Patent decision

BL number

O/228/11

Concerning rights in

GB0806669.8

Hearing Officer

Dr L Cullen

Decision date

28 June 2011

Person(s) or Company(s) involved

INA Research Inc

Provisions discussed

PA 1977, Section 1(1)(b)

Keywords

Inventive step

Related Decisions

None

Summary

The application relates to an arrhythmia model animal that enables an evaluation of the QT interval prolongation by a drug. The QT interval is the time period which elapses between the Q wave and the T wave in the electrical cycle of the heart. Some drugs can prolonging the electrocardiogram QT interval and induce proarrhythmia, such as the fatal ventricular arrhythmia called Torsades de pointes (TdP).

The applicant has produced a monkey model, specifically a cynomolgus monkey model, of proarrhythmia in which the atrioventricular node of the heart has been preablated. Unlike previous model animals (e.g. dogs), this monkey model recovers from any arrhythmia which may develop following administration of the drug being tested, such that the same model animal can be used repeatedly.

The Hearing Officer identified the “skilled person” as being a team including, a cardiologist, a pharmacologist with expertise in the cardiotoxic side-effects of drugs, and a veterinary surgeon. After considering the common general knowledge of the skilled team, the Hearing Officer considered the inventive concept to be the use of a cynomolgus monkey model of proarrhythmia in which the atrioventricular node has been preablated in order to evaluate the QT interval prolongation by a drug and not, as argued by the applicant, the use of an animal model of proarrhythmia for evaluating drug-induced long QT syndrome, which animal recovers from arrhythmia, as proposed by the applicant.

The Hearing Officer held that the claimed invention was obvious in light of the common general knowledge of the skilled team and the prior art disclosures involving surgical ablation of the atrioventricular (AV) node in dogs to produce similar models and that elevated levels of atrial natriuretic peptide (ANP) or cerebral natriuretic peptide (CNP) are associated with AV block. The obvious course of action of producing a cynomolgus monkey model of proarrhythmia in an analogous manner to that already used in dogs w