Patents

Evergreening of Patent: A Legal, Ethical, and Global Perspective

Introduction

Patents are fundamental to promoting innovation and protecting intellectual property, particularly in sectors such as pharmaceuticals, biotechnology, and technology. They grant inventors exclusive rights for a set period, typically 20 years, allowing them to recoup research and development costs. However, some companies employ legal tactics to extend these exclusivity rights beyond the intended term, a practice known as evergreening.

This article explores the concept of evergreening, the strategies used by patent holders, its implications, and the legal landscape—particularly in India. By understanding evergreening, policymakers, businesses, and consumers can navigate the fine balance between fostering innovation and preventing monopolistic practices that hinder access to affordable products. Additionally, it examines how evergreening impacts market competition, regulatory frameworks, and international trade agreements.

Understanding Patent Terms and Evergreening

What is a Patent?

A patent grants an inventor exclusive rights to prevent others from making, using, or selling an invention for a specific period. This system incentivizes innovation by allowing businesses to profit from their creations while eventually contributing to the public domain. Patents cover a wide range of industries, including pharmaceuticals, technology, and manufacturing, playing a crucial role in encouraging investment in research and development.

Definition of Evergreening

Evergreening is the strategy where patent holders, particularly in industries like pharmaceuticals, extend their monopoly beyond the original patent term by making minor modifications to existing products and securing additional patents. These modifications often include changes in dosage forms, new delivery mechanisms, combinations of existing drugs, or alternative chemical formulations—none of which may significantly improve the product’s efficacy or innovation.

By strategically modifying aspects of an invention and filing for new patents, companies effectively delay the expiration of exclusivity, blocking generic competition. A notable example is the case of Pfizer, which extended its monopoly on Lipitor, a blockbuster cholesterol-lowering drug, by patenting new crystalline forms and minor changes in formulation. Similarly, AstraZeneca utilized evergreening strategies to extend the exclusivity of its anti-ulcer drug, Nexium, by making slight modifications to its predecessor, Prilosec. These tactics allowed the companies to maintain revenue streams long after the initial patents had expired, sparking legal challenges and policy debates on the ethics of such practices. This practice raises ethical concerns as it can prevent access to affordable medicines and essential goods for extended periods.

III. Common Methods of Evergreening

1. Patent Clusters

Companies may file multiple, overlapping patents that cover different aspects of the same product, ensuring prolonged exclusivity through a web of intellectual property claims. This discourages competitors from producing generic alternatives due to the risk of infringement lawsuits.

2. Patent Thickets

A dense cluster of interrelated patents is created to deter competitors, making it legally challenging and financially burdensome for them to develop alternative versions of the patented product. By layering patents over different components of a single invention, companies make it difficult for rivals to enter the market.

3. Incremental Innovations

Minor modifications, such as changing an active ingredient’s formulation, can be used to obtain a new patent without substantial improvement in therapeutic effectiveness. For example, a drug manufacturer may file a patent for a new coating that alters a pill’s absorption rate, even though it does not change its medicinal properties significantly.

4. Data Exclusivity and Regulatory Maneuvers

Even after a patent expires, companies may prevent generic competition by restricting access to clinical trial data, thereby delaying regulatory approvals for generics. In some jurisdictions, pharmaceutical companies can extend exclusivity by obtaining additional market protections tied to regulatory approval requirements.

IV. Legal and Ethical Implications

Impact on Innovation

Proponents argue that evergreening fosters continued research and development, leading to improved versions of products. However, critics contend that it primarily serves as a tool to stifle competition rather than drive genuine innovation. Instead of incentivizing breakthrough research, evergreening encourages minor, non-innovative modifications that benefit companies financially without delivering significant improvements.

Effect on Public Health

In the pharmaceutical industry, evergreening can significantly increase drug costs by delaying the entry of affordable generic alternatives, affecting healthcare access in developing nations. Countries with weaker patent laws often experience prolonged periods of high-priced medications, leaving essential drugs out of reach for large portions of the population.

Legal Challenges and Criticisms

Courts and lawmakers worldwide scrutinize evergreening, with some jurisdictions imposing restrictions on the patenting of incremental innovations to prevent monopoly extensions. Many governments have introduced laws preventing the patenting of known substances unless substantial improvements in efficacy or function can be demonstrated. For example, India’s Section 3(d) of the Patents Act restricts patents on incremental innovations without proven therapeutic benefits, while the European Union offers Supplementary Protection Certificates (SPCs), which extend exclusivity for pharmaceutical products under strict conditions. In contrast, the United States follows a more lenient approach, allowing patent term extensions and data exclusivity periods through the Hatch-Waxman Act. These varying regulations reflect different policy priorities—balancing innovation incentives with public health needs.

