Constitutional Mandates And Patent Monopolies: Gender Analysis Of Ribociclib Case

Contemporary oncology resides in a "Gilded Age of Medicine" where rapid breakthroughs coexist with devastating economic barriers (O'Reilly et al., 2025). The escalating costs of life-saving therapies—specifically CDK4/6 inhibitors—create profound friction between the constitutional Right to Life under Article 21 and the statutory Right to Reward for corporate innovation. Indian jurisprudence, however, prioritizes survival. Precedents like Vincent Panikurlangara v. Union of India (1987) and Paschim Banga Khet Mazdoor Samity v. State of West Bengal (1996) establish that protecting life is a primary, sovereign obligation. When private patent monopolies facilitate exorbitant, unregulated pricing, they function as a "constructive denial" of this fundamental right.

This accessibility crisis is illustrated by In Re Exorbitant Pricing of Life Saving Patented Medicines (W.P.(C) No. 18999/2022) before the Kerala High Court. Initiated in June 2022 by a retired bank employee challenging Novartis's Ribociclib (Kisqali), the litigation exposed severe barriers. Priced over Rs. 58,000 per month (rising to Rs. 78,468.75 in July 2026), the medicine was far beyond her pension; she tragically passed away while the case was pending. The High Court converted the petition into a suo motu Public Interest Litigation (PIL). Yet, the case suffered chronic delays, undergoing 58 listings and 40 adjournments. In July 2026, the Supreme Court registered a suo motu petition, In Re: Access to Life Saving Medicines and Judicial Expediency in Article 21 Matters (SMW(C) No. 19/2026), directing the High Court to resolve the matter expeditiously.

The Human Cost and Gendered Injustice of Healthcare Barriers

The structural violence of high pricing is compounded by deep-seated gender inequalities in India (Sen et al., 2007). Indian women face severe healthcare barriers, including a lack of financial autonomy, household prioritization of men's health, and a disproportionate domestic labour burden (Mike, 2020). When therapies cost Rs. 78,000 to Rs. 80,000 per month, they become inaccessible to the majority of women, who lack independent resources or comprehensive insurance (Siddiqui & Rajkumar, 2012). Under CEDAW and the ICESCR, the state must ensure private patent monopolies do not constructively deny women their survival.

This barrier has severe consequences: India's five-year breast cancer survival rate is 65.7%, far below the global average of 77.8%, largely due to unaffordable medicines. The human cost is embodied by Smt. Majida Abdul Majeed, a 49-year-old lawyer who impleaded herself in August 2026. Undergoing treatment costing approximately INR 80,000 per month, she describes it as "life-saving" but "life-punishing" due to constant financial terror (Ramachandran, 2026). Her struggle demonstrates that the state's failure to regulate monopolistic pricing forces an unlawful choice between clinical deterioration and economic ruin.

The Neoliberal Shift in Intellectual Property: From Inventor to Speculative Investor

Historically, patent law rested on a social contract: a temporary monopoly was granted in exchange for public disclosure to stimulate scientific progress (Chander & Sunder, 2004) and reward the individual "inventor" (Coombe, 1998). Under contemporary neoliberal globalization, however, ownership has shifted to speculative corporate investors (Qadeer, 2010). Patents now operate as speculative assets managed to maximize shareholder returns and monopoly rents (Zakout, 2025).

Pharmaceutical corporations deploy secondary patent thickets (evergreening), market-skimming, and trade secret enclosures to exclude generic competition (Durkin et al., 2021). This investor-dominated bioeconomy is visible in oncology: between 2010 and 2019, oncology revenues among ten major firms rose by 70%, while non-cancer revenues fell by 18% (Mike, 2020). This dynamic weaponizes patents as tools of exclusion, contradicting the balance of private reward and public utility in Article 7 of TRIPS. Fiduciary duties to maximize profit directly conflict with the public's right to access scientific progress (Foster, 2012; Zakout, 2025).

