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Mouton thanks for clarification re SG brief relevance to both companies. It would seem that should the case be successfully agued in DC that some liability might fall to both re settlement and punitive damages. My question is this and I am doing this from memory. Did TEVAs product actually come to market? Even if it did it would it have had much less impact on MNTAs income than the avalanche caused by the entry of Ampha/Watson. As Dew has pointed out a potential settlement, assuming the case goes in favor of MNTA as things progress might exceed the value of Amphastar's market valuation. How would you asses the relative risk of each company? Is a single settlement from both companies a possibility? Is Watson still in business and was the time line such that they would have liability? (This possibility was raised by Dew). Thanks and regards, bp
Thanks Mouton, back to District Court we go. bp
Flo, thanks for msg hope you are well. Well we have corresponded for many years! Might be time for me to upgrade my Ihub membership so I can private message. Best regards, bp
Dew, the market place has changed alright! Is there a scenario where if MNTA wins the patent case finally in DC that the damages (ok, I am getting ahead of things a little) could reflect not only lost revenues based on the current market but the market before Ampha entry (plus a multiple for damages?). I remember the CEO saying a long time ago that assessment of damages would be fairly simple arithmetic based on lost revenue plus damages (this was before the CAFC fiasco). If so, MNTA could eventually own Amphastar. Is it more likely after all this that MNTA will (real world) just accept a royalty and be content with the precedent being set to protect them going forward or is there a real chance the damages could be based on pre infringement pricing? Thanks bp
Mouton, The only reason I wondered if it applied to Ampha was their claim to not use MNTAs patents. That remains unclear to me. bp
I read it, looks like the SG channelled Judge Raider himself. Now, does this apply equally to Amphastar?? Regards, and it looks like a beautiful day by the way. bp
Well, I skipped to the end due to time constraints this afternoon, here the good part re TEVA (don't know if the same applies to Amphastar):
<<CONCLUSION
For the foregoing reasons, the safe harbor in 35 U.S.C. § 271(e)(1) does not immunize defendants’ conduct.>>
Mouton, its there now under 14-1274, I can open it (25 pages), will try to read later and maybe post relevant parts. (You actually would be way better at that part)! Regards, bp
Mouton, On pacer.gov under CAFC case 14-1276 no mention of the brief from SG due on July 13th is listed so I may not be looking in right place yet. Re speculation as to the delay being requested by the SG because they were too busy here is the reason they requested a delay from 6/11/15 filing:
<<The questions posed in the Court’s order raise issues of substantial importance to multiple agencies of the federal government, and the litigation histories and factual backgrounds of these cases are complex. The extension is necessary to ensure that the Solicitor General may determine with confidence whether and to what extent it is appropriate for the United States to express definitive views on the issues raised in the Court’s order and the parties’ briefs.1 >>
Dew's comments notwithstanding re limiting SG opinion to a definitional universe, the SG might actually have gone to the FDA and other interested govt agencies as above and maybe just maybe we will get some clarity on the intent of the HW laws. Regards, bp
Thanks Mouton, will check back periodically. This should be interesting. Do you think there is any chance the CAFC will do anything definitive or is it more likely that the case will be kicked back to DC for more (interminable) litigation? regards, bp
Dew, from time to time there has been discussion on this board re Geron. I have not been following this board lately much since I post on the MNTA board once in a while but this seemed to be a good place to ask my question. Anyway I wanted to get your take (and anyone else knowledgeable) about the structure of the impending myelofibrosis trial involving both Geron and mostly Janssen (of J and J). As you know imetelstat is a promising (not so) new drug that inhibits telomerase and is the only drug that has successfully modified disease in MF (and maybe MDS). The large phase II sponsored by Janssen is about to start and will target Jakafi drug failures, a clear unmet needs medical population. Clinical trials.gov lists 39 world wide sites. In the US there are only thirteen but they look very high quality e.g. Mayo, Stanford, Duke etc. My question is this. Janssen