CURING THE SYSTEM: WHY PHARMACEUTICAL PATENT LAW MUST BE REBUILT FROM THE GROUND UP TO PROTECT HUMAN LIFE

Sakshi Agarwal*

Abstract

The global pharmaceutical patent system is suffering a legitimacy crisis. Designed to incentivise innovation by granting temporary monopolies to drug inventors, it has instead been systematically co-opted by corporate actors to construct near-permanent barriers to affordable medicine that kill people. Patent thickets, evergreening, reverse payment settlements, and the aggressive weaponisation of TRIPS-plus standards in bilateral trade agreements have together transformed intellectual property law from a public bargain into a private enrichment mechanism. In 2025 alone, the top twenty brand-name drugs in the United States were each protected by an average of 143 patent applications, the majority filed after regulatory approval and aimed not at genuine innovation but at delaying generic competition. Meanwhile, over three billion people worldwide lack access to essential medicines, a crisis the World Health Organisation has repeatedly characterised as catastrophic. This article argues that incremental reform is insufficient. What is needed is a structural overhaul of the pharmaceutical patent regime at both the national and international levels: adoption of India’s efficacy-enhancement standard under Section 3(d) as a global norm; compulsory licensing mechanisms stripped of the geopolitical coercion that renders them unusable; time-limited monopolies calibrated to genuine R&D costs; and a value-based innovation reward system that ends the perverse incentive to invest in evergreening rather than in drugs the world actually needs. Nothing less will cure the system.

Introduction

Consider a simple arithmetic fact, a monthly supply of imatinib mesylate, the cancer-fighting compound sold by Novartis as Glivec, costs approximately USD $5,000 in the United States and USD $200 as a generic in India. The drug is chemically identical. The patients suffering from chronic myeloid leukaemia are equally human. The difference, in its entirety, is patent law.¹

The pharmaceutical patent system rests on an elegant theoretical bargain society grants an inventor a time-limited monopoly in exchange for disclosure of the invention and the promise that, upon expiration of the monopoly, competition will make the product widely accessible. The system works tolerably well for smartphones, consumer goods, and industrial processes. It works catastrophically badly for drugs that people need to stay alive, because the asymmetry of bargaining power between a multinational corporation and a dying patient is near-infinite. When the monopoly on a life-saving medicine is extended, stretched, and multiplied through legal strategy rather than genuine scientific progress, the result is not merely an economic inefficiency it is a preventable death.

In 2024, total United States spending on prescription drugs reached almost $800 billion. Although low-cost generic drugs accounted for 91% of all prescriptions, the 9% filled with branded medicines accounted for 84% of drug spending.² This arithmetic is not the outcome of superior therapeutic value. It is the outcome of a patent system deliberately gamed. The average top-selling drug in the United States is now protected by 143 patent applications, the majority filed after FDA approval, covering everything from the active molecule to the autoinjector firing button.³ This article calls that system by its name a legal machine for extracting money from sick people, and it argues that the machine must be dismantled.

The Architecture of Monopoly: Patent Thickets, Evergreening, and the Legal Engineering of Scarcity

 A. The Patent Thicket Defined

A patent thicket is a dense web of overlapping intellectual property rights that a company must hack through in order to commercialise a competing product.⁴ In the pharmaceutical context, the strategy operates by stacking secondary patents covering formulations, polymorphs, salts, delivery devices, dosage regimens, manufacturing processes, and metabolites on top of a core molecule patent, such that the expiration of the original patent leaves a successor competitor entangled in hundreds of derivative claims, each of which must be challenged separately in expensive, time-consuming litigation.

AbbVie’s blockbuster immunosuppressant Humira is the canonical example. The drug’s primary patent expired in 2016. By then, AbbVie had filed 311 patent applications, 90% of them after the FDA granted approval in 2002, creating a thicket so dense that biosimilar competition was effectively locked out of the United States market until 2023, a full seven years after the primary patent’s expiry.⁵ During that extended monopoly, AbbVie increased Humira’s list price by 470%, reaching approximately $7,000 per month. The company generated over $114 billion in revenue from the product alone after 2016. On average, the twelve top-selling drugs in the United States carry 143 patent applications and 69 granted patents each, with 56% filed post-approval. Sanofi’s insulin product Lantus is entangled in 74 patents that collectively protect it from competition for 37 years.⁶

The patent thicket is not an accident of zealous inventors; it is a deliberate legal strategy. Pharmaceutical companies employ armies of patent lawyers whose job is not to invent but to forestall competition. This must be recognised for what it is a market-distortion mechanism that diverts scarce R&D capital from genuine scientific discovery into legal manufacturing.

