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COMPULSORY LICENSING THROUGH A GENDER LENS: A CONTROLLER'S APPROACH TO WOMEN'S HEALTH NEEDS

January 15, 2026

*Ms. Ishita Sharma

INTRODUCTION:

Persistent access gaps in women's health remain even today despite a full set of legal and regulatory tools in India. Decisions across patent and non-patent pathways are not anchored in a shared, gender-sensitive evidentiary method, and reliance on national aggregates and generic affordability claims can miss cohort-specific shortfalls and create uncertainty about when compulsory licensing (hereinafter, "CL") is warranted.

This piece proposes a practical method for applying compulsory licensing in women's health under existing Indian law and demonstrates its need through two case studies. It is not a comprehensive audit and does not propose primary-law change. Working within the Patents Act, 1970, it advances an evidence-led approach that defines the "relevant public" as the cohort bearing the burden for the product class and tests adequacy using sex-disaggregated, programme-specific data rather than national totals. A modest administrative adjustment to embed this gender lens is outlined at the end.

THE LEGAL LANDSCAPE

Compulsory licensing is lawful under TRIPS and the Doha Declaration, and in India it operates through sections 84, 92, and 100 of the Patents Act, 1970. In practice, Natco Pharma v. Bayer on sorafenib set a sales-linked royalty of 6 percent, raised to 7 percent on appeal, entrenching affordability and workable supply as operative criteria. By contrast, in 2013, the government declined a trastuzumab CL and relied on biosimilars and litigation to lower prices. Judicial engagement has increased, as shown by the Kerala High Court's 2022 direction to consider a Ribociclib CL after an affordability showing. Alongside CL, India routinely uses NPPA price ceilings and Jan Aushadhi procurement. The policy pattern is a toolbox: use CL when patents are the binding constraint on competition and affordability; use price control, biosimilar competition, and public procurement when system design, not exclusivity, is the problem.

CASE STUDY: RIBOCICLIB AND OXYTOCIN

Ribociclib (Kisqali/Kryxana) treats a common type of advanced breast cancer and is patented in India until 2027. Recent Form 27 filings indicate import-only working, limiting domestic supply. Retail-channel treatment costs remain high relative to household means in public schemes. Section 84 permits a compulsory license where the reasonable requirements of the public are unmet, price is not reasonably affordable, or working in India is inadequate. On the record, ribociclib supply to the relevant public is materially below clinical need (Form 27 volumes versus eligible-patient estimates); the medicine is not available in public channels at a reasonably affordable programme price; and the invention is not adequately worked in India, with import-only supply and no local manufacture or licenses. The criterias in section 84(1)(a) are therefore engaged. A CL here would permit additional Indian suppliers under a sales-linked royalty, while allowing the patentee to rebut through concrete undertakings on price and supply. Ribociclib illustrates why CL remains essential as a gender-just tool for medicines that disproportionately affect women.

Oxytocin is an off-patent obstetric essential whose reliability turns on system design rather than exclusivity. It is cheap and long used safely, yet access failures persist. In 2018, production was restricted to a single state-owned manufacturer, with private manufacture and imports banned. This policy created a de facto monopoly and raised fears of shortages across the country. Subsequently, the Delhi High Court struck down the restriction as arbitrary. The episode shows how exclusivity created by policy or procurement can undermine access even without patents. Oxytocin also suffers from cold-chain problems: it must be stored at 2–8°C. Breaks reduce potency, meaning women may receive an ineffective dose during childbirth. The global solution, heat-stable carbetocin (HSC), which does not require refrigeration, is covered by patents and controlled by Ferring Pharmaceuticals. Oxytocin itself does not need a compulsory license, but it is an indirect IP story.

These cases suggest a simple rule, that is, to choose the instrument that addresses the binding constraint, and where exclusivity and inadequate working keep effective prices high, as with ribociclib, compulsory licensing under section 84(1)(a) is the appropriate route, with terms set under section 90. Where the constraint is system design, as with oxytocin's cold chain, governance tools and procurement should be used first as the least-restrictive, faster remedy that preserves multi-supplier competition; only if the programme elects a patented fix, such as heat stable carbetocin, do licensing tools return to the table, preferably via a voluntary licence and, failing that, a targeted compulsory licence.

ADDRESSING COUNTER ARGUMENTS

The first and most common objection is that CL deters pharmaceutical R&D. In women-predominant indications such as HER2 and HR positive breast cancer, Yang still finds that firms subject to CL obligations increased R&D spending under competitive pressure. This suggests that CL does not inevitably stifle innovation; rather, it can spur a dynamic response in the industry.

