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Wheeler hinted at a legal strategy for countering three times weekly dosing. Perhaps this was it. Thanks Dew, bp
Must be a strategy to prolong the litigation and thereby increase the potential settlement for loss of revenues...bp
The latest from the Pacer site re Amphastar: <<NOTICE OF REJECTION: The brief of Appellants Momenta Pharmaceuticals, Inc. and Sandoz Inc., JOINT APPENDIX & CONFIDENTIAL JOINT APPENDIX [59], [58], [57], is not in compliance with the rules of this court and is therefore rejected for filing. Appendix due 12/19/2014. Service as of this date by Clerk of Court. [202248]>> This does not refer to the case itself but to the filing of the appendix. The case continues in its oddly Dickensian way...At this point is everything the court will (finally) review just on paper or will there still be the opportunity for oral arguments? bp
Dew, Teva submission seems to target Syntheon/Natco. Momenta a notable absence so delay of other generics by TEVA helps MNTA, no? Single product approval seems likely to me, at least short term. bp
DEFRAI, I found the best way to access site is to go to pacer.gov, very easy to find your way around site and set up an account. I learned this from fellow board members. Cost is nominal. Hope this helps. bp
Dew mouton MTB, latest brief posted today re Sandoz/MNTA v Amphastar on PACER site. Just FYI. Regards, bp
Dew, if memory serves they may still have GRN 510, a telomerase enhancer with positive animal studies in pulmonary fibrosis a few years back. Don't think they gave that away with the ESC portfolio. bp
OT, Someone should have told them that Cox knows how to administer "the dementor's kiss".bp
Flo, The goats live! bp
MTB, Dew and Mouton if you are out there. Was tooling around on the PACER site. Was under the mistaken impression that final circuit court arguments in the enox case would be taking place this week... sadly yet another extension has been filed this time by MNTA to put off brief filing until Nov 13 yada yada. Just mention it fyi since I would like to tune in on the recordings once they are available. bp
Dew, I did. MNTA/Sandoz attorney seemed more seasoned, relaxed and accessible and argued the case in a logical way that did not get lost in legalese. The TEVA attorney was more tightly wound, obviously very intelligent. I think the definition of winning is worth discussing since really a major delay is still a win of sorts for TEVA since the '808 expires next Sept anyway and if TEVA succeeds in having the case remanded to the Court of Appeals for "clear error" the time element even if MNTA wins is all TEVA seems interested in. My sense was that the "not worth the candle" argument could carry the day and that contrary to what usually happens, there is some reasonable chance this particular case might be upheld and continued de novo evaluation by the Appeals court affirmed. If the SC court does do this I hope they do it soon. Except for Justice Breyer the other justices that spoke and interrogated the attorneys seemed to not be ready to show any bias. I thought Justices Alito, Sotomeyer and Ginsberg seemed quite willing to evaluate the arguments on both sides with (maybe my biased ear) hearing a tilt toward MNTA. Justice Thomas if he was there was quiet. I am not an attorney but found the proceedings quite fascinating and felt at least acquainted with the issues at hand re stare decesis, denovo evaluation, clear error determinations, hopeless insolubility Markman issues etc. thanks to previous discussions on this board. What was your take? bp
MTB, both lawyers were impressive. Snadoz/Mnta more experienced in arguing before SC (check their CVs) and very poised, skilled and convincing. A very interesting listen. I agree the justices were split but maybe there is a chance...Of course the sphinx, Justice Thomas was not heard from as usual so hard to gauge that one. Would he be more likely to support ne novo review? I think he might be a stare decis leaner. Do you know if they wait to hear all of the cases from a given fall session before rendering decisions or do they render some decisions during the ongoing fall session hearings bp.
