[Healthcare and Life Sciences]

• Advised on drug pricing and reimbursement matters, including reimbursement of new drugs, health insurance coverage, pharmacoeconomic evaluation, reimbursement reassessment, and price-volume agreements (PVAs)

• Advised on medical device regulatory matters, including obtaining and amending marketing approvals, product classification, investigational device approvals, new health technology assessments (nHTA), and innovative medical device designation

• Advised on regulatory compliance relating to medical advertising

• Advised on obtaining marketing approval for digital medical devices and compliance with regulations governing medical software

• Advised on responses to decisions and measures taken by the Health Insurance Review and Assessment Service (HIRA), including reductions or exclusions from reimbursement criteria for drugs and medical devices and determinations concerning excessive patient co-payments and refunds

• Advised on alleged violations of the Food Sanitation Act, Pharmaceutical Affairs Act, Medical Devices Act, and In Vitro Diagnostic Medical Devices Act

• Advised on responses to notices of administrative disposition issued by the Ministry of Health and Welfare

• Advised on regulatory compliance in the operation of medical institutions

• Advised on a challenge to the Ministry of Food and Drug Safety’s rejection of an application for conditional approval of a cell therapy product

• Defended a consumer products company in litigation relating to humidifier disinfectants

• Represented a medical device company in criminal proceedings involving alleged violations of the Medical Devices Act

• Represented a client in litigation concerning the validity of a gift agreement executed by a person alleged to lack legal capacity

• Advised on the importation and commercialization of medical devices

• Advised on medical device recalls

• Advised on the negotiation and execution of a joint research and development agreement for a pharmaceutical product

• Advised on the permissibility of ingredients used in food, health functional food, and cosmetic products

• Advised on labeling and packaging requirements for cosmetic products

• Advised on issues relating to funding contributions to a domestic medical center

• Advised on regulatory matters involving advanced biopharmaceuticals

• Advised on regulatory requirements relating to high-risk pathogens under the Infectious Disease Control and Prevention Act

• Advised on responses to notices of drug price adjustments

• Advised on the research, preservation, management, and provision of human biological materials

• Advised on regulatory compliance for pharmaceutical platform businesses

[Intellectual Property]

• Represented a global pharmaceutical company in patent infringement litigation and preliminary injunction proceedings involving an anticoagulant drug

• Represented a global pharmaceutical company in disputes involving an anticancer drug

• Advised a global pharmaceutical company on the validity of patents relating to an anticancer drug

• Represented a medical device company in criminal proceedings involving alleged trade secret misappropriation

• Represented a Korean pharmaceutical company in disputes involving a botulinum toxin product

• Advised a Korean biosimilar company on patent validity issues

• Represented a major Korean company in patent infringement litigation involving a pharmaceutical product

• Represented a global company in patent infringement litigation and an unfair trade practices investigation involving insulation materials

• Advised on legal and regulatory issues relating to license agreements

• Advised on the disclosure and use of trade secrets by former employees and competitors

• Advised on the launch of educational software in overseas markets

• Advised leading hotel franchise businesses on franchise compliance matters

• Advised on legal and regulatory compliance relating to social media software and services

[Others]

• Advised on quarantine exemption requirements

• Advised on responses to adverse or malicious media coverage

• Reviewed a wide range of commercial agreements for compliance with Korean law