I have difficulty understanding multiple CoM patents in the Copaxone situation as it developed.
IF I have this right, the original CoM patent that expired in early 1990's was the basis for Copaxone which came to market when FDA approved it in 1996. Later CoM patents narrowed the MW of the mixture. Did Copaxone (the FDA approved mix) change* to conform to the newer mix or is Copaxone the same drug that launched in 1996?
I do not recall any change in the composition of Copaxone over this time frame and I was following it since my wife was getting the drug.
IF C was changed, were there new clinical studies?
IF a CoM issues on a mixture, can a change in the mixture support a new CoM? When is the change sufficient to justify the grant of another patent period to the innovator? Does the change produce novel and unexpected improvements?
ij
* IF not then non-infringement would of the later CoM patents would be 100%
PS - Thanks for the insights - greatly appreciated.
There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)