Since Lee & Ko’s founding in 1977, Lee & Ko’s Healthcare/Life Sciences Practice Group has been the highly experienced and largest healthcare/Life Science practice group in Korea.  The Healthcare/Life Sciences Group has been expertly tailored to meet the needs of clients having specific concerns relating to healthcare, IP, regulatory and compliance matters, including pharmaceuticals, bio, medical devices, food, cosmetics, liquor and tobacco products.

Our team is made up of outstanding legal professionals with specialized backgrounds in various relevant fields including pharmaceuticals, medicine, biotechnology, chemical engineering, materials engineering, computer science, the electrical/electronic arts, mechanical engineering, medical devices, and medical AI. Our practice group also includes members who are former judges of the Patent Court and the Seoul Central District Court, former Supreme Court research fellows specializing in IP law, KIPO examiners and IPTAB judges.

Our practice group also employs advisors and experts with special expertise and prior experience in multinational pharmaceutical companies as well as various government ministries and regulatory agencies, including the Ministry of Health and Welfare, the Ministry of Food and Drug Safety and the Health Insurance Review and Assessment Service.  Our experts and advisors maintain a close network and cooperative relationships with the relevant government organizations, public institutions, pharmaceutical and biotechnology associations, multinational pharmaceutical industry associations, medical device associations and cosmetic associations.

In particular, since the protection of Intellectual Property Rights (“IPRs) in the pharmaceutical bio-healthcare field continues to be critical, our practice group provides expert legal services throughout all stages of development and protection for our clients’ technology ranging from patent and trademark filings to IPR disputes.

Our practice team has been consistently ranked as top-tier by numerous international legal surveyors.  Our team is capable of providing the optimal legal service to clients by quickly adopting to the rapid changes in this industry.

Expertise

Our practice tram provides the following service for clients in the fields of medical, pharmaceutical, biotechnology, medical devices, food, cosmetics, liquor, tobacco and household goods:

Represent clients in various IPR (patent, trademark, service mark, copyright and trade secret) disputes and litigations
Advise clients on negotiations, agreements and legal disputes relating to IPRs, licensing and employee inventions
Represent clients on judgments and/or litigations relating to the application, infringement/validity analysis and registration of various IPRs
Advise on various compliance issues under the relevant Korean laws (e.g., the Pharmaceutical Affairs Act, Medical Device Act, Personal Information Protection Act) and represent clients in related administrative/criminal litigations
Review clinical trial agreements and co-marketing/co-promotion agreements, advise on ODD designations and approvals and various import, permit and labeling procedures and represent clients in related administrative/criminal litigations
Advise clients on drug prices and medical bill negotiations and NECA new medical technologies and represent clients in related administrative/criminal litigations
Advise clients on various legal issues arising from medical institutions, overseas export and MSOs
Represent clients in various administrative proceedings and criminal litigations relating to pay-for-delay, rebates, and kickback issues

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Major Cases

For pharmaceutical/bio companies:

Represented global pharmaceutical companies in patent related disputes against Korean generic companies.
Represented a global pharmaceutical company in an immunotherapies patent dispute against a Korean generic company.
Represented a global pharmaceutical company in patent litigation and unfair competition disputes against various Korean pharmaceutical companies.
Represented a global pharmaceutical company in a global unfair competition dispute across multiple jurisdictions.
Advised a well-known Korean pharmaceutical company on responding to global trademark, patent, and unfair competition disputes involving dementia treatments.
Advised a well-known Korean pharmaceutical company on responding to a dispute involving pneumococcal vaccine patent.
Represented a global pharmaceutical company and a Japanese company in a global patent infringement dispute.
Represented domestic and international biosimilar companies in a global biosimilar patent dispute among leading global biopharmaceutical companies.
Represented a global pharmaceutical company in a number of patent disputes against domestic pharmaceutical companies.
Represented a domestic pharmaceutical company in a global trade secret misappropriation dispute involving Botox strains.
Represented original drug companies in drug price reduction cases.
Reviewed and maintained compliance manuals for multinational pharmaceutical companies.
Advised a domestic pharmaceutical company on converting to a holding company.
Represented a Taiwanese pharmaceutical company in acquiring a domestic pharmaceutical company.
Represented multinational pharmaceutical companies in global M&A deals.
Represented a client in Korea’s first lawsuit for pay-for-delay.
Advised on deregulation of biosimilar manufacturing.
Advised on drug price negotiations and ODD designations.
Represented an international pharmaceutical company in the world’s first arbitration case involving a gene therapy product.
Advised on chemical/bio/biosimilar preclinical/clinical licensing agreements.
Advised on patent license agreement involving mammalian cloning.

For medical device companies:

Advised on deregulation of medical devices using big data and Artificial Intelligence.
Advised on deregulation of genetic testing.
Advised on deregulation of diabetes and hypertension apps on cell phones.
Advised on deregulation of innovative medical devices.
Represented a client in a patent litigation related to convergence biomedical devices.
Represented clients in negotiations with HIRA relating to medical devices.

For food/cosmetic companies:

Advised on food/cosmetic ingredients approval.
Advised on food/cosmetic labeling.
Advised on food/cosmetic advertising and related criminal and civil litigations.
Represented franchise restaurants on various civil and criminal litigations.
Advised various franchise restaurants in responding to various administrative and criminal litigations.
Advised on cosmetic side effect disputes.
Advised on genetic testing.
Represented clients in various patent invalidation cases and IPR disputes involving cosmetics.

For liquor/tobacco companies:

Advised on the Liquor Tax Act.
Advised on advertising/labeling.
Advised on responding to the Ministry of Food and Drug Safety’s measures against e-cigarettes.
Advised a global tobacco company on responding to patent disputes involving e-cigarettes.

For medical institutions:

Advised Korea’s largest franchise dental clinic on the Medical Service Act.
Advised on advertising.
Advised on organ transplant and import.
Advised on compensation for death incurred during clinical trial.

For household good companies:

Represented LG H&H and P&G in a patent dispute involving diapers against Yuhan-Kimberly and Kimberly-Clark in Korea’s largest damages compensation case based on patent infringement.
Represented manufacturer of Lilian sanitary pads in civil and criminal litigations.
Handled civil and criminal litigations involving humidifier disinfectants during Korea’s humidifier disinfectant incidents.
Advised LG H&H on responding to National Assembly hearings.