The second objection is trade or diplomatic retaliation. In women's health contexts, Thailand is often cited, yet the WHO's 2007 endorsement confirmed that Thailand's CL was TRIPS-compliant in a documented public health crisis, a frame that equally applies where women face affordability barriers to oncology or reproductive medicines. The point is not that politics disappear, but that law and institutions stand firmer when public health grounds are noted.

Third, critics argue that royalties are unfair. The Natco v. Bayer (Nexavar) decision shows India can fix six to seven percent sales linked royalties and still secure price cuts, which speaks to debates on women’s oncology pricing. So, this balance can compensate patentees while patients receive affordable treatment.

Fourth, some worry about “grey markets”, where medicines produced under a compulsory licence leak into other countries. Yang notes that TRIPS Article 31(f) limits production to “predominantly for the domestic market”, which is meant to address that very real risk. Kaur and Chaturvedi add that measures such as distinct packs, holograms, and tight distribution systems can limit diversion. Ultimately, this is a regulatory issue rather than a flaw in compulsory licensing itself.

Finally, critics argue that the term “emergency” is stretched too far. Kaur and Chaturvedi show that the same prevalence can translate into very different numbers of patients, which matters for programme triggers in women’s health services. A single, rigid cut off would flatten these differences. Letting governments define emergencies locally keeps CL better aligned with real public health need.

Finally, some argue compulsory licensing is unnecessary because procurement can do the work; India’s HPV/Cervavac trajectory suggests that tendering and planning often deliver broad vaccination coverage when exclusivity is not the constraint. This indicates that affordability may be achieved through competition and procurement in such cases. The implication then is not “never CL,” but “CL when patents block access; governance when they do not.”

These worries, therefore, do not call into question the legality or need for compulsory licensing. Instead, they show why it must be used carefully, as a focused public health tool rather than a broadside against patent rights.

ANALYSIS AND CONCLUSION

These examples show not just gaps in public health, but also the way women’s health is routinely treated as peripheral within how the patent system operates today. Despite being listed by the WHO as an essential medicine, the delay in affordable access shows how patents on biologics delay life-saving treatment for women. Endometriosis remains under-researched and underdiagnosed in many nations despite affecting many women of reproductive age. The neglect itself reflects gender bias in innovation pipelines and policy prioritization. These patterns show that some barriers are patent driven while others are systemic.

Another argument is distributive: the social bargain of patents is premised on “public” benefit, but the category of “public” is itself constructed as gender-neutral and therefore blind to gendered burdens. Substantive equality and recognition–redistribution theory indicate that facially neutral metrics reproduce unequal outcomes when need and access are gendered; and intersectionality cautions that “women” itself is internally stratified by caste, class, disability, and place. A gender lens is therefore a method, not an ornament: the relevant public is the cohort that bears the burden for the product class, and adequacy should be judged on sex-disaggregated, programme-specific evidence rather than national aggregates. This reframes patent administration from counting totals to verifying who actually receives access, without departing from the patent bargain.

My proposal is that India should adopt a Gender Impact Test as part of its compulsory licensing process. Much like environmental impact assessments, a gender test would require patentees and regulators to assess whether denial of licences disproportionately affects women’s health outcomes. When a patented product addresses a WHO-listed need, or a condition with a predominantly female burden, and credible evidence shows stock-outs, inadequate coverage, or non-affordable prices in public schemes, Controllers should treat the “reasonable requirements of the public” in section 84(1)(a) as presumptively unmet, subject to rebuttal by patentees by filing concrete, time-bound undertakings on price, supply, and working sufficient to close the documented shortfall; absent fulfilment, the presumption stands. To operationalise this without changing primary law, a possible solution could be to amend the Patents Rules to require both compulsory licence applicants and opposing patentees to file a concise Gender Access Statement that provides sex-disaggregated supply, price, and coverage data where relevant, and attaches program evidence such as NFHS-5 indicators for method mix and unmet need, Pharma Sahi Daam for regulated and retail price evidence, etc. When fixing terms under section 90, Controllers should recognise gendered health externalities within the “nature of the invention” and the public interest, aligning royalty setting with Bayer v. Natco’s reasonable royalty approach.

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Author:
*Ms. Ishita Sharma,
4th Year B.B.A., LL.B (Hons.) Student, O.P. Jindal Global University, Sonepat.

Disclaimer: The opinions expressed in the article are the personal opinions of the author. The facts and opinions appearing in the article do not reflect the views of the Alliance Centre for Intellectual Property Rights (ACIPR) and the Centre does not assume any responsibility or liability for the same.