We counsel and advise on all regulatory issues affecting research, testing, labelling, approval, post-approval compliance, pricing, advertising and marketing, correction, withdrawal or recall of products, data privacy regulations, telecommunications, antimonopoly, antitrust and unfair competition in relation to IP. Our regulatory practice relates to different products such as electronics, appliances, medical devices, pharmaceutical drugs, medical devices/diagnostics products, quasi-drugs, nutritional products, food and beverage products, cosmetics, and various other consumer products.

 In addition, we counsel and assist clients whose granted patents cannot be worked because of a requirement to obtain regulatory approval and certification based on the provisions of the Pharmaceutical and Medical Device Law. This is because in Japan, although the period of a patent right is 20 years from the date of filing of the patent application, such term may be extended for a period of not exceeding 5 years if the claims of the patent encompass the product subject of the regulatory approval by filing Patent Term Extension (PTE) applications. Through our regulatory and compliance practice, we help clients extend the life of their patents to compensate for lost marketing time while developing their respective products and awaiting government approval.

We have handled thousands of Patent Term Extension (PTE) applications thus far.