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As a former OXGN shareholder, I too thought I was having a groundhog day experience when I saw the PR. From the 2008 ASCO abstracts:
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=31905
FWIW, NVO is using EMIS's permeation enhancers in its efforts to produce an oral GLP-1 analogue, NN9924 (3 PI trials to date), and it has licensed another EMIS carrier for use in developing oral insulin. However, the 2 NVO insulin compounds cited in the article -- the failed NN1952 and "successful" NN1953 -- use Merrion Pharma carriers.
NVO did test a Merrion carrier in one of its GLP-1 candidates, NN9925, but it failed its PI. However, NVO more recently entered into another license with Merrion for an oral version of an undisclosed compound, which indicates continuing interest in the Merrion delivery tech. Merrion may represent a good play on NVO if it advances the Merrion insulin tablet into PII, but this decision will not occur until next year according to the article.
In the interim, CT.gov shows that NVO just opened a new P1 for another oral insulin, NN1954, which does not yet appear on NVO's pipeline. The trial has an estimated completion date of March 2013. It would not surprise me if this uses the EMIS carrier, but there has been no PR from EMIS. Unfortunately for EMIS's remaining shareholders (other than its principal shareholder who also owns a $30M convert), the convert comes due in September, and everyone else will likely get wiped out. So any news that an EMIS carrier is still an oral insulin contender will probably be of little consequence.
http://clinicaltrials.gov/ct2/show/NCT01597713
Webcast Calendar
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NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Removed obsolete entries, Added Jefferies 2012 Healthcare Conference
Jefferies 2012 Global Healthcare Conference
http://www.jefferies.com/pdfs/confs/060412/2012GlobalHealthcareConferenceAgenda.pdf
6/4 - 6/7
Baxter Investor Conference
http://www.media-server.com/m/go/baxter2012investorconference
10/13
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antisoma received $75M upfront from NVS
It ran a successful randomized PII trial of its vascular disrupting agent ASA404 prior to striking the deal with NVS in 2007. If I remember correctly, antisoma had less than 2 months cash at time of deal. Royalties were undisclosed, but NVS did grant it a co-marketing option in the US if the VDA was approved. The VDA failed its PIII trials in NSCLC. Although it had other drugs in the clinic at the time of the PIII failures, antisoma now appears to have ceased active business operations.
http://www.antisoma.com/archive/reports/ar2007.pdf
Increased risk of death from sleeping pill consumption
I may have taken 1 or 2 sleeping pills in my lifetime. After reading this article and the full report (link embedded in article), I doubt I will ever take another:
NYT article shows the following pricing for Bydureon and Victoza:
For anyone interested, a replay of yesterday's oral argument is available on the CAFC website. Here's the direct link:
http://www.cafc.uscourts.gov/oral-argument-recordings/search/audio.html
I note that Chief Judge Rader is on the panel. He wrote the recent majority opinion in Celsis upholding a preliminary injuction against the infringer of Celsis's method patents. The other 2 judges on the panel, Dyk and Moore, were not on the Celsis panel, which means that the Celsis dissenter will not have a say on the outcome here.
I will try to listen to the replay this evening.
On Monday, the CAFC isued its opinion in Celsis in Vitro upholding a preliminary injuction against Life Technologies (f/k/a CellzDirect/Invitrogen) for infringing Celsis cryopreservation method patents. One of the 3 panel judges dissented. The opinion provides a good overview of the standards the CAFC will apply in deciding MNTA's case. It does not appear that a panel has yet been assigned to hear the MNTA case, but let's hope the dissenter is left off of it.
Here are links to the opinion and to Celsis's PR:
http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1547.pdf
http://www.invitrotech.com/news
FWIW, NKTR's 118 slide at last year's JP Morgan presentation showed that AZN projects the market for OIC drugs at $6B, so there should be more than enough potential revenue for different types of OIC drugs to share:
Her's a link to Synthon's PIII trial presumably needed for European approval:
Efficacy and Safety of GTR in Comparison to Copaxone® (GATE)
This study is currently recruiting participants.
