Innovation or Evergreening? (Part 1)
A Practitioner’s Detailed Analytical Guide
Covering Malaysia · Indonesia · Thailand · Philippines
By Phylicia Yeoh
The Question That Divides an Industry
Every patent attorney working in the pharmaceutical space has encountered the same uncomfortable question: When does legitimate innovation end and strategic maneuvering begin? Nowhere is this tension more vivid or more consequential than in the doctrine of secondary pharmaceutical patents.
A secondary patent does not protect a new molecule. It protects something further downstream: a new salt form, a new polymorph, a new therapeutic use, a new formulation or dosage strength. In theory, such improvements can transform a medicine, making it more bioavailable, more stable on the shelf, safer to administer. In practice, the same legal instrument has been documented as a tool for extending market exclusivity well beyond the original invention, a phenomenon critics call “evergreening.”
"Patent systems are not just about incentivizing innovation. They are about structuring the social contract between inventors and the public and that contract has terms."
This question carries enormous stakes in Southeast Asia (also known as ASEAN). With a combined population exceeding 680 million people, a rapidly growing middle class demanding higher-quality healthcare, and domestic pharmaceutical industries seeking competitive parity, the region’s legal frameworks governing secondary patents are not merely technical curiosities. They are instruments of public health policy, economic strategy, and innovation governance, simultaneously.
KASS International has advised pharmaceutical innovators and generic manufacturers across Malaysia, Indonesia, Thailand, and the Philippines for more than two decades. What follows is our practitioner’s guide to the divergent secondary patent landscapes across these four specific jurisdictions filtered through the insights of the world’s leading intellectual property and pharmaceutical patent scholars.
Protect Your Patents the Right Way
Part I: The Intellectual Framework: Five Thinkers Who Shape the Debate
1. Peter Drahos: Patent Systems as Social Contracts
Australian National University professor Peter Drahos has spent his career interrogating the political economy of intellectual property. His landmark work, co-authored with John Braithwaite, Information Feudalism (2002), exposed how pharmaceutical companies leveraged international trade mechanisms (particularly TRIPS) to create a global intellectual property system that served their interests at the expense of developing nations.
For Drahos, the critical analytical question is not whether a secondary invention is technically novel, but whether granting a patent for it serves the social contract that justifies the patent system in the first place. He argues that patent offices in developing economies, which lack the institutional capacity to conduct rigorous prior-art searches and inventive-step analyses, are particularly vulnerable to granting low-quality secondary patents that hollow out the public benefit of the system.
Drahos Lens: Practitioner Application
When advising on secondary patent prosecution in Southeast Asia, ask not only whether the claim meets the formal patentability requirements, but whether the improvement being claimed delivers genuine public benefit. Patent offices that apply Drahos’s framework, like the Philippines, will ask exactly this question and will expect a compelling answer.
2. Carlos Correa: The Anti-Evergreening Architect
No single scholar has influenced pharmaceutical patent policy in developing nations more directly than Carlos Correa of the University of Buenos Aires and the South Centre. His 2006 Guidelines for the Examination of Pharmaceutical Patents: Developing a Public Health Perspective, prepared for the WHO, UNCTAD, ICTSD, and the World Bank became the intellectual blueprint for what is now known as “Section 3(d)-style” anti-evergreening provisions, following their adoption in India.
Correa’s central argument is elegant: The standard of inventive step as applied in most national patent offices is insufficiently demanding for pharmaceutical secondary patents, because the relevant comparison is not whether a skilled chemist could have predicted the modification, but whether the modification delivers a clinically meaningful therapeutic advance. His framework directly informs the Philippines‘ enhanced therapeutic efficacy requirement, arguably the strictest in ASEAN.
"The grant of secondary pharmaceutical patents without requiring evidence of enhanced therapeutic efficacy can serve no purpose other than extending monopoly rights."
Correa also pioneered detailed analysis of the specific subject-matter categories that are most commonly used for evergreening: polymorphs, salts, esters, hydrates, ethers, metabolites, particle-size modifications, and prodrugs. His taxonomy remains the definitive practitioner reference for understanding which claim types will face heightened scrutiny in anti-evergreening jurisdictions.
