The “weight-loss drug” gold rush (Semaglutide) has been the biggest pharma story of the decade. Everyone wants a piece of the pie. But can generic manufacturers start making it before the patents expire? On December 17, 2025, the Delhi High Court delivered a nuanced verdict that balances innovation with access—a ruling that every generic manufacturer in ASEAN needs to study closely.

The Story: The giant Novo Nordisk (creator of the blockbuster drug) sought to block Indian pharma major Sun Pharma from manufacturing a generic version of the drug. Novo argued their patent was valid until 2026 and that Sun Pharma’s production was blatant infringement.

Sun Pharma argued for an “Export Exception.” They claimed they wanted to manufacture the drug in India not for local sale, but to export it to countries where Novo’s patent had already expired or never existed.

In a landmark decision just days ago, the court ruled: Yes to Manufacturing, No to Selling. The judge allowed Sun Pharma to keep their factories running and to export the drug to non-patented markets, but strictly banned them from selling a single pill within India until the domestic patent expires in March 2026.

The “Elongated” Lesson: This case highlights the critical “Bolar Exemption” and “Manufacturing for Export” strategies.

• The “Launch at Risk” Myth: Many companies think they can’t touch a patented drug until the day it expires. This ruling proves you can ramp up manufacturing and even export to “safe” markets, provided you ring-fence your domestic sales.

• The “Patent Cliff” Prep: With major drugs like Xarelto and Entresto also facing patent cliffs in 2025, the race is won by those who are ready to ship on Day 1. Sun Pharma’s victory allows them to be ready, rather than starting from zero in 2026.

How ASEAN IPR Helps: For pharma companies in Vietnam, Indonesia, and Thailand, this is the blueprint.

• Patent Mapping: We map out exactly which ASEAN countries have valid patents for a specific drug and which are “open” for export.

• Bolar Exemption Strategy: We help you navigate the “Early Working” provisions in ASEAN laws, allowing you to conduct R&D and regulatory trials during the patent term so you can launch the second the patent expires.

• Export Clearance: We draft the legal affidavits (like the one Sun Pharma had to file) to prove to local courts that your manufacturing is strictly for export, keeping your factories running without infringing local rights.