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p-
Did AMRN do everything possible to resolve this before 3/30...the stakes were way to high in AMRN's case to not to have exausted every possible angle...I have not heard that from JT.
we emphasized for many years that the courts can be unpredictable in such matters
K-
Do you think if AMRN reports a larger loss than expected ...PPS will drop below $6.40 ?
I'm expecting Q2 Revenue to be in the range of $150.4 - 162.5 million
I'm sticking with Net Sales Revenue of $1.21/capsule.
So my estimate for Net Sales Revenue = $146.5 million.
lower Q2 revenue (vs Q1 / $155M) … less than $145M … 50-60% chance of less than $140M
I do not have any idea why anybody give any attention to Case 3:20-cv-00421 (Amarin vs Hikma 500 mg case) ... It is going as I told you: #286202 (before any info from the IR / Co.).
Best,
G
K-
3.) Q2 10-Q (?)
Best,
G
o-
I strongly disagree that Judge Du introduced the new terms pos/neg to define scs, which has origins on this board.
r-
Will the case boil down to this?
The judges will ask the Generics to explain/define "neg SC"
if they cannot, Amarin wins?
o-
At the end, I'm just coming at it from the POV of a Judge Dyk or a Judge Prost who will not use the "pos/neg" language and can easily affirm Judge Du on "strong/weak" language. Just my two cents.
evidence of secondary considerations when such evidence is, of course, present
these secondary considerations are outweighed by the fact that the Court found Plaintiffs’other proffered secondary considerations favor Defendants.
evidence of secondary considerations must be examined to determine its impact on the first three Graham factors
It is to be considered as part of all the evidence, not just when the decisionmaker remains in doubt after reviewing the art
o-
I've seen the words "positive" and "negative" secondary considerations used on the board but the CAFC has historically adopted the language of "strong" and "weak" secondary considerations ... The difference is subtle and I would caution the board not to use the "pos"/"neg" language but "strong"/"weak".
r-
(Relevant) Events
(Relevant) Events:
Dancing in the dark: If you think, please replace my previous post (sticky) with this one. Thx.
August
- Week 32: Q2 2020 (10-Q and CC)
September
- September 2, 10:00 a.m: Oral argument (CAFC)
- September 14-17: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- Decision about EU approach (partnership or GIA or hybrid)
October
- October 5: Preliminary Q3 (TBC)
November
- Week 45: Q3 2020 (10-Q and CC)
- November 23: EU Commission Decision / formal approval (based on Day 180 Opinion by EMA, September 17)
December
- December 23*: Response to Day 180 LoOI, September 17 (Amarin will have three months to answer the LoOI.)
- Chinese MARINE trial completion / result
January
- Order (CAFC) (average time is 4 months after oral argument)
- January 28: Day 210 Opinion by EMA / recommendation of approval
April
- April 5: EU Commission Decision / formal approval (based on Day 210 Opinion by EMA, January 28)
Note:
a.) dates are (i) all “on or before” (ii) lot of them TBA or TBC
b.) EMA approval calculated by the “longest” (3-months reply) timeframe due to changed communication by the company:
“Our expectation is that VASCEPA will be approved near the end of this year for launch in Europe” vs. “recommendation for approval of VASCEPA by the European Medicines Agency near the end of this year” (latest).
Amarin “speed” (reply) will depends (IMO) on the appeal procedure: expedited or normal
c.) *clock restart
d.) if something will be sometime during the relevant quarter it is listed for the last month of the quarter
Best,
G
ps.:
(i) “shortest” EMA timetable in case of LoOI
- September 14-17: Day 180 List of Outstanding Issues (LoOI)
- October 13*: Response to Day 180 LoOI, September 17
- November 9-12: Day 210 Opinion by EMA / recommendation of approval
- January 15: Commission Decision / formal approval (based on Day 210 Opinion by EMA, November 12)
(ii) “longest” EMA timetable
- September 14-17: Day 180 LoOI
- December 7-10: CHMP meeting, Request extension of time (+3-months) for response to Day 180 LoOI,
- March 23*: Response to Day 180 LoOI, September 17
- April 19-22: Day 210 Opinion by EMA / recommendation of approval
- June 28: Commission Decision / formal approval (based on Day 210 Opinion by EMA, April 22)
20-1723 Appeal (& 216-cv-02525-MMD-NJK)
CalMustang: Please replace my previous post, sticky this one. Thx.
