For Irish Companies Entering the U.S.
Irish device companies grow up in one of the world's densest medtech ecosystems, and many look to the United States early. A U.S. patent strategy should be built for that market on its own terms.
Ireland's medtech sector is large for the size of the country. The Irish Medtech association within Ibec reports roughly 50,000 people employed, about 20 billion euro in exports, and a base in Ireland for nine of the world's ten largest medtech companies. Galway in particular has developed a concentrated cluster of device companies, and home-grown firms operate alongside multinational sites, often sharing talent, suppliers and clinical networks.
Irish patents are granted by the Intellectual Property Office of Ireland (IPOI), which offers both a 20-year full-term patent and a 10-year short-term patent that is not substantively examined. Ireland is a member of the European Patent Convention and the Patent Cooperation Treaty, and applicants can file European and PCT applications through the IPOI. Ireland's position on the Unitary Patent is distinctive: it signed the Agreement on a Unified Patent Court, but ratification requires a constitutional referendum, and in 2024 the Government deferred the referendum without setting a new date. For now, a unitary patent does not cover Ireland, and Irish protection runs through national patents or European patents validated in Ireland. For the European route, Article 55 EPC offers no general grace period, excusing only disclosures from evident abuse or certain recognized exhibitions within six months, while U.S. law generally disregards an inventor's own disclosure made within one year of filing.
At home, the Health Products Regulatory Authority (HPRA) oversees medical devices under the EU Medical Device Regulation. CE marking does not carry over to the United States. 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. Many Irish companies also have U.S. subsidiaries, clinical partners or co-inventors; for inventions made in the United States, U.S. law requires a foreign filing license before filing abroad, which can affect where the first application is filed.
Patent rights are territorial. An Irish or European patent confers no 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 goods at the border.
Home-country organizations active in this sector include Irish Medtech (Ibec), Enterprise Ireland. Knechtel Law Group is not affiliated with them.
Patent Strategy Considerations
Ireland's short-term patent is quick and inexpensive, but the United States has no equivalent right, and an unexamined filing may not describe the invention the way U.S. claims will need. If an Irish application will serve as the priority document for U.S. filings, we review it with Irish counsel so that it supports the U.S. claim scope you expect to pursue.
Where engineers or clinicians in the United States contribute to an invention, U.S. foreign filing license rules can dictate filing order, and inventorship and assignments must be documented for U.S. prosecution. Settling these points at the start avoids defects that are harder to correct after filing.
Because a unitary patent does not currently extend to Ireland, companies relying on the Unitary Patent for Europe should confirm with Irish or European counsel how Irish coverage will be secured. The U.S. portfolio is a separate decision, and we help align its timing and budget with the European plan.
How Engagements Work
Knechtel Law Group is based in Carefree, Arizona, and advises on U.S. patent strategy. Questions of Irish 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. Irish counsel continues to handle Irish and European filings, and we handle U.S. strategy, prosecution and freedom-to-operate analysis. We coordinate claim drafting and deadlines across both. We do not advise on Irish law.
No. Patents are territorial, and U.S. protection requires a U.S. application filed within the Paris priority year or a PCT national stage entry by 30 months from the priority date.
Possibly. For inventions made in the United States, a U.S. foreign filing license is generally required before filing abroad, and inventorship must be correctly named in the U.S. application. These questions should be resolved before the first filing.
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