B. Evergreening: The Art of Patenting the Obvious

Evergreening is the practice of obtaining new patents for minor, clinically immaterial modifications of an existing drug, such as a new salt form, a new polymorph, a new delivery mechanism, or a new dosage, to extend effective market exclusivity beyond the term of the original patent. In most jurisdictions, because patentability requires only novelty, inventive step, and industrial applicability, a new crystal form of an existing molecule qualifies as a ‘new’ substance even if it has identical therapeutic properties. The system, designed to reward genuine discovery, ends up rewarding the capacity to recognise that your original molecule can be crystallised in a different spatial arrangement.

The pharmaceutical industry has developed this strategy into a sophisticated playbook. Markush claims capture entire families of compounds under a single patent, blocking competitors from modifying even remotely related chemical structures. Polymorphic patents protect alternative crystal arrangements of the same active ingredient. Formulation patents cover extended-release versions or new excipients. Method-of-treatment patents claim new indications for existing molecules. Each of these secondary patents resets the clock, extending the effective period of exclusivity by years, even decades.

The Novartis Glivec case before the Indian Supreme Court stands as the global judicial high-water mark in resisting evergreening. Novartis sought a patent on the beta-crystalline form of imatinib mesylate, a specific polymorph of the compound, arguing that its improved bioavailability in rats constituted sufficient innovation. The Supreme Court disagreed, holding that increased bioavailability without demonstrated enhanced therapeutic efficacy did not satisfy the standard set by Section 3(d) of the Indian Patents Act. In consequence, the generic version of imatinib became available in India at approximately 90% below the Novartis list price, and an estimated 500,000 chronic myeloid leukaemia patients gained access to treatment they could afford.⁷

The case is instructive not only for its outcome but for what it reveals about the global patent system’s design flaw. In forty other countries, including the United States, China, and Russia, Glivec received a patent on the same polymorph that India rejected.⁸ The difference was not the molecule; it was the standard of patentability. Where the standard is low, evergreening succeeds. Where it is higher, it fails. This observation contains the kernel of the entire reform agenda.

C. Regulatory Exclusivity: The Hidden Monopoly Extension

Beyond patents, pharmaceutical companies benefit from regulatory exclusivity—a parallel system of market protection granted by drug regulators independently of patent validity. Under United States law, new chemical entities receive five years of data exclusivity during which generic manufacturers cannot rely on the innovator’s clinical data to obtain FDA approval. Biologics receive 12 years of exclusivity under the Biologics Price Competition and Innovation Act.⁹ Orphan drug designations confer 7 years of exclusivity, and a 6-month pediatric extension is available for pediatric trials. These exclusivities are layered on top of patent protection, often running concurrently or, more damaging still, consecutively, meaning that by the time both the patents and the regulatory exclusivities have expired, the effective monopoly period may far exceed the nominal twenty-year patent term.

The 30-month automatic stay provision of the Hatch-Waxman Act compounds the problem. When a generic manufacturer files an Abbreviated New Drug Application and certifies that the brand-name company’s patents are invalid or not infringed, the FDA is required to automatically halt the approval process for thirty months, giving the brand-name manufacturer time to litigate regardless of the merit of the underlying patent claims.¹⁰ This provision was designed as a safeguard; it has become a routine delay tactic, systematically weaponised to postpone generic entry irrespective of whether the asserted patents would survive scrutiny.