jmkobers, I think you may be oversimplifying here with your interpretation. This SC proceedings are not really about this case specifically although clearly the case is a vehicle for the court to review and define for other courts some fine points of law: how rule 52a must be viewed, whether other cases such as Markman effectively address the law vs fact interpretation allowed to courts at various levels, whether the Circuit Court of Appeals is allowed de novo powers and so on. Your attempt to apply "logic" is not totally applicable here as there are many questions being asked for the SC to define. I don't think the SC is concerned whether Momenta has been wronged or Teva has been. Its much more about big picture issues and our case is caught in the middle by some very skilled legal maneuverings that have resulted in the delays that Teva is looking for. Lets hope for a favorable ruling at the SC level, since remanding itself may ultimately allow for the appeals courts to find "clear error" in MNTAs favor but at the expense of the clock so at that point Teva has won anyway. Please understand that these comments are from a NON lawyer who has enjoyed trying to learn more about how our court system works by reviewing the statutes and pertinent legal briefs, and who has been very appreciative of mouton and others who have graciously helped me abandon my overly simplified early approach in trying to understand this case. bp
Here's the Scotus blog take: http://www.scotusblog.com/2014/10/argument-analysis-if-gut-feelings-could-control/
Just read the transcripts. Very interesting to a non legal type. Will try to listen to the recordings when available at the end of the week to try to get a sense for the justices tone. Clearly there is disagreement among the justices. The presenting attorneys are interrupted a lot with questions and its seems hard for either one to gain momentum (an oblique reference to our company) during their arguments. Would be interested in the opinions of resident legal eagles on the board re odds assessment. I thought Dr. Grant was a paid expert for TEVA but this point was not brought up. The case seems to turn on the importance of the fact vs law issue which has been turned over and discussed a lot in the past on this board, which seems to be why the SC took the case in the first place. A lot of legal nuance which I am in no position to interpret. Thanks to those of you who have tried to help me gain some rudimentary understanding of the legal issues at stake. Regards, bp
Thanks to MTB and Dew for info. EOM bp
Dew and Mouton, will the arguments be available to review on PACER? Thanks, bp
IF MNTA and Sandoz are the single generic copax this should allow for operating funds and a profit. They are counting on this. Also the say what you will, esp jbog but the enox case is not over yet. Mouton and Dew, if you are tuned in when do you expect resolution of the Appeals court case for enox? And how long after the Oct 15th arguments before the SC before they are likely to render a ruling re Copax? Thanks bp
In 1978, as a senior resident in medicine at the Beth Israel Hospital in Boston I attended a Saturday morning conference given by the famous Dr. Judah Folkman at the old Peter Bent Brigham hospital, one of the historic predecessors of the new Brigham and Women's hospital which opened in 1980. Dr. Folkman was such a committed researcher that he had a bedroom adjoining his lab so he could stay close to his experiments, one of which was to look at the effects of heparin (and protamine) on cancer cell growth. His lab results were electrifying to a young medical resident. The petri dishes he showed had large holes in the treated cellular sheets of malignant cells that were reminiscent of Flemming's 1928 concentric circles of no growth of bacteria near penicillium mold. The applicability to patients of course was limited by bleeding in the doses required achieve any clinical effect. (Of course other antiangiogenic agents are in clinical use today.) Now 36 years later the data on Momenta's phase I/2 study is released with not too much notice so far. And yet an ORR of 90 + percent and some PR responses in a disease with a 4% 5 year survival rate is worthy of note. Very worthy. The drug has orphan status. While very early in its clinical study lifetime perhaps tomorrow's conference might provide some sense as to whether fast track or best available therapy status might be granted by FDA at some point. I think we will see a (justifiably) enthusiastic presentation tomorrow and in coming conferences. A spark of hope in a hopeless disease always gets my attention. Regards, bp
Good idea. I did hear him say that when I reviewed the pacer tapes link that was provided on this board lo these many years ago. And yet he held only the minority opinion and the case did not carry (at least at that point in the legal process) even though he was there and knew the intent of the law from the outset. bp
Stockbettor, Thanks for posting this. Will be very interested in Dew and Mouton's take but my read is that Amphastar is protected and allowed to use the Momenta patent to gain approval, they just can't use it to manufacture, assure safety and sell the drug and it appears that this is just what they are doing. bp
Mouton, true. Just didn't see his name on the TEVA file (the last listing on SCOTUSblog) of several weeks ago. bp
I should mention the original link was kindly provided by mouton. bp
Interesting reading indeed. Didn't see his name on the last filing though. Should be an interesting Oct. bp
Teva's latest reply re SC review now posted on SCOTUSblog. bp
Dew, I can't tell from the TEVA "rebuttal" who engaged TPI's services. Was it the FDA or another (besides MNTA) applicant for Copax approval? The fact that TPI misspelled Copaxone and related chemical compounds does not speak too well for them and TEVA seized on this. The rest of the report continuesTEVA's ongoing bloviation. Its enough already! bp
I can take no credit here. Dew knows the science and Mouton knows the law. They both have been very generous in providing links and analysis. I just try to follow the threads they have laid out and contribute what little I can. Regards, bp
Two recent amicus briefs on Scotus blog, one from Google and the other from Intel filed Aug 18th in support of upholding appellate court ruling. bp
Thanks. Eom bp
Surely unless some elaborate legal plan is in place, what utility could there be in applying for something protected by Orange book patents for the next 16 years? It seems unlikely there would be much of a market for 40 mg 3x/wk copax by then. Are the patents protecting 3x/wk copax not solid? bp
Mouton, you wrote: <<If the Supreme Court decides that the clear error standard was incorrect,...>>
I think you may have meant <<If the SC decides the de novo standard was incorrect>>...
