BEYOND CIVIL REMEDIES: THE NEED FOR CRIMINAL LIABILITY IN INDIAN PHARMACEUTICAL PATENT INFRINGEMENT

1. INTRODUCTION

In January 2025, the World Health Organization issued a medical product alert warning that counterfeit versions of the immunotherapy drug IMFINZI (durvalumab) had been identified in Lebanon, Turkey, and Armenia, with the falsified products reported to contain no active ingredients.[1] That alert was not an isolated occurrence. According to a 2023 report of the United Nations Office on Drugs and Crime, falsified and substandard antimalarial medicines account for an estimated 267,000 deaths annually in Sub-Saharan Africa alone, with a further 169,000 deaths attributable to counterfeit antibiotics administered to children suffering from severe pneumonia.[2] The global counterfeit medicine market has been valued at up to 432 billion United States dollars per year, a figure that exceeds two hundred times the annual budget of the World Health Organization.[3]

India, which supplies approximately twenty percent of global generic medicines and is widely described as the pharmacy of the world, occupies a unique and paradoxical position in this crisis. The Patents Act, 1970 provides patent holders with an exclusively civil enforcement mechanism.[4] No criminal sanction exists for patent infringement, regardless of the scale, commercial intent, or public health consequences of the infringing act. This stands in sharp contrast to the position under the Trade Marks Act, 1999, the Copyright Act, 1957, and the Geographical Indications of Goods (Registration and Protection) Act, 1999, each of which provides for criminal prosecution and imprisonment.[5]

This article argues that the absence of criminal sanctions for patent infringement in India constitutes a structural inadequacy that facilitates the manufacture and distribution of counterfeit pharmaceutical products, and that the legislature should amend the Patents Act, 1970 to introduce targeted criminal liability for wilful infringement of pharmaceutical patents on a commercial scale. Section II sets out the existing legal framework and identifies the asymmetry between patents and other intellectual property rights. Section III analyses the public health consequences of the enforcement gap. Section IV examines comparative models from the United States, China, and the European Union. Section V offers proposals for legislative reform.

2. The Existing Legal Framework

2.1. Patent Enforcement Under the Patents Act, 1970

The Patents Act, 1970 confers upon a patent holder, by virtue of section 48, the exclusive right to prevent third parties from making, using, offering for sale, selling, or importing the patented product or process without authorisation.[6] When those rights are infringed, the statute provides for enforcement exclusively through civil proceedings. Sections 104 to 114 of the Act govern infringement suits and the reliefs available therein.[7] Under section 108, a court may grant a permanent injunction, award damages or an account of profits, and order seizure, forfeiture, or destruction of infringing goods.[8]

No provision of the Patents Act, 1970 creates a criminal offence for the act of patent infringement itself. Where the Act does prescribe criminal liability, these instances are confined to narrow ancillary matters such as falsely claiming that an article is patented, making unauthorised use of words indicating royal or government patronage, or furnishing false information to the Patent Office.[9] Even in those limited cases, the offences are non-cognisable and bailable, meaning the police may not arrest without a court order and bail is available as of right.[10] For the act of infringement itself, therefore, no police authority may investigate, no arrest may be made, and no criminal prosecution may be instituted.

2.2. The Asymmetry Among Intellectual Property Statutes

The exclusively civil character of patent enforcement is anomalous when viewed alongside the treatment of other intellectual property rights under Indian law. Section 103 of the Trade Marks Act, 1999 makes it a criminal offence to apply a false trade mark, and section 104 imposes a minimum imprisonment of six months, extendable to three years, together with a fine.[11] Section 63 of the Copyright Act, 1957 similarly criminalises infringement and prescribes a minimum imprisonment of six months.[12] Section 39 of the Geographical Indications of Goods (Registration and Protection) Act, 1999 makes infringement punishable with imprisonment of not less than six months.[13]

The result is a hierarchy within intellectual property law that is difficult to justify on principled grounds. A person who counterfeits the trade mark on a luxury consumer product may be arrested and imprisoned. A person who replicates the patented formula of a life-saving antibiotic and distributes it commercially faces, at most, a civil suit that may take many years to conclude. This inversion of moral and legal seriousness is the central problem that this article addresses.

2.3. The Inadequacy of Civil Remedies

Civil remedies, though formally available, suffer from structural limitations that render them ineffective against large-scale pharmaceutical counterfeiting operations. Injunctions require a patentee to satisfy courts of a prima facie case, balance of convenience, and irreparable injury before interim relief is granted.[14] Damages are notoriously difficult to quantify in patent matters: section 108(1) of the Patents Act, 1970 is silent on the method of quantification, and courts retain broad discretion.[15] The absence of a statutory minimum damages provision means that awards often bear little relationship to the actual harm inflicted or the profits earned by the infringer.

