Freedom To Operate Study For A Japanese Medical Devices Company

The client partnered with SPA to identify potential patents that could block the right to use of their multi-functional surgical device.

• A 3-member team of Biomedical engineers from SPA was assigned to the project.
• The multi-functional surgical device comprised about 30 critical components.
• The Right to use (RTU) study involved conducting searches for each of the structural components (including major and minor components), functional and mechanistic aspects.
• Searches by competitors and inventors were also conducted.
• Relevant patent documents were identified after screening large datasets, and an element by element analysis was done for all the aspects.
• Differences between the aspects of the client’s device vis-à-vis that claimed in identified patents were assessed.
• There were no blocking patents for the major components/aspects; however, there was a potential blocking patent that claimed a minor component that was identical to that in the client’s device.
• The client opted to procure a license from the patent holder for its use in their device and the device was subsequently commercialized.
• This study helped the client understand the potential freedom to operate (FTO) risks and undertake appropriate action.

• 5 months

• $ 100,000