has stated that they are looking to file in 2017 in the US and that they expect this to be a product with 1 B sales/yr. They already have orphan drug status. Since they have so many multinational sites, Spain, France, South Korea, Germany etc etc do you think this implies an intended path to approval outside the US that might have a faster timeline? Or is it just a desire to enroll the 200 patients fast and get the study done. Time to response in many cases seems to be measured in weeks so they may have results fairly soon. I am unfamiliar with the paths to approval in Europe and Asia and wondered if the choice of study sites and the skewing of site selection outside the US tells us anything about future intention. TIA bp
Dew, how does one go about tracking script numbers? Thanks, bp
Fight on brother Boing, Cox problems not withstanding. If it gets harder as you get older you are among the fortunate few. bp
Dew and Boing my recollection is the same and there definitely appears to be disharmony between what was said in court and what investors were told in Amphastar's report referenced by Dew. The only way I am able to reconcile this is a little far fetched but implied in the recordings of the recent court hearing: if I understand this correctly, it appears that Momenta's patent is used to identify impurities that are discarded leaving behind the pure product, (product is taken off the production line--not added) hence my analogy earlier of the statue within the stone. So technically the patent and I know this is a stretch, is used in the " reduction" of the product not the production! I believe Ampha is capable of trying to define what "is" is, especially in light of the way they withheld information from the courts and were sanctioned before as noted by Boing. I think Ampha could just be parsing here. Too crazy? Maybe, just trying to make sense of it all and I am very appreciative of those that have helped me along the way. Regards, bp
Mouton, hope you are well. Thanks for the update. I am encouraged a bit by this, (what am I the only one who loves legal delays around here?). Clearly simple definitions can just be looked up or supplied from the bevy of existing briefs. I am hoping the SG has the "seichel" to understand that in order to truly fulfill the Appellate Court's request, and for the definitions and clarification requested by the CAFC to have any validity, they must be understood in the context of the wording, context and the intent of HW (are you listening Judge Raider ret.?) I wonder if as the SG does his/her research in preparation for the brief whether they have constraints they must honor or whether they can take an expansive view in the collection of information beyond just the filed briefs. For example, could the SG request FDA input, or interview legislators involved in the drafting of the original law so as to ensure the intent of the law is understood fully. Dew has tried to guide me on this point way back and I have not gone back to his original comments but my recollection was that he thought the information reviewed would be relatively narrow. The delay (unless its for another reason--we're too busy) makes me wonder if maybe they need more time because of the complexities that require review of the original HW act for intent, or a de facto understanding of how the FDA views all of this. Regards, bp
Thanks, will watch for it. EOM
In order to comply with the CAFC's invitation to the SG to provide amicus as follows (provided by mouton):
<<ORDER The court invites the Attorney General to present the views of the United States as amicus curiae on the statutory interpretation issues raised in these cases within 45 days of this Order, including the meaning of the statute’s “submission” and “solely” language and also including whether performing a process and retaining process records after initial FDA approval for the purposes of demonstrating compliance with FDA requirements is protected by the safe harbor of § 271(e)(1) if that activity also has a commercial purpose.>>
Will the SG not have to visit the original Hatch Waxman act, its language and its intent, to provide clarity here? The recorded comments by Judge Raider (a minority opinion unfortunately), indicted something to the effect that "I was there" for the construction of the HW act and the intent clearly was not honored by the previous CAFC injunction etc. Will the SG brief be posted and where? Thanks and regards, bp
Dew, right, so its a narrow request. I hope the SG reads Raider's dissenting opinion re "Safe Ocean" before a final response. Regards, bp
<<What we do use is the official test of the United States Pharmacopeia known as USPTO-7, which we utilized solely to meet an ongoing requirement of FDA. >>