Civil litigation in India is also characterised by significant delay. Patent infringement suits, which involve complex technical questions, are among the most protracted forms of commercial litigation. A well-resourced infringer may therefore continue manufacturing counterfeit pharmaceutical products throughout the pendency of proceedings, secure in the knowledge that the ultimate civil sanction will not include imprisonment or the disruption of criminal investigation.

3. Public Health Consequences of the Enforcement Gap

3.1. The Scale of Pharmaceutical Counterfeiting

The World Health Organization estimates that approximately one in ten medical products circulating in low- and middle-income countries is either substandard or falsified.[16] India’s own Central Drugs Standard Control Organisation data corroborates the persistence of quality failures within the domestic market. The CDSCO reported that 877 drug samples were declared not of standard quality during 2024, a figure that more than doubled to 1,879 samples in 2025, a rise attributed in part to enhanced surveillance and greater participation by state regulatory authorities.[17]

The distinction between substandard drugs, which fail to meet quality specifications due to manufacturing deficiencies, and falsified medicines, which are deliberately deceptive imitations of patented or branded products, is analytically significant. Falsified pharmaceutical products represent a deliberate commercial decision to exploit a patented formula without authorisation. It is this category of conduct, wilful, commercial, and potentially lethal, for which the Patents Act, 1970 provides no criminal remedy.

3.2. The Causative Link Between Impunity and Counterfeiting

The absence of criminal deterrence is causally connected to the persistence of large-scale pharmaceutical counterfeiting. A rational actor engaged in commercial patent infringement must weigh the expected cost of enforcement against the expected profit from the infringing activity. Where the only available remedy is a civil suit that may take years to conclude and that will, at most, result in an injunction and uncertain damages, the expected cost of infringement is low relative to its commercial reward. Criminal sanctions fundamentally alter this calculus by introducing the prospect of imprisonment, which cannot be discharged by payment of a monetary sum and which carries significant reputational consequences.

The deterrent function of criminal law in intellectual property enforcement is not a theoretical proposition. The significant reduction in trade mark counterfeiting following the introduction of criminal penalties under the Trade Marks Act, 1999 demonstrates that the threat of arrest and imprisonment operates as a meaningful constraint on commercial infringement. There is no principled reason why the same logic should not apply to pharmaceutical patent infringement, which carries considerably more serious consequences for public health than the counterfeiting of consumer goods.

4. Comparative Perspectives

4.1. The United States

The United States patent system does not create a direct criminal offence of patent infringement under Title 35 of the United States Code. However, United States federal prosecutors have prosecuted wilful pharmaceutical patent infringers under general criminal statutes, including wire fraud and conspiracy provisions under Title 18, particularly where the conduct involves misrepresentation to regulators or importation of falsified products.[18] Additionally, section 337 of the Tariff Act of 1930 empowers the International Trade Commission to exclude infringing imports from the United States market without requiring a civil court judgment, providing a swift border enforcement mechanism that supplements the civil patent regime.[19]

4.2. The People’s Republic of China

China presents the most instructive comparative model for India’s purposes. The 2021 amendments to the Patent Law of the People’s Republic of China significantly strengthened the patent enforcement regime, including by raising statutory damages to a maximum of five million yuan for wilful infringement and by facilitating the involvement of criminal law enforcement authorities in cases of large-scale commercial patent infringement.[20] The involvement of the Public Security Bureau in patent crime investigations has produced a demonstrable deterrent effect on industrial-scale infringement. India, whose pharmaceutical market and generic industry present comparable structural features to China’s pre-2021 position, may draw instructive lessons from this legislative experience.

4.3. The European Union

Within the European Union, Directive 2004/48/EC on the Enforcement of Intellectual Property Rights establishes a harmonised civil enforcement framework but does not mandate criminal sanctions specifically for patent infringement.[21] However, several member states, including Germany and France, have enacted national provisions that permit criminal prosecution for commercial patent infringement under general fraud or deception statutes where the conduct involves deliberate misrepresentation. The ongoing deliberations within the European Commission regarding enhanced criminal sanctions for intellectual property offences signal a broader trajectory toward greater criminalisation, from which India’s law reform process may usefully draw guidance.

5. Proposals for Legislative Reform

5.1. Targeted Criminal Offence

It is submitted that Parliament should amend the Patents Act, 1970 by inserting a new provision that creates a criminal offence for wilful patent infringement in the pharmaceutical sector on a commercial scale. Three elements of this proposal require elaboration.