Verified on December 2011 by Synthon BV
First Received on December 8, 2011. No Changes Posted
Sponsor: Synthon BV
Information provided by (Responsible Party): Synthon BV
ClinicalTrials.gov Identifier: NCT01489254
Purpose
The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple sclerosis
http://clinicaltrials.gov/ct2/show/NCT01489254
Link to recent updates on the KODIAC trial:
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_N/threadview?m=te&bn=9519&tid=97026&mid=97026&tof=10&frt=1#97026
The Pulmicort reference you added includes a cite to the Federal Circuit affirmance of the DC's PI. I read the Fed. Cir's opinion and came away quite confident that the Ampha PI will be affirmed. Pulmicort did not involve infringement of a CoM patent, which is what I expected would be the issue in the cases listed in the table, but rather "kit" and methods of "kit" use claims (the kit being an inhalation device for a specified asthma drug). Interestingly, the DC ruled, and a 2/3 majority of the Fed. Cir. panel affimed, that the "kit" claims were invalid as obvious but that Apotex's use of the FDA-approved label (to titrate to the lowest effective dose) encouraged a method of use (once daily dosing) that would violate AZN's once daily method claim for the kit (Apotex received approval for twice daily dosing of its generic kit). One judge in the 3-judge appellate panel would have reversed the DC's finding as to method of use infringement.
Based on the majority opinion, it's my opinion, FWIW, that the Fed. Cir. will uphold Judge Gorton's findings as to Ampha infringement of MNTA's process claims, the validity of those claims, and the irreparable harm likely to be suffered by MNTA/Sandoz, especially MNTA. Here's a direct link to the Fed. Cir. opinion (and I welcome any contrary views as I am not a patent lawyer and may add more MNTA tomorrow based in part on my view of the case):
http://www.cafc.uscourts.gov/images/stories/opinions-orders/09-1381-1424.pdf
The appeal was filed with the Federal Circuit, which is located in DC and hears all patent case appeals. It should be before a 3-judge panel.
Iwfal provided a timeline for the appeal of a PI in another case earlier today:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=68463186
I doubt the appeals court would take any action on the case before it received the DC record.
Note also the timeline provided by iwfal in another PI appeal:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=68463186
notice of appeal file (no surprise)
Full docket text for document 94:
NOTICE OF APPEAL to the Federal Circuit as to [93] Preliminary Injunction, [92] Memorandum & ORDER, by Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharma, Inc., Watson Pharmaceuticals, Inc. Filing fee: $ 455, receipt number 0101-3649467 Fee Status: Filing Fee paid. US District Court Clerk to deliver official record to Court of Appeals by 11/17/2011. (Attachments: # (1) Exhibit A - Memorandum and Order, # (2) Exhibit B - Preliminary Injunction)(Bauer, Steven)
notice of appeal just posted
Full docket text for document 94:
NOTICE OF APPEAL to the Federal Circuit as to [93] Preliminary Injunction, [92] Memorandum & ORDER, by Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharma, Inc., Watson Pharmaceuticals, Inc. Filing fee: $ 455, receipt number 0101-3649467 Fee Status: Filing Fee paid. US District Court Clerk to deliver official record to Court of Appeals by 11/17/2011. (Attachments: # (1) Exhibit A - Memorandum and Order, # (2) Exhibit B - Preliminary Injunction)(Bauer, Steven)
>>MNTA should cross 20 on this, IMO.<<
My expectation as well. I made my first-ever purchases of a stock in after-hours trading, paying between $14.20 and 14.40/sh. Until the potential for t-enox surfaced, the stock was above $20 if my recollection is correct, and this should diminish, if not eliminate, concern that t-enox will be launched in the foreseeable future.
I wonder if anyone will ask Bill Marth at Teva's 3Q call about the impact of the PI on the t-enox launch.
And once infringment is conceded, the patent claims infringed upon can ruled invalid only if Amphastar can present clear and convincing evidence of lack of enablement, if my understanding of patent law is correct. Perhaps this will be the rare case in with a PI is granted.
I agree on the PI, with the caveat that I lack any scientific background. I did find quite helpful the posts by RockRat, iwfal and poorgradstudent on the BV board earlier today, which gave me some understanding of the issues addressed in the MNTA memo. I was encouraged by the fact that PGS was able to describe Amphastar's use of MNTA's characterization process based on his scientific knowledge and the explanation of the process in the '886 specification, which should make it difficult for Amphastar to prevail on the enablement issue.
