Expertise
Life SciencesㆍPharmaceuticals
In addition to traditional legal services, the life sciences field has increasingly generated a need for services relating to industry-specific regulations as well as intellectual property rights. Lee & Ko's Life Sciences Practice Group has been highly active in providing such in-depth legal services to numerous clients, tailored to the specific needs of each client.
The practice group assists both domestic and foreign/multinational pharmaceutical, biotech and healthcare companies with professional advice in connection with all relevant regulatory matters, including product approvals, reimbursement pricing, advertising and labelling, as well as clinical trials. In order to provide the most practical and accurate advice possible, the Group maintains cordial and cooperative working relationships and channels of communication with relevant governmental agencies (e.g., the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, the National Health Insurance Corporation and the Health Insurance Review and Assessment Service) and industry associations.
Since the protection of intellectual property is always a particularly important concern in the life sciences sector, the practice group has consistently devoted itself to providing the highly experienced level of service for each step involved in the development and protection of life sciences technology, covering the full gamut of intellectual property concerns, including initial patent application procedures, patent infringement litigation and all categories of procedures and legal issues in between. The members of our Life Sciences Practice Group are recognized as the most highly qualified IP specialist lawyers in the nation and, together, this team of professionals is fully committed and devoted to helping to ensure that clients have the most efficient for their valuable intellectual property assets.
In addition to assisting clients with IP matters, the Life Sciences Practice Group has a robust compliance practice, furnishing clients with thorough analyses of applicable compliance requirements customized to each client's circumstances and providing advice in setting up compliance manuals and management checklists to effectively prevent the occurrence of non-compliance events, as well as providing expert assistance and solutions for any instances of non-compliance that are encountered. The practice group's available compliance-related services cover the complete spectrum of compliance issues that may potentially be faced by our clients, including, among other things, fair-trade and anti-corruption related compliance issues. The practice group also provides its life sciences clients with efficient professional services in the traditional corporate practice areas, such as M&A transactions, as well as advice on industry specific contracts concerning subject areas such as clinical trials, research and development, marketing/promotional activities and distribution arrangements.
As one of the fastest evolving commercial/technology sectors, the life sciences field is subject to ever changing government policies and regulation. Our Life Sciences Practice Group continuously strives to most efficient and most up-to-date services possible in order to respond to and stay ahead of the latest developments in the business and regulatory environment.
Expertise
Industry-Specific Regulatory Compliance
The life sciences sector has been heavily regulated due to the high potential for significant direct effects on public health and welfare. Social and political attention has increasingly focused on this sector in recent years, resulting in rapid changes in applicable statutory and regulatory regimes as the industry itself continues to see substantial new developments and technological advances being introduced at an accelerating rate. Essential to the provision of top quality legal services in this ever changing environment is the ability to accurately anticipate new developments and reliably relate such developments to the real-world circumstances of each client. The ability to interpret and effectively analyze relevant legal developments necessarily depends on a deep and thorough understanding of the interrelated technical, social and legal background, policy considerations, enforcement trends and future outlooks that shape and influence such legal developments. The members of our Life Sciences Practice Group are especially well equipped to carry out such analytical and advisory tasks. Indeed it would be difficult to find such a similarly well-equipped and highly experienced team of professionals anywhere else.
In actively representing clients for several decades now, Lee & Ko has accumulated extensive know-how and specialized experience in all regulatory areas, notably including regulations applicable to product approvals, import procedures, labelling, distribution, advertising, reimbursement pricing and clinical trials. Our attorneys draw upon this wellspring of knowledge, as well as their own knowledge and experience, to provide timely, practical and accurate advice f to assist clients in navigating through the complex and rapidly changing life sciences regulatory environment.
Intellectual Property
The life sciences field requires substantial investment from research and development to commercialization of products and, as such, the establishment and protection of intellectual property rights is extremely important. With the introduction of the patent linkage system pursuant to the Korea/US FTA, intellectual property protection in the life sciences sector in Korea is embarking on a new and challenging era.
Attorneys in our Life Sciences Practice Group, having diverse backgrounds including pharmacology, medicine, biology, biochemistry and chemical engineering, provide top quality services to leading companies and innovators in the life sciences sector, including assistance with patent applications, infringement litigation and all other aspects of establishing, preserving and protecting intellectual property rights.
Fair-Trade and Anti-Corruption Compliance
Compliance relating to anti-corruption has been a center of increasing focus in the life sciences sector both internationally and domestically.
Lee & Ko's Life Sciences Practice Group not only provides advice on Korean compliance related laws and regulations, including fair-trade laws, but also provides comprehensive advice on foreign anti-corruption laws (such as the U.S. Foreign Corrupt Practices Act and the U.K. Bribery Act) and foreign industry codes (such as the IFPMA Code of Practice).
Further, through many years of experience as professionals actively involved in dealing with industry-related issues, the members of our Life Sciences Practice Group provide customized and practical advice on preventive measures that can be taken by clients to minimize the risk of the occurrence of non-compliance events. Such precautionary measures include the creation and updating of compliance manuals, checklists and corporate policies, as well as leading compliance training sessions. Additionally, the Life Sciences Practice Group has much experience in providing effective advice for responding to investigations by government authorities.
Corporate
Having a consistently top-rated corporate practice, Lee & Ko also provides the highest quality advice to its clients in the life sciences sector with regard to related corporate and transactional matters.