First, the offence should require proof of wilfulness. A defendant who genuinely and reasonably believed that no valid patent subsisted, or that the relevant act fell within a permitted exception under sections 47 or 107A of the Patents Act, 1970, should not be exposed to criminal liability.[22] The wilfulness requirement limits the reach of the offence to those who knowingly and deliberately appropriate the patented formula of another, thereby distinguishing genuine commercial wrongdoing from good-faith disputes about patent scope.

Second, the offence should be confined to infringement on a commercial scale. Small-scale, non-commercial, or compulsorily licensed activities should be entirely excluded. The focus of criminal enforcement should be on organised operations that manufacture or distribute infringing pharmaceutical products for commercial gain, thereby most directly implicating the public health interests that patent protection is designed to serve.

Third, the offence should be limited to patents in the pharmaceutical sector, meaning patents relating to products or processes used in the manufacture, compounding, or distribution of drugs as defined under section 3(b) of the Drugs and Cosmetics Act, 1940.[23] This sectoral limitation reflects the unique public health dimension of pharmaceutical patent infringement and avoids over-extension of criminal liability into areas such as mechanical or electronic inventions, where the case for criminalisation is considerably less compelling.

5.2. Addressing the Counterarguments

The principal counterargument to criminal sanctions for patent infringement is that patent law involves complex technical and commercial disputes that are ill-suited to the binary determinations of criminal proceedings. Patent validity is frequently contested, and it would be unjust to expose a defendant to imprisonment for infringement of a patent that may subsequently be revoked.

This objection carries weight but does not defeat the case for reform. It may be addressed through procedural design. A criminal prosecution for pharmaceutical patent infringement could be made conditional upon the prior determination of patent validity by a civil court, or could include a statutory defence of genuine belief in invalidity supported by expert evidence. These mechanisms are not unprecedented, and analogous safeguards exist in several jurisdictions that have successfully introduced criminal patent enforcement without producing unjust outcomes.

A second counterargument holds that existing provisions of the Drugs and Cosmetics Act, 1940 already criminalise the manufacture of spurious drugs and are therefore sufficient to address the public health dimension of pharmaceutical counterfeiting.[24] This argument misapprehends the analytical distinction between a spurious drug, which is one manufactured by an entity other than the genuine manufacturer and sold under that manufacturer’s name, and a patent-infringing drug, which may be of adequate pharmacological quality but is manufactured without authorisation of the patent holder. The two categories may overlap but are not coextensive, and the existence of one legal remedy does not render the other unnecessary.

6. CONCLUSION

The Patents Act, 1970 was enacted in an era when Indian patent policy was principally concerned with restricting the scope of pharmaceutical monopolies in the interest of public access to medicines. That policy context has evolved considerably. India is now a major innovator and manufacturer in the global pharmaceutical market, and the protection of pharmaceutical patents from wilful commercial infringement is a matter of both domestic integrity and international legal obligation under the Agreement on Trade-Related Aspects of Intellectual Property Rights.

The absence of criminal sanctions for patent infringement represents an anomaly within the intellectual property framework that is difficult to justify on grounds of principle and impossible to defend in light of the public health consequences of pharmaceutical counterfeiting. The existing civil enforcement mechanism is structurally inadequate to deter organised commercial infringement: it is slow, costly, and incapable of producing the immediate consequences that criminal prosecution provides.

This article has argued that Parliament should amend the Patents Act, 1970 to introduce a targeted criminal offence for wilful infringement of pharmaceutical patents on a commercial scale, incorporating a wilfulness requirement, a commercial-scale threshold, and a sectoral limitation to the pharmaceutical field. The comparative experience of China demonstrates that such reform is both achievable and effective. India, as the pharmacy of the world, has both the capacity and the obligation to ensure that its legal framework reflects the gravity of the conduct it is designed to prevent.

7. References and Bibliograph

Cases

1. Hoffmann-La Roche Ltd. v. Cipla Ltd., (2008) 148 DRJ 629 (India).
2. Natco Pharma Ltd. v. Bayer Corporation, Compulsory Licence Application No. 1 of 2011 (Controller of Patents, Mar. 9, 2012) (India).
3. Novartis AG v. Union of India, (2013) 6 SCC 1 (India).

Legislation

4. The Copyright Act, 1957 (India).
5. The Drugs and Cosmetics Act, 1940 (India).
6. The Geographical Indications of Goods (Registration and Protection) Act, 1999 (India).
7. The Patents Act, 1970 (India).
8. The Trade Marks Act, 1999 (India).
9. Council Directive 2004/48/EC of 29 Apr. 2004 on the Enforcement of Intellectual Property Rights, 2004 O.J. (L 195) 16 (EU).
10. Patent Law of the People’s Republic of China (4th revision, 2021) (China).
11. Tariff Act of 1930, 19 U.S.C. § 1337 (United States).

