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Industry

Biotechnology, Pharmaceutical, Medical Device & Healthcare

Jipyong’s Bio & Healthcare Team provides comprehensive, industry-focused, expert legal services to our clients. We navigate the constantly evolving regulatory environment of today’s healthcare and life sciences industries, and our comprehensive practice spans the entire spectrum of the healthcare and life sciences industries: from advising biotech start-ups regarding licensing of their intellectual property innovations overseas, to representing Korean hospitals in precedent-setting legal challenges in Korea’s highest courts, to guiding pharmaceutical companies in meeting their anti-rebate compliance obligations, to assisting medical device companies formulate their regulatory approval strategy in the US, to representing small and large biotechnology companies in their capital market transactions, including a recent going public transaction by a Korean conglomerate’s pharmaceutical subsidiary. We advise biotechnology, pharmaceutical, medical device, and medical technology companies throughout a product’s entire life cycle and guide Korean health institutions in meeting ever-changing Korean regulatory requirements.

Our interdisciplinary team of lawyers combines extensive industry knowledge, deep legal expertise, and a global outlook in supporting our client’s businesses. Many of our lawyers hold degrees in scientific fields and have experience that are uniquely suited to advising our diverse clients, including a medical doctor, a former official with the US Department of Health and Human Services, a former judge in the Korean patent court, a biotech patent agent, and a pharmacist. Our team is unique, global, and experienced and is committed to solving and anticipating challenges faced by today’s healthcare and life sciences companies.

Key Practice Areas Close

    [Compliance Program and Industry Regulations]

    • Compliance Guidelines on Pharmaceutical Affairs Act
    • Fair Trade Law
    • Medical Law and related Administrative Law
    • Legal matters in the operation of hospitals and clinics
    • Drug pricing system and price adjustment of drugs covered by insurance
    • U.S. Medicare/Medicaid, Manufacturers’ sales/marketing compliance, and fraud & abuse
    • Ministry of Health and Welfare and the KFDA

    [Intellectual Property Counseling]

    • Patent, licensing agreement of biomedical, pharmaceutical, medical device companies, and trade secret protection
    • Patent dispute
       

    [Licensing, Collaboration, Partnership, JV]

    • Product Development, Technology transfer, and outsourcing deals
    • Biomedical, pharmaceutical, medical device companies’ overseas expansion
    • Trade and contract negotiations with global companies in bio, pharmaceutical, medical device


    [Contracts on Biomedical, Pharmaceuticals, Medical Devices]

    • CRO, CDMO, quality, product development, clinical research, distribution, sales, consulting contracts
    • Manufacture, sales, import/export license of medicine and medical devices
    • Distribution, sales, and other general issues related to medicine and medical devices


    [M&A and Investments]

    • Due diligence, investment, joint ventures and M&A for biomedical, pharmaceutical and healthcare companies
    • Bio, pharmaceutical, and medical device companies’ IPO and investment transactions


    [Litigation and Arbitration]

    • Criminal and administrative litigation related to biomedical, pharmaceuticals and healthcare issues
    • Criminal and civil disputes of medical malpractice

Experiences Close

    [Regulatory Requirements and Compliance Obligations]

    • Advised company “L” on compliance by a Vietnamese subsidiary
    • Advised “I” pharmaceutical company on the regulations under the Fair Trade Act
    • Advised “S” biopharmaceutical company on FCPA Compliance Obligations
    • Represented “C” and “D” pharmaceutical companies in the rebate cases
    • Advised “G”, a global medical device company, on sales/marketing compliance program
    • Advised on the legal issues related to enhancement of health care
    • Advised a special inter-departmental government organization on supporting the new drug development project and issues related to the state-funded research projects
    • Advised “D” pharmaceutical company to defend claims related to drug side effects and on the issues related to the scope of rebate
    • Advised the Ministry of Food and Drug Safety and the Ministry of Health and Welfare


    [Intellectual Property]

    • Advised Merck on legal remedies against acts threatening sound transaction of medicines such as illegal sales of products and trademark infringement
    • Advised company “R” on legal issues related to stem cells, establishment of foundation, and technology leakage
    • Advised the pharmaceutical companies on issues related to unfair competition prevention and trade secret protection including trademark, patent and/or license contract(s)
    • Advised company “S” company on approvals/permits for manufacturing, sales and import of medical devices
    • Advised “D” pharmaceutical company on trademark infringement of a contrast media
    • Advised “B” medical device company to defend the trade secret infringement


    [License, Collaboration/Partnership, JV]

    • Advised “B” Biopharmaceutical company on transfer of chemotherapy technology from the world's largest research institute, joint R&D, and establishment of JV
    • Advised “S” diagnostics company on collaboration and partnership transactions such as multinational diagnosis, strategic alliances with biomedical companies, joint R&D, product development and technology transfer
    • Advised Medicinal Bioconvergence Research Center on license agreement(s) and joint R&D agreement(s) for targeting
    • Advised “M” company on the establishment of Singapore joint venture and Vietnam medical corporation
    • Advised “B” company on the establishment of a joint venture in China
    • Advised “S” Hospital on doing business in Iran and Russia
    • Advised many medical foundations including “A” Medical Foundation on medical laws related to medical foundations and overseas expansion


    [Contracts in Biotechnology, Pharmaceutical and Medical Device Industries]

    • Advised “C,” “B,” and “I” medical device companies on general contracts
    • Advised “R” NASDAQ-listed pharmaceutical company on negotiation for various contracts related to clinical tests, product development and production
    • Advised “G” company on general contracts related to the development of new biotechnology products


    [M&A / Investment]

    • Advised on merger between Genexine and Toolgen
    • Advised on acquisition of a contrast media manufacturing from Bayer
    • Advised Easy Bio Inc. on acquisition of shares in Pathway Intermediates Inc., a British bio company
    • Advised LegoChem Biosciences, Inc. on its merger with a medical device distributor KHANMED Co., Ltd.
    • Advised company “B” on listing in Canada
    • Advised ICure, a company developing medicine patches to treat dementia, on listing on KOSDAQ
    • Advised T&RBiofab, a 3D bio-printing based medical engineering company, on listing on KOSDAQ
    • Advised BIFIDO, a microbiome R&D company, on listing on KOSDAQ
    • Advised Newtree, an inner beauty company, on listing on KOSDAQ
    • Advised on Prestige BioPharma, a Singapore-based biosimilar company, on listing on KOSDAQ
    • Advised on Nanogen, the largest biosimilar company in Vietnam, on listing on KOSDAQ


    [Litigation / Arbitration]

    • Advised “C” and “D” pharmaceutical companies on rebate-related criminal/tax cases
    • Advised “S” pharmaceutical company on clinical medication accident
    • Advised on civil and criminal cases and professional analysis of medical records in case of medical accidents
    • Represented a client before the Supreme Court in a case on the measures to be taken in case of an emergency patient transfer
    • Sought and obtained the Constitutional Court Decision (cancellation of no-indictment) related to the petition on the respiratory tract preservation obligations