For German Companies Entering the U.S.
German device makers often arrive in the United States with a mature European portfolio and a CE-marked product. The U.S. market asks for a separate patent position, built on U.S. law and timed to the FDA pathway.
Germany's medical technology industry pairs large, long-established manufacturers with a deep base of small and mid-sized firms. The Tuttlingen region in Baden-Wurttemberg, anchored by Karl Storz and Aesculap, is home to roughly 600 related businesses, most of them SMEs working in surgical instruments, endoscopy and implants. The industry association BVMed reports that a majority of German medtech revenue comes from exports, so foreign markets, including the United States, sit at the center of many growth plans.
At home, inventions are protected through the German Patent and Trade Mark Office (DPMA) or the European Patent Office, and Germany participates in both the Patent Cooperation Treaty and the Unified Patent Court system that began operating on 1 June 2023. Two home-country rules deserve attention before a first filing leaves Germany. Under Section 52 of the German Patent Act, an application containing a state secret may be filed abroad only with written consent of the competent federal authority; most device inventions will not engage that rule, but the question belongs with German counsel before any direct U.S. or PCT filing. Second, European patent law has no general grace period. Article 55 EPC excuses only disclosures resulting from evident abuse or display at certain officially recognized exhibitions within six months. A German utility model (Gebrauchsmuster) carries its own six-month grace period, but a conference talk or trade-show demonstration can still defeat a European patent even where U.S. law would disregard the inventor's own disclosure made within one year of filing.
On the regulatory side, German manufacturers work under the EU Medical Device Regulation (EU) 2017/745 and notified-body certification. A CE certificate 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. The regulatory file and the patent file should be read together, because the device FDA ultimately reviews may differ from the embodiment described in the original German or European filing.
Patent rights remain territorial. A European patent, including a unitary patent, confers no rights in the United States. U.S. protection must be pursued within the 12-month Paris Convention priority year or by entering the U.S. national stage of 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 support both federal court litigation and a Section 337 investigation at the U.S. International Trade Commission, where the principal remedy is an exclusion order barring the goods at the border.
Home-country organizations active in this sector include BVMed (Bundesverband Medizintechnologie), SPECTARIS. Knechtel Law Group is not affiliated with them.
Patent Strategy Considerations
Section 52 of the German Patent Act restricts foreign filing only for applications containing state secrets, and violations cannot be cured after the fact. Confirm the answer with German counsel before filing directly in the United States or under the PCT. If engineers in a U.S. subsidiary contributed to the invention, U.S. foreign filing license rules may also apply, so both sides of the filing sequence should be mapped at the outset.
The Gebrauchsmuster is registered without substantive examination and has no direct U.S. counterpart. U.S. protection comes from examined utility patents, and continuation practice can keep claims aligned with a device that changes between first filing and FDA submission. We plan U.S. claim sets around the commercial embodiment rather than simply mirroring the German or European claims.
German employee-invention law governs how rights move from employee inventors to the company. U.S. prosecution, licensing and eventual enforcement or acquisition diligence depend on inventor declarations and recorded assignments. We coordinate with German counsel so the U.S. record reflects the ownership position already established at home.
How Engagements Work
Knechtel Law Group is based in Carefree, Arizona, and advises on U.S. patent strategy. Questions of German 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 German counsel continues to handle German and European matters, and we handle U.S. strategy, prosecution and freedom-to-operate questions. Coordinating the two from the first filing avoids priority, translation and claim-scope problems later. We do not advise on German law.
No. Patents are territorial. U.S. rights require a U.S. application filed within the Paris priority year or a PCT national stage entry by 30 months from the priority date.
Not necessarily. U.S. law generally disregards an inventor's own disclosure made within one year before the effective filing date. European rules are far narrower, so the effect on your European position is a question for German or European counsel, and the U.S. filing should not wait.
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