It boggles my mind that the court below dismissed this argument.
Agree.
The court was lost in the weeds.
From a policy standpoint, the safe harbor makes sense as a way of shortening the time gap between drug approval and marketing the drug without eviscerating the patent. It allows the patent its full value without granting additional years of protection caused by the FDA time line.
How else can you explain that a safe harbor that is solely for the development of the drug and FDA approval turns into a right to use the patented process without paying for the right?
Given the breadth and comprehensive nature of the requirements relied on by the Federal Circuit, its ruling (if left standing) would expand the safe harbor into a safe ocean.
Emphasis added. (Thanks to ‘stockbetter’ for posting the complete document.)