Article 53(c) EPC, novelty Article 54(5) EPC

The appeal lies from the decision of the Opposition Division to revoke European Patent 2588154.
Granted claim 1 is worded as follows:
“A bone regenerative material comprising calcium sulfate, calcium phosphate, or demineralized bone matrix (DBM), or a combination thereof, for use in a method of treating a patient suffering from a degenerative bone condition that can be characterized by a loss of bone mineral density (BMD), the method comprising:
forming a void in a localized area of intact bone by clearing degenerated bone material and optionally removing a portion of the degenerated bone material; and
at least partially filling the formed void with a bone regenerative material that facilitates formation of new, non-degenerated bone material in the void.”
That the method defined in the claim is as such excluded from patentability under Article 53(c) EPC is self-evident. The method is for therapeutic treatment of the human body and, additionally, involves a surgical step. Thus, claim 1 of the granted patent is clearly drafted in the format provided for in Article 54(5) EPC, generally called second medical use.
The approach of the Opposition Division for assessment of novelty of this claim is based on the second part of Article 54(5) EPC, "provided that such use is not comprised in the state of the art". The novelty exception defined in Article 54(5) EPC only applies under this condition. Following this approach, in order to assess whether the novelty exception applies, it is first examined whether the specific use of the substance or composition defined in the claim is already known or not. If the use is already known, the claim cannot benefit from the novelty exception. The claim is considered not novel since the composition as such is already known.
The approach proposed by the appellant, i. e. reading the claim as it is drafted, assuring that the method falls under Article 53(c) EPC, then considering the use and method features as limiting and assessing whether the specific use defined by them is already known from the prior art is, in the Board's view, aligned with the wording of Article 54(5) EPC and follows its logic. The Article starts by stating that Articles 54(2)(3) shall not exclude the patentability of a substance or composition referred to in paragraph (4), thus implying that the substance or composition is already known. The article then continues to state that a specific use can provide novelty, in case it is not comprised in the state of the art.
The approach taken by the Opposition Division appears to be prone to errors, in particular when the specific use includes various method steps to be taken into account.
Claim 1 defines a method for treating a patient suffering from a degenerative bone disease comprising two steps. This is the "specific use in a method" referred to in Article 54(5) EPC, and this use needs to be compared with the disclosure of the prior art. The surgical step of the present claim is clearly a part of the therapeutic method. The method defined in the present claim has to be assessed as a whole. Thus, the surgical method steps cannot be ignored when assessing novelty of the claim.
The material and the method used in D3 are according to the claim. The appellant defended novelty of the claim arguing that D3 failed to disclose the formation of "non-degenerated bone material".
However, this feature cannot establish novelty of the claim because the formation of new bone material disclosed in D3 anticipates the granted claim.
The granted claim lacks novelty over the disclosure of D3 under Article 54(5) EPC.
The method defined in claim 1 of auxiliary request 2 requires additional steps.
The Opposition Division held this claim to lack novelty, it did not consider the method steps to provide a "new technical teaching". This terminology is taken from the Enlarged Board's decision G 02/08.
The passage the Opposition Division referred to reads as follows:
"In particular, the claimed definition of the dosage regime must therefore not only be verbally different from what was described in the state of the art but also reflect a different technical teaching."
This passage refers to a new dosage regime but the essence of it, i. e. that for establishing novelty a new technical teaching is required, may well be applied to the present case.
As set out above, in a claim drafted according to Article 54(5) EPC the method steps must be taken into account when deciding on novelty. Requiring additional surgical steps clearly provides a new technical teaching compared to the disclosure of D3 already because additional physical actions must be undertaken. The method defined in the claim is thus not just verbally different from the method disclosed in D3, but differs in tangible, physical method steps.
The Board concluded that the subject-matter defined in claim 1 of the second auxiliary request is novel and not obviously derivable from the cited prior art.
In summary, claim 1 of the second auxiliary request defines a non-obvious method of treating bone degenerative diseases, correctly drafted as medical use claim in the format foreseen under Article 54(5) EPC.
The case is remitted to the opposition division with the order to maintain the patent on the basis of auxiliary request 2.