Life Sciences, Healthcare, Medical, and Pharmaceuticals SERVICES
We advise a wide range of domestic and international pharmaceutical and healthcare-related companies on various legal matters in the life sciences and healthcare fields, including contract drafting and review, regulatory matters, internal compliance, and risk/crisis management. We also provide litigation services and other support for dispute resolution related to contract breaches, quality issues, and intellectual property infringement, as well as the filing of patent applications in these fields. Regarding contract drafting and review, we handle a large number of industry-academia collaboration projects from companies and research institutions (including universities). We serve clients of various sizes and industries, including not only major pharmaceutical companies but also pharmaceutical and biotech ventures.
Main Services
Regulatory Compliance and Legal Consultation for R&D and Sales of Pharmaceuticals and Medical Devices
We have extensive experience in providing legal consultations concerning legal issues and regulations—such as research ethics, conflicts of interest, and competition law—related to R&D in life sciences and healthcare, including pharmaceuticals and medical devices. We also have experience in drafting and reviewing various agreements such as clinical trial contracts, joint research and joint application agreements, and license agreements for the out-licensing and in-licensing of pharmaceuticals.
Legal Affairs related to Labeling, Advertising, and Promotion of Pharmaceuticals and Medical Devices
In the area of sales and information provision for pharmaceuticals and medical devices, we handle contract work such as drafting and reviewing various consignment agreements for manufacturing/sales, and collaboration agreements (e.g., co-promotion and co-marketing). In addition, we receive numerous consultations requiring legal checks from the perspectives of the Pharmaceuticals and Medical Devices Act (PMDA), fair competition rules, and other relevant regulations.
Internal System Support for Pharmaceutical Companies, Medical Institutions, and Research Institutions
In the pharmaceutical sector, we have provided long-standing and close legal support to a broad range of Japanese clients as well as international corporations and their Japanese subsidiaries. For some clients, we provide in-depth support such as participating in internal committee meetings to offer opinions, or engaging in internal review processes for sales-related materials. Furthermore, we serve as committee members for Clinical Trial Review Boards, Conflicts of Interest Committees, and Ethics Committees at pharmaceutical companies, medical institutions, and research institutions, where we provide opinions and advice on legal and compliance matters.
Regulatory Compliance and Legal Consultation for Life Sciences and Healthcare Products/Services
Legal regulations have recently become stricter regarding the advertising and labeling of life sciences and healthcare products and services. These include pharmaceuticals, medical devices, Foods for Specified Health Uses (FOSHU), Foods with Function Claims (FFC), and cosmetics. Consequently, we are receiving an increasing number of consultations seeking legal advice on appropriate labeling for these products.
Intellectual Property and Pharmaceutical (Patent Linkage) Matters in the Life Sciences and Healthcare Fields
We have handled numerous requests from pharmaceutical companies over many years, advising on legal issues concerning intellectual property rights, including patents related to pharmaceuticals, medical devices, and healthcare products. We handle numerous patent infringement lawsuits, invalidation trials for both patents and patent term extensions (PTE), and other intellectual property disputes. We also represent clients in patent prosecution, including prosecution of PTE applications. In particular, we have extensive experience and specialized knowledge in representing original drug manufacturers to prevent patent infringement by generic drug companies. This includes not only seeking injunctions through litigation but also handling matters with the Ministry of Health, Labour and Welfare (MHLW) and the PMDA, utilizing patent linkage know-how, and dealing with issues unique to the pharmaceutical industry.
Consultations concerning Medical Institutions and Elderly Care Facilities
We have extensive experience in handling disputes between medical institutions and patients, representing clients in negotiations, mediation, and litigation. In resolving these conflicts, we draw on our deep understanding of the practices specific to medical disputes. Our clients include a company that operates elderly care facilities, for which we provide a wide range of legal consultations and litigation representation.
We frequently advise medical institutions on matters such as drafting informed consent documents for clinical trials, clinical and research ethics, university spin-off ventures, and the handling of sensitive personal information.