Hien Thi Thu Vu

Head of Regulatory Affairs and Manager of Legal Division of Patent Department

Biography

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 assists with analyzing technical matters and assessing the possibility of infringement in patent infringement cases.

In a region where generic drugs are increasingly promoted and given market access, Hien advocates for the rights of healthcare companies that devote extensive assets to R&D activities, and helps pharmaceutical companies to list their products in the original brand-name lists issued by the Drug Administration of Vietnam. She 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.

Hien is a licensed attorney and a Vietnam-qualified IP agent, and previously headed the patent unit at a leading local firm in Hanoi.

Experience

  • 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.
  • Prepared arguments/explanations to submit to the Drug Administration of Vietnam to successfully declare a biologic drug as an original brand-name drug, thereby allowing it to join drug tenders for original brand-name drugs in hospitals in Vietnam.
  • 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.
ABOUT Hien Thi Thu

Industries

Life Sciences

Location

Languages

    Vietnamese

    English

Education

    LLB, Hanoi Law University

    Bachelor of Pharmacy, Hanoi University of Pharmacy

    Bachelor of English, Hanoi University of Foreign Language

Insights

Awards & Rankings

Other Professionals

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