Dew I think I remember that after reading about the Pharmacopeia entry (lo these many years ago) that that the Pharmacopeia "official test" was actually a manifestation of the very Momenta patent to confirm purity of Lovenox that is being contested and that Amphastar argued they were required to use this method since it was "official" . At this point its all pretty circular and I guess we have to wait. Would the SG ever interview FDA officials to get more info before rendering an position as requested by the CAFC or will they opine based on the available paper? Regards, bp
Mouton, when I read the amicus brief before it certainly was not too "friendly" to the Momenta case and may not continue to be so. However, since the SG brief, correct me if I am wrong a few things came to light. One was that Amphastar deliberately withheld information from the court that was relevant and was subsequently reprimanded for that and the other was an admission by Amphastar that utilization of the Momenta patent was not the only way to provide required information to the FDA. If my timeline is right, these two mitigation pieces of the case not previously available to the SG might allow for a different take by the SG this time. Maybe too optimistic. Too bad Judge Raider is not still around...Regards, bp
Mouton and Dew, thank you for providing the links and your input which I have always found interesting and helpful. I envision a marble slab--a perfect and beautiful sculpture lies within but can only be revealed by the skilled artisan removing the exact amount of marble to fashion the sculpture. Well it beats the salt sugar cake analogy anyway. Will be following with interest--please share any additional thoughts. Regards, bp
Many Thanks to Dew, mouton and flo for the insight, support and humor. I think they will launch at risk given the previous appellate finding that the much discussed molecular weight graph presented an "insoluble" picture (that's from memory and I hope accurate.)--so a better than good chance of a win at the appellate level in my non legal and not very weighty opinion. Next stop:clarity on the much abused Hatch Waxman based injunction by the courts re Amphastar. Regards to all, bp
Dew, thanks I missed it when you posted the info earlier. How long after arguments can we expect a ruling? Regards, bp
Mouton, thank you for clarification. Since there was no mention attorney for Sandoz/MNTA (and there was for Amphastar by name), it sounded like only one attorney would be presenting an argument. I believe after your comment that I misinterpreted what I read on PACER. Thanks, bp
Also from PACER: 03/20/2015 86 NOTICE OF CALENDARING. Panel: 1505A. Case scheduled May 04, 2015 10:00 a.m. at the United States Court of Appeals for the Federal Circuit (Howard T. Markey National Courts Building, 717 Madison Place, N.W. Washington, DC 20439), Courtroom 201. Response to oral argument order due: 04/15/2015. Counsel should check-in 30 minutes prior to the opening of the session. Please review the Oral Argument Order. [225937] THIS NOTICE APPLIES TO CASE(S): [14-1274, 14-1276, 14-1453, 14-5045]
"Case scheduled for May 04, 2015 at 10:00 a.m." Regards, bp
Re Amphastar, from pacer.gov: 04/03/2015 87 Response to oral argument order from the Appellees Actavis Pharma, Inc., Actavis, Inc., Amphastar Pharmaceuticals, Inc. and International Medication Systems, Ltd.. designating Pratik A. Shah as arguing attorney. Designated time for argument: 15 minutes. Designated time for rebuttal: 0 minutes. Service of other counsel by Notice of Docket Activity from this entry. [229397]
No rebuttal from Sandoz/MNTA? Is it usual to have an oral argument on one side and a Docket on the other? Is this unusual? Just curious or am I perhaps not reading this correctly. Regards, bp
Dew, given the success of TEVAs legal strategy in delaying approval, if that is true why should MNTA extend any further legal fight at this point? They could just save the money. On the other hand even if an en banc hearing is requested since it would be unlikely to occur until after the patent was expired one might think the en banc hearing would be denied, assuming the case is held in Sandoz/MNTAs favor on remand so maybe its still "worth the candle" to fight on. I guess TEVA could file for damages should an en banc decision return in their favor, even after the patent expired, but then MNTA et al could do the delaying while building assets and benefiting from a (tiny) head start over other competitors . Pretty Dickensian. bp
Dew five hundred thousand to one million dollars a day for maybe two months before patent expiry ain't just chopped liver. It might even pay the lawyers fees. Bp
Joda, why do you think he cashed these in? It looks like they were awarded but not exercised to me, can you clarify? bp
