For Swiss Companies Entering the U.S.
Swiss device companies are navigating a changing relationship with the EU market while planning for FDA. A deliberate U.S. patent position helps make the U.S. launch an asset rather than an exposure.
Switzerland's medical technology sector is export-driven and made up largely of smaller companies, with a handful of widely known names such as Straumann in Basel (dental implants), Sonova in Stafa (hearing systems) and Ypsomed in Burgdorf (injection systems). The industry association Swiss Medtech represents more than 800 companies, and the sector employs over 70,000 people.
Swiss patents are handled by the Swiss Federal Institute of Intellectual Property (IPI) in Bern, and Swiss applicants can also file European and PCT applications through the IPI. Switzerland is a contracting state of the European Patent Convention, so a European patent can take effect there. Because the Unitary Patent and the Unified Patent Court are open only to EU member states, however, Switzerland is outside that system, and Swiss protection continues to run through national rights or European patents validated in Switzerland. Swiss law has no general grace period: Article 7b of the Patents Act excuses only disclosures resulting from manifest abuse or display at an officially recognized exhibition within six months before filing. U.S. law, by contrast, generally disregards an inventor's own disclosure made within one year of filing, a difference that matters when clinical collaborators, investors or congress audiences see a device early.
The regulatory backdrop has been unsettled. Since May 2021 the European Commission has treated Switzerland as a third country for medical devices, after the device chapter of the EU-Swiss Mutual Recognition Agreement was not updated for the EU MDR. On 2 March 2026 the EU and Switzerland signed a package of agreements that includes an updated MRA, which enters into force only after both sides complete ratification. Swiss legislators have also authorized a route to recognize devices with FDA clearance or approval, with implementation still in progress. None of this changes the U.S. side: FDA clearance or approval is its own process, and a foreign establishment whose devices are imported into the United States must register and designate a U.S. agent.
For patents, the rule is territorial. Neither a Swiss patent nor a European patent designating Switzerland protects a device in the United States. U.S. rights require filing within the 12-month Paris Convention priority year or entering the U.S. national stage of a PCT application by 30 months from the priority date. Before commercial launch, a U.S. freedom-to-operate review is prudent, because importing an infringing product can lead to federal court litigation or a Section 337 investigation at the U.S. International Trade Commission, where exclusion orders can stop goods at the border.
Home-country organizations active in this sector include Swiss Medtech. Knechtel Law Group is not affiliated with them.
Patent Strategy Considerations
With EU market access requiring its own regulatory work and the United States on the roadmap, patent budgets are often stretched across too many countries. We help Swiss companies decide where U.S. claims deserve priority, and when the 30-month PCT decision should track the expected FDA timeline rather than a default calendar.
Swiss and European rules forgive very little pre-filing disclosure. Clinical studies, investor decks and scientific presentations should be sequenced behind a filing that supports both the European and U.S. claims you expect to need. A U.S. provisional application can be one tool, used in coordination with Swiss counsel.
If Switzerland implements recognition of FDA-cleared devices, a U.S.-first regulatory strategy may carry added value at home. That makes early U.S. freedom-to-operate work and U.S. claim coverage of the cleared product more important. Swiss regulatory questions stay with Swiss regulatory advisers; we address the U.S. patent consequences.
How Engagements Work
Knechtel Law Group is based in Carefree, Arizona, and advises on U.S. patent strategy. Questions of Swiss 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. Swiss counsel continues to advise on Swiss and European matters, and we handle U.S. patent strategy, prosecution and freedom-to-operate analysis. We coordinate filing dates, claim drafting and translations so both portfolios support each other. We do not advise on Swiss law.
No. U.S. protection requires a U.S. application, either filed within 12 months of your first filing under the Paris Convention or entered from a PCT application by 30 months from the priority date.
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