For Dutch Companies Entering the U.S.
Dutch device companies often start from a strong technology base and a European patent plan. Entering the United States calls for a separately examined, separately enforced U.S. portfolio.
Dutch medical technology is closely tied to the country's high-tech manufacturing base. The Brainport Eindhoven region, where Philips laid the foundation for a medtech cluster, reports more than 350 medtech companies working in areas such as robotics, smart diagnosis and smart interventions. Life sciences and health is one of the Dutch government's designated top sectors, with Health~Holland supporting public-private research, and industry groups such as Nefemed and FHI represent device manufacturers and suppliers.
Dutch national patents are handled by the Netherlands Patent Office (Octrooicentrum Nederland), part of the Netherlands Enterprise Agency (RVO). Under the current Patents Act 1995, a Dutch patent is granted after a prior-art search and written opinion but without refusal on substantive grounds; a bill to introduce substantive examination has been moving through the legislative process. The Netherlands is a member of the European Patent Convention and the Patent Cooperation Treaty, and it participates in the Unitary Patent and the Unified Patent Court, so a single European right and a single court action can reach the Netherlands together with other participating EU states. Dutch rules on first filing and secrecy are reserved for inventions of defense and national-security significance, a point to confirm with Dutch counsel for dual-use technology. For European rights, Article 55 EPC offers no general grace period, while U.S. law generally disregards an inventor's own disclosure made within one year of filing.
At home, the Health and Youth Care Inspectorate (IGJ) supervises compliance with the EU Medical Device Regulation. A CE mark does not open the U.S. market: FDA clearance or approval is a separate process, and a foreign establishment whose devices are imported into the United States must register and designate a U.S. agent. Because FDA review may focus on a later design than the one in the first patent filing, the U.S. claim strategy should be revisited as the regulatory submission takes shape.
Patent rights remain territorial. Neither a Dutch patent nor a unitary patent confers rights in the United States. U.S. protection requires a filing within the 12-month Paris Convention priority year or U.S. national stage entry from a PCT application by 30 months from the priority date. Before launch, a U.S. freedom-to-operate review is prudent: importing an infringing device can lead to federal court litigation or a Section 337 investigation at the U.S. International Trade Commission, where exclusion orders can stop products at the border.
Home-country organizations active in this sector include Health~Holland (Top Sector Life Sciences & Health), Nefemed, FHI Medische Technologie. Knechtel Law Group is not affiliated with them.
Patent Strategy Considerations
A Dutch national patent granted without substantive examination may carry claims that have not been measured against the prior art the way a U.S. examiner will. Before relying on a Dutch filing as the basis for U.S. claims or valuation, we review the search report and written opinion and plan U.S. claims accordingly.
Within the UPC system, one proceeding can affect rights across participating states. The United States has its own venues, including federal courts, the Patent Trial and Appeal Board and the International Trade Commission. We help Dutch companies plan U.S. assertion and defense positions independently of their European litigation posture.
Brainport-style collaboration among companies, universities and suppliers is productive but can blur inventorship and ownership. U.S. prosecution and enforcement depend on correctly named inventors and recorded assignments, so collaboration agreements should be reviewed with U.S. requirements in mind before filing.
How Engagements Work
Knechtel Law Group is based in Carefree, Arizona, and advises on U.S. patent strategy. Questions of Dutch 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. Your Dutch patent attorney continues to handle Dutch and European matters, and we handle U.S. strategy, prosecution and freedom-to-operate analysis. We coordinate deadlines and claim drafting between the two. We do not advise on Dutch law.
No. The Unitary Patent covers participating EU member states only. U.S. protection requires a U.S. application within the Paris priority year or a PCT national stage entry by 30 months from the priority date.
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