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TRO/PI
"Specifically, as set forth more fully in the accompanying memorandum and supporting
declarations, the Plaintiffs have established that: 1) based on publically available information, it
is highly likely that the Defendants’ process of manufacturing generic enoxaparin infringes the
claims of each of the '866 and '466 patents (the Plaintiffs also have filed herewith a motion for
limited expedited discovery in order to obtain targeted discovery from the Defendants that will
confirm details of the Defendants’ manufacturing process); 2) the Plaintiffs will suffer immediate
irreparable harm if the Defendants are not enjoined from launching their product made by infringing Momenta’s patents; 3) the balance of hardships favors granting a temporary
restraining order and preliminary injunction; and 4) the public interest favors an injunction.
WHEREFORE, for the reasons set forth herein and more fully in the accompanying
Memorandum In Support of Plaintiffs’ Motion for Temporary Restraining Order and Preliminary
Injunction and the supporting declarations filed herewith, Plaintiffs respectfully request that this
Court immediately issue a temporary restraining order enjoining the Defendants from selling
their infringing generic enoxaparin product in the United States for a period of at least fourteen
days or until the Court conducts a full hearing on this motion and, thereafter, issue a preliminary
injunction enjoining the Defendants from selling their infringing enoxaparin product during the
pendency of this litigation.
REQUEST FOR ORAL ARGUMENT
Pursuant to Local Rule 7.1(d), plaintiffs respectfully request that this Court schedule a
hearing on this motion.......
Reading the accompanying memo now.
iwfal
you wrote: "you do realize Mouton is a lawyer"
My previous post was a cut and paste from IR email response
I guess they filed the PI motion today
http://online.wsj.com/article/BT-CO-20110930-712786.html
Outon
This document is the Complaint. It asks for injunctive relief along with every other type of relief (i.e., money damages) but is not a Motion for a PI. A Motion for PI is a more complete stand-alone document that sets out the basis for the PI under the PI legal requirements, and which triggers the Judge to act on it.
btw this is what I got from IR. maybe she is wrong. the court motions do indicate PI motion.
Pacer Case# 1:11-cv-11681-NMG
filed in the U.S. District Court for the District of Massachusetts.
Summons issued on 09/22 - Amphastar has to respond to summons within 23 days so by around 10/15
Why PI has not been filed yet?
Does anyone know why a PI has not been filed yet against Amphastar launching ? They have filed the suit but not PI.
If this has been discussed, please point me to the message. Thanks!
go-seek - sometimes 'surreal' messages need to be countered by reality checks. The reality is craig got 2% of this company at the same time when he contributed to shareholder's loss of 50%. The reality is craig and shea care less about maximizing shareholder's value...it was implied 'emphatically' in the UBS call by none other shea.
didn't you hear they are going to spend 90m no matter what. shea said it to use his own words 'emphatically'. they want to work on all their programs(maximize their programs-whatever that means) without doing a business case(cost,benefit analysis) of alternative ways of using cash (small buyback of 100m) to maximize shareholder value.
go-seek
is this what u want us to believe ? shea & wheeler could care less if the stock goes to 5$. they will find a way to get bonuses.
have you read the email from bdover23 ?
the poor long term(most abused word IMO) shareholder from 2005 has taken >50% haircut while wheeler who came in around the same time, got 2% of this company
Another Patent filed for a Combo with Niacin
http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PG01&s1=amarin&OS=amarin&RS=amarin
Voice of another Retail shareholder No. 4
Here u go go-seek
This time from Silicon investor
http://www.siliconinvestor.com/readmsg.aspx?msgid=27658905
To: mopgcw who wrote (2838) 9/24/2011 2:20:40 PM
From: Kaalia 1 Recommendation of 2854
Believe they will still end up with about 100m$ rev. & 80m$ costs = 20m$ cash flow per annum i.e. around 0.4$/ share. hence 0.4$/ share x 5 = 2$/ share + 7$/ share end of the year cash. there you go... approx. 9$/ share imminent value unless someone can fire the management to focus on r&D of 80m$ only if something productive comes out of it. Shea at UBS mentioned that 80m$ p.a. of cash burn is not going to change until launch of copaxone generic version in 2014 which WILL happen though.
