Replies to post #120714 on Biotech Values

[tony111]

I am guessing claimed MW is not the true MW of branded Copaxone

[DewDiligence]

why are they saying the proposed generic's avg mol weight or peak mol weight does not conform to within claimed ranges of branded drug copaxone? If so, how will this product be considered equivalent by FDA?

The answer to your question is in the other bulleted items on the same page:

It is not possible to determine the molecular weight of individual polypeptides or “species” of Sandoz’s proposed product (see Plaintiffs’ Response to Defendants’ Statement of Material Fact paragraph 60).

...Sandoz’s proposed product does not include a “predetermined molecular weight profile” or “reacting protected copolymer-1 with hydrobromic acid…for a time and at a temperature predetermined by test reaction.

[exwannabe]

why are they saying the proposed generic's avg mol weight or peak mol weight does not conform to within claimed ranges of branded drug copaxone ?

The patent's range of average MW is 4-8.6 kD. The FDA label states 4.7-11 kD.

Is the 4-8.6 range better? I neither know nor care. Copaxone is defined by what the FDA says it is. If TEVA had wished to submit some data stating that lower weight was better and get that approved, fine. But they did not. Instead they told the FDA they higher weight was fine,

If all they did was tweek the range a tad in order to gain a new patent, that is obvious.

Try looking at it this way. Does Copaxone infringe on the '847 patent? If yes, then you would have to explain how a third party could have come up with the same '847 patent a decade after Copaxone was on the market and claim infringement. If no, then a clone of Copaxone will not infringe. If you believe Copaxone was improved, then you need to ask why it no longer conforms to the FDA label.

I seriously doubt the CoM patents will both hold up and be deemed reading. One or the other, but not both.

The process patents are right up MNTA's alley, they will be able to non-infringe very easy, unless MNTA is a scam, in which case I will have to kill DD :-)

On a lighter side, I believe the Indian courts have already rulled the patents invalid :-)

P.S., agree that this really matters little. It's the FDA, stupid.