TRIPS and the Failure of Global Flexibilities: Paper Rights in a Hostile World

A. The TRIPS Architecture and the Doha Promise

The Agreement on Trade-Related Aspects of Intellectual Property Rights, which entered into force in 1995 as part of the World Trade Organisation legal framework, established minimum standards of intellectual property protection applicable to all WTO member states.¹¹ Among its most consequential provisions, Article 27 requires members to grant patents for inventions in all fields of technology, ending developing countries’ ability to exclude pharmaceutical products from patent eligibility, as India had done until 2005 under its 1970 Patents Act.¹²

The immediate effect on access to medicines was severe. Antiretroviral drugs for HIV/AIDS, which Indian generic manufacturers had been producing and exporting at a fraction of Western prices, became subject to patent protection. Countries that had relied on Indian generics principally in sub-Saharan Africa suddenly faced a choice between paying brand-name prices and watching their populations die. The HIV/AIDS crisis made the contradiction between TRIPS and public health politically untenable, and in 2001, the WTO Ministerial Conference adopted the Doha Declaration, which affirmed that the TRIPS Agreement ‘does not and should not prevent Members from taking measures to protect public health’ and confirmed the right of member states to determine the grounds for issuing compulsory licenses.¹³¹⁴

The Doha Declaration was greeted as a breakthrough. In the two decades since, it has proven to be largely a paper promise. The compulsory licensing mechanism under Article 31 of TRIPS, while theoretically available to all member states, carries stringent procedural requirements, and Article 31(f) historically restricted production under compulsory license to predominantly domestic supply, an enormous constraint for least-developed countries with no manufacturing capacity.¹⁵ The 2003 General Council Decision and the subsequent 2017 Protocol Amending TRIPS addressed this by allowing countries with manufacturing capacity to export under a compulsory license, but the implementing conditions are so complex and the transaction costs so high that the mechanism has been used only sparingly.¹⁶

B. The Chilling Effect: Geopolitical Coercion and the Threat of Trade Retaliation

The deepest failure of the TRIPS flexibility regime is not procedural; it is political. Countries that have attempted to use compulsory licensing have faced systematic coercion from the governments of patent-holding nations, operating on behalf of their pharmaceutical industry.¹⁷

Thailand’s experience is illustrative. In 2006 and 2007, Thailand issued government-use licenses for antiretroviral and cardiovascular drugs, including efavirenz, lopinavir/ritonavir, and clopidogrel. The United States government placed Thailand on its Special 301 ‘Priority Watch List,’ a designation that signals the possibility of trade sanctions. The Swiss government sent formal diplomatic communications threatening consequences for Thai investment in pharmaceutical manufacturing. The European Commission threatened sanctions after Thailand announced plans to license Plavix.¹⁸ These were not isolated incidents; they represent a systemic pattern of using bilateral trade pressure to deter the legitimate exercise of rights explicitly conferred by multilateral agreements.

India’s experience reinforces this pattern. After issuing its first compulsory license for sorafenib tosylate (Nexavar), Bayer’s kidney cancer drug, in 2012, India faced intense backlash from the US government and pharmaceutical industry lobbies. The generic version was priced approximately 96% below Bayer’s original price. India has issued no further compulsory licenses since, despite numerous patented medicines being unaffordable to the vast majority of its population.

Throughout the COVID-19 pandemic, which offered the most urgent possible justification for compulsory licensing, only three compulsory licenses appear to have been issued globally. The India-South Africa TRIPS waiver proposal, advanced at the WTO in 2020 and backed by over 100 developing countries, sought a temporary waiver of TRIPS obligations for COVID-19 health products. It was blocked for nearly two years, primarily by the United States, the European Union, the United Kingdom, and Switzerland, the home jurisdictions of the major vaccine manufacturers, before a narrow, heavily negotiated compromise emerged in 2022 that many public health advocates condemned as inadequate.

The lesson is clear. The TRIPS flexibility regime, as currently designed, is not a genuine mechanism for ensuring access to medicines. It is a pressure-release valve that functions only when the countries invoking it are too large or important for coercion to succeed. For small, economically vulnerable nations, that is, those with the greatest unmet pharmaceutical needs, it is effectively inoperative.¹⁹

C. TRIPS-Plus Provisions: The Bilateral Erosion of Flexibilities

Parallel to the failure of the multilateral system, a process of bilateral erosion has been underway since the 1990s. Free trade agreements negotiated by the United States, the European Union, and other IP-exporting nations have systematically included TRIPS-plus provisions, intellectual property standards exceeding TRIPS minimums, as a condition of market access. These provisions routinely include data exclusivity periods longer than TRIPS requires, patent term extensions for regulatory delays, linkage requirements that tie drug approvals to patent status, and restrictions on the grounds for compulsory licensing.