Thanks Dew, hope its not a long run for a short slide. bp
mouton, true enough, thanks for the reality check. bp
Thanks mouton, presumably the briefs are ready to go as soon as they are allowed to be filed. Looks like of the seven months remaining before the TEVA patent expires perhaps they can capture a few months with a favorable ruling. The classic "long run for a short slide," and an expensive one at that. Regards, bp
The Solicitor Generals amicus brief seemed to be predictive of the ultimate SC decision. This brief also noted the likelihood of a Federal Circuit ruling in favor of MNTA/Sandoz even with the application of clear error standard. It also noted that the time element of the upcoming expiration of the Sept patent might make the ruling even if favorable to MNTA/Sandoz moot. Clearly the request for expedited implementation of the SC ruling (so far declined by the SC) is important. With impending FDA approval any day, a poll (perhaps via Dew) might be interesting to see if MNTA/Sandoz might release at risk. My vote is yes based on the Solicitor General's brief. A few questions for mouton, when the Federal Circuit reviews this case (finally), will they hear any additional arguments or just rule or re rule on the basis of already filed briefs. Might they seek additional expert opinion even at this point? What kind of timeline would you give it? Would the Federal Circuit expedite the case to try to address any sense of fairness since a decision has dragged on so long? Thanks and regards, bp
It might--a 10 million dollars a day drug and reasonably good odds of a positive outcome (of course this is debatable and uncertain) on remand. Even the Solicitor General was of the opinion that if "clear error" standard was applied on remand, the case would still come out in favor of MNTA/Sandoz. A risk for sure but with a potential big return if FDA approved today. Regards, bp
From SCOTUS blog. Looks like SC remands case back for "clear error" evaluation. Await FDA approval, followed by probable at risk release. bp
The SC court has chronologically leap frogged the Teva case to render opinions on cases argued after this case was. Looks like the wait continues and becomes less important with each passing day. One can still hope for FDA approval and an at risk release. Any updates on Amphastar? bp
For board members following the TEVA/Momenta-Sandoz copax case (guess that's just about everybody): ScotusBlog today provided details of two cases decided last week presumably from last Friday's SC conference. Neither was pertinent to us. I believe one was argued chronologically after the the MNTA case yet the decision was obviously rendered before delivery of that of the MNTA case. More decisions due to be released tomorrow. Not sure what this means but it could support the contention by some that because the court appears divided, a decision may come later rather than sooner. If true it seems odd that circuit court cases being heard now would be deprived of SC guidance re clear error vs de novo process. One would think there is some urgency to provide clarity to the Federal Circuit so delays could be avoided due to lack of clarity on this issue. Anyway I suppose there is some small chance of a decision being delivered tomorrow but if it doesn't happen I think we could be in for a long wait or perhaps it speaks for the SC courts intention to remand anyway so time may not matter much. Just some random musings (a la Dew). I suspect FDA must be waiting for the SC to opine, to avoid any more mishagaus from TEVA. Regards, bp
It appears the FDA (clearly an organization above being subject to political and legal pressure) is waiting for the Supreme Court's opinion on the Teva appeal. No doubt to try to avoid more of the costly, time consuming legal morass that Teva has used as an effective weapon to ensure delay in approval. Looking the the SC schedule, they meet Friday in conference. Judging by the other cases and the time frame for decision release, it may be that the Teva/Momenta case will be decided then. Also in the wings is the Circuit Court of Appeals enox case, not getting much press but very important as discussed previously on this board. Waiting (and waiting) with interest. Regards, to all bp
t57, I am not qualified to answer your question but two major cases decided at a Friday conference seems like plenty. I would think we have to wait until January. bp
From SCOTUS blog: SC justices conference again on Jan 9th. This week they returned opinions on two cases argued one week before the Momenta case, one of which (heard by the court on Oct 7th) returned with a 5-4 decision so maybe even if a split decision, the case will be decided by the justices during the Jan 9th meeting. bp