(Relevant) UPDATE: below
Appellant: Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (AMRN)
Appellee:
- West-Ward Pharmaceuticals International Limited (n/k/a Hikma Pharmaceuticals International Limited) and Hikma Pharmaceuticals USA Inc. (Hikma)
-Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. (Reddy)
CAFC; 20-1723 Appeal Available documents #:
4: DOCKETING STATEMENT (AMRN)
8: UNOPPOSED MOTION TO EXPEDITE BRIEFING AND ORAL ARGUMENT
13: DOCKETING STATEMENT (Hikma)
23: DOCKETING STATEMENT (Reddy)
30: APPELLANTS’ OPENING BRIEF
31: NOTICE OF CORRECTION OF APPELLANTS’ OPENING BRIEF
32: APPELLANTS’ CORRECTED OPENING BRIEF
33: ORDER]
34: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
35: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
36: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
37: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
38: ENTRY OF APPEARANCE / Aimed Alliance / Amicus curiae
39: BRIEF OF THE BIOTECHNOLOGY INNOVATION ORGANIZATION AS AMICUS CURIAE IN SUPPORT OF NEITHER PARTY
40: CERTIFICATE OF INTEREST / Aimed Alliance
43: BRIEF OF AIMED ALLIANCE AS AMICUS CURIAE IN SUPPORT OF APPELLANTS
44: NOTICE OF NON-COMPLIANCE (AIMED ALLIANCE)
47: CERTIFICATE OF INTEREST (Reddy)
49: BRIEF FOR DEFENDANTS-APPELLEES
50: APPELLANTS’ REPLY BRIEF
51: JOINT CERTIFICATE OF COMPLIANCE WITH FED. CIR. R. 33(a)
52: PLAINTIFFS-APPELLANTS’ STATEMENT OF COMPLIANCE WITH FEDERAL CIRCUIT RULES 11(d) AND 30(h)(1)(B)
53: CERTIFICATE OF COMPLIANCE WITH CONFIDENTIALITY RULES (Hikma)
54: CERTIFICATE OF COMPLIANCE WITH CONFIDENTIALITY RULES (Reddy)
55-1: NON-CONFIDENTIAL JOINT APPENDIX VOLUME I (APPX1-APPX1512)
55-2: NON-CONFIDENTIAL JOINT APPENDIX VOLUME II (APPX1567-APPX50688)
55-3: NON-CONFIDENTIAL JOINT APPENDIX VOLUME III (APPX50689-APPX111621)
57: ORDER
58: NOTICE TO ADVISE OF SCHEDULING CONFLICTS OF ARGUING COUNSEL
60: ENTRY OF APPEARANCE (AMRN)
61: ENTRY OF APPEARANCE (AMRN)
63: RESPONSE TO NOTICE TO ADVISE OF SCHEDULING CONFLICTS (AMRN)
69: RESPONSE TO NOTICE TO ADVISE OF SCHEDULING CONFLICTS (Appellee)
70: RESPONSE TO NOTICE TO ADVISE OF SCHEDULING CONFLICTS (Appellee)
71: NOTICE OF TELEPHONIC ORAL ARGUMENT (September 2, 2020 at 10:00 a.m. )
DC; 216-cv-02525-MMD-NJK Available documents
Best,
G
20-1723 Appeal (& 216-cv-02525-MMD-NJK)
CalMustang: Please replace my previous post, sticky this one. Thx.
