29 June 2020
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Case 8 – T 1695/07 (EPO Board of Appeal, 28 September 2011)                

 

We helped determine the meaning of “surgery”

Our extensive arguments in relation to exclusion from patentability criteria have proved instrumental in guiding practice for drafting medical devices claims

With one of the strongest life sciences’ patent teams in Europe, we’ve always played an active role at the EPO – and in some of the most important legal decisions of the Boards of Appeal cited in the “White Book” or in the EPO Guidelines for Examination. In this series, we’re reviewing the ones we feel are most memorable in terms of making the law.

In T 1695/07, Mewburn Ellis represented the patentee in front of the EPO Board of Appeal (BoA), arguing for the reversal of a decision from the Opposition Division. That decision granted claims related to a process for measuring the rate of blood flow in a shunt (during haemodialysis), determining they fell within the scope of the exception to patentability under Article 53(c) EPC (methods for treatment of the human or animal body by surgery or therapy).

This case provided the BoA with an opportunity to interpret the G1/07 decision from the Enlarged Board of Appeal (EBoA), made the previous year.

In G1/07, the EBoA had concluded that the concept of “treatment by surgery” was to be interpreted more narrowly than in G1/04 (where “any physical intervention” on the human or animal body was considered a method of surgery). The EBoA did not provide a precise definition of what would fall within the scope of this narrower definition, and instead indicated that this should be assessed on a case-by-case basis.

Guidance: five essential criteria

The EBoA did, however, provide some guidance in relation to criteria that can be applied to the assessment of whether a method should fall outside of the exclusion. These criteria were summarised by the BoA in T 1695/07 as:

  1. criticality of the parts of the body affected by the method
  2. degree of intervention on the body
  3. environment in which the method is carried out
  4. required professional medical expertise and
  5. health risks incurred.

Much of the discussion in T 1695/07 focused on whether the claimed steps – “continuously removing blood from a downstream location in the shunt (12) by way of an inlet (28) to an inlet side (26) of a circulating line; delivering the removed blood flowing in said circulating line by way of an outlet (34) connected to an outlet side (32) of said circulating line to an upstream location of said shunt (12) …” – represented a method step excluded under Article 53(c) EPC, using the criteria summarised by the BoA.

The BoA decision

The BoA decided in this regard that:

  1. Blood and a shunt (when created by anastomosis) are not “uncritical parts of the body”.
  2. The claimed step involves the flow of a large proportion of the blood volume of the patient in an extracorporeal circuit connected to the patient, which could not be considered to be a “minor intervention”.
  3. The claimed process is performed during haemodialysis which is “as a rule” carried out in a medical environment (where carrying out the process at home was considered the exception), such that the claimed process would be performed in an “essentially clinical environment”.
  4. Haemodialysis is prescribed and managed by specialised medical staff, and interruption of the dialysis treatment in order to perform the claimed measurement process would require a “dedicated decision of the responsible physician”, such that the claimed process requires “professional medical expertise”. The BoA further commented that the reference to acts that represent the “core of the medical profession’s activities” (as being excluded) should not be interpreted to mean that only such acts fall under the exception (but that at least those acts should be excluded). It also indicated that the wording “medical profession” should be interpreted to cover “all health care providers who professionally practise medical acts, thus also physicians under training, nurses and other paramedical professionals”.
  5. The assessment of risk is limited to an abstract basis rather than a factual risk analysis based on objective evidence, and in particular to assessing whether “a certain health risk” is present and whether this risk is “substantial” (that is, beyond “harmless infections of superficial tissues”). The risks associated with the implementation of the claimed method (for example, embolism, thrombosis) were deemed to be “substantial”, and whether the likelihood of the occurrence of the risk was low was considered irrelevant.

The BoA concluded on these bases that the method steps noted earlier “are invasive and represent a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise”. As such, they are excluded under Article 53(c) EPC.

Single step sufficient for exclusion

Because a single such method step is sufficient under G1/07 for the whole claim to fall within the scope of the exclusion, the status of other claimed method steps was not discussed.

Therefore, by filing extensive arguments in relation the criteria of G1/07, we pushed the BoA to produce a concrete interpretation of the “new concept” that the EBoA had only broadly delineated.

This has been instrumental in guiding the practice when drafting specifications in the medical devices field, as a single method step that fails to meet the five criteria that had been summarised could result in the claim as a whole being excluded under Article 53(c) EPC.

Apparatus claim allowable

Anticipating the decision of the BoA on this point, auxiliary requests comprising only apparatus claims were filed and one of these was deemed allowable. Indeed, the BoA confirmed that the provisions of Article 53(c) EPC do not apply to apparatus claims, even if some of the features of the claimed apparatus are functionally defined in relation to the body of the patient. This underlines the point that, if at all possible, apparatus claims or claim-like wording should be included in any application that could be considered to relate to or involve a method of treatment by surgery. In opposition and appeal, auxiliary requests comprising apparatus claims only should preferably be put on file, as was done successfully here.

Find the decision here.

This blog was drafted by Camille Terfve

Simon is a Partner and Patent Attorney at Mewburn Ellis. He also heads up the firm’s Life Sciences practice group and is a member of our management board. Simon has nearly 30 years’ experience in original patent drafting, patent strategy European oppositions and appeals, including complex multi-party proceedings, and due diligence work, across the life sciences field for both large and small molecule therapeutics. He has worked on the portfolios covering many top selling biologics and has been at the forefront of patenting in the field of precision medicine and life cycle management for therapeutics.
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