Here are links to 2 of the posts (which then can be tracked to find their remaining posts)
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=68346675
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=68368676
From the '886 patent (and beyond being able to look up patents, I have no technical expertise whatsoever to explain what this process is or does):
>>In a preferred embodiment, capillary electrophoresis (CE) is used to identify the disaccharide/tetrasaccharides building blocks. CE is superior to SAX HPLC in oligosaccharide analysis for several reasons. CE is significantly more accurate and precise than traditional LC due to the fact that there is no peak broadening resulting from laminar flow (as is the case with LC). The use of CE allows for 100% mass balance of di- and oligosaccharides after heparinase digestion. As a result, it is possible to resolve all of the lower prevalence oligosaccharides that are responsible for many of the clinical characteristics of heparins. In addition, CE requires the injection of 20 to 100 fold smaller amounts of saccharides compared to LC (500 fmols or less vs. at least 10 pmoles for capillary LC). Also, due to a larger number of theoretical plates, the resolving power of CE is higher than LC enabling separation of unique products (isomers) that contain an identical number of sulfates over a short run time. Thus the use of CE makes it possible to resolve all 32 building blocks that make up heparins.
CE also affords an added degree of flexibility in terms of complementarity to other analytical methodologies, including MALDI MS. In a further embodiment, the method of the invention relates to the use of CE separation and analysis followed by off-line MALDI MS analysis to derive structural information in an iterative way using bioinformatics. <<
MNTA's latest "proposed" submission to the Judge, in response to a motion (sealed) filed by Amphastar today. First I will post the latest filings shown on the docket (thanks to invesorgold for pointing out the filings):
88 Filed & Entered: 10/26/2011
Terminated: 10/26/2011
Motion for Leave to File
Docket Text: MOTION for Leave to File Defendants' Response to Plaintiffs' 10/25/11 Submission by Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc.. (Attachments: # (1) Exhibit A - Proposed Response - FILED UNDER SEAL)(Hubner, Isaac)
89 Filed & Entered: 10/26/2011
Terminated: 10/26/2011
Motion to Seal Document
Docket Text: Assented to MOTION to Seal Document ~ Defendants' Response to Plaintiffs' Submission Pursuant To This Courts October 21,2011 Minute Order Regarding Claim Construction by Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc..(Hubner, Isaac)
90Filed & Entered: 10/26/2011
Response
Docket Text: Sealed Response by Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc. to [81] Order Re: Claim Construction. (Patch, Christine)
91 Filed & Entered: 10/26/2011
Motion for Leave to File
Docket Text: MOTION for Leave to File Reply to Defendants' Response to Submission Regarding Claim Construction (Separation Method) by Momenta Pharmaceuticals, Inc., Sandoz Inc.. (Attachments: # (1) Exhibit A [Proposed Reply])(Lee, Jessica)
Here is the text of the MNTA/Sandoz "proposed reply" (which today's much appreciated postings by iwfal, poorgradstudent and RockRat gave me some clues to comprehending):
PLAINTIFFS’ REPLY TO DEFENDANTS’ RESPONSE TO SUBMISSION REGARDING
CLAIM CONSTRUCTION (SEPARATION METHOD)
**************
This memorandum replies to the defendants’ October 26, 2011 response to plaintiffs’ October 25 submission that addressed the inquiry made by the Court in its October 21, 2011 Minute Order.
1. Independent claims 6, 15, and 53 of the '886 patent include the step of “using a separation method to determine … the presence of a structural signature associated with the nonnaturally occurring sugar associated with peak 9.” It is the presence of the structural signature that is to be “determined.” The structural signature is further defined as being associated with a non-naturally occurring sugar. The non-natural sugar is, in turn, defined as being associated with peak 9 of Fig. 1 of the '886 patent. There is no requirement that the separation method find peak 9. The separation method is required to determine the presence of the structural signature.
2. The structural signature of enoxaparin is that oligosaccharide chains of enoxaparin include a particular sugar that includes a 1,6 anhydro ring structure. A sugar that includes a 1,6 anhydro ring structure is, in fact, non-natural, and it is, in fact, the sugar associated with peak 9 of Fig. 1 of the '886 patent. Crawford Decl., ¶51. Amphastar has presented no contrary evidence. As the '886 patent explains: “the structural signature can be provided by determining one or more primary outputs chosen from the following: the presence or the amount of one or more component saccharides …. Component saccharides can include … non-natural and modified sugars.” 7:1-10; see also 7:28-32.
3. The independent claims call for the use of a separation method to determine the presence of a structural signature of noxaparin. It is undisputed that HPLC is a separation method. Further, it is undisputed that Amphastar actually uses HPLC “to determine the presence of a structural signature of enoxaparin,” and that the structural signature whose presence Amphastar actually determines is a non-naturally occurring sugar that includes a 1,6 anhydro ring structure. Thus, it cannot be disputed that separation methods other than CE may be used, and are used, to determine the presence of this structural signature of enoxaparin.
