Replies to post #114348 on Biotech Values

[DewDiligence]

Re: Handicapping the Copaxone patent case

My main point is the analysis really needs to be broken out by the 2 sets of patents.

Feel free to post your own numbers using your own model. That’s what message boards are for :- )

[exwannabe]

Re: Copox trial odds

Tried to reply this to DD (who I thought made a very valid point that I should post my guess, I have no clue why he deleted that post).

I would say:

For the CoM patents

Obviousness etc. : 5%
Non-infringement : 10%
Indefiniteness/BestPractice/Enablement : 40%
Inequitable conduct : 15%.

For the rest:

Obviousness etc. : 1%
Non-infringement : 80%
Indefiniteness : 10%
Inequitable conduct : 10%.

That would be 80% to beat the CoMs and 84% on the rest

Final answer, 67%

Kind of surprised that the 2 groups came out that close when I put numbers on them. Granted they were pure guesses, but so was my earlier statement that the process patents would be much easier to avoid.

EDIT: Don't know whats up with board software, DDs post was there, not there, now there.

[zipjet]

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.