Case Study 8 – Internal structure of a tablet

The Challenge:

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.
The Result:

Case was won by Acumen client, an innovator company, with the product proven to infringe the patents en suit.