For Japanese Companies Entering the U.S.
Japanese device makers often arrive in the United States with a mature home portfolio built for the JPO and PMDA. Carrying that work into the U.S. market takes a deliberate plan for filing sequence, claim scope, and launch risk.
Japan's device industry has deep roots in optics, imaging, and precision instruments. Olympus traces its endoscope business to the practical gastrocamera it developed in 1950, and Terumo, founded in 1921 to produce clinical thermometers, now works across vascular intervention, cardiac surgery, and blood and cell technologies. The Japan Federation of Medical Devices Associations (JFMDA) groups 21 member associations representing roughly 4,280 companies. At home, devices are regulated under the PMD Act, with the Ministry of Health, Labour and Welfare making approval decisions and the Pharmaceuticals and Medical Devices Agency (PMDA) conducting reviews across four risk classes, from simple notification for Class I to ministerial approval for Class IV.
On the patent side, the Japan Patent Office (JPO) examines domestic filings, and Japan is a PCT contracting state. Since June 2018, Article 30 of the Japanese Patent Act has provided a one-year exception to loss of novelty for qualifying disclosures, which lines up in length with the one-year inventor-disclosure exception in U.S. law. A newer factor is the patent non-disclosure system that took effect on May 1, 2024 under the Economic Security Promotion Act. Inventions made in Japan that fall within Specified Technology Fields, defined by reference to the International Patent Classification, generally must be filed in Japan first, and the JPO accepts requests to confirm whether the prohibition on foreign filing applies. In the first year, more than 1,300 such requests were filed, 90 cases were referred for security review, and no security designations were made. Whether a device invention touches those fields is a question for Japanese counsel to answer before any U.S.-first plan is adopted.
The regulatory shift matters for patent planning. FDA uses a three-class scheme and three principal routes: 510(k) clearance based on substantial equivalence to a predicate, De Novo classification for novel low-to-moderate-risk devices, and premarket approval (PMA) for Class III. Japan and the United States both participate in the Medical Device Single Audit Program, so quality-system audits can overlap, but patent rights do not. Only patents covering devices reviewed through PMA can qualify for U.S. patent term extension under 35 U.S.C. 156; 510(k) and De Novo devices cannot.
U.S. patent rights are territorial. A Japanese application supports a U.S. priority claim only if the U.S. or PCT filing follows within the 12-month Paris Convention period, and PCT applications must enter the U.S. national stage within 30 months of the priority date. Before launch, a freedom-to-operate review of U.S. patents is prudent, because importing an infringing device is itself an act of infringement and the U.S. International Trade Commission can exclude infringing imports under Section 337. We coordinate with a company's Japanese counsel on home-country questions and focus our work on the U.S. portfolio.
Home-country organizations active in this sector include Japan Federation of Medical Devices Associations (JFMDA). Knechtel Law Group is not affiliated with them.
Patent Strategy Considerations
If development took place in Japan and the subject matter may sit near a Specified Technology Field, Japanese counsel should confirm whether the first-filing obligation applies before any U.S. provisional or nonprovisional is filed. Where engineering is split between Japan and a U.S. site, the U.S. foreign filing license rules under 35 U.S.C. 184 need to be addressed as well.
Japan's one-year novelty exception and the U.S. one-year inventor-disclosure exception are similar in length, but a disclosure that is harmless in both countries can still defeat protection in Europe, where Article 55 EPC is limited to evident abuse and certain officially recognized exhibitions. Early conference presentations and publications should be planned around the narrowest market the company cares about.
A 510(k) submission identifies a predicate, which often points to the very competitors whose U.S. patents deserve study. For Class III devices on a PMA route, identifying which patents could support term extension belongs in the plan well before approval.
How Engagements Work
Knechtel Law Group is based in Carefree, Arizona, and advises on U.S. patent strategy. Questions of Japanese or European law are for your home-country counsel; the work here is coordinated with them so priority claims, filings and deadlines line up. Consultations are scheduled across time zones.
Request a Confidential ConsultationCommon Questions
Yes, provided a U.S. or PCT application claiming priority is filed within 12 months of the Japanese filing. A PCT application then has until 30 months from the priority date to enter the U.S. national stage. The U.S. claims must still be supported by the disclosure in the priority document, so translation quality and completeness matter.
No. Regulatory approvals and patents are both national. FDA reviews the device on its own terms, and only U.S. patents can be enforced against infringement in the United States, including against infringing imports.
Our practice is U.S. patent law. On questions of Japanese law, including the non-disclosure system and JPO practice, we work alongside the company's Japanese patent counsel.
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