Legal Evaluation of Each Statement
A. The legal issue: Art. 53(c) EPC exclusions
Under Article 53(c) EPC, European patents shall not be granted for:
- methods for treatment of the human or animal body by surgery or therapy, and
- diagnostic methods practised on the human or animal body,
while the exclusion does not apply to products (e.g. devices, substances, compositions) for use in such methods.
This means the key patentability question here is whether the proposed claim category and features fall within the method exclusions.
a) EP patent on a method claim comprising (a) and (b). — False
Because the claim would include a biopsy step, it includes a surgical step. Under Art. 53(c) EPC as interpreted in G 1/07, one surgical step in a multi-step method is enough to exclude the entire method claim.
B. Step (a): biopsy performed by a medical practitioner
A biopsy is an invasive sampling step performed on the living body. Under the EPO approach confirmed by the Enlarged Board in G 1/07, a method is excluded as “treatment by surgery” if it comprises or encompasses an invasive step representing a substantial physical intervention on the body, requiring professional medical expertise and entailing a health risk, even if the overall method is not therapeutic.
The Guidelines reflect the same principle: if a method claim includes at least one step that is a surgical (or therapeutic) step, the method claim is not allowable under Art. 53(c) EPC.
So any method claim that includes “carrying out a biopsy to extract a tissue sample from a patient” is, as drafted, caught by the surgical-method exclusion.
b) EP patent on a method claim comprising only (a). — False
A biopsy method is a method for treatment by surgery and is excluded under Art. 53(c) EPC. Additionally, your fact pattern says (a) is known, so it would also fail novelty (Art. 54 EPC) even if it were not excluded.
C. Step (b): diagnostic analysis on the sample in an analysing liquid (in vitro)
For “diagnostic methods”, Art. 53(c) EPC only excludes diagnostic methods practised on the human or animal body.
In G 1/04, the Enlarged Board clarified the scope of the diagnostic-method exclusion and the multi-step nature of diagnosis; the Guidelines explain that a method is only regarded as an excluded diagnostic method if the technical steps constitutive for making the diagnosis (phases (i)–(iii)) are practised on the body.
A method carried out on a tissue sample in a liquid outside the body is therefore, in principle, not “practised on the body” and is generally not excluded by Art. 53(c) EPC on diagnostic grounds (subject to the usual requirements: novelty, inventive step, industrial applicability, sufficiency, clarity).
c) EP patent on a method claim comprising only (b). — True
A method carried out on the extracted tissue sample in an analysing liquid (i.e. in vitro) is generally not a diagnostic method “practised on the human or animal body” and is thus not excluded by Art. 53(c) EPC, consistent with G 1/04 and the Guidelines’ explanation of the “practised on the body” criterion for the constitutive technical steps. Patentability then depends on the normal requirements (notably Art. 54/56 EPC).
D. Drafting consequence: omit the non-essential biopsy step
Your client states that how the sample is obtained is not essential. In that case, you would typically draft the independent method claim to cover only the in-vitro analysis (b), e.g. “A method of diagnosing … comprising contacting a liver tissue sample with analysing liquid …” without defining a biopsy/extraction step.
This is consistent with the general EPC principle that claims should contain the features necessary to define the matter for which protection is sought (clarity/support under Art. 84 EPC), and it avoids importing an excluded surgical step into the claim. (A practical caution: don’t draft in a way that makes a biopsy implicit in the claim wording—keep it explicitly in vitro and sample-focused.)
d) No EP patent can be obtained for the development. — False
Even though you can’t get a method claim including the biopsy, you can potentially obtain protection for:
- the in-vitro diagnostic method (b), and/or
- product claims (e.g. kit, reagent composition, device) used in the method (products are not barred by Art. 53(c) EPC).
Exam Tip:
When you see a medical/diagnostic invention, immediately apply this checklist:
- Does the claim include any surgical or therapeutic step?
If yes → method claim excluded (Art. 53(c)); one surgical step is enough (G 1/07). - Is the diagnostic part “practised on the body” or in vitro?
In-vitro sample analysis is typically not excluded; the diagnostic-method exclusion is narrowly tied to steps practised on the living body (G 1/04; Guidelines). - Draft around the exclusion:
Claim the in-vitro method and/or products (kits/reagents/devices)—and avoid wording that makes a biopsy implicit.
Legal Disclaimer
The information provided in this post is for general informational purposes only and does not constitute legal advice. This content should not be used as a substitute for professional legal advice tailored to your specific circumstances. For advice related to any specific legal matters, you should consult a qualified attorney.