-licence applicant evidence for the &#8220;not worked in India&#8221; ground.<\/p>\n<p><strong>16. What was the Natco Pharma v. Bayer compulsory license case about?<\/strong>\nIt was India&#8217;s first compulsory licence, granted in 2012 over the anti-cancer drug sorafenib (Nexavar). The Controller found the drug unaffordable and not adequately worked in India, and allowed a domestic manufacturer to sell it at a fraction of the originator&#8217;s price. The grant was upheld on appeal and by the Bombay High Court.<\/p>\n<p><strong>17. What was Nexavar&#8217;s price before and after the compulsory license?<\/strong>\nThe originator priced a month&#8217;s therapy at roughly Rs 2,84,428. After the compulsory licence, the generic version cost roughly Rs 8,880 for the same month&#8217;s supply, a reduction of about 97%. The licensee also had to pay a 6% royalty and supply the drug free to at least 600 patients a year.<\/p>\n<p><strong>18. Why was BDR&#8217;s application for dasatinib rejected?<\/strong>\nThe application was refused in 2013 for want of a prima facie case. The applicant had not made a genuine effort to obtain a voluntary licence first, so the mandatory pre-condition was unmet and the Controller never reached the public-health merits. It is the leading example of how a procedural gap alone can sink a filing.<\/p>\n<p><strong>19. Why was Lee Pharma&#8217;s application for saxagliptin rejected?<\/strong>\nThe application was refused in 2016 because the applicant failed to evidence any of the three Section 84(1) grounds. It could not establish actual public demand, the extent to which that demand was unmet, or a reliable comparison proving the price was unaffordable. The refusal illustrates the evidentiary burden the applicant carries.<\/p>\n<a id=\"h2-9\"><\/a>\n<h2>References<\/h2>\n<h3>Case Law<\/h3>\n<ol>\n<li><a href=\"https:\/\/indiankanoon.org\/doc\/28519340\/\" target=\"_blank\" rel=\"noopener\">Bayer Corporation v. Union of India, (2014) 60 PTC 277 (Bom)<\/a>: 2014 SCC OnLine Bom 963; Bombay High Court, 15 July 2014 (writ challenge to India&#8217;s first compulsory licence over Nexavar, dismissed; the Controller&#8217;s grant, 6% royalty and price cap upheld).<\/li>\n<li><a href=\"https:\/\/indiankanoon.org\/doc\/56241748\/\" target=\"_blank\" rel=\"noopener\">Bayer Intellectual Property GmbH v. Alembic Pharmaceuticals Ltd. (2017)<\/a>: Delhi High Court, CS(COMM) No. 1592\/2016, 8 March 2017 (working of patents and export activity during the patent term).<\/li>\n<li>BDR Pharmaceuticals International Pvt. Ltd. v. Bristol-Myers Squibb Co.: Controller of Patents, Compulsory Licence Application No. 1 of 2013, order dated 29 October 2013 (compulsory licence over dasatinib\/Sprycel refused for want of a prima facie case; administrative order, not indexed on Indian Kanoon).<\/li>\n<li>Lee Pharma Ltd. v. AstraZeneca AB: Controller of Patents, Compulsory Licence Application No. 1 of 2015, order dated 19 January 2016 (compulsory licence over saxagliptin refused; none of the three Section 84(1) grounds evidenced; administrative order, not indexed on Indian Kanoon).<\/li>\n<\/ol>\n<h3>Statutes<\/h3>\n<ol>\n<li><a href=\"https:\/\/www.indiacode.nic.in\/handle\/123456789\/1392\" target=\"_blank\" rel=\"noopener\">Patents Act, 1970<\/a>. Sections cited: 84, 84(1), 84(7), 85, 87, 88, 89, 90, 92, 92A, 100.<\/li>\n<\/ol>\n<hr>\n<p>This article is for informational purposes only and does not constitute legal advice. For specific legal guidance, consult a qualified legal professional.<\/p>\n\n\n\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"Article\",\n  \"headline\": \"Compulsory Licensing of Patents Under Section 84 Guide\",\n  \"description\": \"Compulsory licensing of patents under Section 84 lets anyone apply 3 years after grant on grounds of unmet need, unaffordable price, or non-working in India.\",\n  \"author\": {\n    \"@type\": \"Organization\",\n    \"name\": \"LawSikho\",\n    \"url\": \"https:\/\/lawsikho.com\"\n  },\n  \"publisher\": {\n    \"@type\": \"Organization\",\n    \"name\": \"LawSikho\",\n    \"logo\": {\n      \"@type\": \"ImageObject\",\n      \"url\": \"https:\/\/lawsikho.com\/logo.png\"\n    }\n  },\n  \"datePublished\": \"2026-07-24\",\n  \"dateModified\": \"2026-07-24\",\n  \"mainEntityOfPage\": {\n    \"@type\": \"WebPage\",\n    \"@id\": \"https:\/\/lawsikho.com\/blog\/compulsory-licensing-patents-section-84\"\n  },\n  \"image\": \"https:\/\/lawsikho.com\/blog\/images\/compulsory-licensing-patents-section-84.png\",\n  \"citation\": [\n    {\n      \"@type\": \"CreativeWork\",\n      \"name\": \"Bayer Corporation v. Union of India\",\n      \"identifier\": \"(2014) 60 PTC 277 (Bom)\",\n      \"url\": \"https:\/\/indiankanoon.org\/doc\/28519340\/\",\n      \"datePublished\": \"2014-07-15\"\n    },\n    {\n      \"@type\": \"CreativeWork\",\n      \"name\": \"Bayer Intellectual Property GmbH v. Alembic Pharmaceuticals Ltd.