Hence if optimized R&D then i would agree with 17$/ share straight forward valuation. + upside on Copaxone would give another 3-5$/ share hence we are looking at a stock which by Q3'2013 will be $20-$22/ share by pure fundamentals.
Priority for management -
1. Avoid launch of Watson to prolong the cash flow via legal means
2. Cut down highly non-productive R&D (not a single REAL new molecule so far.. not even in Phase 2)
3. Reshape the self rewarding managment that is buring a hole with stock op rewards.
Mad- good points.
shea & wheeler are 'executive types'. they will find a way to get paid and get paid well with bonuses even if they fail miserably to maximize value for shareholders. so they say stuff
ahande,
don't count on that..
Go-seek
let us know when IR responds..(hopefully u didn't receive any vacation auto replies)
"If copaxone fails then they can buy their stock back even cheaper. If it get's approved, they'll have a nice cash flow again and can start buying shares back"
First of all, the company's worst case scenario is copaxone launch in 2014. Company has been saying they are very confident about the FDA review that is currently in progress and the discussions that they are having . Shea said, they think the FDA's equivalence criteria for Copaxone would be a page from their ANDA.
Once Copaxone get's approval, market will value MNTA much much much higher. No use in buying back shares when it is valued appropriately (say 5-7 times earnings).
The MXXX's are just job guarantee schemes for the current management...something to talk about for cw & rs for years and years. Hardly going to add value to shareholders in the next 5 years.
FOB - I am disappointed with the speed/slowness they are approaching it. But I am hopeful they will be able to rope in partner in a quarter or two. FDA's release of pathway will act as a catalyst. Based on what they said recently, they are expecting partner to get cash in addition to doing clinical trials, manufacturing and sales. Remember they have said they are having CEO level talks with some companies.
Thanks for clarifying
Reputation of Amphastar
http://www.foxnews.com/health/2011/09/26/popular-asthma-inhaler-to-be-pulled-off-market/
http://www.mnn.com/health/allergies/blogs/fda-to-ban-certain-asthma-inhalers
Asthmatic patients who use over-the-counter Primatene Mist will soon need to find an alternative prescription medicine to control their symptoms. The epinephrine drug will no longer be available after Dec. 31.
Approximately 3 million people in the United States rely on Primatene Mist, according to the latest statistics from Amphastar Pharmaceuticals, the company that produces the drug.
However, a few years ago, Primatene Mist came under scrutiny due to environmental concerns, primarily because the inhaler type uses chlorofluorocarbins. The compounds, commonly referred to as CFCs, are known to damage the ozone layer.
In 2006, an FDA advisory panel voted 11-7 that Primatene Mist did not serve an essential health need, and in 2008, they finalized plans to phase the drug out.
The action was a part of an agreement signed by the U.S. and other nations to stop using substances that deplete the ozone layer, which blocks harmful ultraviolet rays from the sun.
Since the FDA’s decision, Amphastar has included information on Primatene Mist’s availability on the company website and the product’s packaging.
Amphastar spokesman Dan Dischner said in a statement that the company is in talks with the FDA about bringing a new, environmentally-friendly version of the OTC drug to the market, but that won’t happen before the current drug is made unavailable.
The principal concern in pulling Primatene Mist and other CFC-driven inhalers off the shelves is the difference in cost between these products and their prescription alternatives.
Currently, Primatene Mist sells for about $20 and is easily available in drug stores and online. Prescription inhalers, which treat the same symptoms but use environmentally-safe hydrofluoralkene, require a doctor’s visit and can cost up to three times as much as the epinephrine version of the drug.
There are also some differences between HFA and CFC inhalers that consumers need to be aware of. These include the need to “prime” an HFA inhaler – in other words, users need to spray a pump or two in the air before administering a pump to themselves, and the need to clean HFA inhalers more often.
Also, some patients who have made the switch say they feel as if they're not getting enough medication because the spray from HFA inhalers does not come out as forcefully.
Easing the transition, the FDA said two other CFC-propelled products, one that uses a combination of ipratropium and albuterol and another that uses pirbuterol, may stay on the market until Dec. 31, 2013.
