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r-
Reverse 75+%*
Affirm 20+%*
Remand <5%
Settle 0.00% (-100% ....)
Best,
G
* subject to change
B-
we can assume that the AMRN team pulled any and all relevant evidence from the record.
Cases get decided based on the record, not the emotions and frustrations of the party (or its shareholders) that lost at trial.
brain is beyond tired, not thinking clearly and having visual migraines now - had a horrendous allergy attack yesterday that knocked the crap out of me, so if I wrote some dumb stuff today
g-
complete reading of the defendants' expert testimony on Kura interpretation
does the defendants expert's claim of "no statistical difference between the two groups" apply to LDL-C only or both LDL-C and Apo B?
r-
Does Amarin gain anything here, besides Apotex not challenging their RI patents?
B-
what day was this testimony and who is the witness?
Is your point that this testimony was not presented vis a vis Mori?
Substitute "Apotex" with "Hikma and DRL" - Apotex is no longer a threat after settling with AMRN to delay until 2029 - did you miss that news or is it a statin caused memory issue?
B-
the problem we have is that AMRN did not present an expert who testified as to the proper statistical interpretation of the Mori and Kur studies.
Q How would a person of ordinary skill in the art determine the effect of EPA alone on LDL cholesterol, given the results in Kurabayashi?
A Well, what you can conclude in this study is that in a patient treated with estriol, that EPA intervention lowers the LDL cholesterol relative to a person who is taking estriol that didn't get the EPA. So in other words, this is -- for this specific population where both groups were treated with estriol, EPA lowers the LDL cholesterol in that -- in that particular
Q And
A -- group.
.
.
.
Q But -- but it's fair to say from the results presented in Kurabayashi that EPA did not, in a statistically significant way, reduce LDL-C cholesterol compared to control?
A Okay. I'm having to look at the figure legend here, because I think this is a fairly technical point. Yes, okay, I think that's reasonable conclusion. It looks like there were similar reductions in LDL cholesterol in both groups.
Q Right. Numerically, estriol alone reduced LDL-C to a greater extent than estriol plus EPA, correct?
A Well
MR. REIG-PLESSIS: Objection to form.
A -- I think the correct interpretation is there's no statistical difference between the two groups.
Q (BY MR. SIPES) Right. The -- which is to say the addition of EPA to estriol did not make any statistically significant difference on LDL-C?
A I think it would be correct to say that in this particular study in these patients, yes.
g-
will the 715 and the 677 patents be validated if the unexpected benefit of Apo B reduction be recognized by the CAFC panel of judges?
P- (& HinduKush)
My post was not about V vs gV or about anything but (as I quoted)
a drug that required one brand for one indication and another brand for a different indication
P-
As a pharmacist I have never seen a drug that required one brand for one indication and another brand for a different indication.
if sales drop
don't think for a second that Thero wouldn't do another secondary priced at four or five bucks!
If somebody would like to read the two (three) USPTO documents:
- 2-16-cv-02525-MMD-NJK - Doc 89 - Exhibit 27
- 2-16-cv-02525-MMD-NJK - Doc 262 - Exhibit 18
It is available "across" the sticky ( 20-1723 Appeal (& 216-cv-02525-MMD-NJK) ) or directly: DC; 216-cv-02525-MMD-NJK Available documents
Best,
G
ps.: maybe additional USPTO docs are available in other docs also
(Relevant) Events:
Dancing in the dark: If you think, please replace my previous post (sticky) with this one. Thx.
June
- June 26 : Plaintiffs-Appellants’ Reply Brief (CAFC)
July
- July 1: Joint appendix (CAFC)
- July 6: Preliminary Q2 (TBC)
- 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 … *clock restart)
- Healthcare professional and consumer launch
August
- Week 32: Q2 2020 (10-Q and CC)
September
- Week 36 (August 31- September 4): Oral argument (CAFC) …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)
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.) if something will be sometime during the relevant quarter it is listed for the last month of the quarter
Best,
G
ps.: alternative (“longest”) EMA timetable
- June 25: CHMP meeting, Request extension of time (+3-months) for response to Day 120 LoQ, March 26
- October 9*: Response to Day 120 list of questions (LoQ), March 26
- December 10: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- February 15: Commission Decision / formal approval (based on Day 180 Opinion by EMA, December 10)
- March 25: CHMP meeting, Request extension of time (+3-months) for response to Day 180 LoOI, December 10
- June 22*: Response to Day 180 LoOI, December 10
- July 22: Day 210 Opinion by EMA / recommendation of approval
- September 27: Commission Decision / formal approval (based on Day 210 Opinion by EMA, July 22)
g-
without this settlement, you would see a headline about the FDA has approved Apotex's ANDA within the next week or so
H-
See my recent post ( #280973 )
At least two (three) docs (from the USPTO) is available:
- 2-16-cv-02525-MMD-NJK - Doc 89 - Exhibit 27
- 2-16-cv-02525-MMD-NJK - Doc 262 - Exhibit 18
Meanwhile ... I waiting patiently for the quote by eightisenough ... the relevant part of the Order (about USPTO PFO) that says: LDL-C and/or Apo-B effect is/are PFO acc. to the USPTO ...
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
DC; 216-cv-02525-MMD-NJK Available documents
Best,
G
e-
I don't have access to the USPTO documents--just relied on Du's ruling.
