Replies to post #10630 on Momenta Pharmaceuticals, Inc. (MNTA)

[pollyvonwog]

CW lately has alluded to the fact that he expects HW to eventually be clarified correctly even if MNTA is not the case that does it. If it does take another case to clarify, would that ever have an effect on MNTA?

[linhdtu]

Amazing. Life and fortune do seem to favor the bold.

That is how a non lawyer person like myself sees it.

OTOH, Amphastar may just happen to be lucky or perhaps be very smart in legal terms.

Consider the sizable recent penalty assessed against Teva (I believe) for early launch, there are early launches and then there are other early, very early launches like Ampha's, lol.

[iwfal]

The Supreme Court's denial of certiorari effectively ends of Lovenox patent case, as far as I can tell.

I would suggest it depends upon *why* it was denied. I.e. as was pointed out on this board one of Ampha's arguments about certiori was that the case wasn't yet "ripe". Anyone looked at the denial yet?

The District Court will now likely order a dismissal based on the Hatch-Waxman Safe Harbor.

Might that depend upon *how* certiori was denied?

Questions, questions... -g-


BTW - I do think that a part of this was that Sandoz/Momenta was just plain out-lawyered at the appelate level (and above). But maybe that is just my excuse for giving reasonably high odds that the USSC would hear the case -g-.

[mouton29]

<<The Supreme Court's denial of certiorari effectively ends of Lovenox patent case, as far as I can tell. The District Court will now likely order a dismissal based on the Hatch-Waxman Safe Harbor.>>

That's not absolutely clear. Five pages of the Amphastar brief were devoted to the argument that cert was inappropriate because the appeal is "interlocutory," i.e., there has not been a final judgement in the lower court. Put another way, the H-W holding could be moot if the district court holds a trial and finds the patents invalid. On the other hand, if, as you surmise, the district court enters summary judgement based on the H-W argument, Momenta can try again. Here is a portion of the argument from the Amphastar brief. We can't really know for sure given that the court, as is typical, simply denied cert with no explanation.

Finally, the petition’s interlocutory posture is “of
itself alone” a “sufficient ground for the denial of the [writ].” Hamilton-Brown Shoe Co. v. Wolf
Bros. & Co., 240 U.S. 251, 258 (1916). This Court “generally await[s] final judgment in the lower
courts before exercising [its] certiorari jurisdiction.” Virginia Military Inst. v. United
States, 508 U.S. 946 (1993) (Scalia, J., concurring in denial of certiorari); see also Estelle v.
Gamble, 429 U.S. 97, 114 (1976) (Stevens, J., dissenting) (referring to the Court’s “normal
practice of denying interlocutory review”); Goldstein v. Cox, 396 U.S. 471, 478 (1970) (“[T]his
Court above all others must limit its review of interlocutory orders.”); Brotherhood of Locomotive
Firemen & Enginemen v. Bangor & Aroostook R.R. Co., 389 U.S.
327, 328 (1967) (per curiam) (“[B]ecause the Court of
Appeals remanded the case, it is not yet ripe for review by this Court. The petition for a writ
of certiorari is denied.”); American Constr. Co. v. Jacksonville, T & K. W. Ry. Co., 148 U.S. 372,
384 (1893) (“Clearly, therefore, this court should not issue a writ of certiorari to review a
decree of the circuit court of appeals on appeal from an interlocutory order, unless it is
necessary to prevent extraordinary
25
inconvenience and embarrassment in the conduct of the cause.”).

That petitioners seek review of the court of appeals decision to vacate a preliminary injunction
(that ceased operation over 16 months ago) magnifies the inappropriateness of interlocutory review.
See Meccano, Ltd. v. John Wanamaker, New York, 253
U.S. 136, 141 (1920) (“Upon appeal, an order granting or denying such an injunction
will not be disturbed, unless contrary to some rule of equity, or the result of improvident
exercise of judicial
discretion. The informed judgment of the Circuit Court of Appeals exercised upon a view of all
relevant circumstances is entitled to great weight. And, except for strong reasons, this
court will not interfere
with its action.”) (citations omitted).

It also bears noting that, contrary to their position here that the “court of appeals definitively
determined the scope of Section 271(e)(1),” Pet. 32, petitioners have told the district court that
they “will oppose” respondents’ “motion for summary judgment based solely upon the [safe harbor]
issue,” Joint Mot. to Stay, Dist. Ct. Dkt. No. 327 at 2 (D. Mass. Aug. 9,
2012); see also Am. Order, Dist. Ct. Dkt. No. 431 (D.
2012); see also Am. O
Mass. May 2, 2013).

[jbog]

If that happens will the tables turn and will Amphastar sue Sandoz/Momenta for damages?