Expert witnesses for UK Pharma

Royce researchers at the University of Leeds acted as expert witnesses for GSK in a patent dispute, using state-of-the-art electron microscopy to map particles in an inhaler powder used to treat progressive lung disease.

Using Royce equipment at the Leeds Electron Microscopy and Spectroscopy Centre, researchers provided vital evidence and support to a multi-million pound patent dispute in the Pharma sector, resulting in a favourable judgment for GSK in relation to the production of several of its inhaler products used to treat patients with asthma and Chronic Obstructive Pulmonary Disease (COPD).

Professor Rik Drummond-Brydson, together with expert operator and Facility Manager John Harrington, were able to demonstrate that there was no clear evidence of an intellectual property infringement from the application of a particular chemical used as a powder lubricant in therapeutic products and their work helped demonstrate that the monopolies claimed by the patents in question were invalid. Examining and chemically analysing powder particles at the micrometre scale, the researchers showed that the compound, magnesium stearate, could not be reliably detected as a surface coating on particles delivered by the inhaler.

Professor Drummond-Brydson was approached by GSK due to his unparalleled experience in Electron Microscopy and Chemical Microanalysis, as well as the world-leading microscopy capability supported by the Royce and available at the University of Leeds.

Further collaboration with GSK

This collaboration resulted in GSK successfully defending the patent dispute and has stimulated further research with the UK Pharmaceutical Industry in the application of microscopic imaging and analytical methods to these materials.