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Overview
The Bio Health Center provides comprehensive solutions to all legal issues in the bio-health industry based on the expertise of the Patent Team, Payment Strategy Team, Approval & GMP Team, Regulation and Litigation Advisory Team, and Criminal Defense Team, each of which consists of professionals who have experience and know-how at the patent Court, Ministry of Health and Welfare, Ministry of Food and Drug Safety, the Health Insurance Review & Assessment Service, administrative courts, the Criminal Investigation Division of the Ministry of Food and Drug Safety, the prosecution and the police, etc.
The Payment Strategy Team and the Approval and GMP Team provide a one-stop portal for all legal issues related to the entire life cycle of a drug, including their development, clinical trials, product permissions, registration for health insurance, price determination and adjustment, distribution, and after-sales care, etc.
The Regulation and Litigation Advisory Team provides strategic and comprehensive one-stop legal advice for the bio-health sector, including licensing, mergers and acquisitions, patent applications, and legislative consulting, with a focus on response to regulations and litigations, such as administrative dispositions, in the bio-health industry, e.g., pharmaceuticals (including biologics and biosimilars), medical devices, food, and cosmetics.
The Payment Strategy Team and the Approval and GMP Team provide a one-stop portal for all legal issues related to the entire life cycle of a drug, including their development, clinical trials, product permissions, registration for health insurance, price determination and adjustment, distribution, and after-sales care, etc.
The Regulation and Litigation Advisory Team provides strategic and comprehensive one-stop legal advice for the bio-health sector, including licensing, mergers and acquisitions, patent applications, and legislative consulting, with a focus on response to regulations and litigations, such as administrative dispositions, in the bio-health industry, e.g., pharmaceuticals (including biologics and biosimilars), medical devices, food, and cosmetics.
Key Services
- Patent Team: Handling disputes and providing advice on intellectual property issues, including patents related to the bio-health industry
- Payment Strategy Team: Advising on registration for insurance benefits (generic drug pricing, risk-sharing, etc.), expansion of the scope of insurance payment, and adjustment of limit of insurance payment (price-volume agreement, drug pricing after termination of determination as an orphan drug, etc.)
- Approvals & GMP Team: Providing advice on R&D, clinical trials and related permissions, and permission or permission for modification of drug/medical device/cosmetics/food products, while providing solutions on business directions and strategies
- Regulations and Litigation Advisory Team: Advising and handling litigations on administrative dispositions imposed by government agencies under the National Health Insurance Act, the Pharmaceutical Affairs Act, the Medical Service Act, the Medical Devices Act, and the Cosmetics Act, etc.
Criminal Defense Team: Advising and handling litigations on investigations and trials related to violations of the Pharmaceutical Affairs Act and the National Health Insurance Act, etc.
Representative Cases
- Advised on the registration of various new drugs, assessment of economic feasibility and risk sharing, reviewed drug pricing strategies, conducted assessment of economic feasibility to expand the scope of payment and evaluate cost-effectiveness, and advised on product permissions
- Represented Medytox in hearings on order to the order to suspend manufacturing and sales, the disposition to cancel product permission and the order for recall and destruction issued by the Ministry of Food and Drug Safety; won 16 out of 17 cases for request of suspension of execution of 6 administrative dispositions
- Represented Hanmi Pharmaceutical in a patent invalidation case related to Entresto tablets and a passive trial to confirm the scope of rights
- Represented SK Chemicals in litigations to cancel the disposition to adjust the upper limit of drug price of Promac tablets and the relevant case involving suspension of execution
- Represented SK Chemicals in a patent infringement litigation related to a pneumococcal conjugate vaccine
- Handled litigations on patent invalidation and patent infringement related to the extension of pharmaceutical patents
- Handled a patent infringement litigation related to pharmaceutical patents
- Responded to a disposition imposed by the Ministry of Food and Drug Safety in relation to rebates
- Advised on the patent-approval linkage system
- Advised on management disputes and criminal cases involving a bio-health sector company
- Represented a pharmaceutical company in connection with violations of the Monopoly Regulation and Fair Trade Act
- Advised a multinational pharmaceutical company on clinical trials
- Advised on joint development of drugs and relevant license agreements
- Advised a bio-health sector company on the Financial Investment Services and Capital Markets Act
- Advised a bio-health sector company on mergers and acquisitions
Advised a bio-health sector company on telemedicine
