Patents are designed to protect innovation and reward inventors for their contributions by granting them exclusive rights for a limited period, usually 20 years. However, some corporations, particularly in the pharmaceutical and technology sectors, employ a strategy known as evergreening of patents to extend their monopoly beyond this period. This practice has sparked widespread debate, with proponents arguing that it promotes continued innovation and critics asserting that it stifles competition and limits access to affordable medicines.
What is Evergreening of Patents?
Evergreening refers to the process by which patent holders attempt to extend the life of their existing patents by making minor modifications, reformulations, or incremental improvements to a product. These changes often do not significantly alter the product’s core functionality but allow the company to file for a new patent, effectively extending its exclusivity and delaying the entry of generic competitors.
Common Strategies for Evergreening
Patent holders use various tactics to prolong their monopoly, including:
1. Formulation Changes – Altering the composition, dosage, or delivery method of a drug to secure a new patent. Example: Converting a capsule into a slow-release tablet.
2. Polymorph Patents – Claiming new crystalline forms of a known drug to justify additional patent protection.
3. Combination Therapy Patents – Combining an existing drug with another compound to create a new patentable product.
4. Method of Use Patents – Patenting a new use of an existing product, even if the core compound remains unchanged.
5. Biological and Genetic Modifications – Making slight alterations in biologics to extend the exclusivity period.
6. Process Patents – Patenting a new method of manufacturing the same product to prevent competition.
Evergreening in the Pharmaceutical Industry
The pharmaceutical industry is the most common beneficiary of evergreening. Many multinational drug companies have successfully used this strategy to maintain high prices and market dominance. Some notable cases include:
• Novartis and Glivec (Imatinib Mesylate): Novartis sought patent extension in India for a modified version of its cancer drug Glivec. However, the Indian Supreme Court rejected the claim in 2013, citing that the modification was not significantly innovative under Section 3(d) of the Indian Patent Act.
Legal and Ethical Concerns
Evergreening raises several legal and ethical concerns, particularly in the context of public health:
• Access to Affordable Medicine – By delaying the entry of generics, evergreening keeps drug prices high, making essential medicines unaffordable for many patients, especially in developing countries.
• Stifling Innovation – Instead of investing in groundbreaking new drugs, companies focus on minor modifications to extend patent protection.
• Legal Challenges – Countries like India have introduced legal provisions (e.g., Section 3(d) of the Indian Patent Act) to prevent evergreening by rejecting patents that do not show significant therapeutic efficacy improvements.
Global Regulatory Approaches to Evergreening
Different jurisdictions have adopted varied approaches to tackle evergreening:
• India: The Indian Patent Act (Section 3(d)) prevents the granting of patents for mere modifications of known substances unless they show enhanced efficacy.
• United States: The Hatch-Waxman Act allows generic manufacturers to challenge weak patents through Paragraph IV certifications, but evergreening is still prevalent.
• European Union: The EU closely monitors evergreening and allows compulsory licensing in cases where excessive monopolization harms public interest.
• World Trade Organization (WTO): Under TRIPS (Trade-Related Aspects of Intellectual Property Rights), countries have flexibility in implementing patent laws to balance innovation with public health.
Conclusion
Evergreening of patents remains a controversial topic in intellectual property law. While it provides financial incentives for companies to invest in research and development, it also raises ethical concerns about monopolization and access to affordable medicines. Countries worldwide are attempting to strike a balance between rewarding innovation and preventing market abuse through stricter patent laws and regulatory oversight. As the debate continues, policymakers must ensure that patent laws promote genuine innovation without unduly restricting competition and public access to essential products.
Frequently Asked Questions (FAQs)
Q1. What is evergreening of patents?
Ans. Evergreening is a strategy used by patent holders to extend their monopoly beyond the standard patent term by making minor modifications to an existing patented product and obtaining a new patent.
Q2. How do companies practice evergreening?
Ans. Companies engage in evergreening by making small changes to drug formulations, polymorphs, combination therapies, methods of use, or manufacturing processes to secure new patents.
Q3. Why is evergreening controversial?
Ans. Evergreening is controversial because it prevents competition, delays the availability of generic medicines, and keeps drug prices high, making essential medicines less accessible.
Q4. Which industries use evergreening most commonly?
Ans. The pharmaceutical industry is the most common user of evergreening, but it is also prevalent in technology, biotechnology, and chemical industries.
Q5. What are some famous cases of evergreening?
Ans. Some well-known cases include Novartis’ attempt to patent Glivec in India and AbbVie's multiple patents on Humira to delay biosimilar competition.