4. The fact that the patent states that CE is a preferred method of determining the presence of a structural signature (see 47:54-59) does not mean that the claims are limited to the use of CE. If that were the intent of the patent applicant or the Examiner, the independent claims would say: “using CE to determine ….” In fact, they say using “a separation method to determine ….” As the prosecution history makes very clear, the Examiner himself identified HPLC as a separation method that the claims encompass as a way of determining the presence of the relevant structural signature. See plaintiffs’ Slides 15 and 16. Further, the fact that HPLC is said by the patent to be not “sufficiently sensitive” to detect “small amounts” of certain oligosaccharides (47:49-53) -- the reason CE is said to be preferred -- does not mean that it cannot determine the presence of the structural signature that is claimed in the '886 patent. As Amphastar’s conduct demonstrates, HPLC is more than adequate for that purpose.
5. The defendants now purport to find a difference between the language of the independent claims and the language of dependent claims 54-60. They state that independent claims 6, 15 and 53 use a separation method “to determine the presence of … a structural signature,” while the dependent claims state that “the structural signature is determined using” a particular method. Thus, the argument runs, dependent claims 54-60 are actually addressing a separate step. Per the defendants, the independent claims determine the presence of a structural signature, while the dependant claims determine what the structural signature actually is. There are at least three responses to this argument.
First, there is no difference between the meaning of the independent. and the meaning of the dependent, claims. The patent defines the term “structural signature.” It states a structural signature can be provided by “determining” certain “primary outputs.” One such “primary output” is “the presence or amount” of one or more component saccharides,” including “non-natural sugars.” 7:1-10. Thus, determining a structural signature (the dependent claims) and determining the presence of a structural signature (the independent claims) mean the same thing where the structural signature is itself “the presence or the amount” of a non-naturally occurring sugar. The defendants omit reference to this definitional language. In fact, the definitional language defeats the distinction that the defendants make between the language of the independent claims and the language of the relevant dependant claims.
Second, the independent claims call for the use of “a separation method to determine the presence of a structural signature” of enoxaparin. Claim 56 states that the structural signature is determined using CE. As explained, “determin[ing] a structural signature” is determining the presence or amount of a non-naturally occurring sugar. Therefore, if the independent claims were interpreted to mean that CE, and only CE, must be used “to determine the presence of a structural signature,” dependent claim 56 would be entirely duplicative of the independent claims. Any such interpretation would be at odds with the doctrine of claim differentiation. Moreover, there is no suggestion in the patent, no suggestion in the record of this case, and no scientific basis for suggesting, that CE could be used once to determine the presence of a structural signature and then used again to determine what the underlying sugar actually is. To the contrary, the patent teaches that different and additional methods would have to be used for that purpose. See, e.g., 47:62-65.1 Thus, as applied to claim 56, the defendants’ argument is nonsense. Similarly, claim 54 is directed to the use of HPLC to determine a structural signature. HPLC, like CE, is a separation method. Like CE, it can be (and is) used in commercial production release testing to determine the presence of the relevant structural signature of enoxaparin. (Recall that, by the time of commercial production, the identity of the sugars under each peak in the output of the HPLC device has previously been determined.) And, like CE, nothing in the patent, nothing in the evidence before the Court, and nothing in scientific fact, suggests that the use of two separation methods -- e.g., HPLC followed by HPLC, CE followed by HPLC, or HPLC followed by CE -- could be used to understand what is the structure of a particular sugar that is associated with a particular peak that is the output of either an HPLC or a CE process. Instead, both CE and HPLC, when referenced in the dependent claims, are fairly understood to be sub-categories of the separation method of the independent claims.
Third, even if it were correct that the separation methods of dependent claims 54 and 56 were directed to a different objective than the separation method of the independent claims, it would not matter. Amphastar uses HPLC to determine the presence and amount of a structural signature of enoxaparin. HPLC is conceded to be a separation method. The structural signature whose presence
___________________________________________________________
1 In this context, the Court should note that the '886 patent states that “in a further embodiment the method of the
invention relates to the use of CE separation followed by off-line MALDI-MS analysis to derive structural
information …. 34:7-10. Defendants cite this language at p. 1 of their submission, but omit the italicized language,
thereby suggesting that what the patent calls an “alternate embodiment” is actually the invention of the patent. In
any event, this disclosure indicates that the use of CE alone, no matter how often CE is run, will not determine what
is the actual structure of a sugar that CE has separated from other sugars.