However, before we start regulating, we have to think about the patients—and as I always like to say, if it ain’t broke, don’t fix it.
Read more: http://www.foxnews.com/health/2011/09/26/popular-asthma-inhaler-to-be-pulled-off-market/#ixzz1ZCZe9zRl
----------------------------------------------------------
Most folks probably don't even remember chlorofluorocarbons, or CFCs - those nasty ozone depleting chemicals that caused such a stir a few decades ago and were even banned in the late 70s. Apparently, even since the ban, CFCs have been permitted in medical products when the FDA deems them essential. But all of that is about to end as the FDA recently announced that asthma inhalers that use CFCs will be banned at the start of the new year.
Right now, the inhaler under scrutiny is Primatene Mist, a popular asthma inhaler used by roughly 2 million patients each year. It's also the only over-the-counter inhaler currently available in the U. S. market without a prescription. ?But Primatene Mist uses CFCs to propel medicine out of the inhaler so it can be breathed it into the lungs. According to the FDA, other asthma-inhaler manufacturers now use a propellant called hydrofluoroalkane, which is less harmful to the environment, instead of CFCs.
Primatene Mist is marketed by Armstrong Pharmaceuticals, a unit of Amphastar. Two other prescription asthma inhalers that use CFCs are to be phased out by the end of 2013. They are Boehringer Ingelheim's Combivent Inhalation Aerosol and Graceway Pharmaceuticals' Maxair Autohaler.
"stalling the rest of the pipeline"
Do you really think M118 or M302 will add value ? M118 has been languishing forever and they have not been able to find a partner. I sometimes feel they are just 4-alphabet something so management can talk about it for years and years to come. I hope I am proven wrong.
"Evidently he believes in a somewhat larger cushion than you would urge on MNTA."
It is 2 different things.
I don't think Buffet's cash hoard is seen as a cushion (to cover all kinds of worst case scenarios for his underlying companies), It is a war chest to buy up opportunities if they ever arise in the market. Of course if his holding company was so heavily undervalued, most of his cash would probably go to buy the holding co's stock.
Also, my question was specific. Can we temporarily readjust expenses (temporarily cut expenses on M118 and M302) until we launch Copaxone and use those 100m savings instead to buy up 15% of company's stock at current price of $11
Which has the potential to maximize shareholder value ?
Spending/allocating resources on M118 and M302 for next 3 years
OR
Cutting resources temporarily for 3 years on M118 and M302 and buying up undervalued stock(100m) and then after the launch of Copaxone pushing M118/M302
Again I am suggesting only around 20-25% of cash hoard be used for this purpose
Investing 100m cash on M118/M402 over 3 years versus Buyback
At this juncture,considering stock price, Which one has better potential to unlock and maximize shareholder value within a reasonable time frame of 2-3 years, at the same time assuring Momenta has enough cash to handle worst case scenarios?
Investing 100m cash to support expenditure(internal expense as well as external) on M118/M402 over 3 years
VERSUS
Using 100m cash to buyback approx 15% of shares so a greater %age of Copaxone earnings, Lovenox earnings and long term FOB earnings goes to Shareholders
They can always carry forward the M118/M402 projects when they have surplus cash after Copaxone gets to market. But stock price will not be so low to buyback them. This is an opportune time to buyback shares(that may not be available) and maximize shareholder value.
For the Buffet admirers
I guess Buffet is stupid.
In a share repurchase, or buyback, a company takes some of its shares off the market by buying them from outside investors, which gives remaining holders a larger proportionate stake in the company's future earnings.
http://online.wsj.com/article/SB10001424052970204831304576594582853871222.html?mod=WSJ_hp_LEFTWhatsNewsCollection
Copaxone - Infringement arguments in court ?
Teva has burden to prove on infringement.
On Molecular weight where Momenta contends their co-polymer1 molecular weight does not conform to 4-9kda, what has been TEVA's arguments to prove infringement ?
Canaccord also believed the non-infringement arguments were pretty strong.
Misc notes from trial:
"Teva’s expert testimony was puzzling at times: Teva began the day by having one of its experts, Dr. Goekel, affirm in detail that Teva itself, in the manufacturing of Copaxone, practices the patents at issue in the case.