V. Evergreening in India

Relevant Provisions in Indian Patent Law

India’s Patents Act, 1970, particularly Section 3(d), restricts patents on modifications of existing drugs unless they demonstrate significant efficacy improvement. This prevents frivolous patent extensions and encourages genuine innovation. Section 3(d) has been hailed as a model for ensuring that patent laws do not hinder public access to critical medications.

Landmark Cases

A key case in India’s stance against evergreening is Novartis AG v. Union of India, where the Supreme Court rejected Novartis’s patent application for an updated version of its cancer drug Glivec. The court ruled that the changes made to the drug did not demonstrate a significant enhancement in therapeutic efficacy, a requirement under Section 3(d) of the Indian Patents Act. This landmark decision set a precedent by preventing companies from obtaining new patents for minor modifications, reinforcing India’s commitment to affordable healthcare and curbing monopolistic practices in the pharmaceutical industry., ruling that the modification did not enhance efficacy. This case set a precedent by establishing that minor modifications without significant benefits to consumers do not qualify for new patents.

Policy Rationale

India’s stringent laws aim to ensure affordable medicines and curb unnecessary patent extensions that could harm public health. By blocking evergreening strategies, India maintains a competitive pharmaceutical industry that benefits both local manufacturers and international consumers seeking cost-effective treatment options.

VI. Global Perspective

Contrasting Approaches

United States & European Union: More lenient frameworks permit patent term extensions and supplemental protection certificates for minor modifications, allowing companies to maintain longer monopolies.
India: Strict regulations prevent patent extensions without genuine improvement, prioritizing access to affordable medicines.

International Treaties and Obligations

The TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) sets minimum global patent standards while allowing national flexibility.
Doha Declaration on Public Health affirms the right of WTO member nations to protect public health and promote access to medicines.

VII. Strategies to Tackle Evergreening

Stringent Examination Processes

Patent offices should carefully assess whether modifications constitute genuine innovation or are attempts to extend exclusivity. Strengthening patent examination procedures ensures that only truly novel inventions receive protection.

Opposition and Revocation Mechanisms

Pre-grant and post-grant opposition procedures empower third parties to challenge weak or redundant patents before and after they are issued. Countries like India allow civil society organizations and generic manufacturers to contest questionable patent filings.

Policy Recommendations

Governments can implement stricter guidelines to prevent evergreening while ensuring that legitimate incremental innovations receive appropriate recognition. Specific measures could include tightening patent examination standards to scrutinize minor modifications, strengthening post-grant opposition mechanisms to challenge weak patents, and mandating transparent disclosures on efficacy improvements for pharmaceutical patents. Additionally, introducing a global framework for monitoring evergreening practices and fostering international cooperation could help balance innovation incentives with public health needs. Strengthening international cooperation and establishing clearer global policies on patent extensions would also help balance innovation and accessibility.

VIII. Practical Insights

For Innovators

Focus on meaningful innovation rather than relying on evergreening strategies.
Strengthen R&D investment to create substantial advancements.

For Generic Manufacturers

Monitor patent landscapes and challenge questionable evergreening practices through legal opposition mechanisms.
Leverage compulsory licensing provisions where applicable.

For Policymakers and Advocates

Ensure transparency in patent grant processes.
Foster a balance between rewarding innovation and maintaining market competition.

IX. Conclusion

Evergreening remains a contentious issue in patent law, particularly in high-stakes industries such as pharmaceuticals. A recent example is the controversy surrounding AbbVie’s patent extensions on its best-selling drug Humira, where multiple secondary patents delayed generic competition for years in various markets. This case, along with growing regulatory scrutiny in jurisdictions like the U.S. and EU, highlights the need for continuous policy evaluation to prevent abuse while still fostering genuine innovation. While some argue that it promotes further research, others see it as an obstacle to competitive pricing and accessibility. India’s restrictive approach, emphasizing enhanced efficacy for secondary patents, sets a unique precedent in global IP law. As legal frameworks continue to evolve, policymakers, businesses, and advocates must strike a fair balance between fostering innovation and ensuring fair market competition.