\",\n      \"identifier\": \"CS(COMM) No. 1592\/2016\",\n      \"url\": \"https:\/\/indiankanoon.org\/doc\/56241748\/\",\n      \"datePublished\": \"2017-03-08\"\n    },\n    {\n      \"@type\": \"CreativeWork\",\n      \"name\": \"BDR Pharmaceuticals International Pvt. Ltd. v. Bristol-Myers Squibb Co.\",\n      \"identifier\": \"Compulsory Licence Application No. 1 of 2013\",\n      \"datePublished\": \"2013-10-29\"\n    },\n    {\n      \"@type\": \"CreativeWork\",\n      \"name\": \"Lee Pharma Ltd. v. AstraZeneca AB\",\n      \"identifier\": \"Compulsory Licence Application No. 1 of 2015\",\n      \"datePublished\": \"2016-01-19\"\n    },\n    {\n      \"@type\": \"Legislation\",\n      \"name\": \"Patents Act, 1970\",\n      \"identifier\": \"Act No. 39 of 1970\",\n      \"url\": \"https:\/\/www.indiacode.nic.in\/handle\/123456789\/1392\",\n      \"legislationJurisdiction\": \"IN\"\n    }\n  ]\n}\n<\/script>\n\n\n\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"FAQPage\",\n  \"mainEntity\": [\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What is compulsory licensing of patents under Section 84?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"It is a statutory mechanism that lets any interested person apply, three years after a patent is granted, to work the invention without the patentee's consent, on public-interest grounds. The Controller of Patents grants the licence on terms it fixes. The patent itself stays valid and in force; only the patentee's exclusivity is overridden.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What are the three grounds for a compulsory license under Section 84(1)?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"The three grounds are that the reasonable requirements of the public with respect to the invention are not satisfied, that the invention is not available to the public at a reasonably affordable price, and that the invention is not worked in the territory of India. Any one ground, if proved, supports a grant. Strong applications plead and evidence all three.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Who can apply for a compulsory license in India?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Any person interested may apply, which in practice means a manufacturer that wants to make the patented product. The applicant does not need to be an existing licensee or to have the patentee's permission. A genuine intention and capacity to work the invention is enough to establish standing.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"After how many years can a compulsory license be applied for?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"An application can be filed only after three years from the date the patent was granted. The clock runs from the date of grant, not the date of the patent application. The wait gives the patentee a reasonable chance to work the invention in the Indian market first.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Does a compulsory license mean the patent is cancelled?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"No. This is the most common misconception. The patent remains valid, stays on the register, and runs its full term; the patentee keeps ownership and continues to earn a royalty. What the licensee gets is a non-exclusive right to work the invention alongside the patentee, not the patent itself.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Must an applicant first try for a voluntary license before Section 84?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Yes. The applicant must make a genuine, bona fide effort to obtain a voluntary licence from the patentee on reasonable terms before applying. Skipping this step is fatal, as one landmark application discovered. A token letter that is not a real negotiation does not satisfy the requirement.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"How long is the voluntary-license negotiation period?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"A reasonable period, treated as six months, must be allowed for the voluntary-licence effort before a compulsory-licence application can be filed. If the patentee refuses reasonable terms or does not respond within that period, the pre-condition is met. The effort must be genuine, not a formality to run down the clock.