___________________________________________________________
Amphastar determines is, in fact, associated with the non-naturally occurring sugar that is associated with peak 9 of Fig. 1 of the '886 patent. Therefore, Amphastar infringes the independent claims of the '886 patent.
Respectfully submitted, ************
Here is the text of the MNTA/Sandoz "proposed reply":
PLAINTIFFS’ REPLY TO DEFENDANTS’ RESPONSE TO SUBMISSION REGARDING
CLAIM CONSTRUCTION (SEPARATION METHOD)
**************
This memorandum replies to the defendants’ October 26, 2011 response to plaintiffs’ October 25 submission that addressed the inquiry made by the Court in its October 21, 2011 Minute Order.
1. Independent claims 6, 15, and 53 of the '886 patent include the step of “using a separation method to determine … the presence of a structural signature associated with the nonnaturally occurring sugar associated with peak 9.” It is the presence of the structural signature that is to be “determined.” The structural signature is further defined as being associated with a non-naturally occurring sugar. The non-natural sugar is, in turn, defined as being associated with peak 9 of Fig. 1 of the '886 patent. There is no requirement that the separation method find peak 9. The separation method is required to determine the presence of the structural signature.
2. The structural signature of enoxaparin is that oligosaccharide chains of enoxaparin include a particular sugar that includes a 1,6 anhydro ring structure. A sugar that includes a 1,6 anhydro ring structure is, in fact, non-natural, and it is, in fact, the sugar associated with peak 9 of Fig. 1 of the '886 patent. Crawford Decl., ¶51. Amphastar has presented no contrary evidence. As the '886 patent explains: “the structural signature can be provided by determining one or more primary outputs chosen from the following: the presence or the amount of one or more component saccharides …. Component saccharides can include … non-natural and modified sugars.” 7:1-10; see also 7:28-32.
3. The independent claims call for the use of a separation method to determine the presence of a structural signature of noxaparin. It is undisputed that HPLC is a separation method. Further, it is undisputed that Amphastar actually uses HPLC “to determine the presence of a structural signature of enoxaparin,” and that the structural signature whose presence Amphastar actually determines is a non-naturally occurring sugar that includes a 1,6 anhydro ring structure. Thus, it cannot be disputed that separation methods other than CE may be used, and are used, to determine the presence of this structural signature of enoxaparin.
4. The fact that the patent states that CE is a preferred method of determining the presence of a structural signature (see 47:54-59) does not mean that the claims are limited to the use of CE. If that were the intent of the patent applicant or the Examiner, the independent claims would say: “using CE to determine ….” In fact, they say using “a separation method to determine ….” As the prosecution history makes very clear, the Examiner himself identified HPLC as a separation method that the claims encompass as a way of determining the presence of the relevant structural signature. See plaintiffs’ Slides 15 and 16. Further, the fact that HPLC is said by the patent to be not “sufficiently sensitive” to detect “small amounts” of certain oligosaccharides (47:49-53) -- the reason CE is said to be preferred -- does not mean that it cannot determine the presence of the structural signature that is claimed in the '886 patent. As Amphastar’s conduct demonstrates, HPLC is more than adequate for that purpose.
5. The defendants now purport to find a difference between the language of the independent claims and the language of dependent claims 54-60. They state that independent claims 6, 15 and 53 use a separation method “to determine the presence of … a structural signature,” while the dependent claims state that “the structural signature is determined using” a particular method. Thus, the argument runs, dependent claims 54-60 are actually addressing a separate step. Per the defendants, the independent claims determine the presence of a structural signature, while the dependant claims determine what the structural signature actually is. There are at least three responses to this argument.
First, there is no difference between the meaning of the independent. and the meaning of the dependent, claims. The patent defines the term “structural signature.” It states a structural signature can be provided by “determining” certain “primary outputs.” One such “primary output” is “the presence or amount” of one or more component saccharides,” including “non-natural sugars.” 7:1-10. Thus, determining a structural signature (the dependent claims) and determining the presence of a structural signature (the independent claims) mean the same thing where the structural signature is itself “the presence or the amount” of a non-naturally occurring sugar. The defendants omit reference to this definitional language. In fact, the definitional language defeats the distinction that the defendants make between the language of the independent claims and the language of the relevant dependant claims.