The "Interchangeability Impasse" and Clinical Realities

A central defense raised by the Government of India and Novartis AG in the Kerala High Court is that sovereign intervention in patent rights is unnecessary because cheap, generic alternatives are already widely available. Specifically, they state that Palbociclib is produced by over 20 domestic generic companies, reducing treatment costs to Rs. 2,000–4,000 per month. This led the Kerala High Court to initially observe that if Palbociclib is a clinically viable substitute, the question of compulsory licensing for Ribociclib is "purely academic."

However, medical experts challenge this "same indications" assertion as a misleading scientific claim. Dr. R. Ravi Kannan (Director of Cachar Cancer Hospital) explained that the three CDK4/6 inhibitors are clinically distinct and not therapeutically interchangeable. Conflating the metastatic setting (where Palbociclib has a limited role) with early-stage settings (where it failed to show therapeutic benefit) is a dangerous scientific error (Provenzano et al., 2025). Forcing low-income women to accept a cheaper, clinically ineffective treatment constructively shuts down their only chance of survival (Ramachandran, 2026).

The Respondent Defense Framework: Risk Capital and Market Reality

In defending their pricing models, pharmaceutical respondents utilize a sophisticated socio-economic and legal framework to protect corporate capital and resist regulatory interventions:

The Economics of Innovation: Citing Tufts CSDD data, pharmaceutical companies argue that high pricing is essential to recoup the average $2.6 billion development cost of a drug, given a mere 12% clinical approval rate.

Evidence of Active Working: Corporations point to Form 27 filings to demonstrate active commercial working via importation. For instance, Eli Lilly imported Abemaciclib worth INR 21.32 crore in 2021-22, and Novartis imported Ribociclib worth INR 83.67 crore in 2022.

Access and Compassionate Initiatives: Respondents highlight that India's market pricing (e.g., Kryxana at INR 23,625) is lower than Western markets (approx. INR 1.76 lakh in Germany). They argue that the NPPA's 30% Trade Margin Rationalization (TMR) and programs like UMAANG are sufficient.

Statutory Safeguards and the Threshold of Judicial Intervention

The Indian Patents Act, 1970, contains robust legislative "safety valves" designed to prevent monopolistic abuse and protect public health, in line with Article 7 of TRIPS. Sections 84, 92, and 100 represent the primary legal mechanisms for state intervention:

Section 84 (Compulsory Licensing): Allows any person interested to apply for a license three years post-grant if public requirements are unmet, the drug is unaffordable, or the patent is not locally manufactured ("worked") in India.

Section 92 (Special Provisions): Empowers the Central Government to notify compulsory licensing in situations of national emergency, extreme urgency, or public non-commercial use, bypassing standard procedural delays.

Section 100 (Government Use): Grounded in Directive Principles (Article 39), this provision grants the Central Government broad power to use or manufacture any patented invention "for the purposes of the Government."

Judicial interpretation has defined "affordability" and "working." In Natco v. Bayer (2012) (Sorafenib Tosylate), the court ruled that "working" a patent requires local manufacturing where feasible, not mere importation, adopting a patient-centric view of "reasonably affordable price." However, subsequent decisions show a rising evidentiary threshold that has stalled applications, as summarized below:

Compounding this, executive authorities resist invoking public health safeguards due to neoliberal pressure (Helfer, 2007). The MoHFW and DPIIT maintain that breast cancer (which kills 82,000+ annually in India) does not constitute a "national emergency" under Section 92. This defense conflates Section 100 with Section 92 to justify inaction, protecting corporate monopolies. This administrative resistance directly contradicts the constitutional mandate. Under Vincent Panikurlangara, state-sanctioned profiteering over scarce medical resources is "diabolic," and leaving monopolistic pricing unmitigated operates as a constructive denial of life under Article 21.

Institutional Reform: The Centralized Procurement Model and Universal Care

The prolonged Kerala litigation reveals the limits of case-by-case legal battles to resolve systemic healthcare access failures. Patients should not have to litigate to obtain essential healthcare. Realizing the state's positive obligations under Article 21 requires a fundamental transition away from a narrow, patent-by-patent compulsory licensing framework toward a comprehensive, publicly guaranteed continuum of care.

