Diagnostic Methods

Under Article 53(c) of the European Patent Convention (EPC), European patents shall not be granted in respect of “diagnostic methods practiced on the human or animal body”.

Although the intention of Article 53(c) EPC is to (somewhat) protect medical and veterinary practitioners from infringing patent rights, there is no language to this effect in the EPC. As a result, the presence, or otherwise, of a medical practitioner is irrelevant when determining whether or not subject matter falls under this exclusion.

To be excluded from patentability under this provision, a patent claim must include all steps necessary to reach a medical decision: (i) examination phase, i.e., collecting data; (ii) comparison of these data with standard values; (iii) finding of any significant deviation; and (iv) decision phase which involves attribution of this deviation to a particular clinical picture.

If a patent claim lacks any of the above steps, it is not considered a diagnostic method; but rather an intermediate finding of diagnostic relevance and therefore should not be excluded from patentability under Article 53(c) EPC. However, it is worth considering that an applicant cannot avoid this exclusion by omitting one of the above steps from a claim if said step is essential to the method - because removing such step(s) from the claim would contravene the clarity requirements of Article 84 EPC.

Furthermore, Article 53(c) EPC specifies diagnostic methods “practiced on the human or animal body” and as such this exclusion requires the presence of a live human or animal body. EPO Enlarged Board of Appeal Decision G1/04 ruled that this criterion must be satisfied by all method steps of a technical nature. Technical steps of diagnostic methods are generally limited to the (i) examination phase, as steps (ii) to (iii) are predominantly non-technical in nature and not practised on a human or animal body.

It therefore follows that if a claim comprises at least one technical step not practiced on the human or animal body, then this subject matter is not an excluded diagnostic method under Article 53(c) EPC. However, such a claim may still be excluded under this provision as reciting a surgical method.

The exclusion of diagnostic methods practiced on the human or animal body under Article 53(c) EPC does not extend to products for use in any such method. In fact, under Article 54(5) EPC, the use of a known substance or composition in an excluded diagnostic method may be patentable (as a purpose-limited product claim) provided said use is not comprised in the state of the art.

It is noted that Article 54(5) EPC is limited only to substances or compositions for use in a method excluded under Article 53(c) EPC and case law has ruled that in most instances medical devices are not eligible for protection under Article 54(5) EPC for use in a new but excluded diagnostic method.

Drafting tips to help European Prosecution

To help avoid an objection, from a European Examiner, that claimed subject matter encompasses a diagnostic method practiced on the human or animal body – and so is excluded from patentability under Article 53(c) EPC – when drafting claims for patent prosecution at the EPO, it may be beneficial to:

• omit one or more of steps (i) to (iv) above (as long as such omitted steps are not essential), in addition to including wording in the description to support that such omitted steps are not essential;
• limit appropriate steps of the method as ex-vivo or in vitro;
• disclaim any step performed on a live human or animal body;
• include, if appropriate, a purpose limited product claim directed to a substance or composition for use in an excluded diagnostic method i.e. “product X for use in a in vivo diagnostic method comprising…”.

If claims are being drafted for prosecution at multiple jurisdictions (e.g., as part of an international (PCT) application), then it may be beneficial to include explicit language in the application as filed to provide basis for amending the claims to include any of the above suggestions (as appropriate) when entering the European Regional Phase, or as required during examination in Europe.

The attorneys at Secerna LLP have a wealth of experience in drafting and prosecuting patent applications relating to diagnostic methods in Europe. If you would like any further information, please do not hesitate to contact us at docketing@secerna.co.uk.