Law | Lee International

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  • Pharmaceuticals / Medical Supplies / Foods / Cosmetics

    As is the case with most countries, Korea closely regulates products that go into or are used on the human body to try to ensure safety and avoid harmful health consequences. This regulation relates to pharmaceuticals, medical devices, foods and cosmetics. Navigating through the regulatory maze can be a daunting task for any company. At Lee International, we assist clients with this process by helping them to understand the Korean regulatory scheme applicable to different regulated processes and we guide them through the steps needed to comply with these processes.

    Our practice group is comprised of attorneys and professionals who have a high level of professional knowledge and extensive experience with legal issues related to the sale and distribution of pharmaceuticals, medical devices, foods and cosmetics in Korea. We advise on regulations and requirements applicable to different products, the permitting process, standards to be applied, necessary testing and other means of providing evidence of efficacy and safety. We also provide other ancillary services to assist our clients with protecting intellectual property associated with their pharmaceuticals, medical supplies and devices, food products and cosmetics by advising on obtaining and registering their different intellectual property rights in these products including patent rights, design rights, trademark rights and botanical plant variety rights. Additionally, we assist with and provide representation related to associated customs and trade matters, government investigations, litigation and arbitration matters that arise in connection with the import/export, sale and distribution of these regulated products in Korea.

    We have the breadth of knowledge and experience needed to get the job done. Our team of professionals includes attorneys and consultants who have worked for many years at the Korea Food and Drug Administration and the Ministry of Health and Welfare dealing with these types of regulatory issues and who know the paths that must be taken to successfully navigate through the applicable regulatory processes. We have patent attorneys recognized for their expertise with products and processes relating to medical treatment, pharmaceuticals, medical devices, biotechnology, food technology and cosmetics. Our other experienced intellectual property attorneys have been providing advice and helping clients to protect their brands, marks and other intellectual property assets related to these types of products for many years. Our many customs and trade department professionals have decades of experience dealing with customs-related issues that arise in connection with the import/export of drugs, medical supplies and devices, food products and cosmetics. Finally, we have skilled and experienced litigation attorneys who support our clients and defend their rights and interests in government investigations and prosecutions, litigation matters and arbitration proceedings related to these types of products.

    In addition to our experienced lawyers, our team at Lee International Law contains an array of veteran consultants who have worked at various government agencies and other organizations as well as a large group of engineers and scientists who are experts dealing with matters at the intersection of law, technology and science. They understand our clients’ products and processes and can provide unique perspectives to assist our clients with issues that crop up in the regulatory, intellectual property protection, government investigation or litigation processes.

    All of our professionals – attorneys, consultants and scientists - are able to work together as an integrated team to enable our clients to obtain all of the services they need in a single location. Not only does this save our clients valuable time but it saves money by avoiding having to educate new law firms and new professionals for each type of service needed. We handle all necessary matters efficiently, without duplicating efforts and at cost-effective billing rates.

     

    Services

    • Medicine and medical supplies – Pharmaceuticals for humans and veterinary drugs.
    • Quasi-drugs – hair-dyeing products, hair tonics, toothpastes, bath products, depilatories and tooth whiteners.
    • Functional cosmetics – sun blocks, whitening products, wrinkle reduction products.
    • General cosmetics – hair products, body care products, perfumes, basic skin care products and color cosmetics.
    • Foods – general foods, health functional foods, genetically modified foods (GMO).
    • Advise clients on regulatory processes to manufacture, sell, distribute, import and export the above-listed types of products and assist clients in complying with the regulatory requirements.
    • Represent clients in litigation and administrative proceedings related to regulations involving these types of products.
    • Advise and represent clients on compliance with laws and regulations related to labeling and advertising of these types of products.
    • Advise clients and assist them with obtaining product licenses, and protecting and preventing infringement of their intellectual property rights connected with these types of products.
    • Advise and assist clients in connection with customs and other regulations related to importing and exporting these types of products.
    • Advise and represent clients in connection with government investigations and criminal matters relating to these types of products.
    • Advise clients on pricing, unfair competition, antitrust and other laws related to selling these types of products and represent clients in related actions.
    • Advise and represent clients in connection with product liability lawsuits involving these types of products.

     

    Representative Work

    • Advised clients and represented them in actions related to compliance with laws and regulations pertaining to fair labeling and advertising with pharmaceuticals, food and cosmetics.
    • Advised clients on permits and protection of various intellectual property rights associated with pharmaceuticals, food, medical supplies and cosmetics.
    • Advised multinational pharmaceutical companies on laws and regulations under the Korean Drug Approval-Patent Linkage System and assisted them in complying with the Linkage System.
    • Assisted innovative pharmaceutical companies in listing patents in the Green List before the Ministry of Food and Drug Safety and obtaining patent term extensions before the Korean Intellectual Property Office based on new drug approvals.
    • Provided Freedom-To-Operate and/or Invalidity Opinions with respect to patents related to pharmaceuticals, medical devices and cosmetics.
    • Represented multinational pharmaceutical companies in infringement lawsuits before the Korean courts and in invalidity or declaratory judgment proceedings before the Intellectual Property Tribunals.
    • Provided comprehensive legal services and advice to major pharmaceutical, food, medical supplies and cosmetic companies in Korea, Japan, Australia, the United States and Europe on issues related to the Fair Trade Act, general corporate matters and preparation and execution of M&A strategies.
    • Advised the Wonderful Company on import, registration, distribution of products, packaging, production, and advertising (including labeling) requirements for food products in Korea.
    • Advised a major United States multinational food and beverage company on claimed KFDA regulation violations and represented client in multiple administrative actions.
    • Advised Paramount Farms on the importation of pomegranate extracts and usage in food products including manufacturing requirements
    • Advised Guthy Renker on import, registration, and distribution of beauty, skin care and wellness products in Korea.
    • Advised Blackmores on the import, registration, and distribution of vitamins, supplements, and food products in Korea.
    • Advised multinational Chinese food manufacturer on the licensing requirements for the importation and distribution of certain ingredients to be used in food products.
    • Advised large US sugar manufacturer on the import, registration, and distribution of sugar products in Korea.
    • Advised large US sugar manufacturer on local distribution strategy including customary business practices in the sugar industry.

    Key Contacts

    Emma (Kyoung-Joo) Park Kurt B. Gerstner
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