Among other things, the Life Sciences Practice Group has been very active in assisting multinational companies in the life sciences field with matters such as the establishment of Korean branches and subsidiaries, domestic and cross-border M&A transactions and other business expansions in Korea. The practice group has also been active in providing tax advice in relation to these transactions, involving a comprehensive range of issues, including designing tax-efficient business structures and dealing with various complex tax issues, such as transfer pricing.
The Life Sciences Practice Group also excels at assisting clients in the negotiation, preparation and review of complex contractual arrangements relating specifically to the life sciences field, including such things as clinical trial agreements, co-marketing/co-promotion agreements and CRO agreements, etc.
The life sciences sector has been heavily regulated due to the high potential for significant direct effects on public health and welfare. Social and political attention has increasingly focused on this sector in recent years, resulting in rapid changes in applicable statutory and regulatory regimes as the industry itself continues to see substantial new developments and technological advances being introduced at an accelerating rate. Essential to the provision of top quality legal services in this ever changing environment is the ability to accurately anticipate new developments and reliably relate such developments to the real-world circumstances of each client. The ability to interpret and effectively analyze relevant legal developments necessarily depends on a deep and thorough understanding of the interrelated technical, social and legal background, policy considerations, enforcement trends and future outlooks that shape and influence such legal developments. The members of our Life Sciences Practice Group are especially well equipped to carry out such analytical and advisory tasks. Indeed it would be difficult to find such a similarly well-equipped and highly experienced team of professionals anywhere else.
In actively representing clients for several decades now, Lee & Ko has accumulated extensive know-how and specialized experience in all regulatory areas, notably including regulations applicable to product approvals, import procedures, labelling, distribution, advertising, reimbursement pricing and clinical trials. Our attorneys draw upon this wellspring of knowledge, as well as their own knowledge and experience, to provide timely, practical and accurate advice f to assist clients in navigating through the complex and rapidly changing life sciences regulatory environment.
Intellectual Property
The life sciences field requires substantial investment from research and development to commercialization of products and, as such, the establishment and protection of intellectual property rights is extremely important. With the introduction of the patent linkage system pursuant to the Korea/US FTA, intellectual property protection in the life sciences sector in Korea is embarking on a new and challenging era.
Attorneys in our Life Sciences Practice Group, having diverse backgrounds including pharmacology, medicine, biology, biochemistry and chemical engineering, provide top quality services to leading companies and innovators in the life sciences sector, including assistance with patent applications, infringement litigation and all other aspects of establishing, preserving and protecting intellectual property rights.
Fair-Trade and Anti-Corruption Compliance
Compliance relating to anti-corruption has been a center of increasing focus in the life sciences sector both internationally and domestically.
Lee & Ko's Life Sciences Practice Group not only provides advice on Korean compliance related laws and regulations, including fair-trade laws, but also provides comprehensive advice on foreign anti-corruption laws (such as the U.S. Foreign Corrupt Practices Act and the U.K. Bribery Act) and foreign industry codes (such as the IFPMA Code of Practice).
Further, through many years of experience as professionals actively involved in dealing with industry-related issues, the members of our Life Sciences Practice Group provide customized and practical advice on preventive measures that can be taken by clients to minimize the risk of the occurrence of non-compliance events. Such precautionary measures include the creation and updating of compliance manuals, checklists and corporate policies, as well as leading compliance training sessions. Additionally, the Life Sciences Practice Group has much experience in providing effective advice for responding to investigations by government authorities.
Corporate
Having a consistently top-rated corporate practice, Lee & Ko also provides the highest quality advice to its clients in the life sciences sector with regard to related corporate and transactional matters.
Among other things, the Life Sciences Practice Group has been very active in assisting multinational companies in the life sciences field with matters such as the establishment of Korean branches and subsidiaries, domestic and cross-border M&A transactions and other business expansions in Korea. The practice group has also been active in providing tax advice in relation to these transactions, involving a comprehensive range of issues, including designing tax-efficient business structures and dealing with various complex tax issues, such as transfer pricing.
The Life Sciences Practice Group also excels at assisting clients in the negotiation, preparation and review of complex contractual arrangements relating specifically to the life sciences field, including such things as clinical trial agreements, co-marketing/co-promotion agreements and CRO agreements, etc.
Major Cases
Regulation and Compliance
· Advising clients regarding investigations by the Korea Fair Trade Commission and the Prosecutor’s Office concerning rebate practices of domestic and multinational pharmaceutical companies. Assistance with internal audits
· Advising clients on product approvals, import procedures, labelling, advertising and other regulatory matters
Intellectual Property
· Patent applications and trademark registration
· Patent infringement litigation, patent invalidation challenges, confirmation of patent scope, etc.
Corporate
· Establishment of local branches/offices and acquisition of local companies
· Advice on M&As and business transfers resulting from global M&As and Spin-off Transactions
· Advice on responses to tax investigations and litigation relating to international taxation issues, including transfer pricing.
· Advising clients regarding investigations by the Korea Fair Trade Commission and the Prosecutor’s Office concerning rebate practices of domestic and multinational pharmaceutical companies. Assistance with internal audits
· Advising clients on product approvals, import procedures, labelling, advertising and other regulatory matters
Intellectual Property
· Patent applications and trademark registration
· Patent infringement litigation, patent invalidation challenges, confirmation of patent scope, etc.
Corporate
· Establishment of local branches/offices and acquisition of local companies
· Advice on M&As and business transfers resulting from global M&As and Spin-off Transactions
· Advice on responses to tax investigations and litigation relating to international taxation issues, including transfer pricing.
Key Contacts
Recent Accolades
Recent Developments