Second, the independent claims call for the use of “a separation method to determine the presence of a structural signature” of enoxaparin. Claim 56 states that the structural signature is determined using CE. As explained, “determin[ing] a structural signature” is determining the presence or amount of a non-naturally occurring sugar. Therefore, if the independent claims were interpreted to mean that CE, and only CE, must be used “to determine the presence of a structural signature,” dependent claim 56 would be entirely duplicative of the independent claims. Any such interpretation would be at odds with the doctrine of claim differentiation. Moreover, there is no suggestion in the patent, no suggestion in the record of this case, and no scientific basis for suggesting, that CE could be used once to determine the presence of a structural signature and then used again to determine what the underlying sugar actually is. To the contrary, the patent teaches that different and additional methods would have to be used for that purpose. See, e.g., 47:62-65.1 Thus, as applied to claim 56, the defendants’ argument is nonsense. Similarly, claim 54 is directed to the use of HPLC to determine a structural signature. HPLC, like CE, is a separation method. Like CE, it can be (and is) used in commercial production release testing to determine the presence of the relevant structural signature of enoxaparin. (Recall that, by the time of commercial production, the identity of the sugars under each peak in the output of the HPLC device has previously been determined.) And, like CE, nothing in the patent, nothing in the evidence before the Court, and nothing in scientific fact, suggests that the use of two separation methods -- e.g., HPLC followed by HPLC, CE followed by HPLC, or HPLC followed by CE -- could be used to understand what is the structure of a particular sugar that is associated with a particular peak that is the output of either an HPLC or a CE process. Instead, both CE and HPLC, when referenced in the dependent claims, are fairly understood to be sub-categories of the separation method of the independent claims.
Third, even if it were correct that the separation methods of dependent claims 54 and 56 were directed to a different objective than the separation method of the independent claims, it would not matter. Amphastar uses HPLC to determine the presence and amount of a structural signature of enoxaparin. HPLC is conceded to be a separation method. The structural signature whose presence
___________________________________________________________
1 In this context, the Court should note that the '886 patent states that “in a further embodiment the method of the
invention relates to the use of CE separation followed by off-line MALDI-MS analysis to derive structural
information …. 34:7-10. Defendants cite this language at p. 1 of their submission, but omit the italicized language,
thereby suggesting that what the patent calls an “alternate embodiment” is actually the invention of the patent. In
any event, this disclosure indicates that the use of CE alone, no matter how often CE is run, will not determine what
is the actual structure of a sugar that CE has separated from other sugars.
___________________________________________________________
Amphastar determines is, in fact, associated with the non-naturally occurring sugar that is associated with peak 9 of Fig. 1 of the '886 patent. Therefore, Amphastar infringes the independent claims of the '886 patent.
Respectfully submitted, ************
The motions keep coming (so will we see another extension of the TRO?):
91 Filed & Entered: 10/26/2011
Motion for Leave to File
Docket Text: MOTION for Leave to File Reply to Defendants' Response to Submission Regarding Claim Construction (Separation Method) by Momenta Pharmaceuticals, Inc., Sandoz Inc.. (Attachments: # (1) Exhibit A [Proposed Reply])(Lee, Jessica)
With the time saved, the Judge would be well-advised to read poorgradstudent's, iwfal's and RockRat's posts earlier today on the BV board regarding the enablement issue. For anyone has not yet read them, here's a link to last of the posts:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=68371943
MNTA: Judge just issued order extending TRO for 7 days.
I would reproduce but it is a photo image that I am not adept at converting into text.
Judge just issued order extending TRO for 7 days.
I would reproduce but it is a photo image that I am not adept at converting into text.
Nothing new on PACER as of 8 pm, so Judge Gorton once more will likely have another full day at the courthouse on a Friday.
