Patent absolutely necessary prior to launch I believe the process was originally patented and FDA approved and not the spectrophotometric measurements unit. Now that they have the spectrophotometric measurements unit patented, it cannot be copied, which had to be a major concern to them. Now, once they receive FDA approval for this unit, they can launch worldwide.
Step 1 was this patent, step 2 FDA approval for the unit and then step 3, the launch. Any other views on this matter?