3. Jerome Reichman: The Flexibility Architect
Duke University’s Jerome Reichman occupies a different position in this debate. While sympathetic to public health concerns, Reichman’s most influential contribution has been his rigorous articulation of the TRIPS flexibilities available to developing nations and his critique of over-restrictive domestic patent laws that, paradoxically, can harm local innovation ecosystems.
Reichman’s work on “calibrated exceptions” argues that developing nations are entitled under TRIPS to design patent laws that serve their specific development stage, industrial capacity, and public health priorities including broader Bolar exemptions, compulsory licensing provisions, and flexible approaches to patent term. His framework is particularly visible in Indonesia’s 2024 reforms, which simultaneously expanded secondary patent protection (serving pharmaceutical innovators) while strengthening Bolar exemptions and parallel import rules (serving generic manufacturers and patients).
Reichman Lens: The Indonesia Paradox
Indonesia’s Law No. 65 of 2024 is arguably the most sophisticated example of Reichman-style “calibrated flexibilities” in ASEAN: it expands the scope of protectable inventions while simultaneously strengthening the public health safeguards that limit the practical effect of that expansion. Understanding this dual architecture is essential for advising clients on post-2024 Indonesian pharmaceutical patent strategy.
4. Dan Burk and Mark Lemley: The Patent System's Policy Levers
Stanford’s Mark Lemley and University of Minnesota’s Dan Burk, in their seminal article The Patent System for the 21st Century (2003) and subsequent book-length treatment, introduced the concept of “policy levers”, the idea that the same doctrines (obviousness, written description, claim construction) can and should be applied differently across different technology sectors because the economics of innovation differ radically between industries.
Their insight is directly applicable to pharmaceutical secondary patents. They observe that the pharmaceutical sector is unique in the patent landscape: it is the industry where the patent system is most essential to recouping research and development investment, but also the one where patent claims are most readily subject to incremental extension strategies. The appropriate policy response, they argue, is not to weaken patent protection generally, but to calibrate the application of patentability standards, particularly inventive step and industrial applicability to the specific economic realities of pharmaceutical research and development.
This framework helps explain why Malaysia‘s general patentability approach, while defensible, leaves pharmaceutical innovators in an environment of strategic uncertainty: without pharmaceutical-specific guidance, both innovators and generic manufacturers face unpredictable outcomes in prosecution and opposition proceedings.
5. Amy Kapczynski: Access, Innovation, and the Knowledge Economy
Yale Law School’s Amy Kapczynski represents a newer generation of intellectual property scholars who situate the secondary patent debate within the broader political economy of knowledge production. Her work on the “access to knowledge” movement and on pharmaceutical patent evergreening in the United States, particularly her contributions to the landmark study of secondary pharmaceutical patents in the U.S. market offers ASEAN practitioners a crucial analytical tool: empirical evidence.
Kapczynski’s research demonstrates that secondary pharmaceutical patenting is not a marginal phenomenon. Her work shows that the most commercially successful drugs attract the most secondary patents, and that these patents correlate strongly with delayed generic entry. For ASEAN practitioners, this empirical grounding is important: it confirms that the policy concerns driving countries like the Philippines toward strict anti-evergreening rules are grounded in documented pharmaceutical industry behavior, not theoretical speculation.
Kapczynski Lens: Strategic Implication
Patent portfolio strategies for pharmaceutical clients in ASEAN should anticipate heightened scrutiny of secondary patent claims in jurisdictions that have internalized empirical anti-evergreening concerns. The Philippines is the current benchmark, but practitioner experience across the region suggests that Indonesia and Thailand are watching the evidence base closely.
Coming in Part 2.
Armed with these five frameworks, Part 2 of this guide examines the practical landscape across Malaysia, Indonesia, Thailand, and the Philippines covering the specific rules, the strategic implications for pharmaceutical innovators and generic manufacturers, and the overarching practitioner principles that distinguish sophisticated ASEAN pharmaceutical patent strategy from routine prosecution.