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"How is the royalty rate decided in a compulsory license?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"The Controller fixes the royalty under Section 90, balancing a reasonable profit for the licensee against adequate remuneration for the patentee. In the Nexavar matter the rate was set at 6% of the licensee's net sales. The Controller retains discretion to set a different rate on different facts.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What is Section 92 compulsory licensing?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Section 92 is the emergency route. It lets the Central Government, by notification, make compulsory licences available in situations of national emergency, extreme urgency, or public non-commercial use, with no three-year wait. It is aimed at public-health crises rather than ordinary commercial disputes.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What is Section 92A?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Section 92A permits a compulsory licence solely for the manufacture and export of patented pharmaceutical products to a country that has insufficient or no manufacturing capacity of its own. It implements the international mechanism that allows producer countries to supply medicines to countries that cannot make them. It is an export-only route, distinct from the domestic Section 84.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Why has India granted only one compulsory license since 2012?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"The restraint is strategic rather than legal. Granting a compulsory licence signals to foreign patent holders that their monopolies are vulnerable, inviting trade friction and unsettling investors, and no government since 2012 has judged a single drug worth that cost. The machinery works and is lawful; it has simply been left largely unused.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Is compulsory licensing legal under international law and TRIPS?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Yes. Article 31 of the TRIPS Agreement expressly permits members to authorise use of a patent without the holder's consent, subject to conditions, and the 2001 Doha Declaration confirmed each member's freedom to set its own grounds. India's Section 84 conditions map closely onto the Article 31 requirements. The Nexavar grant survived the argument that it breached international obligations.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What is the difference between voluntary and compulsory licensing?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"A voluntary licence is granted by the patentee by choice, on freely negotiated terms. A compulsory licence is granted by the Controller without the patentee's consent, on terms the Controller fixes, and is always non-exclusive and non-assignable. One flows from agreement; the other from statute and a public-interest ground.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Has any compulsory license been granted in India after the Nexavar case?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"No. The 2012 Nexavar grant remains the only compulsory licence India has ever issued under Section 84. Two later applications, for the drugs dasatinib and saxagliptin, were both rejected, one on procedure and one on evidence. No grant has followed since.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Is it mandatory to file a statement of working of patents?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Yes. Every patentee must file a statement of working, Form 27, recording whether and to what extent the patent is being worked in India. The obligation applies to all patents in every field, not only pharmaceuticals. A failure to file, or a false statement, carries penal consequences and hands a compulsory-licence applicant evidence for the 'not worked in India' ground.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What was the Natco Pharma v. Bayer compulsory license case about?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"It was India's first compulsory licence, granted in 2012 over the anti-cancer drug sorafenib (Nexavar). The Controller found the drug unaffordable and not adequately worked in India, and allowed a domestic manufacturer to sell it at a fraction of the originator's price. The grant was upheld on appeal and by the Bombay High Court.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What was Nexavar's price before and after the compulsory license?