MNTA: hearing over, taken under advisement -- no surprise
Full docket text:
ELECTRONIC Clerk's Notes for proceedings held before Judge Nathaniel M. Gorton: Motion Hearing held on 10/20/2011 re [18] MOTION for Preliminary Injunction filed by Momenta Pharmaceuticals, Inc., Sandoz Inc. Court hears arguments of counsel and takes matter under advisement. (Court Reporter: Cheryl Dahlstrom at 617-951-4555.)(Attorneys present: Marandett, Gan Lee, Frank, Steindler, Bauer, Goldsmith, Hubner, Weir, Robell) (Patch, Christine)
MNTA: hearing over, taken under advisement -- no surprise
Full docket text:
ELECTRONIC Clerk's Notes for proceedings held before Judge Nathaniel M. Gorton: Motion Hearing held on 10/20/2011 re [18] MOTION for Preliminary Injunction filed by Momenta Pharmaceuticals, Inc., Sandoz Inc. Court hears arguments of counsel and takes matter under advisement. (Court Reporter: Cheryl Dahlstrom at 617-951-4555.)(Attorneys present: Marandett, Gan Lee, Frank, Steindler, Bauer, Goldsmith, Hubner, Weir, Robell) (Patch, Christine)
It also makes it 2 straight Fridays where Amphastar has kept Judge Gorton working late, which cannot help Amphastar's cause.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67801797
MNTA: NO CHANGE IN TRO
MEMORANDUM & ORDER
GORTON, J.
On October 12, 2011, the defendants submitted an Emergency
Motion to Modify or Dissolve the Temporary Restraining Order that
was entered by the Court on October 7, 2011 (Docket No. 39). The
temporary restraining order (“TRO”) prohibits the defendants from
advertising, offering for sale or selling a generic enoxaparin
product that allegedly infringes one or more of the patents
issued to Momenta Pharmaceuticals, Inc. until after the Court
conducts a preliminary injunction hearing on October 20, 2011.
In their emergency motion, defendants contend that they will
suffer two distinct harms if the TRO remains in effect and is not
modified until after the preliminary injunction hearing. First,
defendants purportedly will be unable to sell at fair value one
lot of their enoxaparin product that is due to expire on December
31, 2011. They contend that the product must have a minimum
shelf life of eight weeks to be sold at market price and that an
additional two weeks is generally needed for processing and
shipping. Second, defendants will be unable to bid on two longterm
supply contracts with Group Purchasing Organizations
(“GPOs”) because the deadlines for those bids (which have already
expired or are about to expire) may not be able to be extended
after the TRO period.
After consideration of the parties’ pleadings, the
accompanying exhibits and affidavits and the oral arguments of
counsel at the hearing on this date, the Court has determined
that modification or rescission of the TRO is unwarranted.
With respect to defendants’ inventory with a shelf-life
problem, the defendants have not demonstrated that maintaining
the status quo for six days will prevent them from locating
interested buyers and executing sales or cause them any material
harm. The balance of the harms remains in plaintiffs’ favor for
the time being.
With respect to the bidding issue, the defendants have not
demonstrated that the temporary restriction of their ability to
record bids on the two GPO contracts will cause them an
irrevocable loss of business. The precise terms of the potential
contracts, including whether they are “sole source” contracts
with or without “termination rights” or “rights of first
refusal”, is unclear, and defendants’ indeterminate harm does not
warrant modification of the TRO. The Court has temporarily
restrained the defendants to prevent potential harm to the
plaintiffs in the form of price erosion. Nothing in defendants’
offer of proof has persuaded the Court to alter its decision in
the short term.
ORDER
In accordance with the foregoing, Defendant’s Emergency
Motion to Modify or Dissolve Temporary Restraining Order (Docket
No. 43) is DENIED.
So ordered.
/s/ Nathaniel M. Gorton
Nathaniel M. Gorton
United States District Judge
Dated October 14, 2011
Most recent pacer action as of 3 pm is a motion from MNTA (which Amphastar assented to) to seal the 2 docs reproduced by mouton on the BTV board because they contained confidential info; they are no longer available except on BTV:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=68002939
MNTA TRO hearing notes
Filed & Entered: 10/14/2011 Hearing (Other)
Docket Text: ELECTRONIC Clerk's Notes for proceedings held before Judge Nathaniel M. Gorton: Motion Hearing re [43] Emergency Motion to Modify the TRO held on 10/14/2011. Court takes the matter under advisement. (Court Reporter: Cheryl Dahlstrom at 617-951-4555.)(Attorneys present: Schou, Frank, Steindler, Bauer, Goldsmith, Hubner, Weir, Mansour,) (Patch, Christine)
57 Filed & Entered: 10/14/2011 Opposition to Motion
Docket Text: Sealed Supplemental Opposition re [19] MOTION for Discovery [Limited Expedited] filed by Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc.. (Patch, Christine)
The WPI press release announcing approval of a/enox states that it has an exclusive distribution agreement with Amphastar. It seems unlikely that Amphastar has sold a/enox to a third party.