For Korean Companies Entering the U.S.
Korean device companies frequently build strong KIPO portfolios before looking to the United States. A U.S. plan should decide early which inventions justify U.S. protection and how those claims will hold up against U.S. competitors.
South Korea's device sector combines large electronics-linked manufacturers with fast-growing specialists. Samsung Medison, established in 1985 and part of Samsung Electronics, develops ultrasound systems, while Osstem Implant, founded in 1997, supplies dental implants to more than 70 countries. The Korea Medical Devices Industry Association (KMDIA) represents manufacturers and importers. Devices are overseen by the Ministry of Food and Drug Safety (MFDS) in four risk classes: Class I devices generally proceed by notification, many Class II devices by certification, and Class III and IV devices by MFDS approval, with Korean Good Manufacturing Practice certification a prerequisite from Class II upward. MFDS is an affiliate member of the Medical Device Single Audit Program rather than one of its full participating authorities.
The Korean Intellectual Property Office (KIPO) examines domestic applications, and Korea is a PCT contracting state. Article 30 of the Korean Patent Act allows an application to preserve novelty if it is filed within 12 months after a qualifying disclosure, but the applicant must invoke the exception, and for its own voluntary disclosures must supply supporting evidence shortly after filing. Korea does not run a general foreign filing license system of the kind found in China or the United States. Instead, Article 41 permits the government to prohibit foreign filing, or to order secrecy, for inventions necessary for national defense, with foreign filing allowed on government permission and compensation available for resulting losses. Most device work will never draw such an order, but companies with dual-use imaging, sensing, or communications technology should have Korean counsel confirm their position.
Moving to FDA changes both the evidence package and the competitive map. FDA sorts devices into three classes and uses 510(k) clearance, De Novo classification, and premarket approval. Because a 510(k) rests on substantial equivalence to a predicate device, the predicate choice often identifies U.S. competitors whose patents deserve close review. For software-driven and AI-assisted products, a growing area for Korean developers, U.S. claims must also be drafted with the subject-matter eligibility analysis applied by U.S. examiners in mind. Only PMA-route devices can support patent term extension under 35 U.S.C. 156.
U.S. rights are territorial and do not follow from KIPO grants. A Korean application can anchor U.S. filings only if the U.S. or PCT application follows within the 12-month Paris Convention priority period, and PCT applications must enter the U.S. national stage within 30 months of priority. A freedom-to-operate review before launch is prudent, since importing an infringing device infringes under U.S. law and the International Trade Commission can issue exclusion orders against infringing imports. We work with a company's Korean counsel on home-country matters and concentrate on the U.S. portfolio.
Home-country organizations active in this sector include Korea Medical Devices Industry Association (KMDIA). Knechtel Law Group is not affiliated with them.
Patent Strategy Considerations
Korea's 12-month exception depends on a statement at filing and, for the applicant's own disclosures, supporting evidence. A U.S. filing plan should be built from the earliest public disclosure date, since the U.S. one-year exception is measured from the effective filing date and Europe offers far less room.
Claims that are routinely allowed abroad can meet subject-matter eligibility objections at the USPTO. Tying claims to concrete device operation, signal processing, or hardware integration tends to matter more in the United States than in many other offices.
If a platform has military or dual-use applications, Korean counsel should confirm that no Article 41 order limits foreign filing before the U.S. application is prepared. For engineering performed at a U.S. subsidiary, a U.S. foreign filing license may also be needed before filing in Korea.
How Engagements Work
Knechtel Law Group is based in Carefree, Arizona, and advises on U.S. patent strategy. Questions of Korean 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
Not as a general requirement. Korean law instead lets the government restrict foreign filing or order secrecy for inventions necessary for national defense. Korean counsel should confirm whether any such restriction applies to a particular invention.
Clinical and technical data may be useful, but FDA applies its own classification and submission requirements, and Korea is an MDSAP affiliate rather than a full participant. Patent protection is a separate question in each country.
Twelve months to claim Paris Convention priority, whether by a direct U.S. filing or a PCT application. A PCT application must then enter the U.S. national stage within 30 months of the priority date.
Discuss Your Portfolio
Schedule a confidential consultation to discuss your technology, your existing portfolio, and your plans.
Request a Confidential Consultation