(Relevant) UPDATE: below
Appellant: Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (AMRN)
Appellee:
- West-Ward Pharmaceuticals International Limited (n/k/a Hikma Pharmaceuticals International Limited) and Hikma Pharmaceuticals USA Inc. (Hikma)
-Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. (Reddy)
CAFC; 20-1723 Appeal Available documents #:
4: DOCKETING STATEMENT (AMRN)
8: UNOPPOSED MOTION TO EXPEDITE BRIEFING AND ORAL ARGUMENT
13: DOCKETING STATEMENT (Hikma)
23: DOCKETING STATEMENT (Reddy)
30: APPELLANTS’ OPENING BRIEF
31: NOTICE OF CORRECTION OF APPELLANTS’ OPENING BRIEF
32: APPELLANTS’ CORRECTED OPENING BRIEF
33: ORDER]
34: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
35: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
36: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
37: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
38: ENTRY OF APPEARANCE / Aimed Alliance / Amicus curiae
39: BRIEF OF THE BIOTECHNOLOGY INNOVATION ORGANIZATION AS AMICUS CURIAE IN SUPPORT OF NEITHER PARTY
40: CERTIFICATE OF INTEREST / Aimed Alliance
43: BRIEF OF AIMED ALLIANCE AS AMICUS CURIAE IN SUPPORT OF APPELLANTS
44: NOTICE OF NON-COMPLIANCE (AIMED ALLIANCE)
47: CERTIFICATE OF INTEREST (Reddy)
49: BRIEF FOR DEFENDANTS-APPELLEES
50: APPELLANTS’ REPLY BRIEF
51: JOINT CERTIFICATE OF COMPLIANCE WITH FED. CIR. R. 33(a)
52: PLAINTIFFS-APPELLANTS’ STATEMENT OF COMPLIANCE WITH FEDERAL CIRCUIT RULES 11(d) AND 30(h)(1)(B)
53: CERTIFICATE OF COMPLIANCE WITH CONFIDENTIALITY RULES (Hikma)
54: CERTIFICATE OF COMPLIANCE WITH CONFIDENTIALITY RULES (Reddy)
55-1: NON-CONFIDENTIAL JOINT APPENDIX VOLUME I (APPX1-APPX1512)
55-2: NON-CONFIDENTIAL JOINT APPENDIX VOLUME II (APPX1567-APPX50688)
55-3: NON-CONFIDENTIAL JOINT APPENDIX VOLUME III (APPX50689-APPX111621)
57: ORDER
58: NOTICE TO ADVISE OF SCHEDULING CONFLICTS OF ARGUING COUNSEL
60: ENTRY OF APPEARANCE (AMRN)
61: ENTRY OF APPEARANCE (AMRN)
63: RESPONSE TO NOTICE TO ADVISE OF SCHEDULING CONFLICTS (AMRN)
69: RESPONSE TO NOTICE TO ADVISE OF SCHEDULING CONFLICTS (Appellee)
DC; 216-cv-02525-MMD-NJK Available documents
Best,
G
c-
So amrn did not slow walk EU process
c-
What is your take on this hls news?
c-
Believe the WS price in Us is ~$1500/yr
(Relevant) Events:
Dancing in the dark: If you think, please replace my previous post (sticky) with this one. Thx.
August
- Week 32: Q2 2020 (10-Q and CC)
September
- Week 36 (August 31- September 4): Oral argument (CAFC) … September is the earliest but could be later
- September 14-17: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- Decision about EU approach (partnership or GIA or hybrid)
October
- October 5: Preliminary Q3 (TBC)
November
- Week 45: Q3 2020 (10-Q and CC)
- November 23: EU Commission Decision / formal approval (based on Day 180 Opinion by EMA, September 17)
December
- December 23*: Response to Day 180 LoOI, September 17 (Amarin will have three months to answer the LoOI.)
- Chinese MARINE trial completion / result
January
- Order (CAFC) (average time is 4 months after oral argument)
- January 28: Day 210 Opinion by EMA / recommendation of approval
April
- April 5: EU Commission Decision / formal approval (based on Day 210 Opinion by EMA, January 28)
Note:
a.) dates are (i) all “on or before” (ii) lot of them TBA or TBC
b.) EMA approval calculated by the “longest” (3-months reply) timeframe due to changed communication by the company:
“Our expectation is that VASCEPA will be approved near the end of this year for launch in Europe” vs. “recommendation for approval of VASCEPA by the European Medicines Agency near the end of this year” (latest).
