What is the rule regarding testing drugs for government regulatory approval?
Acts related to testing, making, or selling a patented drug are allowed if done solely for government regulatory submissions. This allows pharmaceutical developers to prepare for market entry once the patent expires. The law protects submitted data from unfair commercial use during this process. This regulatory testing exception is found in Section 72 Intellectual Property Code of the Philippines. “72.4. In the case of drugs and medicines, where the act includes testing, using, making or selling the invention including any data related thereto, solely for purposes reasonably related to the development and submission of information and issuance of approvals by government regulatory agencies…” January 3, 2026About Nicolas and De Vega Law Offices
Nicolas and De Vega Law Offices is a full-service law firm in the Philippines. You may visit us at the 16th Flr., Suite 1607 AIC Burgundy Empire Tower, ADB Ave., Ortigas Center, 1605 Pasig City, Metro Manila, Philippines. You may also call us at +632 84706126, +632 84706130, +632 84016392 or e-mail us at [email protected]. Visit our website https://ndvlaw.com/.
