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Healthcare

Overview

Yoon & Yang’s Healthcare Practice Group consists of attorneys and experts with an in-depth understanding of the healthcare industry in general, including pharmaceuticals, medical devices, foods, cosmetics and medical institutions, who can provide comprehensive and strategic legal advisory services in all relevant business areas. The Group advises medical institutions, pharmaceutical companies, medical device companies, food companies and cosmetics companies on regulations, licensing, M&A, intellectual property including patent application, antitrust law, general corporate matters and litigation, by providing the most effective and efficient solutions with respect to a wide scope of legal issues in the field.

Our Group puts in the effort to understand the needs of our clients, which range from leading multinational and domestic pharmaceutical companies and biotechnology start-ups to medical device companies, hospitals, cosmetics and food companies. We strives to provide careful and strategic legal solutions to meet those needs in compliance with applicable laws and regulations.

Practices

Advisory Service on Regulations of the Healthcare Industry by the Ministry of Food and Drug Safety (“MFDS”)
Our Group provides clients with legal advisory services with respect to the manufacture, import, and sale of products of various kinds, while at the same time making sure of legal compliance with relevant healthcare laws and regulations including Pharmaceutical Affairs Act, Medical Device Act, Medical Service Act, Monopoly Regulation and Fair Trade Act, Food Sanitation Act, Act on Fair Labeling and Advertising and other applicable laws.

The Group advises clients to avoid and prevent the occurrence of any potential legal issues by providing legal consultation with respect to drafting of a compliance program including: Legislation of internal operation manuals, conducting internal auditing and establishing effective and lawful marketing strategies in compliance with relevant laws and regulations. The Group also represents clients in criminal investigations to defend against investigations conducted by the Korea Fair Trade Commission (“KFTC”), MFDS and the Ministry of Health and Welfare (MoHW).

Advisory Service on Product Approvals
Our Group provides legal advisory services to pharmaceutical and medical device companies with respect to obtaining licenses and permits for pharmaceutical products and medical devices. The Group provides comprehensive advice, from the development stage of the product to the sale of the product after government approval, and also assists clients on any issues that relates to intellectual property rights and or other administrative matters, such as listing and pricing on the national health insurance system.

Our Group has represented major domestic pharmaceutical companies and won favorable judgments in litigations against the MFDS regarding the cancellation of a pharmaceutical product approval, which were nearly unprecedented in Korean jurisprudence.

Advisory Service regarding Listing and Pricing on the National Health Insurance System
Our Group provides a wide range of advisory services regarding the listing and pricing of pharmaceutical products and medical devices on the national health insurance system. The Group has a history of successfully advising pharmaceutical companies regarding the listing and pricing of orphan drug on the national health insurance system and on the various legal issues related to such listing and pricing process.

Our Group represented major domestic medical device companies and won favorable judgments in litigations against MoHW regarding the cancellation of a listing on the national health insurance system for a medical device, which was an unprecedented case in Korean law.

Advisory Service regarding Antitrust and Fair Trade Regulations by the KFTC and MFDS
Our Group provides advisory services on a wide array of legal issues regarding antitrust and fair trade regulations that may arise in the healthcare industry including unfair trade practice (e.g., provision of rebates), labeling and advertising of medical, pharmaceutical, food and cosmetic products.

The Group has provided legal advice and represented a major multinational pharmaceutical company during the KFTC investigation into alleged provision of rebates and during subsequent administrative litigation process to revoke corrective orders and penalties assessed against the company.

Advisory Service regarding Protection of Intellectual Property Rights
Our Group provides counsel and assistance with the protection of clients’ intellectual property rights, including licenses, patents, and trademarks, among others. In particular, the Group has experience in providing comprehensive legal consultation regarding legal compliance of pharmaceutical products with the new patent-approval linkage system including registration of patents on the “Green List” under the Korea-US Free Trade Agreement.