When asked if Copaxone and Teva’s manufacturing process meet at least one of the asserted claims in each patent in dispute, Dr. Goekel answered in the affirmative. This focus on Teva’s adherence to the patents, however,seems strange as the case is about whether the defendants’ generic versions of Copaxone infringe upon the patents. Moreover, the expert never
opined on an important argument by the defense – that they have changed the production process in order to avoid the patented claims. Most surprisingly, the expert did not address the one process change that the defense emphasized earlier in the trial – the abandonment of the “time andtemperature” test reaction. Teva’s lawyers presumably have reasons for
framing their questions in the manner they did, which will likely come outwhen their brief is written, but are not yet clear. "
sodrock
there could be several ...but prime one probably is legal risk due to potential patent infringement. IMO It is very likely considering what is at stake, Amphastar may wait for court decision(which may take 2-3 months) on PI before launching.
Hattie
"So it is likely that Amphastar may launch after PI is granted in next few months."
Sorry - I meant to say Amphastar will launch after PI motion is NOT granted (rejected)
niles-
you may be right on damages to Momenta.
the damages awarded to Reddy's was lost revenue and litigation costs during PI period
"On the flip side, Amphastar would be liable for all future revenue that Momenta lost. "
Just speculation...read it for fwiw.
on the Amphastar damages I am not sure.
If the party was just Momenta I would have agreed. That Amphastar's damages could include future revenue. But Sandoz was also tagged into the litigation as co-plaintiff. So one can make a case that the loss to the 2 parties together is Amphastar's gain and that's all damages Amphastar is liable for ??? Sandoz would be the biggest beneficiary if that happens..they go to sole generic status and get to retain much of the profits.
I do think it is likely that PI may not be granted based on Obviousness of innovation/patent. Also, keep in mind getting damages awarded because of wrongful PI is unusual and not the norm. So it is likely that Amphastar may launch after PI is granted in next few months.
Patent prosecution of 7,575,886
It had received final rejection letter as well as non-final rejection letter.
Hmmm, rejection letter does talk about the analysis method as obvious. It has obviousness written all over it! see page 8 frequently quotes prior art Desai, et al
although claims being rejected have number in the 300's...their description looks much the same as claims 20, etc!
http://portal.uspto.gov/external/portal/!ut/p/c5/04_SB8K8xLLM9MSSzPy8xBz9CP0os3hff1NDc1NLYwN3SzcDA08PwyD_YF8zINcYKB-JW97AiCLdBgR0h4Nci992vPIGEHkDHMDRQN_PIz83VT9SP8ocpylGZvqROanpicmV-gW5oREGmQEZgY6KigBnIW_S/dl3/d3/L0lJSklna21DU1EhIS9JRGpBQU15QUJFUkNKRXFnLzRGR2dzbzBWdnphOUlBOW9JQSEhLzdfTU81MTc1OTMwRzlGMDBJSDFST1NNNjMwMjYvR2FGNTA3ODYwMDEyL3NhLmdldEJpYg!!/
A PI order that was rejected
based on obviousness defense(likelihood/lack there-of of patentee's success on the merits) and also failure to prove Irreparable Harm To Movant If The Injunction Is Not Granted
pages 6,7 are interesting
http://patentdocs.typepad.com/files/nycomed.pdf
again in this case, it boils down to if those analysis methods(claims 54-62) to determine specified amount of non-naturally occurring sugar are obvious or not?
it seems those analytical methods are obvious(of course I am no expert and this has gone thru patent examination rigor - maybe somebody here can pull the prosecution of this patent and see if there were any doubts of obviousness raised by the examiner)
I am going to read why judge also found "the Court does not find that Plaintiffs have made a sufficient showing in
regard to irreparable harm."
But reading this(esp if you believe in obviousness) you get a feeling that getting a PI granted is a tall order for MNTA ?
BEGIN QUOTE
Instead of the alleged infringer having to persuade the trial court that the patent is invalid, at this stage it is the patentee, the movant, who must persuade the court that, despite
the challenge presented to validity, the patentee nevertheless is likely to succeed at trial on the validity issue.