As the UN Secretary-General’s High-Level Panel on Access to Medicines concluded in 2016, the resulting patchwork of international obligations has ‘distorted innovation and access to medicines,’ setting IP protections on a trajectory that consistently favours wealthy nation interests over global health equity. The report called on WTO members to make full use of the policy space in Article 27 by adopting rigorous patentability criteria that curtail evergreening. As of 2026, fewer than a handful of countries have followed this recommendation.²⁰

The Current Reform Wave: Necessary but Insufficient

 A.  The United States Inflation Reduction Act

 The Inflation Reduction Act of 2022 represents the most significant legislative intervention in the United States pharmaceutical pricing in the country’s history.²¹ Its core drug-pricing provision grants Medicare for the first time the authority to directly negotiate prices for high-cost prescription drugs. The first negotiation cycle produced dramatic results: the ten selected drugs, including blockbusters Eliquis, Jardiance, and Januvia, saw prices reduced by an average of 38% to 60% below their 2023 list prices, with negotiated prices taking effect in 2026.²²

The IRA is consequential because it ruptures the political orthodoxy that government price negotiations amount to ‘price controls,’ which are antithetical to innovation. But its structural limitations are severe. The IRA’s pricing provisions apply only to Medicare, roughly one in five Americans, leaving the vast majority of patients without its protections. Small-molecule drugs become eligible for negotiation only after nine years on the market; biologics must wait thirteen years. These timelines are long enough that, combined with evergreening strategies, a company can cycle to a next-generation product before the original is ever put up for negotiation.²³

Industry critics argue that the IRA has already begun to chill innovation by shortening the period of effective revenue capture. The Information Technology and Innovation Foundation has argued that the IRA leaves companies with fewer incentives and resources to invest in future drug development, particularly for small-molecule drugs that face a shorter effective commercial window.²⁴ This argument contains a kernel of genuine concern: if reform is so aggressive as to eliminate genuine innovation incentives, it achieves access at the cost of the future drugs that people need. But the ITIF’s analysis considerably overstates the threat. The IRA does not eliminate patent protection or prevent companies from charging market-rate prices to non-Medicare payers; it merely introduces a single major payer’s negotiating authority. A system that collapses the moment Medicare can negotiate is not a robust innovation ecosystem; it is one built on artificially inflated rents.

B.  Patent Thicket Legislation

In July 2024, the United States Senate unanimously passed the Affordable Prescriptions for Patients Act, a bipartisan bill that limits the number of patents pharmaceutical companies can assert in infringement litigation against biosimilar competitors. The legislation directly targets the Humira-style strategy of weaponising patent thickets to prevent generic entry. The Congressional Budget Office projected that the bill would generate $1.8 billion in taxpayer savings over a decade, a meaningful but modest sum given the scale of the problem. The USPTO concurrently issued new fee structures for fiscal year 2025 that substantially increase the cost of filing continuation patents, creating financial disincentives to the accumulation of large, overlapping thickets of disclosures.²⁵

These are welcome developments. But they share a structural limitation: they address the symptoms rather than the disease. Limiting the number of assertable patents in litigation does not stop companies from filing hundreds of secondary patents; it merely constrains how many can be deployed in a single suit. A pharmaceutical company with a strategic patent team will adapt sequencing litigation across multiple suits or restructuring patent portfolios to circumvent the new limits. The reform approach is a game of legal whack-a-mole.

C.  India’s Section 3(d) Model: A Global Template Misapplied

The most structurally sound reform innovation in the world today is Section 3(d) of the Indian Patents Act, which disqualifies new forms of known substances from patentability unless they demonstrate significantly enhanced therapeutic efficacy.²⁶ The provision was specifically designed to prevent evergreening, and the Novartis Glivec litigation demonstrated that it can withstand both domestic constitutional challenge and WTO-compatibility scrutiny.

The global impact of Section 3(d) has been significant. India is often described as the ‘pharmacy of the world,’ supplying approximately 20% of all generic medicines globally by volume and 60% of global vaccine production. That capacity depends on the ability to manufacture off-patent or non-patented drugs. Section 3(d) has preserved that capacity against systematic legal capture. South Africa’s draft IP policy has proposed similar standards. The UN High-Level Panel on Access to Medicines has recommended the global adoption of efficacy-enhancement requirements as a condition of pharmaceutical patentability.

