The Challenge:
The case required examining the internal structure of hot melt extrusion and direct compression tablets to determine whether the processes were equivalent.
The Acumen Approach:
Acumen formed a team of four senior academic experts and six laboratory researchers working in four different laboratories to:
- Test the internal structure of tablets using Scanning Electron Microscopy, Energy Dispersive Spectroscopy, Raman Scanning Spectroscopy, and X-Ray Computer Tomography.
- Test product performance and compare it to the attributes of the claimed products.
- Articulate sound technical arguments demonstrating that the processes generated products with very different attributes.
- Support clients in building claim construction arguments.
- Provide deposition testimony.
The Result:
Case was settled favorably post-deposition without going to trial.
