Key points
- The decision was taken on 26.04.2022 and was notified in writing on 18.07.2023. The minutes were forwarded on 06.05.2022. No communications under Art. 15(9) RPBA are visible in the (public) online file.
- A petition for review is pending.
- " claim 18, is directed to the therapeutic use of an oncolytic adenovirus"
- "Use of the oncolytic adenovirus comprising a sequence encoding a hyaluronidase enzyme inserted in its genome for the manufacture of a medicament for the treatment of a cancer or a pre-malignant state of cancer, in a mammal including a human."
- "If the claimed subject-matter pertains to a use in connection with a medical treatment, for the requirement of reproducibility to be regarded as fulfilled it is necessary that the disclosure in the prior art document is such as to make it credible that the therapeutic effect on which the method of treatment relies can be achieved (see decision T 1457/09 of 17 January 2014, point 36 of the Reasons which refers to decision T 609/02 of 27 October 2004, point 9 of the Reasons). The therapeutic application of the present patent is based on the finding that the expression of a sequence encoding a hyaluronidase enzyme inserted in the genome of an oncolytic adenovirus improves the distribution of the virus through the tumour mass, increases its antitumour efficacy and induces tumour regression (see paragraphs [0017] and [0060] to [0064] and Figures 7 to 9 of the patent)."
- "Document (13) [WO 2005/018332] does not include any experimental results whatsoever showing expression of the hyaluronidase sequence in tumour cells infected with the described adenovirus, either in vitro or in vivo, nor improved distribution of the described genetically engineered adenovirus within a tumour or tumour regression induced by administering the adenovirus. As a matter of fact, none of the examples of document (13) involves the use of an adenovirus, let alone an oncolytic adenovirus comprising a sequence which encodes a hyaluronase enzyme. Hence, document (13) itself does not provide anything of substance that makes it credible that the genetically engineered adenovirus described therein is in fact suitable for the treatment of cancer."
- "In the board's view, in the absence of relevant experimental data in the document which may support a therapeutic effect, the common general knowledge of the skilled person at the publication date of document (13) becomes highly relevant. Therefore, only if - in the light of this common general knowledge - it was credible that the genetically engineered adenovirus described in document (13), which comprises a sequence encoding a hyaluronidase, was suitable for treating cancer in a mammal, it can be concluded that the skilled person derives this technical teaching from document (13). The board considers that - in view of the common general knowledge set out below - the skilled person would have had serious doubts in this regard and that, therefore, this technical teaching cannot be seen as being derivable from document (13)"
- Regarding inventive step: "As stated above in connection with novelty, document (13) is not considered to be enabling for the use of the oncolytic adenovirus as defined in claim 1 for the treatment of cancer. If, as the respondent contended, the problem to be solved starting from this document were to provide an adequate treatment for cancer, the statements in document (8) (see page 12, last sentence of the second paragraph) would not suggest to the skilled person the use of an oncolytic adenovirus comprising a sequence which encodes a hyaluronidase, but rather the co-administration of an oncolytic adenovirus and hyaluronidase enzyme in the tumour."
- "It follows from the above that the subject-matter of claim 18 is not obvious to a person skilled in the art in view of document (13) combined with common general knowledge. Hence, inventive step is acknowledged."
- Hence, this second medical use claim appears [*] novel and inventive over a prior art document literally apparently disclosing the second medical use.
- [*] - It is not entirely clear to me what the relevant paragraphs of D13 are. The Board's decision does not seem to contain pin-point citations, as D13 is dismissed as not making certain statements credible.
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.
source http://justpatentlaw.blogspot.com/2023/10/t-120319-novelty-of-second-medical-use.html