India has recently complemented this with the Patents (Amendment) Rules, 2024, which streamline the pre-grant opposition process, a mechanism allowing third parties to challenge a patent application before it is granted.²⁷ Pre-grant opposition, where it functions well, is far more efficient than post-grant invalidation it prevents bad patents from issuing rather than requiring expensive litigation to remove them after they have already been used to delay generic entry for years. Most countries do not have this mechanism, or have versions so procedurally complex as to be effectively unavailable.

Despite these advances, India’s model faces two significant limitations. First, the ‘efficacy’ standard under Section 3(d) has never been clearly defined, creating uncertainty that burdens both innovators and generic manufacturers. The Indian Patent Office’s implementation has been inconsistent, and the academic literature reflects ongoing debate about where the line falls between genuine therapeutic advance and evergreening. Second, even where Section 3(d) successfully blocks evergreening, it operates only at the national level. A company whose polymorph patent is rejected in India may still have it granted in 50 other countries, creating a global thicket it can use to pressure Indian generic manufacturers through export restrictions, international arbitration, or trade agreement mechanisms.

A Comprehensive Reform Agenda: What the Law Must Change

 A.  Raising the Global Floor of Patentability

The most important single reform is the adoption of a global minimum standard of patentability that disqualifies secondary pharmaceutical patents without demonstrated therapeutic advantage. The current TRIPS minimum requirements for novelty, inventive step, and industrial applicability are too permissive. An inventive step requirement that can be satisfied by a crystal polymorph of an existing compound does not serve the purpose that patent law is supposed to serve. The reform agenda should proceed on two tracks simultaneously.

First, at the national level, every country should enact an efficacy-enhancement requirement analogous to Section 3(d). The precise formulation can vary by legal tradition, but the principle should be uniform: a new form of an existing pharmaceutical compound is not patentable unless the applicant demonstrates, through rigorous comparative clinical evidence, that the new form provides a therapeutically meaningful benefit over the original. Bioavailability data in animal models should not suffice; only human clinical evidence of improved therapeutic outcomes should.

Second, at the multilateral level, the WTO TRIPS Council should initiate a negotiation to incorporate an efficacy-enhancement standard as an explicit TRIPS provision. This will require political will that currently does not exist, given the opposition of IP-exporting nations. But it should be framed not as an assault on innovation but as a clarification that genuine pharmaceutical innovation, which does advance therapeutic outcomes, is fully protected. Only the legal simulation of innovation polymorph patents, salt patents, and cosmetic reformulations is excluded. This framing commands broad public support across the political spectrum and should be the foundation of a coalition-building strategy involving patient advocates, generic manufacturers, public health organisations, and the governments of developing nations.

B.  Reforming Compulsory Licensing: Making the Remedy Real

The compulsory licensing mechanism under Article 31 of TRIPS must be fundamentally redesigned to function in practice, not merely in theory. Three structural changes are essential.

First, the WTO must adopt a binding anti-coercion norm prohibiting member states from retaliating, through trade measures, Special 301 designations, or diplomatic pressure, against other member states exercising TRIPS flexibilities in good faith. The current system allows wealthy nations to nullify multilaterally agreed rights through bilateral power asymmetry. The solution is not to plead with powerful nations to behave better but to formalise the prohibition and attach trade consequences to its violation.

Second, the procedural requirements for compulsory licensing under Article 31 must be simplified. The current requirement that countries first negotiate with the patent holder ‘on reasonable commercial terms and conditions’ for a ‘reasonable period of time’ which courts and arbitrators have interpreted expansively creates delay that is unconscionable in a public health emergency. A streamlined emergency pathway should allow health ministers to invoke compulsory licensing for defined essential medicines with a notification period measured in days, not months.

Third, the Article 31bis mechanism for exports under compulsory license the successor to the 2003 General Council Decision must be operationally simplified. The requirement that importing countries establish that they have insufficient domestic manufacturing capacity, combined with the need to specify quantities in advance and satisfy multiple notification requirements, has made the mechanism virtually unusable. A reformed mechanism should impose a single notification requirement, allow blanket designations for categories of essential medicines, and eliminate the requirement of pre-determined quantity specifications.