Before issuing the ‘672 Patent, the United States Patent and Trademark Office(“USPTO”) rejected Plaintiffs’ application three times as being obvious 2 over the ‘994 Wick Patent in view of an extant product specification for super refined oleic acid, (“SROA”). See, e.g., Brown Aff. Exs. M at 4 (second office action), & N. In these rejections, the Examiner
indicated that it would have been obvious to use SROA to improve the stability of oleic acid and thus the entire formulation of imiquimod and oleic acid presented in the ‘994 Patent.
Despite various arguments by the applicants against the obviousness of the combination, the Examiner maintained that it was obvious.3 The Examiner never veered from this finding.
The rejection was finally overcome by a showing of unexpected results in the decreased level of imiquimod-related impurities after combining imiquimod with SROA. But the Examiner offered no explanation, reasoned or otherwise, as to why this showing
outweighed the obviousness of the combination using the invention described in the ‘994 Patent and SROA product specification. See Brown Aff. Ex. O. Where an examiner does not offer a principled reason for allowance after prior rejections by explaining the balance between the obviousness rejection and the unexpected result described in the allowance, the Court will give less deference to the decision of the USPTO because the Court’s ability to understand the examiner’s decision is limited to the record and reasoning the examiner provides. Here, no reasoning is offered, and as a result, there is little to which the Court can
defer.
Examiner’s three rejections in the prosecution history of the ‘672 Patent and the evidence provided by Nycomed that the prior art invited experimentation in regard to testing for
benefits in regard to stability (of the formulation, as explained by Nycomed, and/or of imiquimod, as explained by Plaintiffs, albeit, while denying any conclusion of obviousness).
Plaintiffs have not provided evidence tending to show that the combination of elements would not have been obvious, except for the rebuttal evidence in regard to the unexpected
Adequacy of Money Damages. Nycomed argues that Plaintiffs’ 10 structural claims,including lost jobs, price erosion, market share, and business reputation are compensable by
money damages and readily calculable as Aldara is a mature product. For the reasons explained above, this Court agree
Thanks Mouton. will see if I can dig further in the next few days...
I think it is in interest of both parties to do extensive discovery (don't even know if discovery exists for PI) and understand their strengths/weaknesses in their legal case, so they don't get wrong PI and be liable for future damages...So the best way to be comfortable for both parties (both are small companies and for both wrong PI and subsequent damages is going to be material) by extensive discovery....And if it turns out it is a 50:50,60:40,40:60 (based on obviousness, etc), then settlement is in the best interest of both parties.
But I do think it will be reckless on Amphastar's part to launch before a court decision on PI. Highly unlikely. Court decision may take time...3 months. So 3 more months of same revenue run rate for MNTA
Dr. Reddy's v Albany/Sanofi - Judge's PI Order
PI went in favor of Sanofi
Trial went in favor of Reddy's
And the most interesting part was judge awarded Reddy's damanges(lost revenue due to PI for Reddy's) for wrongfully getting PI (even though he was the guy who ruled on the PI)
http://www.patentdocs.org/2010/06/biotechpharma-docket-2.html
Judge's PI ruling(doesn't have details of arguments..but apparently 2 days of hearings was done before judgement was rendered...maybe I can find this case in pacer. I don;t understand how party is responsible when it was the judge that made the decision on PI, unless party brought false affidavits )
http://patentdocs.typepad.com/files/amri-order.pdf
The interesting part is timeline...It was March when Reddy's got approval and wanted to launch, June 25 they heard about PI.
So it is likely Momenta would get another quarter of lovenox revenue at the same run rate ?
Hattie, What is your take on this ?
RockRat
thought about this . Could be some FDA (like that chinese father & son that got caught) guys!
"Momenta has proved that it can find ways of measuring things that get around others IP, such as the pyro-glu method for Copaxone. It is not unreasonable to believe that after all these years Amphastar may also have figured something like this out for a-enoxaparin, "
Is it possible to have multiple signatures to the same product ?
Let's distinguish Momenta getting around IP of Branded product from another generic also finding another signature to the same product.