Amarin “speed” (reply) will depends (IMO) on the appeal procedure: expedited or normal
c.) *clock restart
d.) if something will be sometime during the relevant quarter it is listed for the last month of the quarter
Best,
G
ps.:
(i) “shortest” EMA timetable in case of LoOI
- September 14-17: Day 180 List of Outstanding Issues (LoOI)
- October 13*: Response to Day 180 LoOI, September 17
- November 9-12: Day 210 Opinion by EMA / recommendation of approval
- January 15: Commission Decision / formal approval (based on Day 210 Opinion by EMA, November 12)
(ii) “longest” EMA timetable
- September 14-17: Day 180 LoOI
- December 7-10: CHMP meeting, Request extension of time (+3-months) for response to Day 180 LoOI,
- March 23*: Response to Day 180 LoOI, September 17
- April 19-22: Day 210 Opinion by EMA / recommendation of approval
- June 28: Commission Decision / formal approval (based on Day 210 Opinion by EMA, April 22)
a-
Nothing special. Response to Day 120 letter was received by the EMA, the clock running again (since July 16).
Icosapent will be on the September agenda (this phase takes 60 days) as List of Outstanding Question (LoOI) or Opinion (recommendation for approval). In case of the later: approval late November.
see: sticky above
Best,
G
p-
I think that is the 5th or 6th attempt
What one shareholder thinks is acceptable could be completely different than another...so how is that acceptable
seeking shareholder input and then not settling because it won't make SOME shareholders happy is a very good example of his thought process
seeking shareholder input
not settling because it won't make SOME shareholders happy
r-
It's not rocket science. How about instead of devoting 100s of posts to mind numbing speculations
Your first judgment assumes that a settlement was available on terms that you would not have been similarly disappointing.
We listened to input from many investors over the past several years. Such input included suggestions on what would be settlement terms that they would accept.
The settlement terms that were suggested by investors were not available
we emphasized for many years that the courts can be unpredictable in such matters
The confidential nature of such court overseen settlement discussions prevent disclosure of further details.
C-
when we would know if they responded to the Day 120 List of questions?
If no issues the Day 180 opinion is in September with a formal opinion November 23?
20-1723 Appeal (& 216-cv-02525-MMD-NJK)
CalMustang: Please replace my previous post, sticky this one. Thx.
(Relevant) UPDATE: below
Appellant: Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (AMRN)
Appellee:
- West-Ward Pharmaceuticals International Limited (n/k/a Hikma Pharmaceuticals International Limited) and Hikma Pharmaceuticals USA Inc. (Hikma)
-Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. (Reddy)
CAFC; 20-1723 Appeal Available documents #:
4: DOCKETING STATEMENT (AMRN)
8: UNOPPOSED MOTION TO EXPEDITE BRIEFING AND ORAL ARGUMENT
13: DOCKETING STATEMENT (Hikma)
23: DOCKETING STATEMENT (Reddy)
30: APPELLANTS’ OPENING BRIEF
31: NOTICE OF CORRECTION OF APPELLANTS’ OPENING BRIEF
32: APPELLANTS’ CORRECTED OPENING BRIEF
33: ORDER]
34: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
35: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
36: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
37: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
38: ENTRY OF APPEARANCE / Aimed Alliance / Amicus curiae
39: BRIEF OF THE BIOTECHNOLOGY INNOVATION ORGANIZATION AS AMICUS CURIAE IN SUPPORT OF NEITHER PARTY
