Author: Jurivine
Introduction
Patent evergreening—when firms extend exclusivity by serially patenting minor modifications to existing drugs—has become a substantial concern for public health. This blog examines the legal mechanics of evergreening strategies, explores global regulatory responses (with focus on TRIPS, Doha Declaration, and national law), analyzes key case studies (especially India’s Novartis v. Union of India), evaluates the social and economic effects on the availability of necessary medications.. Finally, it considers reform proposals to balance innovation incentives with public health imperatives.
Understanding Patent Evergreening
Definition & Mechanisms
Patent evergreening refers to minor tweaks to an existing patented drug—such as new dosage forms, crystalline forms, delivery methods, or new combinations—and securing new patents to extend monopoly periods[1]. These secondary patents may include formulation patents, polymorph patents, chiral switches (single‑enantiomer versions), new therapeutic indications, or delivery mechanisms like auto‑injectors or slow‑release versions[2]
Lifecycle Management vs. Evergreening
While pharmaceutical firms often refer to these strategies as “lifecycle management,” critics argue that many of these modifications do not meaningfully improve therapeutic outcomes—and thus merely prolong monopoly for profit rather than innovation[3].
Scale of the Practice
A retrospective study found that between 2005–2015, roughly 78% of new patents on existing drugs were for products already on the market—not genuinely new compounds—with reasons for filing being comparatively minor modifications[4]. In the U.S. alone, top pharmaceutical firms like AbbVie filed hundreds of patent extension applications—137 granted—to prolong exclusivity even well past standard patent terms.
Legal & Regulatory Frameworks
A. International Law & TRIPS Flexibilities
TRIPS Agreement
Under WTO’s TRIPS, patent protection for pharmaceuticals must last 20 years from filing date. However, TRIPS includes “flexibilities”—such as compulsory licensing, parallel importation, or defining patentability criteria more strictly—to help low‑income countries secure access to essential drugs.
Doha Declaration (2001)
The Doha Declaration reaffirmed that TRIPS obligations should be interpreted in a way that supports public health, affirming members’ rights to use compulsion licensing or determine emergencies for health crises like HIV, TB, or malaria.
B. National Measures Against Evergreening
India – Section 3(d) of the Indian Patents Act
India amended its patent law in 2005 to include Section 3(d), which disallows patents on new forms of known substances unless they yield enhanced therapeutic efficacy. This provision aims to curb evergreening by blocking secondary patents without real health benefit.
Australia
Under amendments to the Therapeutic Goods Act, Australia introduced anti-evergreening measures, such as patent linkage rules and stricter requirements to prevent product-hopping and procedural delays—designed to prevent manipulation of regulatory approval to maintain monopoly.
U.S. & EU
The U.S. Hatch–Waxman Act provides for limited patent extensions tied to regulatory delay (up to five years, capping at 14 years market protection), but does not fundamentally block secondary patents. The EU’s Supplementary Protection Certificates (SPCs) similarly permit extension only for active ingredients not previously marketed, and exclude minor modifications from being eligible[6].
Other Jurisdictions
Brazil, Canada, South Africa engage in legal reforms and administrative mechanisms (e.g., patent review boards, pricing oversight, stricter examination of secondary claims) to combat evergreening while expanding generic access.
Landmark Case: Novartis v. Union of India (2013)
This Indian Supreme Court case is a pivotal legal precedent against evergreening. Novartis sought a patent for the beta‑crystalline form of imatinib mesylate (marketed as Gleevec/Glivec), arguing it was a novel improvement. Indian patent law and lower tribunals rejected the application under Section 3(d), since there was no demonstrated increase in therapeutic efficacy over the known freebase form.
In April 2013, the Supreme Court affirmed this, ruling that Novartis could not patent a change to a well-known drug in the absence of evidence of improved efficacy. The decision reaffirmed India’s commitment to limiting secondary patents and ensuring availability of generics.Additionally, it reaffirmed the constitution’s acknowledged public interest in drug affordability and TRIPS compliance.
In practice, Had Novartis succeeded, generic makers would have had to pay royalties, but generics could still continue using older versions under grandfather provisions. Instead, the rejection preserved low-cost generic supply and enabled significant price reductions—generic versions of Gleevec in India sold for USD 177–266/month vs. USD 2,666/month for the patented version.