C.  Dismantling Patent Thickets Through Structural Patent Reform

Patent thickets cannot be adequately addressed by limiting the number of assertable patents in litigation. The problem is upstream: the patents should not be granted in the first place. Three structural reforms are necessary.

First, pharmaceutical patent offices should implement a pharmaceutical-specific examination standard that requires applicants to affirmatively demonstrate, at the time of filing, that a secondary patent represents a genuine therapeutic advance over the original compound. This places the burden of proof where it belongs: on the applicant seeking a twenty-year monopoly, not on generic manufacturers who must mount expensive invalidation challenges years later.

Second, mandatory patent disclosure requirements should require pharmaceutical companies to identify, in all regulatory submissions to drug approval agencies, every patent or patent application that they assert covers the approved product. This disclosure should be cross-referenced against a public database, and any patent not listed at the time of approval should be ineligible for use to block generic entry under Orange Book mechanisms.

Third, the thirty-month automatic stay under the Hatch-Waxman Act should be reformed to apply only to patents that have survived an inter partes review at the Patent Trial and Appeal Board. A patent that has never been tested for validity should not automatically paralyze a generic approval for two and a half years. As the bipartisan Senate legislation of 2024 represents a step toward controlling thicket litigation, a complementary reform should address the upstream patent quality problem that the legislation does not reach.

D.  Decoupling Innovation Incentives from Monopoly Pricing

The deepest structural flaw in the current system is that it uses monopoly pricing as the exclusive mechanism for rewarding pharmaceutical innovation. Under this model, the manufacturer’s revenue and therefore its capacity to fund future research depend entirely on its ability to prevent competition. The perverse consequence is that investment flows to drugs that can be effectively monopolised for long periods: lifestyle drugs, slightly differentiated me-too products, and chronic-condition treatments where large, wealthy-country populations will pay indefinitely. Investment does not flow to drugs for neglected tropical diseases, antimicrobials threatened by resistance, or conditions concentrated among populations without purchasing power.

The reform agenda should introduce alternative reward mechanisms that decouple access from pricing. Prize funds, in which governments pay a fixed award for the development of drugs that meet specified public health objectives in exchange for dedicating the relevant intellectual property to the public domain, have long been theorised and deserve serious legislative attention. Health impact funds, under which manufacturers elect to receive a payment tied to the actual health benefit their drug delivers globally, in exchange for selling at cost, represent a more sophisticated version of the same idea. Push mechanisms advance market commitments, direct public funding of pre-competitive research, and government-funded clinical trials reduce the private R&D cost burden and therefore the justification for extended monopoly pricing.

None of these mechanisms alone will replace the patent system. Together, they can substantially alter the innovation ecosystem, shifting incentives from monopoly management toward genuine therapeutic advance. The political obstacle is formidable: the pharmaceutical industry has successfully characterized any reduction in monopoly protection as an attack on innovation, and has spent billions of dollars in lobbying and litigation to maintain this framing. The factual case is on the other side. The current system underinvests in critical areas heart disease, early-stage cancers, antimicrobial resistance while overinvesting in legal strategies to protect drugs whose basic science is decades old.²⁸

E.  Reforming Regulatory Exclusivities 

Regulatory exclusivities data exclusivity, biologic exclusivity, orphan designation, pediatric extensions are overlaid on the patent system and independently extend effective monopoly periods. The twelve-year biologic exclusivity under the Biologics Price Competition and Innovation Act should be reduced to seven years, as biosimilar market data consistently demonstrates that the current twelve-year period far exceeds what is necessary to recoup R&D investment for biologics that achieve commercial success. The Association for Accessible Medicines has proposed precisely this reform, citing studies showing that biosimilars entering the market early through settlements have generated a mean of $5 billion in savings per molecule.

Data exclusivity periods should be made non-stackable with patent term. Where a drug is both patented and covered by data exclusivity, the exclusivity periods should run concurrently rather than consecutively. The current system allows manufacturers to treat these two protection mechanisms as additive, creating effective monopoly periods that vastly exceed what any plausible innovation calculus would require.