40: CERTIFICATE OF INTEREST / Aimed Alliance
43: BRIEF OF AIMED ALLIANCE AS AMICUS CURIAE IN SUPPORT OF APPELLANTS
44: NOTICE OF NON-COMPLIANCE (AIMED ALLIANCE)
47: CERTIFICATE OF INTEREST (Reddy)
49: BRIEF FOR DEFENDANTS-APPELLEES
50: APPELLANTS’ REPLY BRIEF
51: JOINT CERTIFICATE OF COMPLIANCE WITH FED. CIR. R. 33(a)
52: PLAINTIFFS-APPELLANTS’ STATEMENT OF COMPLIANCE WITH FEDERAL CIRCUIT RULES 11(d) AND 30(h)(1)(B)
53: CERTIFICATE OF COMPLIANCE WITH CONFIDENTIALITY RULES (Hikma)
54: CERTIFICATE OF COMPLIANCE WITH CONFIDENTIALITY RULES (Reddy)
55-1: NON-CONFIDENTIAL JOINT APPENDIX VOLUME I (APPX1-APPX1512)
55-2: NON-CONFIDENTIAL JOINT APPENDIX VOLUME II (APPX1567-APPX50688)
55-3: NON-CONFIDENTIAL JOINT APPENDIX VOLUME III (APPX50689-APPX111621)
57: ORDER
58: NOTICE TO ADVISE OF SCHEDULING CONFLICTS OF ARGUING COUNSEL
60: ENTRY OF APPEARANCE (AMRN)
61: ENTRY OF APPEARANCE (AMRN)
63: RESPONSE TO NOTICE TO ADVISE OF SCHEDULING CONFLICTS (AMRN)
DC; 216-cv-02525-MMD-NJK Available documents
Best,
G
jl-
Most drug plans do not operate off the Orange book..Nor to the best of my knowledge the OB does not make cross claims concerning substitutions.. The drug plans go off the FDA label and particularly the Indications and Usage
JL-
Why would Du be bringing up the fact that the generics might infringe on Amarin's MARINE patents when she invalidated every one of them. I guess the he does not understand that once the patents are invalidated then the generics don't have to infringe on them.
JL-
That does not mean I am lying..
Vascepa currently has two labels. I have no idea how many other FDA approved drugs have more than one label.
The other fact (I believe is true) is that Lovaza and Generic Lovaza has a label where the indications and usage is identical to generic Vascepa..I also believe generic Lovaza will be be able to sell the drug at a price lower than Gen Vascepa...
And because of the similar labels...State laws will consider the cheaper gen Lovaza to be the preferred drug and will convert Gen V scripts to Gen Lovaza..That will pose a barrier to prescribing gen Vascepa off label for the R-I indication
JL-
I am not spreading false information... I am posting what I believe is the case
Consider the possibility you might be wrong...I am not dismissing the fact you might be right..
I have never knowingly spread lies or deception on the board and never plan to...And I do not appreciate your comment suggesting I am...
m-
Then where will the infringement come from in her opinion. She clearly meant generics are going to infringe cardio space that V has. What else?
II. CLAIMS
Plaintiffs specifically assert infringement of U.S. Patent No. 8,293,728 (“the ’728 patent”), U.S. Patent No. 8,318,715 (“the ’715 patent”), U.S. Patent No. 8,357,677 (“the ’677 patent”), U.S. Patent No. 8,367,652 (“the ’652 patent”), U.S. Patent No. 8,431,560 (“the ’560 patent”), and U.S. Patent No. 8,518,929 (“the ’929 patent”). 1 (ECF No. 331 at 9.) Each of the Asserted Patents is entitled “METHODS OF TREATING HYPERTRIGLYCERIDEMIA.”
Plaintiffs more specifically assert that Defendants infringe the following ten claims of the Asserted Patents: Claims 1 and 16 of the ’728 patent, Claim 14 of the ’715 patent, Claims 1 and 8 of the ’677 patent, Claim 1 of the ’652 patent, Claims 4 and 17 of the ’560 patent, and Claims 1 and 5 of the ’929 patent. 2 (ECF Nos. 331 at 9-10, 333 at 13 n.1.) Defendants asserted counterclaims of noninfringement and invalidity. (ECF Nos. 27 at 28-34, 33 at 33-56.)
