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Bio / Pharmaceutical

Introduction

The ClassHankyul bio/pharmaceutical team is comprised of specialists from major regulatory agencies such as the Health Insurance Review and Assessment Service and the National Health Insurance Corporation. Our team serves as legal advisors to numerous medical institutions, pharmaceutical manufacturers, and medical device companies, and has extensive experience and knowledge on a variety of legal issues arising in the healthcare field. 

More specifically, the bio/pharmaceutical team boasts top tier capabilities in resolving a full spectrum of legal issues, including healthcare-related licensing and registration. Based on the legal knowledge and experience developed over the years, we provide timely and fault-free legal services by utilizing our comprehensive practical experience in the healthcare field and our strong personal network. 

In addition, the bio/pharmaceutical team consistently collects new information to provide unique healthcare-related advice that reflects the latest trends to maximize the value and interests protected and guaranteed for clients, to the extent possible. We provide optimal solutions from the perspective of our clients for medical disputes, regardless of their type, regulatory compliance, and response to policy changes, and contribute to our clients’ business success by ensuring promptness in our response.

Major Business

Bio/Pharmaceutical Litigations

- Appeals against administrative sanctions such as forfeiture of unfair profits, business suspension, imposition of penalty surcharges, and license suspensions (application for appeals, administrative appeals, administrative litigation, etc.)
- Civil lawsuits including claims for damages
- Defense of clients in criminal litigation proceedings for alleged violations of the Medical Service Act, the Pharmaceutical Affairs Act, the Medical Devices Act and other relevant laws

Advice on Regulations and Compliance

- Representation in criminal/administrative lawsuits in relation to various regulations, such as the Pharmaceutical Affairs Act, the Medical Devices Act, the Bioethics and Safety Act, the Cosmetics Act, the Food Sanitation Act, and the Special Act on Imported Food Safety Control

IP Related Services

- Representation in lawsuits related to various types of intellectual property rights, including patents, trademarks, service marks, copyrights, and trade secrets
- Representation in applications for and actions/appeals on intellectual property rights
- Response to disputes related to medical equipment utilizing new technologies and artificial intelligence

Fair Trade and Responses to Rebates

- Response to investigations/sanctions by the Fair Trade Commission, and the Ministry of Health and Welfare in connection with different types of rebates, and representation in criminal/administrative litigation

Major Performance

- Assisted with the revocation of the forfeiture order in Company D’s unfair profits (KRW 22 billion), application for revocation of the penalty surcharges imposed on Company T, registration of new medical equipment of Company P and more
- Successfully represented Dong-A Pharmaceutical Co., Ltd. in multiple instances of litigation against US Pfizer on cholesterol-lowering Atorvastatin, including pharmaceutical patent lawsuits
- Successfully represented LMS in its patent lawsuits and other claims on LCD prism sheets against US 3M
- Successfully represented Samsung Electronics, SKT, Ceragem and others in 100+ cases involving employee inventions

Related members

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