A few considerations.
The MNTA attorney said a month to be ready for trial. They have been dealing with two suits, and likely know the patents inside and out, and likely know what they need to know to be ready for trial.
Ampastar attorney, I need 1 year to get ready for trial. Judge, hmmnnnn. They are in a rush to sell the drug yet can’t be ready for trial for one year. My words.
Next,
“Second, the independent claims call for the use of “a separation method to determine the presence of a structural signature” of enoxaparin. Claim 56 states that the structural signature is determined using CE. As explained, “determin[ing] a structural signature” is determining the presence or amount of a non-naturally occurring sugar. Therefore, if the independent claims were interpreted to mean that CE, and only CE, must be used “to determine the presence of a structural signature,” dependent claim 56 would be entirely duplicative of the independent claims. Any such interpretation would be at odds with the doctrine of claim differentiation. Moreover, there is no suggestion in the patent, no suggestion in the record of this case, and no scientific basis for suggesting, that CE could be used once to determine the presence of a structural signature and then used again to determine what the underlying sugar actually is. To the contrary, the patent teaches that different and additional methods would have to be used for that purpose. See, e.g., 47:62-65.1 Thus, as applied to claim 56, the defendants’ argument is nonsense. Similarly, claim 54 is directed to the use of HPLC to determine a structural signature. HPLC, like CE, is a separation method. Like CE, it can be (and is) used in commercial production release testing to determine the presence of the relevant structural signature of enoxaparin. (Recall that, by the time of commercial production, the identity of the sugars under each peak in the output of the HPLC device has previously been determined.) And, like CE, nothing in the patent, nothing in the evidence before the Court, and nothing in scientific fact, suggests that the use of two separation methods -- e.g., HPLC followed by HPLC, CE followed by HPLC, or HPLC followed by CE -- could be used to understand what is the structure of a particular sugar that is associated with a particular peak that is the output of either an HPLC or a CE process. Instead, both CE and HPLC, when referenced in the dependent claims, are fairly understood to be sub-categories of the separation method of the independent claims.”
“Thus, as applied to claim 56, the defendants’ argument is nonsense.”
Agree Judge might or might not read this. They again, he might.
Next,
“1 In this context, the Court should note that the '886 patent states that “in a further embodiment the method of the
invention relates to the use of CE separation followed by off-line MALDI-MS analysis to derive structural
information …. 34:7-10. Defendants cite this language at p. 1 of their submission, but omit the italicized language,
thereby suggesting that what the patent calls an “alternate embodiment” is actually the invention of the patent. In
any event, this disclosure indicates that the use of CE alone, no matter how often CE is run, will not determine what
is the actual structure of a sugar that CE has separated from other sugars.
___________________________________________________________
Amphastar determines is, in fact, associated with the non-naturally occurring sugar that is associated with peak 9 of Fig. 1 of the '886 patent. Therefore, Amphastar infringes the independent claims of the '886 patent.” Note how they omit stuff?
“but omit the italicized language,”
Again the Judge might or might not read the request to submit.
Even if he does not read it is telling.
Next, if the Judge gives a PI, which as most say they almost never do, how long will he give. 1 year? That is what they said they need. Not us.
One thing for sure, this stock can cause a heart attack.
Last but not least, if he does give a PI, what happens with the 5M shorts?
Oh well, I guess we will know late Friday night.
I hope MNTA mgt. is not expecting great stock options this year.
They should suffer with the stock holders.
They need to get their act into high gear.
Just IMHO.