Footnotes:
1 Collectively, the “Asserted Patents.”
2 Collectively, the “Asserted Claims.”
IV. CONCLUSIONS OF LAW
The Trial focused on induced infringement and whether the Asserted Patents are invalid as obvious in light of the prior art. The Court first addresses infringement below, and then obviousness.
V. CONCLUSION
The Court finds that Defendants’ proposed ANDA Products will induce infringement of the Asserted Claims, but all the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103.
And after she invalidated, Hikamas thought that they can sell the 500mg pill which was clearly designed for cardio older patients to swallow the pills easy, imo.
You are the one spreading false illusion and interpretation in my opinion
JL-
The foregone conclusion on this board is that H&R are going to be able to use the MARINE label to shoehorn into the R-I CVD event indication..Via the proviso that physicians are legally able to prescribe off label. This might have been much easier had not JD (da Judge) offered her opinion on why this might be construed as indirect infringement (of Amarin's valid patents) by inducement.
m-
But 500mg pill was designed after the ReduceIt saga
N-
Just business as usual for AMRN to throw shares at upper management I suppose.
other line has exercise options at $6.62 to buy ... Can't believe they spent monies on exercising their options, but they did.
New poll (new complaint: Case 3:20-cv-00421; Document 1; Filed 07/13/20; 27 & 29)
1.) "Nor does an ANDA applicant establish any new conditions of use for the proposed drug product. Instead, an ANDA applicant may seek approval only for conditions of use that previously have been approved in connection with an approved NDA. 21 U.S.C. § 355(j)(2)(A)(i)."
It is from:
A.) Case 3:20-cv-00421 Document 1 Filed 07/13/20 (27)
B.) Case 2:16-cv-02525 Document 1 Filed 10/31/16 (22)
C.) From both (the two documents are identical regarding this)
2.) "VASCEPA® is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. A true, correct, and complete copy of the Prescribing Information for VASCEPA® approved in NDA No. 202057 is attached as Exhibit A."
(Case 2:16-cv-02525 Document 1 Filed 10/31/16 [24])
vs
"VASCEPA® is currently indicated, inter alia, as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. VASCEPA® is also indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride levels and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. A true, correct, and complete copy of the FDA-approved Prescribing Information for VASCEPA®, covering both the 1 g and 0.5 g strengths, is attached as Exhibit A."
(Case 3:20-cv-00421 Document 1 Filed 07/13/20 [29])
The difference has any significance, it is relevant:
A.) No. It is a description of Vacepa indication(s) only at the time of the document
B.) Yes ... if you live in Wonderland ...
Best,
G
p-
C'on man...
Number one...you don't base a settlement on an investors suggestion ...
Number two....putting the responsibility of not settling on the shoulders of investors
We listened to input from many investors over the past several years.
the normal thing to say is...management and bod did not find the offers for settlement acceptable
JT wrote the response in his words..you don't need to put words in his mouth
There are simply no dots to connect..
We listened to input from many investors over the past several years. Such input included suggestions on what would be settlement terms that they would accept. The settlement terms that were suggested by investors were not available and we emphasized for many years that the courts can be unpredictable in such matters
c-
So the “parties” here mean amrn and hikma?
Any further reading here?
In accordance with the parties’ agreement, you can expect to see that this legal action will be consolidated with the current Federal Circuit appeal in the near term
Also when can we find out whether BB unloaded any position in q2?
e-
In accordance with the parties’ agreement, you can expect to see that this legal action will be consolidated with the current Federal Circuit appeal in the near term
m-
we will just have to see how this plays out
I have just never of a non-litigated District Court filing being consolidated with a fully litigated pending Circuit Court appeal.
c-
I think you misunderstood me ... 4.5 or even 6 is reasonable to me.
I SUSPECT amrn was insisting 9 just like many here.
c-
If I were bp, I will do the same, only offer what amrn can achieve with V or what v is worth to amrn. Why more?
