For French Companies Entering the U.S.
French device companies often build their patent estate around INPI and the European system, including the Unitary Patent. Adding a strong U.S. portfolio means working within French filing rules while taking advantage of the more forgiving U.S. treatment of early disclosures.
France's device sector is dominated numerically by smaller companies. SNITEM, the national medical technology industry association founded in 1987, counts more than 600 member companies, 93 percent of them very small, small, or medium-sized enterprises. Larger groups are also present, particularly in diagnostics: bioMérieux, founded in 1963 and headquartered in Marcy-l'Etoile near Lyon, focuses on infectious disease diagnostics. Devices are regulated under the EU Medical Device Regulation (EU) 2017/745, which has applied since May 26, 2021, and ANSM serves as the French competent authority, including responsibility for notified bodies and vigilance. France is not among the participating authorities of the Medical Device Single Audit Program, so a CE-marking file and notified body certificate do not carry over to FDA review.
French companies can protect inventions through INPI national filings, European patents under the EPC, and, since June 1, 2023, the Unitary Patent enforced before the Unified Patent Court, whose central chamber has its seat in Paris. France is also a PCT contracting state. French filing rules deserve attention before any U.S.-first approach. Inventions that are the subject of French patent applications may not be freely disclosed or exploited until authorization is granted; authorization follows automatically after five months unless the defense ministry seeks an extension, which can be renewed in one-year increments. Applicants domiciled in France must also file European and PCT applications through INPI when they do not claim priority from an earlier French filing, allowing defense review. French counsel should confirm how these rules apply to a particular filing plan.
The grace period gap is significant. Article 55 EPC disregards only disclosures within six months that result from evident abuse or display at an officially recognized international exhibition. U.S. law, by contrast, excludes an inventor's own disclosures made within one year before the effective filing date. A conference presentation that destroys novelty in Europe may still leave room for U.S. protection, but relying on that asymmetry should be a deliberate choice. FDA also applies its own three-class scheme, with 510(k), De Novo, and premarket approval routes, and only PMA-route devices can support U.S. patent term extension.
U.S. rights are territorial. A French or European filing supports a U.S. priority claim only within the 12-month Paris Convention period, and PCT applications must enter the U.S. national stage within 30 months of priority. A freedom-to-operate review before U.S. launch is prudent, because importing an infringing device infringes and the International Trade Commission can exclude infringing imports. We coordinate with French and European patent attorneys on INPI, EPO, and UPC matters and focus on the U.S. portfolio.
Home-country organizations active in this sector include SNITEM (Syndicat national de l'industrie des technologies medicales). Knechtel Law Group is not affiliated with them.
Patent Strategy Considerations
For inventions from a France-based company, the order and office of the first filings matter. European and PCT applications without French priority go through INPI, and French applications are subject to a five-month defense review window. Build U.S. filing dates into that sequence with French counsel.
Where a publication or presentation has already occurred, European rights may be limited, but the U.S. one-year exception for inventor disclosures may still allow protection. The U.S. application should be filed well within that year and should document the disclosure carefully.
CE marking under the MDR does not establish an FDA pathway. Mapping likely U.S. predicates or the need for PMA early helps identify which U.S. patents to monitor and which of the company's own patents could support term extension.
How Engagements Work
Knechtel Law Group is based in Carefree, Arizona, and advises on U.S. patent strategy. Questions of French 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
No. European patents and Unitary Patents have effect only in the European states they cover. U.S. protection requires a U.S. patent, obtained through a direct filing or a PCT national stage entry.
French law requires applicants domiciled in France to file PCT applications through INPI when they do not claim priority from an earlier French filing. French counsel should confirm the correct route before filing.
No. We advise on U.S. patent strategy and prosecution and work alongside French and European patent attorneys on INPI, EPO, and UPC questions.
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