In this case the SC could "reverse and remand"...etc and require the circuit court to apply clear error standard. Do I have this right? Thanks for looking at this. I am approaching this with a totally non legal background, so thanks for your patience ahead of time if I have it backwards. Regards, bp
Also at Cannacord, Wheeler said SC review of Copax case would take place in October, so relatively early in the SC schedule this year. How long generally after that would a determination take? I realize there is a good chance of remand to the Circuit Court of Appeals that will take even more time, but unless the SC upholds, can the Appeals court (re) rule on the basis of existing filings (presumably using the clear error standard this time) or will we have to endure more filings and legal delays at the hands of the evil TEVA legal team? thanks bp
Thanks alternatepatel, I didn't realize it was that easy or inexpensive or I wouldn't have imposed on mouton's kindness. Appreciate the tip. bp
Thanks Mouton, guess we wait. 61 pages x .10/pg. settle for a Starbucks? bp
Thanks, happy to contribute to defray costs. bp
I think a brief from Amphastar is due today re enox would one of our legal eagles please post a link? Thanks, bp
Thanks Mouton, I was mistaken in thinking the quote about a required process originating from the DC, thanks for correcting me. So as it stands now it certainly seems the CAFC will have to correct itself in that the FDA did not require only one test for approval. Would they actually consider correcting their own mistake based on additional information or is there some legal reason they couldn't revisit their own ruling (egos aside). In reading the Safe Harbor language it also seems that while Amphastar was protected in preparing their product for launch and could use the Momenta patent in preparation for approval, the ability to actually use the patent to allow production of product they are actually selling is a different story and appears to infringe. The case for Momenta seems strong at this point. It will be interesting to read the Amphastar rejoinder in mid August. Care to handicap? Regards and thanks for the discussion. bp
Mouton and stockbetter, thanks for posting the pertinent briefs re ongoing lovenox litigation. Mouton, your statement,
<<Unless I am missing something, though, in the end, the court concludes that the patented test is in fact required because it is in the USP (emphasis added): >> My question is this:
Just because a procedure for manufacture is listed in the USP, is its use "required" for approval? If so this would not comport with Momenta using an entirely different test (2D NMR) for their approval. So do you see this finding by the DC as strong?
As I read through the brief I am reminded that the ruling was only on an injunction, and that Ampahstar withheld data from the court and was sanctioned.
So unlike the copaxone case where the CAFC ruling will still be in force at the time of FDA approval (whenever that is...) the lovonox case is different in that only the injunction is in force but the case not as yet determined. Is this correct and if so in this case is there a legitimate chance for treble damages in favor of Momenta since it may be found that Momenta's patent was indeed violated? Thanks and regards, bp
Still, its a little disconcerting to see the DOJ appear to agree with one pillar of the DC argument (the interpretation of Fig. 1) even though the court of appeals found the findings in Fig1 supportive of the indefiniteness argument. Fortunately, the other pillar of the case, the disconjugate fillings by TEVA re use of molecular weight definitions appears strong and perhaps will carry the day. This seems to be acknowledged by the DOJ (as well as the CAFC) and should be a strong positive for MNTA. as noted by Dew. bp