The Biosimilar Frontier: A Global Tug-of-War Between Innovation and Access

Introduction

The traditional, reactive nature of legal frameworks is facing some of its most significant challenges yet in the face of exponential scientific advancement. Recent scientific developments have rendered many existing intellectual property and liability laws antiquated. This phenomenon, often described as law playing “catch-up,” is not merely a procedural delay. It represents a fundamental disruption in how society manages risk, privacy, and truth. This article intends to shed some light on how the rise of biologics in the field of medicine is reshaping the understanding of intellectual property in the field of law.

For decades, intellectual property regimes focused on small molecules, which are so prevalent in the traditional pharmaceutical industry. The rise of “biologics” is disrupting that equilibrium in the most creative of forms. Over the past two decades, the global pharmaceutical landscape has undergone a structural transformation driven by the rise of biologic medicines and, more recently, biosimilars. The fundamental difference between biologics and traditional pharmaceuticals lies in their origin, size, and manufacturing complexity. While traditional drugs are synthesized through chemical reactions, biologics are grown within living systems. Put very simply, traditional drugs are made by mixing chemicals in a controlled, predictable way. Biologics are produced by genetically engineering cells (like bacteria or mammalian cells) to “churn out” the desired protein or therapy. One can make an exact chemical copy of a traditional drug (called a generic), but because biologics are made from living systems, they can never be perfectly replicated; only “highly similar” versions called biosimilars can be made.

Biologics have revolutionised treatment in areas such as oncology, autoimmune diseases, and rare disorders.¹ However, their high cost has placed significant strain on healthcare systems worldwide.² In response, biosimilars have emerged as a mechanism to promote competition and expand access.³ Yet, their rise has exposed deep tensions within existing patent systems. Increasingly, courts are being asked to determine not only what constitutes infringement, but whether the patent system itself is being used beyond its intended purpose.

The Emerging Crisis: When Patents Outlive Their Purpose

For decades, the “patent cliff” represented a predictable milestone: a pharmaceutical company enjoyed approximately twenty years of exclusivity, after which generic manufacturers entered the market, dramatically reducing prices.⁴ However, biologics have disrupted this model. Due to their complexity, they cannot be identically replicated, allowing originator companies to construct extensive patent thickets. Patent thickets can be understood as overlapping layers of secondary patents covering manufacturing processes, formulations, and delivery mechanisms.⁵

The legal system, in turn, has begun to respond. In Amgen Inc v Sanofi, the United States Supreme Court emphasised that broad functional claims must satisfy strict enablement requirements, signalling judicial resistance to overly expansive biologic patents.⁶ Similarly, in Novartis AG v Union of India, the Indian Supreme Court rejected patent protection for a modified cancer drug, explicitly limiting evergreening and prioritising access to medicines.⁷

These cases illustrate a growing global concern: patents may be extending beyond their intended role as incentives for innovation and instead functioning as tools for prolonged market control.

The “Skinny Label” Solution and the Legal Backlash

To navigate patent thickets, manufacturers in the USA developed the “skinny label” (Section 505(j)(2)(A)(viii) of the Federal Food, Drug, and Cosmetic Act (FDCA), or section viii carve-out under the Hatch-Waxman Act), allowing a drug to be marketed only for non-patented uses.⁸ However, this approach has triggered significant legal controversy. The central issue is whether marketing a drug with a limited label can nonetheless constitute induced infringement if physicians prescribe it for patented uses.

This issue lies at the heart of Hikma Pharmaceuticals USA Inc v Amarin Pharma Inc (pending before the US Supreme Court, 2026).⁹ The dispute arises from Hikma’s generic version of Vascepa, which was approved only for non-patented uses. Amarin alleges that Hikma’s conduct, particularly its marketing, encouraged off-label use, thereby inducing infringement under 35 USC §271(b).¹⁰ The Federal Circuit revived Amarin’s claim after initial dismissal, creating uncertainty about the viability of skinny labels.¹¹ The Supreme Court’s forthcoming decision is expected to clarify whether intent can be inferred from market behaviour beyond the label itself.

Earlier precedent provides conflicting guidance. In Caraco Pharmaceutical Laboratories Ltd v Novo Nordisk A/S, the Court supported the use of carve-outs to facilitate generic entry.¹² Conversely, in Global-Tech Appliances Inc v SEB SA, the Court adopted a stringent standard for induced infringement, requiring knowledge and intent.¹³ The Hikma case sits at the intersection of these doctrines and may redefine the boundaries of lawful competition.

Divergence Across National Jurisdictions

For a patient in 2026, the price of a life-saving pill often depends less on the science behind it and more on the borders surrounding it. In the United States, a complex “patent thicket” can shield a drug’s profits for decades, whereas in India, the same medication may see 15 generic competitors hit the market within months of a patent lapse. As we navigate a year defined by record-breaking patent expirations and a pivotal U.S. Supreme Court ruling on generic competition, the rules of the pharmaceutical game are being rewritten.

United States

The United States represents a highly litigation-driven system. The Biologics Price Competition and Innovation Act 2009 (BPCIA) created a structured framework for resolving patent disputes, often referred to as the “patent dance”.¹⁴ In Sandoz Inc v Amgen Inc, the Supreme Court clarified that participation in this process is not fully mandatory, adding procedural flexibility but also uncertainty.¹⁵ At the same time, antitrust scrutiny has increased. In FTC v Actavis Inc, the Court held that reverse payment settlements could violate competition law, signalling judicial willingness to examine strategic patent behaviour.¹⁶ The pending Hikma decision further underscores the instability of the current framework.

