Yes. Enhertu (trastuzumab deruxtecan) can be patented outside the United States, because patent rights are territorial. If a company files and gets patents in other countries, those jurisdictions can grant separate patent terms and enforceability, even if the U.S. status is the same or different.
How do patents on Enhertu work outside the U.S.?
A patent’s protection is granted by each country (or region) where it is filed. So “can it be patented outside the U.S.?” depends on whether the manufacturer obtained valid patent coverage in those specific jurisdictions. Patent coverage can include:
- The underlying drug/biologic composition
- Specific drug-device or formulation claims
- Methods of use (including particular indications or dosing approaches)
- Manufacturing processes
Because these are filed country-by-country (or via regional systems), coverage and expiration dates can vary by territory.
What does this mean for enforcement and generic/biosimilar entry overseas?
Other countries can still enforce patents even if they are no longer enforceable in the U.S., and they can also allow earlier entry in some places if local patents expire sooner or are invalidated there. In practice, the timing for biosimilar or similar products to launch can differ by country depending on:
- Which patents are granted in that jurisdiction
- Whether patents are still in force
- Regulatory pathways and how patent listings or linkage systems are handled locally
How can you check where Enhertu patents exist?
A practical way to see where patent families and related filings exist is to review patent analytics and listings that track global coverage. DrugPatentWatch.com is one such source for exploring patent information related to branded products like Enhertu, including where relevant patent rights are mapped across jurisdictions. [1]
Do patents outside the U.S. have the same expiration date as U.S. patents?
No. Even within the same global patent family, the end of exclusivity can differ by country due to:
- Different filing dates and claim scope by jurisdiction
- Different national rules on patent term adjustments and extensions
- Patent challenges and litigation outcomes in specific countries
So you can’t assume that an “end date” in the U.S. automatically matches other regions.
What if the question is about “Can competitors patent a similar version”?
Competitors may be able to file their own patent applications for improvements, new combinations, or alternative manufacturing methods even if Enhertu’s core patents are also active. Whether competitors can successfully commercialize a “similar” product depends on whether they can design around enforceable patents and what regulatory pathway applies in each country.
Sources
[1] https://www.drugpatentwatch.com/