Do you think the big gap between 9b and 1.8b? That is hard to bridge.
g-
result of new Fisher attorney just added
this new attorneys
Difference in "Nature of the Action".
Case No.: 2:16-cv-02525 (CAFC 20-1723)
This is a civil action for patent infringement arising under the patent laws of the United States, 35 U.S.C. § 100 et seq., and in particular under 35 U.S.C. § 271(a-c, e) for infringement of
U.S. Patent No. 8,293,728 (“the ‘728 Patent”),
U.S. Patent No. 8,318,715 (“the ‘715 Patent”),
U.S. Patent No. 8,357,677 (“the ‘677 Patent”),
U.S. Patent No. 8,367,652 (“the ‘652 Patent”),
U.S. Patent No. 8,377,920 (“the ‘920 Patent”),
U.S. Patent No. 8,399,446 (“the ‘446 Patent”),
U.S. Patent No. 8,415,335 (“the ‘335 Patent”),
U.S. Patent No. 8,426,399 (“the ‘399 Patent”),
U.S. Patent No. 8,431,560 (“the ‘560 Patent”),
U.S. Patent No. 8,440,650 (“the ‘650 Patent”),
U.S. Patent No. 8,518,929 (“the ‘929 Patent”),
U.S. Patent No. 8,524,698 (“the ‘698 Patent”),
U.S. Patent No. 8,546,372 (“the ‘372 Patent”), and
U.S. Patent No. 8,617,594(“the ‘594 Patent”).
This is a civil action for patent infringement arising under the patent laws of the United States, 35 U.S.C. § 100 et seq., and in particular under 35 U.S.C. § 271(a, b, e) for infringement of
U.S. Patent No. 8,293,728 (“the ‘728 Patent”),
U.S. Patent No. 8,318,715 (“the ‘715 Patent”),
U.S. Patent No. 8,357,677 (“the ‘677 Patent”),
U.S. Patent No. 8,367,652 (“the ‘652 Patent”),
U.S. Patent No. 8,377,920 (“the ‘920 Patent”),
U.S. Patent No. 8,415,335 (“the ‘335 Patent”),
U.S. Patent No. 8,426,399 (“the ‘399 Patent”),
U.S. Patent No. 8,440,650 (“the ‘650 Patent”),
U.S. Patent No. 8,518,929 (“the ‘929 Patent”),
U.S. Patent No. 8,524,698 (“the ‘698 Patent”),
U.S. Patent No. 8,546,372 (“the ‘372 Patent”), and
U.S. Patent No. 8,617,594 (“the ‘594 Patent”).
On October 12, 2018, the parties to the new action filed a stipulation and proposed order (Exhibit B attached hereto) which (a) acknowledged that the infringement and validity issues presented by the new 500 mg dosage strength litigation were substantially identical to those in the ongoing consolidated actions; (b) agreed that the prevailing party in the consolidated action would be entitled to a corresponding consent judgment in the 500 mg dosage strength action; and (c) asked the court to stay the 500 mg dosage strength action until the outcome of the consolidated action. ...
No further action took place in the 500 mg action until after the district court entered judgment in the consolidated action on March 30, 2020. After that judgment, the parties agreed to enter a corresponding consent judgment in the 500 mg action. ... The district court entered the consent judgment on May 4, 2020.2 Plaintiffs-Appellants filed a timely Notice of Appeal from the consent judgment on May 22, 2020. ...
Here, the appeals involve the same asserted claims from the same patents-insuit, and therefore involve the same factual and legal issues. ...
In addition, Amarin asserts in this lawsuit patent claims that contain non-obvious limitations as compared to the claims invalidated by the March 30, 2020 judgment. The issues raised by the additional patent claims Amarin asserts in this lawsuit are not identical to the claims that were previously invalidated.
Upon information and belief, on or before June 1, 2020, Defendants, through Hikma Pharmaceuticals USA, Inc., submitted to the FDA an amendment to ANDA No. 209457 to obtain approval for 0.5 g icosapent ethyl capsules purportedly bioequivalent to VASCEPA