Hien Thi Thu Vu

Head of Regulatory Affairs – Vietnam
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T: +84 24 3772 5606
F: +84 24 3772 5568

Practices

Office

Languages

Vietnamese, English

Education

LLB, Hanoi Law University

Bachelor of Pharmacy, Hanoi University of Pharmacy

Bachelor of English, Hanoi University of Foreign Language

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 Vietnam-qualified IP agent and previously headed the patent unit at a leading local firm in Hanoi.

  • 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.

Datesort icon Title
November 15, 2017

Tilleke & Gibbins Vietnam has Strong Showing in Asialaw Profiles 2018

In the 2018 edition of Asialaw Profiles, Tilleke & Gibbins was recognized as a leading law firm in Vietnam in seven practice areas, as follows: Outstanding: Intellectual Property; IT, Telco...

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October 23, 2017

Asia IP Patent 2017: Tilleke & Gibbins Top Tier for Thailand and Vietnam

In the 2017 edition of its annual Patent Survey, Hong Kong-based Asia IP  magazine has again placed Tilleke & Gibbins at the very top of the field, with Tier 1 rankings in the following...

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June 12, 2017

IAM Patent 1000 Awards Top Rankings to Tilleke & Gibbins in Vietnam

Intellectual Asset Management (IAM) Patent 1000 – the World’s Leading Patent Practitioners 2017  has ranked Tilleke & Gibbins at the top of the legal market for patent work in Vietnam in the...

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May 12, 2017

ALB Awards Tier 1 Rankings to Tilleke & Gibbins’ IP Practice in Vietnam

Tilleke & Gibbins’ IP team has earned “Tier 1” rankings for “Patents” and “Trademarks/Copyright” in Vietnam. Asian Legal Business  identified the firm among a select few to be placed in the...

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April 13, 2017

Tilleke & Gibbins Brings INTA’s Unreal Campaign to Vietnam

On April 26, World Intellectual Property Day, Tilleke & Gibbins and the International Trademark Association (INTA) will be organizing a special student outreach event at the Hanoi Law University...

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Datesort icon Title
September 22, 2017

PLC Life Sciences Global Guide 2017 – Vietnam Chapter

Hien Thi Thu Vu, Tu Ngoc Trinh

Pharmaceutical experts from Tilleke & Gibbins authored the Vietnam chapters of the latest edition of the PLC Life Sciences Global Guide. PLC’s popular guides provide a comparative overview, in Q...

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February 27, 2017

PLC Agricultural Law Global Guide 2017 – Vietnam Chapter

Kien Trung Trinh, Hien Thi Thu Vu, Linh Duy Mai

The latest edition of Practical Law Company’s Agricultural Law Global Guide  was recently published, with the Vietnam chapter written by lawyers from Tilleke & Gibbins. The guide’s Q&A...

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February 23, 2017

Vietnam: Improving Pharmaceutical IP Protection

Thomas J. Treutler, Hien Thi Thu Vu

Vietnam’s IP enforcement system has seen great improvements over the last several years. In particular, the Inspectorate of the Ministry of Science and Technology (MOST) has handled many complex...

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February 14, 2017

PLC Distribution and Marketing of Drugs Global Guide 2016/17 – Vietnam Chapter

Tu Ngoc Trinh, Hien Thi Thu Vu

Practical Law has published the 2016/17 edition of the Distribution and Marketing of Drugs Global Guide, a guide to key issues involved in bringing drugs to market in 28 jurisdictions worldwide. The...

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January 23, 2017

2016 Pharmaceutical Patent Overview for Vietnam

Thomas J. Treutler, Thang Duc Nguyen, Hien Thi Thu Vu

With a population approaching 100 million, a burgeoning health care industry, increasing consumer affluence, and relatively weak competition from local pharmaceutical manufacturers, Vietnam would...

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