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
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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March 10, 2017

MIP Global Awards 2017: Tilleke & Gibbins Named Vietnam Firm of the Year for Fourth Straight Year

Tilleke & Gibbins was again honored as Firm of the Year for Vietnam at Managing Intellectual Property’s Global Awards 2017, held at London’s Savoy Hotel on the evening of March 9. This marks the...

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March 3, 2017

Tilleke & Gibbins’ Vietnam Office Earns Top Ranking in MIP Patent Survey 2017

Tilleke & Gibbins’ IP practice in Vietnam has been recognized with the highest possible ranking in the Patent Survey 2017 by Managing Intellectual Property (MIP). The firm’s Vietnam office has...

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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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January 9, 2017

Vietnam: Imported Medical Devices Will Require Registration in 2017

Hien Thi Thu Vu

Starting in 2017, all medical devices imported into Vietnam will be required to register for marketing authorization (MA) licenses. Previously, imported medical devices did not require MA licenses;...

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