Secondary Sources

9. Health Policy Watch, WHO Delays Falsified Medicine Mechanism Reform Amid Health Crisis, HEALTH POL’Y WATCH (May 27, 2025), https://healthpolicy-watch.news/who-delays-falsified-medicine-mechanism-reform-amid-health-crisis/.
10. Legal Service India, Penal Provisions Under the Patents Act, 1970: An In-Depth Examination, LEGAL SERV. INDIA (Nov. 17, 2025), https://www.legalserviceindia.com/Legal-Articles/penal-provisions-under-the-patents-act-1970-an-in-depth-examination/.
11. Outlook India, CDSCO Tightens Drug Quality Surveillance With Revised Sampling Guidelines, OUTLOOK INDIA (June 2025), https://www.outlookindia.com/healthcare-spotlight/cdsco-tightens-drug-quality-surveillance-with-revised-sampling-guidelines.
12. United Nations Office on Drugs and Crime, Trafficking in Medical Products in the Sahel (UNODC, 2023).
13. WIPO, International Patent Judicial Guide: India — Civil Remedies, ch. 6.7, https://www.wipo.int/patent-judicial-guide/en/full-guide/india/6.7 (last visited June 19, 2026).
14. World Health Organization, Medical Product Alert No. 5/2025: Falsified IMFINZI (durvalumab) 500mg/10mL Concentrate for Solution for Infusion (WHO, Jan. 2025).
15. World Health Organization, Substandard and Falsified Medical Products (Fact Sheet, 2023), https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products.

[1]World Health Organization, Medical Product Alert No. 5/2025: Falsified IMFINZI (durvalumab) 500mg/10mL Concentrate for Solution for Infusion (WHO, Jan. 2025).

[2] United Nations Office on Drugs and Crime, Trafficking in Medical Products in the Sahel (UNODC, 2023).

[3] Health Policy Watch, WHO Delays Falsified Medicine Mechanism Reform Amid Health Crisis (May 27, 2025), https://healthpolicy-watch.news/who-delays-falsified-medicine-mechanism-reform-amid-health-crisis/.

[4] The Patents Act, 1970, §§ 104–114 (India).

[5] The Trade Marks Act, 1999, § 103 (India); The Copyright Act, 1957, § 63 (India); The Geographical Indications of Goods (Registration and Protection) Act, 1999, § 39 (India).

[6]The Patents Act, 1970, § 48 (India).

[7]The Patents Act, 1970, §§ 104–114 (India).

[8]The Patents Act, 1970, § 108 (India).

[9]The Patents Act, 1970, §§ 120, 121, 122 (India).

[10]Legal Service India, Penal Provisions Under the Patents Act, 1970: An In-Depth Examination (Nov. 17, 2025), https://www.legalserviceindia.com/Legal-Articles/penal-provisions-under-the-patents-act-1970-an-in-depth-examination/.

[11]The Trade Marks Act, 1999, §§ 103–104 (India).

[12]The Copyright Act, 1957, § 63 (India).

[13]The Geographical Indications of Goods (Registration and Protection) Act, 1999, § 39 (India).

[14]F. Hoffmann-La Roche Ltd. v. Cipla Ltd., (2008) 148 DRJ 629 (India).

[15]WIPO, International Patent Judicial Guide: India — Civil Remedies, ch. 6.7, https://www.wipo.int/patent-judicial-guide/en/full-guide/india/6.7 (last visited June 17, 2026).

[16]World Health Organization, Substandard and Falsified Medical Products (Fact Sheet, 2023), https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products.

[17]Outlook India, CDSCO Tightens Drug Quality Surveillance With Revised Sampling Guidelines (June 2025), https://www.outlookindia.com/healthcare-spotlight/cdsco-tightens-drug-quality-surveillance-with-revised-sampling-guidelines.

[18]18 U.S.C. §§ 1341, 1343, 1349 (United States).

[19]Tariff Act of 1930, 19 U.S.C. § 1337 (United States).

[20]Patent Law of the People’s Republic of China (4th revision, 2021), art. 71 (China).

[21]Council Directive 2004/48/EC of 29 Apr. 2004 on the Enforcement of Intellectual Property Rights, 2004 O.J. (L 195) 16 (EU).

[22]The Patents Act, 1970, §§ 47, 107A (India)

[23]The Drugs and Cosmetics Act, 1940, § 3(b) (India).

[24]The Drugs and Cosmetics Act, 1940, §§ 17B, 27 (India).