Expertise

Healthcare & Life Sciences Disputes

Introduction

Introduction

The Healthcare and Life Sciences Dispute Practice is a leading disputes practice that advises various stakeholders in the industry. The Practice has a wealth of experience in disputes involving medical devices, food, cosmetics, life-science related products and medical insurance. The team of experts with backgrounds in chemistry and pharmacology, is complemented by former judges or prosecutors, and those who have worked in regulatory agencies such as the Ministry of Food and Drug Safety, the Ministry of Health and Welfare and the Health Insurance Review & Assessment Service.

The Practice is known for being a one-stop shop for representing clients in disputes that can arise in the industry with various stakeholders. Our experts are able to advise on regulatory and policy issues with respect to various government agencies such as the Ministry of Food and Drug Safety, the Ministry of Health and Welfare, the Health Insurance Review & Assessment Service and the National Health Insurance Corporation, and also advise on disputes across the whole life cycle of a drug, from its development to clinical trial, distribution to post management. The team of experts with experience in the industry has made the Practice a leader in its field.

Key Services

The Practice provides the following services:

Support for administrative suits filed by the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, or the Health Insurance Review & Assessment Service relating to:
  • administrative suits filed by the Ministry of Food and Drug Safety in connection with drugs, medical equipment, food, cosmetics, etc.
  • suits filed in connection with receiving medical care benefit for a drug or medicine and the drug price determination and adjustment by the Ministry of Health and Welfare and Health Insurance Review & Assessment Service
  • administrative dispositions, such as business suspension, or fines imposed by the Ministry of Health and Welfare against health and medical service providers 
  • administrative sanctions on licensed health and medical professionals, such as suspension or cancellation of license of a health care provider or pharmacist
  • reduction of funds after examination on medical care expenses or propriety assessment conducted by the Health Insurance Review & Assessment Service
  • recovery actions for unjust enrichment, damages claim or etc. filed by the National Health Insurance Corporation
Advice and representation in litigation involving drug and medical device patents
Advice and representation in litigation involving fair trade and rebates:
  • investigation/sanctions by the Korean Fair Trade Commission or the Ministry of Health and Welfare regarding rebate on drugs and medical devices
  • reduction in drug price and suspension of health care benefits on drugs in relation to rebates.
Advice on other related civil/criminal litigations and constitutional lawsuits
Experiences
  • A domestic pharmaceutical company against a bioequivalence test institution in a damage claim in relation to a bioequivalence test result
  • A pharmaceutical company in a claim on return of material synthesis drug costs
  • A pharmaceutical company in filing an injunction in relation to a notification to reduce the drug prices due to rebates
  • A client with respect to a litigation involving a transfer of management rights by a medical foundation
  • Clients in various medical-related litigation on behalf of many domestic university hospitals and mid to large sized hospitals
  • A pharmaceutical company in a patent litigation in relation to the de-registration of patents and patent usage rights for drugs such as Sildenafil, Tadalafil, Rivaroxaban, Rosuvastatin, Candesartan Cilexetil, Docetaxel, and Losatan
  • A client in the first ever lawsuit regarding drug price reduction due to patent infringement
  • Various pharmaceutical companies in filing applications for suspension of efficiency to the Ministry of Food and Drug Safety.