The case required the analysis of the internal structure of tablets manufactured by direct compression and their potential infringement of a patent that claimed that the drug substance was coated by an insoluble polymer.
The Acumen Approach:
Acumen assembled a team involving a senior academic expert supported by two additional laboratory researchers to:
- Perform a comprehensive literature review and analysis of prior art regarding the role of insoluble polymers acting as sustained release agents.
- Perform microtoming and SEM/EDX measurements of the accused tablets to demonstrate that the drug substance was indeed coated by the insoluble polymer within the tablet matrix.
- Develop sound technical arguments to support the infringement allegations.
- Provide court testimony supporting the infringement allegations.
Case was won by Acumen client, an innovator company, with the product proven to infringe the patents en suit.