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"The originator priced a month's therapy at roughly Rs 2,84,428. After the compulsory licence, the generic version cost roughly Rs 8,880 for the same month's supply, a reduction of about 97%. The licensee also had to pay a 6% royalty and supply the drug free to at least 600 patients a year.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Why was BDR's application for dasatinib rejected?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"The application was refused in 2013 for want of a prima facie case. The applicant had not made a genuine effort to obtain a voluntary licence first, so the mandatory pre-condition was unmet and the Controller never reached the public-health merits. It is the leading example of how a procedural gap alone can sink a filing.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Why was Lee Pharma's application for saxagliptin rejected?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"The application was refused in 2016 because the applicant failed to evidence any of the three Section 84(1) grounds. It could not establish actual public demand, the extent to which that demand was unmet, or a reliable comparison proving the price was unaffordable. The refusal illustrates the evidentiary burden the applicant carries.\"\n      }\n    }\n  ]\n}\n<\/script>\n\n\n<style>.ls-cta-br{display:none;}@media(max-width:768px){#ls-floating-cta{padding:8px 12px !important;}#ls-floating-cta .ls-wrap{flex-direction:column !important;align-items:center !important;gap:8px !important;}#ls-floating-cta a{font-size:11px !important;padding:8px 16px !important;white-space:normal !important;text-align:center !important;max-width:90vw !important;}.ls-cta-br{display:block !important;}}<\/style><div id=\"ls-floating-cta\" style=\"position:fixed;bottom:0;left:0;right:0;z-index:9999;background:#0f0f0f;border-top:3px solid #E8382D;padding:12px 20px;box-shadow:0 -4px 20px rgba(0,0,0,0.3);\"><div class=\"ls-wrap\" style=\"display:flex;align-items:center;justify-content:center;gap:24px;\"><div style=\"display:flex;align-items:center;gap:10px;\"><a href=\"https:\/\/growthx.lawsikho.com\/f\/13may-cd-21day-freelance?p_source=cd2_blog_ls&#038;p_cta=cd-compulsory-licensing-of-patents-under\" onclick=\"gtag(&#039;event&#039;,&#039;cta_click&#039;,{send_to:&#039;G-3XDT1KHB05&#039;,p_source:&#039;cd2_blog_ls&#039;,p_cta:&#039;cd-compulsory-licensing-of-patents-under&#039;});\" target=\"_blank\" rel=\"noopener\" style=\"display:inline-block;background:#E8382D;color:#fff;padding:11px 20px;border-radius:7px;font-size:13px;font-weight:700;text-decoration:none;white-space:nowrap;\">Draft contracts clients pay for \u2014<br class=\"ls-cta-br\"> in 3 weeks, Rs. 100 \u2192<\/a><button onclick=\"document.getElementById('ls-floating-cta').style.display='none'\" style=\"background:none;border:none;color:#555;font-size:18px;cursor:pointer;padding:4px;line-height:1;position:absolute;right:16px;\">\u2715<\/button><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Compulsory licensing of patents under Section 84 lets anyone apply 3 years after grant on grounds of unmet need, unaffordable price, or non-working in India.<\/p>\n","protected":false},"author":44,"featured_media":7151,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[260],"tags":[2425,2429,2426,2432],"class_list":["post-7150","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-patents-act-1970","tag-compulsory-license-procedure","tag-form-17","tag-section-84-vs-section-92","tag-trips-article-31"],"_links":{"self":[{"href":"https:\/\/lawsikho.com\/blog\/wp-json\/wp\/v2\/posts\/7150","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lawsikho.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lawsikho.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lawsikho.com\/blog\/wp-json\/wp\/v2\/users\/44"}],"replies":[{"embeddable":true,"href":"https:\/\/lawsikho.com\/blog\/wp-json\/wp\/v2\/comments?post=7150"}],"version-history":[{"count":2,"href":"https:\/\/lawsikho.com\/blog\/wp-json\/wp\/v2\/posts\/7150\/revisions"}],"predecessor-version":[{"id":7154,"href":"https:\/\/lawsikho.com\/blog\/wp-json\/wp\/v2\/posts\/7150\/revisions\/7154"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lawsikho.com\/blog\/wp-json\/wp\/v2\/media\/7151"}],"wp:attachment":[{"href":"https:\/\/lawsikho.com\/blog\/wp-json\/wp\/v2\/media?parent=7150"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lawsikho.com\/blog\/wp-json\/wp\/v2\/categories?post=7150"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lawsikho.com\/blog\/wp-json\/wp\/v2\/tags?post=7150"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}