Healthcare

헬스케어

Introduction

분야 소개

The Current State of the Health Care Industry

As Korea’s economy expanded, so did the demand for good healthcare, and thereby the healthcare industry in the country. The industry’s stature in the Korean economy has also increased, as the Korean government declared it to be one of the three major growth industries in the future.

Because the healthcare industry deals directly with human health, the government imposes strict legal regulations and systematically manages the intellectual property rights. The government has also created a long list of unique legal processes over patents, technology licensing, material licensing, as well consignment of clinical trials. D’LIGHT has been providing legal services to navigate through these complex processes for a wide range of healthcare companies, from start-up bio ventures to leading multinational pharmaceutical companies.

We provide in-depth, comprehensive analysis for the various sectors within the healthcare industry – pharmaceutical, bio, medical devices, digital healthcare, medical care, food, and cosmetics – based on our vast technical knowledge and extensive experience. Our clients seek advice regarding licensing, intellectual property rights, regulatory compliance, M&A, and investments. We are an indispensable guide for our pioneering clients in the healthcare industry.

Practice Group

Our Healthcare Practice Group advises clients based on a swift, detailed, and deep analysis of pharmaceutical and biotechnology sectors and the legal system, through our expert lawyers who have studied Biotechnology at leading domestic and international universities. Along with our lawyers, we have ICT technical experts that assist clients identify and rapidly resolve technical issues that may impact the medical device and digital healthcare sectors. We also provide effective solutions to the problems in the medical field faced by the institutions and personnel, based on our accumulated know-how as legal consultants for the medical community. Finally, we have lawyers who have served as regulatory legal officers at the Ministry of Food and Drug Safety (“MFDS”) who can guide clients through the rules and regulations of the food and cosmetics sectors.

Detailed Industry Sectors

Pharmaceuticals/Bio: New drugs, bioequivalent drug products, raw materials, advanced biomedicine (cell therapy, gene therapy, tissue engineering drugs), microbiome, etc.
Medical Appliances: Diagnostic analysis medical devices, innovative medical devices, software medical devices (SaMD), digital medicine (DTx), etc.
Digital Healthcare: Innovative solutions for medical institutions, such as medical big data, AI, electronic medical records (EMR) and patient information (CRM), fitness and wellness applications, etc.
Medical Care: Operating Medical Services Organization (MSO etc.), advertisements for medicines and medical institutions (CSO etc.), Medical administrative and criminal justice litigation
Food/Cosmetics: Food, health foods, cosmetics, liquor, etc.

Key Business Contents

주요 업무 내용

Licensing
• Advising on licensing in and out, supply and sales contracts, technology and material transfer contracts, clinical trial and research collaboration, consignment contracts, etc.

IP Rights
• Applications for patents, trademarks, and other intellectual property rights, as well as protection, prevention of infringement, etc.
• Consulting on the drug licensing patent linkage

Approvals, Regulations & Compliance
• Consulting on responding to demands for information by regulatory agencies such as the MFDS, the Ministry of Health and Welfare (the “MHW”), and the National Health Insurance Service (the “NHIS”)
• MFDS: Permit approvals, certifications, reporting, and clinical trials (preclinical, IRB, 1-3 phases), conditional permits, etc.
• MHW and NHIS: Evaluation of new medical technology, registration of national health insurance, insurance benefits list, etc.
• Consulting on compliance with domestic pharmaceutical laws, fair trade and anti-corruption laws, international industry codes, and privacy laws.
• Advising on compliance with regulations on advertisements related to medicine and medical care
• Leading litigations appealing administrative disposition from regulatory agencies
• Consulting on the establishment and operation of medical institutions

M&A, Investments & Corporate Governance
• Consulting for Bio Venture/Healthcare Startup investments as well as funding
• Advising on changing corporate governance, including corporate mergers, acquisitions, splits, and establishment of joint ventures (JVs)

Contact Attorneys

담당변호사 및 연락처

Please contact Won H. Cho, Young Hyuk Kim, Chan Woo Sung, Young Jae Choi, Shi Hang Lee, Marie Nam, and Hee Young Lim for any inquiries concerning our Healthcare Practice Group.
「 Healthcare Practice Group 」
  • 02-2051-1870
  • healthcare@dlightlaw.com