LLB, Hanoi Law University
Bachelor of Pharmacy, Hanoi University of Pharmacy
Bachelor of English, Hanoi University of Foreign Language
+84 24 3772 5606 
Hien Thi Thu Vu heads the Tilleke & Gibbins regulatory affairs team in Vietnam, advising and assisting chemical, pharmaceutical, medical device, and biotechnology companies to register their products with Vietnam’s regulatory agencies. She also helps companies understand and comply with a complex regulatory environment when doing business in life sciences sectors in Vietnam. Additionally, as the manager of the legal division of the firm’s patent team in Vietnam, she handles invention novelty evaluation, patent invalidation, and assessing the possibility of infringement in patent infringement cases.
Hien has a strong background in the life sciences, with a degree in pharmacy, two years of industry experience as a medical representative with Hoffman-La Roche, and 15 years as a patent executive. She is a licensed attorney and a Vietnam-qualified IP agent, and previously headed the patent unit at a leading local firm in Hanoi.
- Contributed to a regulatory audit for a well-known cosmetics company to ensure compliance with ASEAN Cosmetic Directive standards, including reviews of product labels, formulas, and Product Information Files (PIF), guaranteeing adherence to regional regulations and maintaining product safety and quality.
- Assisted with a regulatory audit and facility licenses in an M&A deal in the animal health area.
- Analyzed the patent claims, drafted claim charts, and obtained professional conclusions on patent infringement from the Vietnam Intellectual Research Institute in several patent infringement cases concerning patented human drugs.
- Conducted a search and provided a freedom-to-operate opinion pertaining to a vaccine for pigs.
- Advised two international pharmaceutical companies on issues of patent and data exclusivity in Vietnam in light of the Trans-Pacific Partnership.
- Commented on and recommended changes in Vietnamese pharmaceutical legislation in light of the Trans-Pacific Partnership and EU-Vietnam Free Trade Agreement through a roadmap prepared for the government by the European Chamber of Commerce’s Pharma Group.