Impact on Access to Medicines
Economic and Pricing Effects
Evergreening strategies systematically delay generic entry, sustaining high drug prices and raising healthcare costs. Studies consistently find that stronger IPR regimes—or narrower use of TRIPS flexibilities—are associated with higher drug prices and reduced availability of affordable medicines, especially in lower‑ and middle‑income countries[6].
For example, in the U.S., patent term extensions and data exclusivity cost state health programs billions of dollars and delay price reductions by years. According to one FDA/Medicaid analysis, data exclusivity regulations that delay generic entry resulted in an additional $1.5 billion in Medicaid spending over four years.
Product-hopping examples such as glatiramer acetate (Copaxone) led to consumer costs of $4.3–6.5 billion before courts invalidated the new patent—a dramatic illustration of blocked generics multiplying healthcare spending.
Public Health Consequences
Delayed generic competition undermines universal access to essential treatments, particularly in developing countries dependent on low-cost generics (e.g. for HIV, cancer, diabetes). India’s strong legal stance—and rejection of secondary patents—has been critical globally because it supplies 80% of ARV volume for low‑income countries[8].
By contrast, TRIPS‑plus trade agreements—especially with the U.S.—that enforce patent linkage, data exclusivity extensions, or narrower definitions of compulsory licensing, have imposed welfare losses and access delays in countries like Thailand, Guatemala, Peru, and Vietnam
In India, post-2005 introduction of pharmaceutical patents led to welfare losses, price hikes, and slower drug launches. Launch delays for many novel drugs extended up to 4.5–5 years compared to developed countries.
Ethical & Rights-Based Perspectives
Seen from a human rights perspective, indefinite or abusive patent extensions conflict with the constitutional or right-to-health obligations of governments: denying or delaying access to life‑saving medicines disproportionately affects the poorest populations.
Critics argue that marketing budgets for promoting patented modifications often outstrip genuine R&D spending, further questioning the legitimacy of evergreen patenting practices that offer no real therapeutic benefit.
Counterarguments & Innovation Incentives
Patent holders claim evergreening can at times reflect real incremental innovations—improved tolerability, dosing convenience, or better formulations—and justify the costs of these improvements. Extensions via Hatch–Waxman or SPCs are meant to compensate for regulatory delays, not manipulation.
Some analyses show that stronger patent regimes encourage earlier launch of novel medicines in developing countries. But such benefits are more pronounced for genuinely new drugs, not evergreened variants.
Policy Recommendations
To mitigate adverse effects while preserving innovation, scholars and policy groups propose multiple reforms:
Tighten Patentability Thresholds: Require demonstrable therapeutic efficacy improvements for secondary patents, as India does under Section 3(d).
Limit Patent Term Extensions: Cap extensions strictly to compensate regulatory delay, and exclude minor changes from eligibility..
Strengthen Oppositions & Post‑grant Review: Enable generic challengers to file timely oppositions or revocations, speeding up invalidation of weak secondary patents.
Expand TRIPS Flexibilities: Encourage compulsory licenses in health emergencies or parallel importation to lower prices—even when patents exist.
Alternative Innovation Incentives: Shift toward prize funds, public funding, or patent buyouts for public health–critical needs to reduce reliance on monopoly pricing.
A systematic review and legal scholarship emphasize building a balanced regime that aligns incentives with health priorities rather than profit for slightly modified products.
Conclusion
Patent evergreening leverages legal loopholes and minor modifications to extend monopolies, delaying generics and keeping drug prices high. The consequences are especially severe for patients in low‑ and middle‑income countries, where access to essential medicines hinges on affordable generics.
Global governance efforts—like the Doha Declaration—and national legal tools—such as India’s Section 3(d)—provide effective levers to prevent abuse of secondary patents and control health system costs. Empirical studies consistently show that unchecked evergreening leads to delayed access, increased government expenditure, and reduced consumer welfare.
Reforms that tighten patent standards, limit term extensions, bolster generic competition, and explore alternative innovation models are urgently needed. These changes can strike a more equitable balance—encouraging real pharmaceutical innovation while protecting the fundamental right to health.
Reference
[1] https://pmc.ncbi.nlm.nih.gov/articles/PMC3680578
[2]https://jchr.org/index.php/JCHR/article/download/8397/4799/15875
[3]https://theweek.com/health/evergreening-big-pharmas-big-con
[4]https://uclawreview.org/2022/12/13/patent-evergreening-and-the-response-by-the-uspto-and-fda
[6]https://globalizationandhealth.biomedcentral.com/articles/10.1186/s12992-022-00826-4
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