F.  Addressing the Global South: Equity as a Legal Obligation, Not Charity

Access to medicine for populations in low- and middle-income countries must be reframed from a charitable aspiration to a legal obligation. The current international legal framework permits but does not require differential pricing, technology transfer, or health-oriented compulsory licensing. It subjects countries that use these mechanisms to economic coercion. It places no obligation on manufacturers to ensure that their products are available in markets where populations cannot pay patent-protected prices.

An adequate reform would introduce a mandatory access obligation as a condition of patent protection to obtain a patent, a pharmaceutical manufacturer must demonstrate, at the time of application or within a specified period post-approval, either that the drug is available at an accessible price in low-income markets, or that a voluntary license has been granted to a qualified generic manufacturer for supply to those markets, or that the relevant technology has been transferred to a regional manufacturer. Failure to satisfy any of these conditions would trigger automatic compulsory licensing at a rate set by a standing international pricing arbitration panel.

This proposal will be criticised as radical. But the current status quo, in which a person’s access to a cancer drug is determined by their country of birth, is itself a radical inequality that the international legal order has chosen to formalise. A legal system that protects the right to a monopoly without imposing any corresponding obligation to make the monopolised product accessible is not a neutral framework; it is an active choice to prioritise property over life.

Conclusion

The pharmaceutical patent system is not broken in the sense of having strayed from its design. It is, in critical respects, working exactly as its most powerful stakeholders have shaped it to work: delivering extraordinary monopoly rents to corporations, insulating those rents from competitive pressure through legal strategies that bear no relationship to scientific innovation, and ensuring that the costs of this arrangement are borne disproportionately by people who are sick and cannot pay.

The reforms analysed in this article, the IRA’s Medicare negotiation authority, the Senate’s bipartisan patent-thicket legislation, India’s Section 3(d) efficacy standard, and the theoretical flexibilities of the Doha Declaration, are all necessary. None of them, individually or in combination as currently formulated, is sufficient. The system requires structural rebuilding, not incremental repair.

The reform agenda must be ambitious in proportion to the problem. That agenda includes: adopting a global minimum efficacy-enhancement standard for pharmaceutical patents; operationalizing compulsory licensing through an anti-coercion norm and procedural simplification; dismantling patent thickets at the point of examination rather than litigation; reducing regulatory exclusivities and making them non-stackable; introducing alternative innovation reward mechanisms that decouple access from monopoly pricing; and imposing a mandatory access obligation as a condition of patent protection in low-income markets.

The political economy of pharmaceutical patent reform is structurally hostile to change. The industry is among the best-funded lobbying forces in democratic politics. But the calculus is shifting. The COVID-19 pandemic exposed vaccine inequity to global public consciousness in a way that two decades of advocacy had failed to achieve. Rising drug prices have generated bipartisan political anger in the United States. And the moral case is, at bottom, unanswerable: a legal system that lets people die to protect a corporate revenue stream when those deaths could be prevented by modifying a set of laws is not a legal system that deserves its legitimacy.

Final Year, B.A. LL.B Student, University of Allahabad

¹Novartis AG v. Union of India & Others, (2013) 6 S.C.C. 1 (India) [hereinafter Novartis case].

²StatNews,     End     Patent    Extensions     for    Drugs     with     ‘One-and-Done’     Monopolies     (Apr.     1,     2025), https://www.statnews.com/2025/04/01/drug-spending-patent-extension-one-and-done-monopoly-fda-hatch-

waxman-bpcia/.

³Kristi Martin, How Drugmakers Use the Patent Process to Keep Prices High, Commonwealth Fund (Nov. 13, 2025), https://www.commonwealthfund.org/publications/explainer/2025/nov/how-drugmakers-use-patent-process-keep-prices-high.

⁴Ryan Knox & Gregory Curfman, The Humira Patent Thicket, the Noerr-Pennington Doctrine and Antitrust’s Patent Problem, 40 Nature Biotechnology 1761, 1761 (2022).

⁵Evernorth, How Drugmakers Exploit the Patent System to Delay Competition and Inflate Prices (June 4, 2025), https://www.evernorth.com/articles/how-drugmakers-exploit-patent-system-delay-competition-and-inflate-prices.