Because IP of how structure results or how structure affects biomarkers, were actually discovered by Momenta not Sanofi. Remember Sanofi was speculating 1-6 anhydro structure may be controlling anti-coagulant activity, and MNTA established Polysacharide P8 controlling anti-coagulant activity.
Now if Momenta has already identified starting material-to-structural signature relationship and process-to-structural signature , how would it be possible for another company to find another signature ?
For example on process-to-structure relationship,Momenta found the 1,6-anhydro ring structure is result of a process. So you have to believe that Amphastar has to test(using some analysis methods) for the presence of this in defined amounts in order that they prove equivalence to reference product even in their commercial process.
RockRat
RockRat-
Sorry! mouton you are right. wrong wordings.
"So Amphastar will be on the hook for all litigation costs???? Do they have such resources financially????"
My speculation is they will most likely base the decision on what happens on PI motion. If PI is granted(likely IMHO-see below) I think they will not launch. Of course if PI motion is rejected , they will launch at risk .
There are 4 factors in PI motion
1. Likelihood of success on merits
2. Likelihood of Irreparable harm in absence of relief
3. Balance of equities tips in whose favor
4. Public interest in a injunction
I believe 1,2(no way to go back to contractual profit share once it becomes royalty) and 3 are tipped in MNTA's favor. I will make a detailed post on 1) later.
4, is sorta subjective (innovation vs cost to consumer)
A recent PI judgement
http://patentdocs.typepad.com/files/treximet.pdf
http://www.bingham.com/Media.aspx?MediaID=7817
“must establish that he is likely to succeed on the merits [i.e. win at trial], that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in his favor, and that an injunction is in the public interest.” The Court rejected as “too lenient” the Ninth Circuit’s formulation of the standard, under which a plaintiff could show just a possibility of irreparable harm yet still obtain preliminary relief if he showed a strong likelihood of success on the merits. Instead, the Court held, a plaintiff must show that irreparable injury is likely absent an injunction.
I just read the 1st few pages. So take fwiw.
LDL - As I initially maintained, this is a surprise finding...and they have various things to support this like you said
Epadel, Lovaza , the expert's declaration
on your other point, I am yet to read it..
read this -
patent risk seems resolvable.
http://portal.uspto.gov/external/portal/!ut/p/c5/04_SB8K8xLLM9MSSzPy8xBz9CP0os3hff1NDc1NLYwN3SzcDA08PwyD_YF8zINcYKB-JW97AiCLdBgR0h4Nci992vPIGEHkDHMDRQN_PIz83VT9SP8ocpylGZvqROanpicmV-gW5oREGmQEZgY6KigBnIW_S/dl3/d3/L0lJSklna21DU1EhIS9JRGpBQU15QUJFUkNKRXFnLzRGR2dzbzBWdnphOUlBOW9JQSEhLzdfTU81MTc1OTMwRzlGMDBJSDFST1NNNjMwMjYvWnA5YlEzMzIwMDI0L3NhLmdldEJpYg!!/
"providing an enoxaparin sample that has been exhaustively digested with two or more heparin degrading enzymes; using a separation method to determine, in the enoxaparin sample that has been contacted with two or more heparin degrading enzymes, the presence of a structural signature associated with the non naturally occurring sugar associated with peak 9 of FIG. 1"
Just trying to understand this better:
While they have tons of other claims and other structurual signatures and analysis of those signatures...The above is probably the most important.
Potential Amphastar defense:
1) Obviousness defense: Would such an analysis method(determing amount of non-naturally sugar by looking at p9) survive an obviousness defense ? (I understand this is a granted patent)
2)Non-infringement defense: Could there be an alternative way of Analyzing Batch for presence of "non naturally occurring sugar"
The bottomline is we all know Amphastar will be held to same 5 sameness criteria as MNTA. So I would presume Amphastar will also have to prove same amounts of "non naturally occuring sugar" are in their product.
Here MNTA has also identified "Process signature" which is:
Process: .beta.-eliminative cleavage with a benzyl ester and depolymerization
Results in
Signature: predefined amount of non-naturally occuring sugar
Analysis method or Ways to find Signature: use heparin degrading enzymes on Heparin sample and then look for characteristic P9
Analysis method is the IP in dispute