Life Science

We have been providing legal services to Japanese and foreign pharmaceutical companies, medical device manufacturers, bio ventures, research institutions such as universities, hospitals and various other clients for many years. Our services include advising on domestic and cross-border license agreements, research and development agreements, clinical trial agreements, material transfer agreements (MTAs) and the like as well as compliance with statutory regulations applicable to pharmaceuticals and the like. We also represent clients in disputes involving intellectual property rights and product liability. We assist clients in carrying out M&A deals, business alliance and other transactions based on the laws and regulations specifically applicable to the industry.

We have handled a number of domestic and cross-border transactions involving leading-edge technology such as iPS cells and antibody drugs. We also have attorneys who were members of research ethics review committees. We can therefore adequately address not only intellectual property issues but also the latest issues facing this industry, including issues concerning statutory regulations and ethical requirements of regenerative medicine, genetic medicine and bio technology, as well as the handling of data and personal information.

The life science industry is regulated by a number of laws and ethical requirements. We have provided practical advice on the relevant rules and regulations that come into play at the different stages of the business, including research and development, manufacturing, distribution, promotion and advertisement. We have also advised clients on how to respond to administrative investigations relating to labeling regulations, the Pharmaceuticals and Medical Devices Act, the Regenerative Medicine Act and various other regulations as well as the Anti-Monopoly Act.

Our firm also has plenty of experience in resolving disputes arising from the life science business. We have represented clients in many different cases of patent infringement involving many Japanese and foreign pharmaceuticals and companies, product liability cases for pharmaceuticals, and cases relating to license agreements or quality problems. Moreover, we have handled many domestic and cross-border M&A transactions in this industry. Our expert team of lawyers, which includes former in-house counsels of life science companies, can serve the legal needs of clients in this growing and evolving industry.

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