For UK Companies Entering the U.S.
UK device companies are building for three distinct systems at once: Great Britain, Europe and the United States. The U.S. patent position should be planned as its own workstream, not an afterthought to the European filing.
The UK health technology sector spans multinationals and a large base of SMEs, represented by the Association of British HealthTech Industries (ABHI). Smith+Nephew, headquartered in Watford, is one of the best-known UK device manufacturers, with businesses in wound management, orthopaedics and sports medicine. U.S. expansion is a well-worn path: ABHI has run a U.S. Accelerator programme since 2018 to help UK companies enter the American market.
Patents in the UK are granted by the Intellectual Property Office (UKIPO). Leaving the EU did not change UK membership of the European Patent Convention, which is not an EU instrument, so European patents can still be validated in the UK. The UK did, however, withdraw its ratification of the Unified Patent Court Agreement in July 2020, so unitary patents and UPC decisions do not extend to the UK. UK residents should also note section 23 of the Patents Act 1977: where an application contains information relating to military technology, or whose publication might prejudice national security or public safety, it may not be filed abroad without written permission unless it was filed at the UKIPO at least six weeks earlier and no prohibition direction is in force. Violations can carry criminal penalties. On grace periods, section 2(4) excuses only disclosures made within six months that resulted from unlawful taking, breach of confidence or display at an international exhibition. U.S. law generally disregards an inventor's own disclosure made within one year of filing.
Regulation has diverged. In Great Britain, the MHRA oversees the UKCA framework, while CE-marked devices remain accepted for defined transition periods running to 30 June 2028 or 30 June 2030 depending on the device, and Northern Ireland follows EU rules. Non-UK manufacturers need a UK Responsible Person. The UK government has also announced planned international reliance routes under which devices cleared or approved by the FDA, among other regulators, could gain streamlined access to Great Britain, with legislation expected in 2026 and routes opening from 2027. For UK companies, that makes the FDA file increasingly relevant at home as well.
U.S. patent rights must still be secured separately. A UK 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, since importing an infringing device can lead to federal court litigation or a Section 337 investigation at the U.S. International Trade Commission.
Home-country organizations active in this sector include Association of British HealthTech Industries (ABHI), ABHI US Accelerator. Knechtel Law Group is not affiliated with them.
Patent Strategy Considerations
Devices with dual-use sensing, imaging or communications features can raise the question of whether section 23 applies. UK patent attorneys should make that call before a U.S. provisional or PCT filing is made directly abroad, since the consequences of getting it wrong cannot be undone after filing.
If planned UK reliance routes proceed, FDA clearance may support access to Great Britain as well as the United States. That raises the value of U.S. claims that cover the cleared device and of a U.S. freedom-to-operate review completed before the FDA submission becomes public.
A UK company may need UK coverage through a national or European patent, UPC-state coverage in Europe, and a separately prosecuted U.S. portfolio. We help prioritize U.S. filings against commercial timing so that the U.S. portfolio is built deliberately rather than inherited from the European claim set.
How Engagements Work
Knechtel Law Group is based in Carefree, Arizona, and advises on U.S. patent strategy. Questions of UK 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 UK attorney continues to handle UK and European matters, including section 23 questions, and we handle U.S. strategy, prosecution and freedom-to-operate analysis. We do not advise on UK law.
No. Patents are territorial. U.S. rights require a U.S. application within the Paris priority year or a PCT national stage entry by 30 months from the priority date.
Possibly. U.S. law generally disregards an inventor's own disclosure made within one year before filing, but the UK and European rules are much narrower. The U.S. filing should be made promptly, and UK counsel should assess the European position.
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