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The decline was due to half inventory and half pricing. Next Q will be higher than this $47m mark but prob lower than that $80+m number 2 Q ago so if iwfal concedes now, he will have to once again rescind his concession next Q ;)
It's the same shelf that was already in place which expired in 2012 and is simply for housekeeping.
Enox $ for the Q? Anyone catch what they were? TIA
lol. Lazard fluff price upgrade has offering smell all over it... tic toc tic toc
Post-Approval Regulatory Activities—Take Two: Momenta
Less than a year later, however, a divided panel of the Federal Circuit all but overruled Classen. At issue in Momenta was the manufacturing process for a generic version of Lovenox (enoxaparin), a heparin derivative used to prevent blood clots. The FDA required each generic manufacturer to prove on an ongoing basis that its drug contains about 20 percent of a 1,6-anhydro disaccharide derivative. Amphastar chose to satisfy this requirement by implementing during its manufacturing process a batch-testing method that allegedly infringed Momenta's patent. Relying on Classen, the district court concluded that Amphastar's batch-testing method was a post-approval activity that did not fall within the § 271(e)(1) safe harbor, and granted Momenta a preliminary injunction.
A divided panel of the Federal Circuit vacated the district court's decision. The majority, consisting of Judge Moore (the dissenting judge in Classen) and Judge Dyk, acknowledged Classen as holding that § 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained" (quoting Classen). Having said that, however, the majority refused to distinguish pre-approval and post-approval regulatory activity for purposes of the safe harbor, observing that "Classen did not turn on this artificial distinction, and the plain language of the statute is not restricted to pre-approval activities."
Having opened the § 271(e)(1) safe harbor to post-approval regulatory activity, the majority then concluded that Amphastar's batch testing using Momenta's patented method fell within the confines of the § 271(e)(1) safe harbor. According to the majority, Amphastar's testing of each batch of generic enoxaparin was "anything but ‘routine'" because the FDA required that Amphastar demonstrate that its generic enoxaparin possessed the specified composition as a predicate for approval and release of each manufactured batch into commerce. By contrast, the majority further reasoned, the infringing studies at issue in Classen were not themselves mandated by the FDA, but rather were conducted voluntarily for reasons largely unrelated to FDA regulatory approval. Nor did the majority find persuasive the fact that Amphastar could have developed an alternative, noninfringing method to test batches of its generic enoxaparin. ("The safe harbor . . . does not mandate the use of a noninfringing alternative when one exists.").
Judge Rader, a member of the majority Classen panel, penned a lengthy dissent from the Momenta majority's opinion. According to Judge Rader, the Momenta majority ignored the statutory text and legislative history of § 271(e)(1), as well as the binding precedent in Classen explicitly excluding post-approval regulatory activities from the scope of the safe harbor. In addition to expanding upon the analysis in Classen, Judge Rader emphasized that the majority's "interpretation of § 271(e)(1) would essentiSally render manufacturing patents worthless."
As in Classen, however, and despite the seemingly inconsistent ruling of the Momenta panel, the Federal Circuit refused to rehear the case en banc.
Implications
Notwithstanding the contrary assertions of Judges Moore and Dyk, the Federal Circuit's decisions in Classen and Momenta are difficult to reconcile. The most natural reading of Classen excludes all post-approval regulatory activity from the § 271(e)(1) safe harbor. Momenta, by contrast, reaches the opposite conclusion. This inconsistency in the Federal Circuit's § 271(e)(1) jurisprudence is particularly troubling given the weighty public policy considerations at play.
On the one hand—as detailed in the Classen certiorari briefing of Glaxo, amicus Pharmaceutical Research and Manufacturers of America (PhRMA), and, by request of the Supreme Court, the United States—the Classen decision appears to ignore the realities of FDA pharmaceutical regulation. Simply put, the FDA's oversight does not end with the approval of a drug. For example, the FDA may require post-approval studies to assess safety risks that emerge only after a drug has been approved, or to assess the efficacy of a drug whose approval was expedited because it was used to treat a serious or life-threatening disease for which current treatments are inadequate.
21 U.S.C. §§ 355(o)(3)(A), 356(c)(2)(A). Pioneer pharmaceutical manufacturers may also voluntarily undertake post-approval studies in order to obtain FDA approval of new indications for an already approved drug. 21 C.F.R. § 314.70. Exclusion of such post-approval regulatory activity from the § 271(e)(1) safe harbor thus has the potential to discourage manufacturers from seeking new uses for their pharmaceuticals, as well as to expose them to liability where studies required by the FDA infringe another's patent.
On the other hand, as emphasized by Judge Rader, never before has § 271(e)(1) been interpreted to allow sales of the infringing product during the life of the blocking patent. For example, a manufacturer seeking approval for a generic drug is allowed to infringe a patent covering the branded pharmaceutical prior to that patent's expiration in order to generate data required by the FDA for ANDA approval, but, following approval, is not allowed to market the generic drug until after the branded manufacturer's patent has expired. The Momenta decision, by contrast, allows Amphastar to infringe Momenta's patent while selling the infringing generic drug. Such an exemption from patent infringement is unprecedented.
In this latter respect, the implications of the Momenta decision are likely particularly troubling to the manufacturers of biosimilars, the "generic" versions of complex biological products, such as proteins. Such manufacturers may, like Momenta, seek patent protection for the analytical and quality control methods that they often must develop to satisfy FDA regulations requiring a demonstration that the biosimilar "is highly similar to the reference product."
