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Do you have any idea what about you are talking ….?
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i- (circuitcity / 275375)
It is a full approval, Hikma met all requirements (inc. show/prove their generic version is bio-equivalent to Vascepa)
z- "Agree" …. except:
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It is not from the appeal … it is from the DC case .. it was written by Covington.
Best,
G
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20-1723 Appeal
CalMustang: Please replace my previous post, sticky this one. Thx.
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)
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
Best,
G
20-1723 Appeal
CalMustang: Please replace my previous post, sticky this one. Thx.
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)
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
Best,
G
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LOL … pathetic …
First line: (Relevant) Events
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I do not expect any. Meanwhile Judge Du made / applied some "unique" (e.g. weighting SCs against each other) approach, it is one of many patent cases … the CAFC will address it / these.
Basically I do not care, the case does not depend on amicus brief(s). I see one area only (where it could be useful): the HTG vs VHTG topic.
Best,
G
(Relevant) Events:
Dancing in the dark: Please replace my previous post (sticky) with this one. Thx.
May
- May 19: Amicus curiae… if any
June
- June 16: Defendants-Appellees’ Responsive Brief
- June 26 : Plaintiffs-Appellants’ Reply Brief
July
- July 1: Joint appendix
- July 17: Response to Day 120 list of questions (LoQ), March 26 (Please note: all EMA deadlines – below – are based on response by July 17. Amarin has three months to answer the LoQ but the no clock restart in June.)
August
- (Week 32) Q2 2020 (10-Q and CC)
September
- Week 36 (August 31- September 4): Oral argument (FCA) …Meanwhile August is technically possible it is not likely, September is the earliest, realistic time but could be later
- September 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)
November
- Week 45: Q3 2020 (10-Q and CC)
- November 23: 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 (FCA) (average time is 4 months after oral argument)
- January 28: Day 210 Opinion by EMA / recommendation of approval
February
- Healthcare professional and consumer launch: Delayed until after sales representatives can resume face-to-face meetings and pending successful ANDA appeal
April
- April 5: 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.) if something will be sometime during the relevant quarter it is listed for the last month of the quarter
Best,
G
ps.:
(i) alternative EMA timetable, calculated by the 2-months reply
- May 22: Response to Day 120 list of questions (LoQ), March 26
- July 23: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- September 28: Commission Decision / formal approval (based on Day 180 Opinion by EMA, July 23)
- September 15: Response to Day 180 LoOI, July 23
- October 15: Day 210 Opinion by EMA / recommendation of approval
- December 21: Commission Decision / formal approval (based on Day 210 Opinion by EMA, October 15)
(ii) appeal: The Life of an Appeal
20-1723 Appeal
CalMustang: Please replace my previous post, sticky this one. Thx.
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)
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
Thanks to raf- for the Docs.
Best,
G
LOL … breathofthenightwind added more to the board than you … The pot calling the kettle black.
Something rotten in Denmark … The 'something' is not a question anymore ...
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My post (and this discussion) was about FDA approval and not about the patent case.
The points here are that:
- Marine indication were granted by FDA to Amrn on the basis of lowering high TG's. Meanwhile the ability to lower TG's without increasing LDL is good thing it was not a requirement
- ANDAs will be approved based on written requirement
Best,
G
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