T 0235/15 - Tube feeding is medical method

Key points

• Claim 1 of the main request is directed to a method of tube feeding an "adult normometabolic patient under the age of sixty-five who cannot receive nutrition through a normal diet". The question is whether such a method is excluded from patentability under Art.53(c) EPC.
• The Board: " it is clear that [the patients] suffer from a serious condition, namely that they cannot receive nutrition through a normal diet. If this condition were not overcome or at least alleviated, it would inevitably lead to the patient's death." 
• " the artificial administration of nutrition to patients who are unable to eat normally has to be seen as therapeutic since, in its absence, the patient would inevitably die of starvation." 
• " Particularly relevant is the fact that tube feeding requires the use of a tube as an essential element for overcoming the patient's incapacity to eat normally. It is precisely the use of this tube which allows the administration of nutrition and which prevents the patient's death by starvation. Consequently, the method of claim 1 is a method for treatment of the human body by therapy and is therefore excluded from patentability by Article 53(c) EPC." 

EPO T 0235/15 -  link

Reasons for the Decision

1. Exceptions to patentability - Article 53(c) EPC

1.1 Main request

Claim 1 of the main request is directed to a method of tube feeding an adult normometabolic patient under the age of sixty-five who cannot receive nutrition through a normal diet. Thus, although the patients treated according to the method of claim 1 are explicitly defined as not having any metabolic diseases, it is clear that they suffer from a serious condition, namely that they cannot receive nutrition through a normal diet. If this condition were not overcome or at least alleviated, it would inevitably lead to the patient's death. In consequence, the fact that the patient has no metabolic diseases or that the method does not involve the administration of a medicament is not sufficient to say that the method of claim 1 is non-therapeutic; the patient suffers from a serious condition that needs to be treated in order to prevent fatal consequences.

As noted by the respondent, the patient may be treated in two possible ways, either by tube feeding or by intravenous provision of nutrients. However, independently of the method used, the artificial administration of nutrition to patients who are unable to eat normally has to be seen as therapeutic since, in its absence, the patient would inevitably die of starvation.

In this context, contrary to the appellant's view, tube feeding cannot be equated with normal eating since it is not a natural way of providing nutrition and the subject who receives it is a patient with a serious condition. Particularly relevant is the fact that tube feeding requires the use of a tube as an essential element for overcoming the patient's incapacity to eat normally. It is precisely the use of this tube which allows the administration of nutrition and which prevents the patient's death by starvation. Consequently, the method of claim 1 is a method for treatment of the human body by therapy and is therefore excluded from patentability by Article 53(c) EPC.

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4. Admission of auxiliary request 8 - Article 13(1) RPBA

The appellant filed auxiliary request 8 more than one year after the statement of grounds of appeal. The admission of the request into the appeal proceedings is hence at the board's discretion, taking into account, inter alia, the complexity of the new subject-matter submitted, the current state of the proceedings and the need for procedural economy (Article 13(1) RPBA).

The filing of auxiliary request 8 was an attempt by the appellant to overcome the objection that the method of claim 1 of the previous requests was considered to be therapeutic. This objection had been raised in the notice of opposition (point 5.1), and had been accepted by the opposition division in the appealed decision (point 21). Thus, auxiliary request 8 could and should have been filed earlier. Moreover, claim 1 of auxiliary request 8 introduces a change of category with respect to all previous requests on file, from a method claim to a purpose-related product claim. This change of category represents an amendment of the appellant's case at a late stage in the proceedings and prima facie extends the protection conferred by the patent, contrary to Article 123(3) EPC. Taking these facts into consideration, the board decided not to admit auxiliary request 8 into the appeal proceedings.

Regarding the appellant's argument, that the reformulation of claim 1 does not contravene Article 123(3) EPC because claim 1 as granted encompassed the nutrition product by virtue of Article 64(2) EPC, the board notes that the method defined in claim 1 as granted is not a method of preparation of the nutrition product, so Article 64(2) EPC does not apply. Hence, contrary to claim 1 of auxiliary request 8, claim 1 as granted did not provide any protection for the nutrition product.

Order

For these reasons it is decided that:

The appeal is dismissed.