Ⅰ. Chinese biopharmaceutical companies’ accelerating layout in Europe makes quality protection the next priority

Regarding relevant EPO data, the number of European patent applications filed by Chinese applicants in the chemical field has increased dramatically in recent years, especially in the biotechnology sector, application growth rates far exceed the global average.

Ⅱ. Amendment challenges under the standards of EPO's added items:  Future scope of protection depends on application drafting quality

The so-called "Gold Standard" is adopted by the EPO when assessing whether amendments introduce added items. According to the standard, the amended technical solution must be directly and unambiguously derivable by a person skilled in the art from the overall content of the original application documents, taking into account common general knowledge. The aforementioned standard means that applicants cannot freely extract, combine, or reconstruct technical solutions from features that merely appeared individually in the description during subsequent proceedings. The original application documents are not a "reservoir of features" from which applicants may freely select technical characteristics at the examination phase.

In EPO practice, added-items risks primarily show in the following aspects:

1.Intermediate Generalization

2.Combinations across embodiments

3.Selections from lists

4.Range Endpoints

5. Removal of Features

A "three-step test" has been typically adopted in assessing whether the deletion of a technical feature constitutes added items: First, whether the feature explicitly or implicitly described as non-essential in the original application documents. Second, whether the person skilled in the art comprehend that the feature is not essential for achieving the invention's purpose. Third, whether other technical features require corresponding adjustments after deleting the feature. Only when all of the above conditions are met simultaneously will the deletion of a technical feature amendment not be considered as introducing added items.

Ⅲ. Future scope for relief determined by the filing date's technical foundation: supplementary data is not a universal remedy

In EPO practice, the supplementary data follows different logics in the assessment of inventive step and sufficient disclosure.

(1) inventive step assessment: supplementary data can supplement and enhance existing technical effects

Supplementary data can be used to confirm, quantify, compare, or substantiate technical effects that already have a basis in the original application, but new technical contributions cannot be created from them after the filing date.

(2) sufficiency of disclosure: supplementary data cannot remedy lack of credible support at the filing date

When drafting medical use claims, companies need to proactively establish, at the application stage, an evidentiary foundation supporting the technical effects such as representative experimental data, mechanistic bases, credible implementation foundations covering the claim scope, and fallback strategies aligned with different levels of protection.

Ⅳ. Medical use claims: EPO practice under China-EU protection differences

There are significant differences between Europe and China regarding the form of protection and examination logic for medical use claims. In Europe, second and subsequent medical uses can be protected in the form of purpose-limited product claims, whereas in China, Swiss-type claims remain the primary approach.

More notably, the EPO is relatively flexible regarding the manner of limitation in medical use claims. For example, dosage regimens, routes of administration, and patient subgroups may all serve as technical limitations within the claims and be used to distinguish from the prior art.

Ⅴ.  Ownership and chain of title: a fundamental but unignorable risk in European patent strategy

Enterprises must make sure a complete and correct chain of title: Inventor → Employer → Applicant

Key points need to be verified such as:

- Whether the effective transfer of rights between the inventor and the employer has been properly completed;

- Whether the employer has the basis to assign relevant rights to the actual applicant;

- Whether the sequence of assignments is clear and complete.

For patent strategies spanning multiple entities and jurisdictions, completing ownership arrangements in advance not only helps mitigate procedural risks but also avoids obstacles in future licensing, transactions, or patent enforcement.

Ⅵ. Accelerated examination mechanisms: making rational use of EPO procedures to improve examination efficiency

In EPO practice, PACE (Programme for Accelerated Prosecution of European patent applications) is the accelerated examination pathway most commonly used by applicants. Applicants can push their European patent applications into a faster search and examination pace with a PACE request.

In addition, enterprises may consider other procedural routes depending on specific circumstances, for example,

- PPH (Patent Prosecution Highway): it can be used to expedite EPO examination when a corresponding application has received a favorable examination result from another patent office.

- Early Processing: under specific circumstances, applicants may request the EPO to commence processing of relevant procedures ahead of schedule.

From IPRdaily

July 21st, 2026