CABINET CHAILLOT

T2945/18

Disclosure

Claim 1 of the main request reads as follows:
"1. A peptide for use as an analgesic agent for treatment of pain, wherein said peptide consists of the sequence QRFSR (SEQ ID NO: 2), or pyroglutamate-RFSR, and wherein said treatment comprises repeated administrations of the peptide and does not induce pharmacodependence."
The first question to arise is whether the application generally discloses the use of the peptides of the invention for the treatment of pain.
At the end of the introductory part on page 3, lines 4 to 15, the following is stated: "The inventors have found that, surprisingly, opiorphin not only has analgesic properties, but also a psychostimulant effect. It was found that the analgesic potency of opiorphin is as powerful as that of morphine and that its psychostimulant potency is as powerful as that of imipramine.
Therefore, opiorphin and derived peptides may advantageously be used as psychostimulants for treating or preventing diseases such as narcolepsy, hypersomnia, vigilance drop, attention deficit in adults and in children, hyperactivity in adults and in children, attention-deficit/hyperactivity disorder (ADHD), obsessive-compulsive disorders (OCD), and mood disorders such as depression, bipolar disease, dysthymic disorder and cyclothymic disorder."
Neither the aforementioned list of diseases, nor such a list in the claims, nor the definition of diseases mention use in the treatment of pain or as an analgesic agent.
In the board's view, from the cited passages, it remains at least ambiguous whether a medical use relating to the analgesic properties of opiorphin was part of the invention. None of the diseases listed on page 3, page 14 and page 16 to 17 and in the claims include pain.
The only further references to analgesic activity/effect or pain in the earlier application are in the context of the examples carried out with opiorphin.
However, the skilled person, when considering the examples in the context of the earlier application as a whole, would have understood them as attempts to dissect the µ- and delta-opioid receptor pathways (Examples 2 to 4) and obtain further information on the pharmacodependence and tolerance of the agent (Examples 5 and 6). Thus, the skilled person would not have considered them as a direct and unambiguous disclosure of a use of all the peptides of the invention as analgesic agents for the treatment of pain.
The appellant referred to page 16, lines 14 to 16 which discloses the "use in vivo of peptides according to the invention for activating an opioidergic pathway depending on my- and/or delta-opioid receptors". According to the appellant, it would have been clear from the examples that the my-opioid receptors were responsible for the anti-pain activity of the peptides of the invention. It would therefore have been immediately apparent and implicit for the skilled person that potentialising the activation of the opioidergic pathway depending on my-opioid receptors by the peptides of the invention, including Glp-RFSR, was equivalent to the treatment of pain.
However, the board is not persuaded by the appellant's line of argument that it would have been immediately apparent and implicit for the skilled person that potentialising the activation of the opioidergic pathway depending on my-opioid receptors by the peptides of the invention was equivalent to the treatment of pain. This is because the earlier application does not unambiguously disclose that the activation of endogenous µ-receptors is exclusively linked with the treatment of pain.
Thus, the mere disclosure of an in vivo use of the peptides for activation of the my-opioid receptor pathway would not have led the skilled person to conclude that the peptides were to be used as analgesic agents for the treatment of pain.
In conclusion, a general disclosure of "a peptide for use as an analgesic agent for treatment of pain" is lacking from the earlier application as filed, even for the compound opiorphin - and thus even more for the compound pyroglutamate-opiorphin.
The board therefore finds the subject-matter of the claims to extend beyond the content of the earlier application as filed (Article 76(1) EPC).
The appeal of the decision of the examining division refusing European patent application No. 15 188 991.2 entitled "Opiorphin for use as analgesic agent" is dismissed.

 

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