European Union

The European Union adopts a more regulatory-centric model. The European Medicines Agency has established a relatively predictable biosimilar approval pathway, facilitating earlier market entry.¹⁷ While patent disputes remain national, the emerging Unified Patent Court may contribute to greater harmonisation. European jurisprudence has generally been less tolerant of expansive patent thickets, creating a comparatively favourable environment for biosimilars.

India and Emerging Markets

India exemplifies a public health-oriented approach to patent law. The decision in Novartis AG v Union of India remains a landmark in limiting evergreening.¹⁸ Indian manufacturers play a critical role in global biosimilar supply. However, their ability to operate internationally depends heavily on legal developments in Western jurisdictions. If doctrines such as induced infringement are expanded, the viability of exporting biosimilars under skinny labels may be significantly constrained.

Global Implications: A Three-Tier System

The evolving biosimilar landscape reveals a fragmented global system with distinct implications across regions.

In developed markets, the primary concern is economic sustainability. Restricting biosimilar entry—whether through patent thickets or narrowed skinny label pathways—may extend exclusivity and increase healthcare expenditure.¹⁹ The Hikma case is particularly significant in this context, as it may determine whether a key pathway for competition remains viable.

For major manufacturing countries such as India and China, legal uncertainty in the western markets poses substantial risks. Reduced access to these markets could diminish incentives for biosimilar development and disrupt global supply chains.

In lower-income countries, biosimilars are essential for access to life-saving treatments. The affordability of biologics such as trastuzumab and adalimumab remains a critical issue.²⁰ If legal developments in high-income jurisdictions restrict biosimilar competition, the resulting impact may be a widening gap in global health outcomes.

Patent Thickets, Evergreening, and Competition Law

The proliferation of secondary patents has also intensified debates about the legitimacy of patent thickets. Scholars and courts increasingly question whether such strategies align with the objectives of patent law.²¹ Competition law is emerging as a corrective mechanism. The reasoning in FTC v Actavis Inc suggests that courts may be willing to scrutinise conduct that extends exclusivity beyond legitimate bounds.²² At the same time, judicial decisions such as Amgen Inc v Sanofi demonstrate a tightening of patentability standards, particularly in relation to enablement.

Future Outlook: The 2026 Turning Point

The global biosimilar market is approaching a critical juncture. The outcome of Hikma v Amarin is likely to shape the future of skinny labels, the scope of induced infringement, and the balance between innovation and competition. More broadly, biosimilars are forcing a re-evaluation of the patent system itself. The traditional model—granting exclusivity followed by generic entry—is increasingly difficult to sustain in the context of biologics.

As we await the verdict in Hikma v. Amarin, the global community stands at a crossroads. The current understanding of patents as a “reward for a specific invention” is being challenged by a system where patents are used as a “tool for perpetual market control.” How nations choose to define “infringement” in the age of biosimilars will determine the health outcomes for millions of patients over the next decade. The era of the “simple generic” is over; the era of the “complex legal battle” has only just begun.

Conclusion

Biosimilars represent both an opportunity and a challenge for the global pharmaceutical system. While they offer the potential to expand access to essential medicines, they also expose structural weaknesses in patent law. The divergence between jurisdictions, the rise of patent thickets, and the uncertainty surrounding cases such as Hikma v Amarin illustrate a system in transition. Ultimately, the way courts define infringement in the coming years will determine whether patent law continues to serve its foundational purpose—or evolves into a mechanism of prolonged exclusivity.

Reference(S):

1. World Health Organization, Biologicals and Biosimilars: Policy Brief (WHO 2021)
2. OECD, Pharmaceutical Spending and Biosimilars (OECD 2020)
3. European Medicines Agency, Biosimilars in the EU (EMA 2019)
4. ibid
5. Robin Feldman, ‘May Your Drug Price Be Evergreen’ (2022) SSRN
6. Amgen Inc v Sanofi 598 US 594 (2023)
7. Novartis AG v Union of India (2013) 6 SCC 1
8. 21 USC § 355(j)(2)(A)(viii)
9. Hikma Pharmaceuticals USA Inc v Amarin Pharma Inc (US Supreme Court, No 24-889, cert granted 2026)
10. 35 USC § 271(b)
11. Amarin Pharma Inc v Hikma Pharmaceuticals USA Inc 104 F 4th 1370 (Fed Cir 2024)
12. Caraco Pharmaceutical Laboratories Ltd v Novo Nordisk A/S 566 US 399 (2012)
13. Global-Tech Appliances Inc v SEB SA 563 US 754 (2011)
14. Biologics Price Competition and Innovation Act 2009
15. Sandoz Inc v Amgen Inc 582 US 1 (2017)
16. FTC v Actavis, Inc., 570 US 136 (2013)
17. European Medicines Agency, Biosimilars in the EU (EMA 2019)
18. Novartis AG v Union of India (2013) 6 SCC 1
19. OECD, Pharmaceutical Spending and Biosimilars (OECD 2020)
20. World Health Organization, Biologicals and Biosimilars: Policy Brief (WHO 2021)
21. Robin Feldman, ‘May Your Drug Price Be Evergreen’ (2022) SSRN
22. FTC v Actavis, Inc., 570 U.S. 136 (2013)