⁶PharmExec, The New Era of U.S. Pharmaceutical Pricing: From Policy Upheaval to Strategic Adaptation (Apr. 2026), https://www.pharmexec.com/view/pharmaceutical-pricing-policy-strategic-adaptation.

⁷South Centre, The Novartis Decision by India’s Supreme Court: A Good Outcome for Public Health (2013), https://www.southcentre.int/question/the-novartis-decision-by-indias-supreme-court-a-good-outcome-for-public-health/.

⁸Dorothy Du, Novartis AG v. Union of India: ‘Evergreening,’ TRIPS, and ‘Enhanced Efficacy’ Under Section 3(d), 21

1. Intell. Prop. L. 1 (2014)

⁹Biologics Price Competition and Innovation Act of 2009, Pub. L. No. 111-148, 124 Stat. 804 (2010).

¹⁰Drug Price Competition and Patent Term Restoration Act, Pub. L. No. 98-417, 98 Stat. 1585 (1984).

¹¹Agreement on Trade-Related Aspects of Intellectual Property Rights art. 27, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organisation, Annex 1C, 1869 U.N.T.S. 299 [hereinafter TRIPS Agreement].

¹²TRIPS Agreement, art. 28.

¹³Declaration on the TRIPS Agreement and Public Health, WTO Ministerial Conference, 4th Sess., Nov. 14, 2001, WT/MIN(01)/DEC/2.

¹⁴Doha Declaration, para. 5(b).

¹⁵TRIPS Agreement, art. 31.

¹⁶Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WTO General Council Decision of Aug. 30, 2003, WT/L/540 (2003).

¹⁷Boston Univ. Global Dev. Policy Ctr., GEGI Policy Brief 027 2 (Feb. 2024), https://www.bu.edu/gdp/files/2024/02/GEGI-PB-027-DOHA-FIN.pdf (noting that throughout the COVID-19 pandemic, only three compulsory licenses appear to have been issued).

¹⁸Medicines Law & Policy, Pressure from European Countries Related to the Use of TRIPS Flexibilities (May 2024), https://medicineslawandpolicy.org/2024/05/pressure-from-european-countries-related-to-the-use-of-trips-flexibilities/.

¹⁹Li & Guo, Compulsory Licensing of Pharmaceuticals During Public Health Crisis: A TRIPS Framework Analysis, 13 Frontiers in Pub. Health art. 1630586, at 5 (Sept. 12, 2025), https://doi.org/10.3389/fpubh.2025.1630586.

²⁰Marq. Intell. Prop. L. Rev., Peter K. Yu, TRIPS and Its Discontents, 10 Marq. Intell. Prop. L. Rev. 369, 410 (2006).

²¹Inflation Reduction Act of 2022, Pub. L. No. 117-169, 136 Stat. 1818 (2022) [hereinafter IRA].

²²PharmExec, supra note 8 (the first ten drugs subject to Medicare negotiation, including Eliquis, Jardiance, and Januvia, saw prices reduced by an average of 38–60% below their 2023 list prices).

²³Ass’n         for         Accessible          Meds.,         Intellectual         Property         &          Patent         Reform         (2025), https://accessiblemeds.org/advocacy/intellectual-property-patent-reform/ (citing IQVIA Institute data showing patent settlements since FTC v. Actavis have saved the healthcare system $423 billion through early generic market entry).

²⁴ITIF, The Inflation Reduction Act Is Negotiating the United States Out of Drug Innovation (Feb. 25, 2025), https://itif.org/publications/2025/02/25/the-inflation-reduction-act-is-negotiating-the-united-states-out-of-drug innovation/ .

²⁵Global Legal Post, How Proposed Drug Pricing and Patent Reform Bills Will Impact US Pharma Innovation (July 17, 2024), https://www.globallegalpost.com/news/how-proposed-drug-pricing-and-patent-reform-bills-will-impact-us-pharma-innovation-1926815740.

²⁶Patents Act, No. 39 of 1970, § 3(d) (India).

²⁷Patents (Amendment) Rules, 2024, G.S.R. 183(E) (India)

²⁸Stanford Lawyer Magazine, Pharmaceutical Pricing and Access Beyond Patent Reform (Dec. 5, 2023), https://law.stanford.edu/stanford-lawyer/articles/pharmaceutical-pricing-and-access-beyond-patent-reform/.