A viable pathway is found in the Supreme Court's pandemic-era jurisprudence. In its landmark Suo motu COVID-19 decision (AIR 2021 SC 2356), the Court proposed a "Centralized Procurement" model. Under this model, the Central Government acts as the sole negotiator, leveraging the state's bulk purchasing power to drive down prices. By negotiating directly with patent holders and decentralizing distribution, the state can bypass private monopolies and eliminate the "constructive denial" of healthcare. This model balances stakeholders' interests: it respects the "Right to Reward" by securing a predictable market for manufacturers while fulfilling the constitutional mandate to ensure healthcare access.

To operationalize this model, the Working Group on Access to Medicines and Treatments advocates for three key institutional reforms:

Universal Access to Cancer Treatment: The state must guarantee a free, continuous continuum of cancer treatment care, treating oncology services as a public good rather than a market commodity.

Systemic Price Controls and Generic Entry: The executive must proactively utilize Sections 92 and 100 to facilitate generic competition, which can reduce drug prices by 90% to 97%.

Clinical Trial Transparency: Regulators must require drug trials to focus on long-term overall survival rather than short-term surrogate endpoints that inflate perceived therapeutic value.

Upholding the Sovereign Obligation to Protect Life

The Ribociclib litigation is a critical proxy for the broader constitutional battle for affordable healthcare. It exposes how unregulated patent monopolies under the TRIPS Agreement compromise the state's positive duty to safeguard life under Article 21. Furthermore, the slow institutional response of the executive, legislature, and judiciary to women's health struggles in India reflects a troubling systemic inertia that must be dismantled.

Fulfilling the constitutional mandate requires a gender-sensitive, proactive framework. Whether by invoking Sections 92 and 100 of the Patents Act or adopting a centralized negotiation model, the state must dismantle investor-driven monopolies. The fundamental right to life must take precedence over speculative patent interests, ensuring that human survival is never treated as a luxury.

References: 

Chander, A., & Sunder, M. (2004). The romance of the public domain. California Law Review, 92(4), 1331-1373.

Coombe, R. J. (1998). The cultural life of intellectual properties: Authorship, appropriation, and the law. Duke University Press.

Durkin, A., Kesselheim, A. S., & Ross, J. S. (2021). Addressing the risks that trade secret protections pose for health and rights. Health and Human Rights Journal, 23(1), 129-138.

Foster, L. A. (2012). Patents, biopolitics, and feminisms: Locating patent law struggles over breast cancer genes and the Hoodia plant. International Journal of Cultural Property, 19(3), 371-400.

Helfer, L. R. (2007). Toward a human rights framework for intellectual property. Davis Law Review, 40, 971-1020.

Mike, J. H. M. (2020). Access to essential medicines to guarantee women's rights to health: The pharmaceutical patents connection. The Journal of World Intellectual Property, 23(3-4), 473-517.

Provenzano, L., Dieci, M. V., Curigliano, G., et al. (2025). Real-world effectiveness comparison of first-line palbociclib, ribociclib or abemaciclib plus endocrine therapy in advanced HR-positive/HER2-negative BC patients: results from the multicenter PALMARES-2 study. Annals of Oncology, 36(7), 762-772.

Qadeer, I. (2010). New reproductive technologies and health care in neo-liberal India: essays, CWDS, New Delhi.

Ramachandran, R. (2026, August 22). A Keralam patient dies, another joins legal battle as breast cancer drug case drags on. The Federal. https://thefederal.com/category/states/south/kerala/a-keralam-patient-dies-another-joins-legal-battle-as-breast-cancer-drug-case-drags-on-254333

Sen, G., Iyer, A., & George, A. (2007). Systematic hierarchies and systemic failures: Gender and health inequities in Koppal District. Economic and Political Weekly, 682-690.

Siddiqui, M., & Rajkumar, S. V. (2012). The high cost of cancer drugs and what we can do about it. Mayo Clinic Proceedings, 87(10), 935-945.

Zakout, G. A. (2025). Public versus Private Interests in Intellectual Property Rights Law: Where does the Right to Science Stand in Cancer Research? European Health and Pharmaceutical Law Review, 8(1), 3-17.

Author is a Faculty, School of Indian Legal Thought Mahatma Gandhi University. Views are personal.