In a significant verdict reinforcing India’s pro-access approach to pharmaceuticals, a local patent court has rejected a patent application filed by Japan-based Zeria Pharmaceutical Co. The application was denied on the grounds of “evergreening,” a controversial practice where pharmaceutical companies attempt to extend patent protection through minor, non-therapeutic modifications to existing drugs.
Zeria, a well-known player in the global pharmaceutical industry, had sought patent rights in India for a revised formulation of an already marketed drug. However, the court ruled that the new version did not demonstrate a significant enhancement in therapeutic efficacy and therefore did not qualify for patent protection under Indian law.
What Is Evergreening?
Evergreening is a tactic used by some pharmaceutical companies to maintain market exclusivity beyond the original patent term. This is typically done by making minor changes to a drug’s formulation, dosage, or delivery method—without a corresponding improvement in medical effectiveness. Such practices can delay the introduction of cost-effective generic versions, which are crucial for public access in low- and middle-income countries.
India’s Patents Act, specifically Section 3(d), was crafted to prevent evergreening by allowing patents for known substances only if the modification leads to enhanced efficacy. This clause has been pivotal in ensuring that patent protection in India is reserved for true innovations, rather than incremental tweaks.
The Court’s Reasoning
In its ruling, the Indian patent office found that Zeria’s revised formulation lacked a demonstrable improvement over the original drug in terms of efficacy. Without substantial scientific evidence supporting a therapeutic benefit, the application fell short of the legal requirements outlined in Section 3(d) of the Patents Act.
The court’s decision echoed the landmark 2013 Supreme Court ruling in the Novartis v. Union of India case, where a similar application was rejected for the cancer drug Glivec. In that ruling, the Supreme Court clarified that the Indian patent regime prioritizes therapeutic advancements over commercial interests.
Industry Reactions and Implications
Health advocacy groups welcomed the verdict, stating that it will help preserve India’s role as a global supplier of affordable medicines. “This decision is a clear message that India’s patent system values real innovation over commercial strategy,” said a spokesperson from a Delhi-based public health NGO.
Meanwhile, industry analysts noted that multinational pharmaceutical companies operating in India may need to revisit their intellectual property strategies. Zeria’s case highlights the risks of relying on reformulated versions of existing drugs to secure long-term market exclusivity in countries with stringent anti-evergreening laws.
Broader Impact on Access to Medicines
India is often referred to as the “pharmacy of the developing world” due to its robust generics industry and relatively strict patent regime. Decisions like this one ensure continued access to affordable medications not only for Indian citizens but also for millions in other countries who depend on Indian generics.
By upholding its legal safeguards against evergreening, India continues to balance the protection of intellectual property with public health needs—a position that has made it both a model and a battleground in global pharmaceutical patent debates.
Conclusion
The rejection of Zeria Pharmaceuticals’ patent application marks another chapter in India’s ongoing effort to promote genuine innovation while preventing the misuse of the patent system. As the global conversation around drug pricing and access intensifies, India’s legal framework remains a critical reference point in the evolving dialogue on intellectual property and public health.