March 4, 2026

Drafting Patent Applications That Travel the Atlantic – Tips for Companies Filing in the United States and Europe

Ian Soule, Tyler Tassone Sterne, Kessler, Goldstein & Fox P.L.L.C. + Follow Contact LinkedIn Facebook X Send Embed

Europe is an important market for many U.S. companies in various industries, including medical devices or biologically adjacent industries (e.g., diagnostics or formulations). In practice, however, drafting first-filed U.S. patent applications through the lens of U.S. patent practices and subsequently filing the same application in Europe can result in significant strategic challenges during European examination. Indeed, for in-house counsel overseeing global portfolios, the key question is not whether European counsel can navigate prosecution. It is whether the original application was engineered to survive it.

European practice is significantly stricter on specification support, inventive step framing, and, in some ways, subject-matter eligibility. For companies seeking strong, strategic portfolios (e.g., either for future monetization or competitor deterrence) in both the U.S. and Europe, the drafting stage is where outcomes are largely determined.

Four key considerations to keep in mind are:

1. Remember that added matter considerations mean future claim scope is locked at filing – In Europe, any claim amendments must be “directly and unambiguously” derived from the specification. This often requires nearly verbatim support for the amendment in the specification. For example, if your commercial product evolves after filing—not uncommon for products undergoing regulatory approval—the ability to pivot and capture that subject matter depends on how the specification is written.

Claiming combinations of features not clearly disclosed together or omitting a feature originally disclosed in combination with other features can raise added matter concerns. To help avoid issues with added matter and allow for claiming of different combinations of features in the event the commercial embodiment changes after the application is filed, applicants should draft the application to start with a broad framing of the invention, and gradually introduce features of the invention. As the features are introduced, applicants should explain variations of the features (e.g., broad and narrow variations), and the technical effect of those features. Applicants should also be sure to disclose different combinations of features to provide express support for key embodiments.

Keeping these principles in mind will allow you to be better positioned to add or omit features to allow for claiming different combinations of features should the invention change—or should competitors attempt to design around the initially drafted claims.

2. Consider inventive step and draft an application from the problem-solution approach to help avoid rejections later – The European analog to U.S. obviousness is “inventive step.” Under the problem-solution approach used to assess inventive step, the European examiner identifies the closest prior art and evaluates the differences between the closest reference and the claimed invention. The technical effect of the distinguishing features is assessed by the examiner, and the problem solved by the distinguishing feature is determined. If the examiner determines a skilled artisan having the cited references and faced with the technical problem would arrive at the claimed solution, the claims are rejected for lack of inventive step.

To help future-proof against inventive step rejections in Europe, the initial disclosure should provide benefits or advantages of various features of the invention along with some characterization of the problem(s) that the features solve. Providing technical features and tying them to an explanation of the benefit or purpose of the feature in the specification can help applicants address these issues.

Evaluating user-facing features of a product, including aesthetic choices, user interface behaviors, or workflow improvements that are perceived as valuable but lack an articulated technical rationale should be scrutinized during drafting and inventor disclosure interviews. Additionally, in-house counsel should push drafters to document the “why” behind every potential distinguishing feature. What problem does it solve? What measurable benefit does it provide? This is not just good European practice—it produces richer prosecution histories and stronger patents in any jurisdiction.

3. Think about differences in patent eligible subject matter early and tailor claim options for both jurisdictions – European law statutorily excludes methods of treatment or diagnosis from patent eligibility. As a result, applicants in medical device technologies may prefer to focus on claiming the medical device itself rather than the use of the medical device to apply a treatment or to render a diagnosis. If the application is drafted from the perspective of applying treatment to a person, due to restrictions on added matter discussed above, it may be challenging for applicant to later revise the claims to use alternative language or to omit steps and features relating to providing treatment. For Europe, applicants should focus on claiming the instrument, the implant, the diagnostic system itself, and not the act of using it on a patient.

Similar technical effects analysis applies to claims relating to information displays (e.g., graphical user interfaces, “GUIs”) in Europe. While not statutorily excluded, to avoid rejections of lack of technical character, applicants seeking patent protection for GUIs should not merely disclose the content and arrangement of the GUI and should instead clearly describe the technical effects achieved by the GUI. Additional description of how the GUI is used to guide a human-machine interaction should also be included.

4. Take the time to evaluate additional miscellaneous claim strategy prior to filing – In the U.S., an applicant can file multiple claims in the same category, e.g., multiple system claims or multiple method claims. Much to the dismay of many U.S. practitioners and European practitioners alike, under European practice, an applicant may pursue only one independent claim per category (e.g., method, apparatus) with limited exceptions. Rule 43 (2) EPC. And to have the claims examined together in Europe, the independent claims must share a special technical feature.

Another difference is that in the United States, applicants can file three independent claims and 20 total claims without paying additional claims fees. In contrast, in Europe applicants can file only 15 total claims before excess claims fees are assessed. However, the smaller number of claims can be offset by the use of multiple dependent claims which are permitted in Europe without additional fees.

An adaptive approach for Europe includes drafting a relatively broad independent claim and building up the invention through dependent claims with multiple dependencies to cover different combinations of features. In-house counsel reviewing prosecution strategy should confirm that European filings are structured this way from the outset, not simply copied from the U.S. application.

The Bottom Line

Considering these differences reveals that a “U.S.-only” mindset may yield overly narrow European claims, added-matter vulnerabilities, limited fallback positions during prosecution, and lingering subject matter eligibility issues. By integrating European considerations into first-filed U.S. cases, counsel can be better positioned to adapt claim scope to evolving product roadmaps or potential third-party infringers, provide stronger inventive step arguments if needed during prosecution, and have meaningful coverage on both sides of the Atlantic at the end of the process.

The incremental cost of more disciplined, Europe-aware drafting at filing is typically modest relative to the downstream value preserved—or lost. In the competitive medical device sector and related markets, that difference has the potential to affect downstream value, transaction leverage, litigation posture, etc. Intentional drafting of a specification written with both jurisdictions in mind, and a claim architecture designed for European constraints (and U.S. flexibility) can give companies added comfort to avoid narrowed claims, post-grant challenges, or gaps in a portfolio intended to cover key products or markets.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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