Summary
This application relates to the use of a specific peptide in the treatment of benign prostatic hyperplasia (BPH) in humans.The peptide isa Neural Thread Protein (NTP) of sequenceIle-Asp-Gln-Gln-Val-Leu-Ser-Arg-Ile-Lys-Leu-Glu-Ile-Lys-Arg-Cys-Leureferred to asSEQ ID 66.It is injected into the prostate of humans who have not been treated for BPH before and the improvement in symptoms of BPH is measured using the International Prostate Symptom Score (IPSS).
The examples describe the use of an active agent referred to as DRUG to treat human patients with BPH. DRUG is not identified explicitly in the examples or in the description prior to it being mentioned in the examples. The examiner considered that claim 1 lacks sufficiency under s14(3) as there is no evidence thatSEQ ID 66has a therapeutic effect on BPH. Reviewing the specification as filed and considering that the person skilled in the art is seeking to work the patent before them, the HO found that the skilled person would recognise that 4 of the 116 NTP peptides identified are closely related to the peptide of claim 1 and are -preferred-. Thus, there was enough to suggest that it is worth tryingSEQ ID 66or one of the 3 closely related peptides as DRUG. The skilled person will appreciate that DRUG is an NTP Peptide and that the examples show that DRUG works to treat BPH in humans. Definite proof is not necessary that SEQ ID 66 is DRUG but there must be something in the specification to suggest that it is plausible. As a result, the HO found that claim 1 does comply with Section 14(3) of the Patents Act 1977.
Taking account of the disclosure in US2013/0040900 A1, and applying the approach set down in Windsurfing/Pozzoli for considering inventive step, the HO found that the person skilled in the art would consider it reasonable to treat human patients with the claimed peptide given that it was known that this peptide worked well in rat models. It would also be reasonable that such patients would be treatment naive patients. The fact that once the skilled person has started to use this peptide in human patients, they would discover that it works better in treatment naive patients rather than treatment failure patients is not a distinguishing feature of the invention. It is information that would emerge from the studies carried out with the peptide in humans. As the application was found not to involve an inventive step under Section 1(1)(b) of the Act, the application was refused under Section 18(3) for failing to meet the requirements of the Act.
Full decisionO/552/21 152Kb