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Hyun Ock Kim
Partner
- TEL 82 2 6182 8391
- FAX 82 2 6003 7029
- E-MAIL hokim@hwawoo.com
Biography
Hyun Ock Kim is a partner at Yoon & Yang LLC, and his main practice areas include biohealth and intellectual property.
After graduating from Seoul National University with a degree in pharmacy, Mr. Kim earned his LL.M. from Sogang University Graduate School of Law. Thereafter, he served at the Ministry of Food and Drug Safety (MFDS), where he handled legal advisory matters, administrative dispositions, and administrative litigation across the entire healthcare sector, including pharmaceuticals, medical devices, narcotics, food, and cosmetics.
Since joining our law firm in 2020, Mr. Kim has been providing legal advice on healthcare-related laws, such as the Pharmaceutical Affairs Act, the Medical Devices Act, the Cosmetics Act, and the Medical Service Act. He also represents numerous clients in administrative litigation and disposition cases, as well as criminal proceedings initiated by the MFDS. Furthermore, Mr. Kim’s practice encompasses advisory and dispute resolution in intellectual property matters (e.g., pharmaceutical patents and trade secrets) as well as various legal issues pertaining to pharmaceutical and bio industries (e.g., rebates and compliance).
Based on his practical experience at regulatory bodies, Mr. Kim possesses a profound understanding of healthcare-related laws and regulatory frameworks. Leveraging his pharmaceutical expertise, regulatory background, and litigation capabilities, he provides practical and effective legal services for complex matters where healthcare regulation and intellectual property intersect.
After graduating from Seoul National University with a degree in pharmacy, Mr. Kim earned his LL.M. from Sogang University Graduate School of Law. Thereafter, he served at the Ministry of Food and Drug Safety (MFDS), where he handled legal advisory matters, administrative dispositions, and administrative litigation across the entire healthcare sector, including pharmaceuticals, medical devices, narcotics, food, and cosmetics.
Since joining our law firm in 2020, Mr. Kim has been providing legal advice on healthcare-related laws, such as the Pharmaceutical Affairs Act, the Medical Devices Act, the Cosmetics Act, and the Medical Service Act. He also represents numerous clients in administrative litigation and disposition cases, as well as criminal proceedings initiated by the MFDS. Furthermore, Mr. Kim’s practice encompasses advisory and dispute resolution in intellectual property matters (e.g., pharmaceutical patents and trade secrets) as well as various legal issues pertaining to pharmaceutical and bio industries (e.g., rebates and compliance).
Based on his practical experience at regulatory bodies, Mr. Kim possesses a profound understanding of healthcare-related laws and regulatory frameworks. Leveraging his pharmaceutical expertise, regulatory background, and litigation capabilities, he provides practical and effective legal services for complex matters where healthcare regulation and intellectual property intersect.
Practice Areas
Experience
- 2020-present Yoon & Yang LLC
- 2026-present Vice Chair, International Committee, Korea Industrial Pharmacists Association (KIPHA)
- 2026-present Member, Korea Industrial Security Academy (KISA)
- 2016-19 Public Service Advocate, Regulatory Reform and Legal Affairs Division, Ministry of Food and Drug Safety / Jinju Branch of Changwon District Prosecutors’ Office
- 2012-13 Pharmacist, Seoul St. Mary’s Hospital / Inha University Hospital
- 2011-12 Pharmacist, Munjeon Pharmacy (adjacent to Seoul National University)
Education
- 2025 UCLA School of Law (LL.M.)
- 2016 Sogang University Law School (J.D.)
- 2011 Seoul National University (B.S. in Pharmacy)
Qualifications
- Admitted to bar, Korea (2016)
- Pharmacist, Korea (2011)
Representative Matters
[Pharmaceuticals]
- Represented Medytox in administrative suits and preemptive legal responses against the Ministry of food and Drug Safety regarding the revocation of marketing authorization (prevailed in all cases)
- Represented Medytox in civil and criminal cases involving trade secret misappropriation
- Advised Medytox on obtaining export approvals for national core technologies from the Ministry of Trade, Industry and Energy
- Represented and advised Yuhan Corp. in civil and criminal cases pertaining to royalty payments
- Advised Yuhan Corp. on numerous matters relatng to joint R&D and pharmaceutical supply agreements
- Represented PharmaResearch in the administrative litigation regarding pharmaceutical recall and destruction orders
- Advised PharmaResearch on pharmaceutical and medical devices
- Represented Merck in the domestic patent litigation concerning vaccine products
- Advised AstraZeneca on compliance issues and the Pharmaceutical Affairs Act
- Advised Astellas Pharma on patient assistance program (PAP) and related regulatory issues
- Advised Bukwang Pharm on new drug development and indication expansion strategies
- Advised Kolon Pharm on pharmaceutical licensing agreements
- Advised CGBio on licensing agreements
- Advised a foreign pharmaceutical company on the outsourcing of clinical trials
- Represented Daewon Pharm in handling internal compliance audits and preparation of compliance reports
- Advised Celltrion on internal compliance manuals
- Advised Celltrion on matters relating to the drug price reduction system.
- Advised Huons Global on the contract manufacturing (CMO) of global pharmaceuticals
- Advised on the establishment and deal structure of management service organizations (MSO) and contract sales organizations (CSO)
[Medical Devices]
- Represented Dawon Medical in responding to the Ministry of Food and Drug Safety with regard to issues concerning the Medical Devices Act and the Safety and Management of Human Tissues Act
- Advised AI medical device company on varoius laws under the Ministry of Food and Drug Safety’s jurisdiction, including the Medical Devices Act and the Digital Medical Products Act
- Advised Seegene on the Ministry of Food and Drug Safety’s marketing authorization for medical devices
- Advised Lutronic on the export of laser medical devices and legal issues regarding trade secret leakage
- Represented Rapigen in responding to the Ministry of Food and Drug Safety pertaining to good manufacturing practice (GMP) of medical devices
- Advised GE Healthcare on the legal permissibility of telemedicine
- Advised on medical device advertising regulations in the US and EU
- Represented Selumed in the Ministry of Food and Drug Safety’s on-site inspections and criminal proceedings
- Handled civil suits regarding medical device defects
[Food & Cosmetics]
- Advised LG Household & Healthcare on cosmetics and related products
- Advised Hyundai Green Food on food labeling and advertising regulations
- Handled responses to the Ministry of Food and Drug Safety’s investigations regarding alleged violations of the Food Sanitation Act involving food ingredients
- Advised on food classification based on the standards and specifications for food products
- Handled responses to the Ministry of Food and Drug Safety’s investigations regarding violations of food labeling requirements
- Handled responses to the Ministry of Food and Drug Safety’s investigations pertaining to caviar manufacturer
Languages
Korean and English