42 U.S.C. § (k)(2)(A)(i)(I)(aa). Momenta strips such patents of all value, allowing competing biosimilar manufacturers to use the patented methodology with impunity. Thus, under Momenta, pioneer pharmaceutical companies also seeking to market biosimilars could find their innovations taken by follow-on biosimilar manufacturers.
Given the clear split in Federal Circuit jurisprudence as to whether post-approval regulatory activities fall within the § 271(e)(1) safe harbor, and the associated contrary public policy considerations, the Supreme Court's guidance on this issue would be welcome. Although the Court's denial of Glaxo's certiorari petition may signal its approval of the Momenta decision, only time will tell. The particular facts of future cases may, however, be better suited for allowing the Supreme Court not only to opine on the scope of § 271(e)(1), but also to delineate bright-line limits to exemption of post-approval regulatory activities from patent infringement. As Momenta has itself recently petitioned for certiorari, that opportunity may be at hand.
http://www.fenwick.com/Publications/Pages/Intellectual-Property-Bulletin-Winter-2013.aspx#murky
Repros Reports Issuance of Two Additional U.S. Androxal(R) Patents
http://finance.yahoo.com/news/repros-reports-issuance-two-additional-162202770.html
IE much ado about nothing.
NVS will report 4/24...
Any insight for the strategy of not responding? TIA
FoB legislation: Virginia just signed a law that bans biosimilars until 2015.. Any thoughts especially if this becomes a trend with the states?
http://www.fiercebiotech.com/story/biotechs-beat-generics-rivals-state-biosimilars-battle/2013-03-22
Looks like the market saw right through that bogus report.
so wait, what exactly are they valuing generic copaxone at? $50m?
ACRX: Anyone familiar or have an opinion on this stock/space?
LOL. Maybe a entry into telecom is in the cards?
RS at Barclays: Same ole same ole, but Rick Shea mentioned that 2013 is "certainly possible" for M-Copax approval. Correct me if I'm wrong, but isn't this is the first time they've actually given any semblance of a time frame for m-copax approval?
Blackrock now up to 5,248,262 or 10.15%
The same can be said for M-Copaxone. I assume you're also rooting for that to be approved being the altruistic investor you are.
One of the best MNTA presentations I've heard in a while. The IVIG stuff is fascinating.
Was it shibani? I'd be disappointed if she didn't get after rick on m copax
Mind boggling indeed. It's really a baffling case. Judge Moore's reasoning has more holes than swiss cheese.
Not taking the case seems absolutely ridiculous. As others have mentioned, these patent disputes will continue with the makeup of the panel at the CAFC being the concluding factor on who comes out on top. It is not inconceivable that the same thing happens with M-Copax, except MNTA gets a different panel and wins.
MNTA at RBC this Wednesday (at 3PM). It might prove a good listen if Shibani is asking the questions. She's pretty well versed in MNTA dealings while also firmly in the camp that M-copax will never get approved without trials.
Thanks DD. 65 seems reasonable, although reason has not been particularly useful so far in this case :)
The SG won't be consulted since he already chimed in, correct?
Thanks Stockbettor.
Is the response due going to be SCOTUS response whether to take or not? Care to handicap MNTA's chances here?
To clarify, MNTA never had a chance to defend it's patents. The CAFC ruling had to do with safe harbour and nothing to do with the actual patents.
Just curious jbog, who was actually right on MNTA in that the CAFC would not uphold the PI set by the district and give Ampha free reign to use their patent at will?
In the webcast yesterday Rick Shea states MNTA expects the appeals trial to start in the 2nd Q with ruling by end of 2013.
He also states that 40% of patent cases that go to appeals are overturned. Can anyone confirm that #?
Apologies for so much posting today. Might be my record! :)
FMR reported its holdings up slightly to 3,146,221
Of course that's the point and I appreciate the civil nature of this discussion. It's when the discussion degenerates into blaming and accusing DD, other MNTA longs, and MNTA management that the usefulness of the discussion becomes nil.
No one whether it was bulls, bears, analysts etc predicted the CAFC would overturn safe harbor rules and allow another company to explicitly steal from MNTA. If you and IO and whoever else want to take credit for "calling" that and the current PPS, so be it. I think MNTA has a lot of upside from here and will hold accordingly.
Best of luck JM.
I think it would take a catastrophic event for MNTA (ie something goes terribly awry via copax) to be <$5 anytime soon. MNTA is my largest holding and I feel comfortable with my position so do not plan on adding, but that could always change.
I think it is quite likely Copax will get approved in 2013 and I also think MNTA has a very good shot of overturning TEVA's 2015 patents so I am holding in anticipation of a 2014 launch.
What's changed for me is the unexpected nature the courts have taken in regards to Safe Harbor. MNTA didn't even get a chance to defend its patents and instead was blind sided by a pretty absurd interpretation of Hatch Waxman. Even more ridiculous is that if MNTA had a different CAFC panel the district court ruling never would have been overturned. But it was overturned and that's the facts.
I'm not sure I agree with DD that the FDA will change what it does in regards to giving other companies MNTA's blueprint (only way Ampha got approved). Unless something changes in the court's decision or I see something different from the FDA upon Copax approval, I will most likely sell in the event of Copax approval and re-renter at another time because I do believe their FOB program will ultimately be quite successful.
Scopia reduced its position to 3,799,786
Okay I'll bite.
I'm with DD that at the current price reflects cash on hand + enox revs and ascribes little value to m-copax or the FOB program. Obviously, as time goes on the cash will dwindle but I think an M-Copax approval will put MNTA over the $1b market cap once again. What happens after M-copax approval is anyone's guess.
MNTA expects up to $26m in milestones in 2014 for FOB program (from Leerink webcast).