Advisory Service regarding Investments, M&A and Restructuring in the Healthcare Industry
Our Group provides clients with legal advisory services with respect to the terms and structure of a transaction that can minimize risks and maximize effectiveness in the course of M&As, restructuring procedures, investment attraction, and establishment of joint ventures in the healthcare industry. The Group also provides legal consultation regarding the overseas expansion of major domestic pharmaceutical companies.

• Advisory Service on Food & Cosmetic Products
Our Group provides legal advisory services regarding the Food Sanitation Act, Functional Foods for Health Act and Cosmetics Act, and provides solutions to legal issues that arise in the course of manufacturing, importation and exportation of food and raw materials, nutrition content inspection and customs clearance of products.

Representation in Lawsuits and Other Legal Disputes
Our Group has had great success and recognition in representing a large number of medical institutions and companies in various kinds of civil litigations (compensation for damages, evacuation of hospital room, and preliminary injunction against obstruction of business, etc.), criminal litigations (complaints and accusations regarding malpractice, obstruction of business, and medical advertisement, etc.), administrative litigations (revocation of license, suspension of business, and cancellation of imposition of administrative fine, etc.), litigations on constitutional issues (constitutional complaint etc. on infringement of fundamental rights of medical practitioners), and litigations related to industrial accidents (accidents related to work, and occupational disease, etc.).

Advisory Service on General Corporate Matters
Our Group provides general and comprehensive advisory services on the establishment of medical institutions in free economic zones, resolution of labor conflicts, drafting of privacy policies with respect to protection of personal information, preparation and review of all kinds of agreements, including co-marketing and co-promotion agreements, and service contracts on clinical trials, based on the Group’s practical experience and understanding of realistic issues that may be encountered in the healthcare industry.

Representative Matters

Regulation matters, including antitrust and fair-trade issues, in the healthcare industry
Advised a major multinational pharmaceutical company regarding the listing and pricing of an orphan drug on the national health insurance system
Advised a major multinational pharmaceutical company during the KFTC investigation into alleged provision of rebates and subsequent administrative litigation process for corrective order and administrative penalties
Advised on and reviewed legal issues that may arise during clinical trials of pharmaceutical products
Advised a multinational medical device company regarding legal issues with regards to the MFDS’s permit and license in connection with the business transfer
Advised a multinational eye bank on establishment of an eye bank in Korea

In relation to investment, M&A and restructuring of the healthcare industry
Advised on the acquisition of a European pharmaceutical company by a major domestic pharmaceutical company
Advised on investment into a hair implantation machine manufacturer
Advised on Korea’s first pharmaceutical industry specific fund (Global Pharmaceutical Fund) sponsored by the MOHW and the Korean Finance Corporation in its outbound investment in foreign pharmaceutical and biotechnology companies

In relation to intellectual property-related issues and disputes in the healthcare industry
Represented and won in litigation for a major domestic pharmaceutical company against the MFDS involving the cancellation of approval for a pharmaceutical product
Represented a major domestic pharmaceutical company and won in litigation against the MoHW regarding the delisting of a drug under the national health insurance system
Represented a major domestic pharmaceutical company and won in litigation. Now recognized as a landmark case for manufacturing standards of pharmaceutical product (Contac-600 case)
Represented a major domestic pharmaceutical company and won in litigation against the National Health Insurance Corporation in a claim for damages regarding raw material synthesis
Represented a major multinational pharmaceutical company during the KFTC investigation into alleged provision of rebates and subsequent administrative litigation process for corrective orders and administrative penalties

In relation to general corporate advisory service in the healthcare industry
Provided legal auditing projects for major multinational pharmaceutical company to inspect exposure to legal risk in relation to fair trade laws, labor laws, personal information protection and corporate governance
Advised a major domestic pharmaceutical company regarding a dispute over right of management


18th, 19th, 22nd, 23rd, 34th Fl., ASEM Tower 517 Yeongdong-daero, Gangnam-Gu, Seoul 135-798, Korea / Tel:+82-2-6003-7000 / Fax:+82-2-6003-7800

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