Ms. Minyoung Park is a foreign attorney at Shin & Kim, specializing in the pharmaceutical, biotechnology, and healthcare sectors. Her expertise extends to providing intellectual property (IP) and regulatory advice, as well as handling disputes in these fields.

Representing both multinational and domestic companies, Ms. Park adeptly manages a wide range of issues across the product life cycles of pharmaceutical and biological products and medical devices. Stemming from her background as a licensed pharmacist, Ms. Park has a profound understanding of the advanced technologies in these industries, and insights into the regulatory and IP challenges of these industries. Ms. Park’s key experiences include advising on legal and regulatory matters and contract negotiations during pre-clinical/clinical R&D phases, advising on complex cross-border research collaboration and technology/IP licensing transactions, and drafting relevant license agreements and other legal documentation. Ms. Park is also experienced in guiding clients through the intricate review processes of marketing authorization applications, advising on market access strategies, including pricing and reimbursement, handling post-marketing regulatory sanctions and penalties, as well as assisting clients with administrative proceedings in Korea.

Furthermore, Ms. Park provides advice to foreign and domestic clients on a range of IP issues, transactions, and disputes. Ms. Park specializes particularly in advising on disputes involving patents and trade secrets in Korea and abroad, with a focus on sectors such as chemical, pharmaceutical, biotechnology, and other advanced technologies.

• Advised and represented multinational and domestic large pharmaceutical companies in patent infringement and invalidation lawsuits involving chemical compounds and biological products
• Advised clients on disputes in foreign jurisdictions regarding the infringement and misappropriation of intellectual property rights
• Advised a large medical device manufacturer regarding foreign patent infringement and invalidation lawsuits related to its diagnostic device products
• Conducted patent analyses of medical device products for medical device manufacturers
• Drafted and provided advice on cross border licensing transactions involving pharmaceutical/biopharmaceutical technologies, chemical manufacturing technologies, and various industrial technologies for research, development and commercialization
• Advised large multinational pharmaceutical companies on strategies for environmental shaping, market access and regulatory approval
• Advised pharmaceutical companies in administrative proceedings, including marketing authorization cancellations and re-evaluation of maximum reimbursement prices
• Advised numerous foreign clients on reviewing marketing authorization procedures for their medical device products and various other products within the jurisdiction of Ministry of Food and Drug Safety
• Advised regulatory requirements for marketing authorization, including modifications, for medicinal products and medical devices
• Advised a medical device manufacturer in developing response strategies for the recall of its exported medical device products
• Advised multinational pharmaceutical companies on compliance with industry’s fair competition codes and regulations regarding improper provision of economic benefits
• Advised foreign cosmetics and food companies on compliance with labeling requirements
• Advised clients in evaluating potential investments in pharmaceutical companies and assessing legal and contractual risks associated with their key product portfolio
• Drafted and reviewed various commercial contracts for pharmaceutical and biotechnology companies and medical device manufacturers, including NDA, MTA, co-development, promotion, distribution, and supply agreements
• Drafted and reviewed various CRO, CMO, CDMO contracts, including master services agreements, clinical trial agreements, and representation agreements