Also, this case is unlike many other obviousness cases because, when the Patent Office issued the patents-in-suit, it maintained its finding from earlier rejections that the prior art rendered all of the claims prima facie obvious. (Ex. 1521 at 1822-35, see also id. at 1830-31.) As the examiner explained, “it was concluded that it will be obvious to treat patients having triglycerides above 500 mg/dL with 96% pure ethyl-EPA."
"the Examiner concluded that it would be prima facie obvious to treat patients having TG above 500 mg/dl with 96% pure ethyl-EPA"
JL-
Why do we have these governmental agencies like the USPTO or the FDA who cost the tax payers so much if one brainless ignoramous of Judge can strike them down with no rhyme or reason.
e-
You're Incorrect-USPTO stated Vascepa obvious to not increase LDL as well. Read Du's ruling she strongly relied on it.
Also, this case is unlike many other obviousness cases because, when the Patent Office issued the patents-in-suit, it maintained its finding from earlier rejections that the prior art rendered all of the claims prima facie obvious. (Ex. 1521 at 1822-35, see also id. at 1830-31.) As the examiner explained, “it was concluded that it will be obvious to treat patients having triglycerides above 500 mg/dL with 96% pure ethyl-EPA."
"the Examiner concluded that it would be prima facie obvious to treat patients having TG above 500 mg/dl with 96% pure ethyl-EPA"
e-
Point #1 is USPTO fault--for giving her the prima facie of obviousness (they ruled non obviousness only b/c sec. cons. which makes things complicated)
Settlement ... management attitude ... etc.
If you have a car (Vascepa) parking at the front of your house ... you think it worth $500k (valid patents) and somebody offers $250k (Generics' settlement proposal): will you wait for the next offer (DC Order) or not?
Next day, somebody drives her/his car into your parking car (DC Order) and your car worth $100k now ... Were you incompetent? Were you stupid?
But no (real) problem, the insurance Co (CAFC) will pay you ... and the repaired car could be sold for $499.999k
Best,
G
c-
the 180 days definition should start from dc ruling
(AA) In an infringement action brought against that applicant with respect to the patent or in a declaratory judgment action brought by that applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed.
not launch
The FD&C Act provides that the 180-day exclusivity period is triggered by “first commercial marketing of the drug (including the commercial marketing of the listed drug) by any first applicant
otherwise, what if first ANDA receiver dragged their feet and never came to market? Then all other applicants have to wait forever?
Also, based on your quote here, does this mean each one in the chain will has a 180 days excluding upon subsequent ANDA filers?Hikma got 180 first, then R got 180 in front Teva?
So amrn has not filed suit yet, filed but has not realesed cc yet, or settled already? Silence...
c-
Yep
On May 6, 2020, Amarin received a new notice from Apotex with new paragraph IV certifications (the “2020 Notice”). The 2020 Notice reflects that Apotex has amended its ANDA and has made new paragraph IV certifications with regard to patents listed in the Orange Book for the VASCEPA indication, originally approved by the FDA in July 2012, for the reduction in triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. As previously disclosed, Amarin is currently appealing the United States District Court for the District of Nevada’s March 30,2020 ruling in favor of generic companies in Amarin’s patent litigation against two filers of ANDAs for VASCEPA (the “Nevada Litigation”) to the United States Court of Appeals for the Federal Circuit. The 2020 Notice alleges to varying degrees that the certified patents, including those subject to the Nevada Litigation and related appeal, are invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of the proposed generic product for which the Apotex ANDA was submitted. In light of the Nevada Litigation and related appeal, Amarin is currently considering the most effective path to respond to the 2020 Notice and plans to update investors at an appropriate time after such decision is acted upon. Because Apotex is not a party to the Nevada Litigation or related appeal, it is not directly subject thereto. Generally, options include litigation and settlement.
g-
That's my take in this case.
Q18. Does 180-day exclusivity block approval of all ANDAs that reference the same RLD?
No. 180-day exclusivity blocks only the approval of subsequent ANDAs that also contain a paragraph IV certification. There are several examples in which 180-day exclusivity does not block approval of another ANDA referencing the same RLD:
• If an ANDA was approved before the NDA holder submitted a patent that provides the basis for first applicant status for a pending ANDA, any related 180-day exclusivity would not affect the previously approved ANDA.
• If an ANDA applicant seeks to omit the approved method(s) of use covered by a listed patent with a section viii statement, another ANDA applicant’s paragraph IV certification to that same patent, and any related 180-day exclusivity, would not block approval of the ANDA that contained the section viii statement.
• If a patent was late-listed vis-à-vis a pending ANDA under FDA’s regulations, a first applicant’s paragraph IV certification to that patent, and any related 180-day exclusivity, would not block approval of the ANDA for which the patent is late-listed and for which
as a result no patent certification was required.
AFAIK Apotex doesn't have an ANDA filed with the FDA, believe they withdrew when AMRN filed the patent lawsuit
anyone think it's a little odd that only Hikma has gotten it's ANDA approved? DRL hasn't - maybe they didn't meet FDA quality or PK requirements
N-
A hypothetical example illustrates how FDA determines whether forfeiture has occurred under the “failure to market” provision. For the purposes of evaluating item (aa), presume that on June 1, 2009, the applicant for ANDA A submitted its substantially complete application containing a paragraph IV certification, which it lawfully maintained. FDA approved the ANDA on December 20, 2012, and the 75-day period identified in subitem (AA) of this forfeiture provision ended on March 4, 2013. Thirty months after the date the ANDA is submitted was December 1, 2011 (the date identified in subitem (BB)).
The relevant date for item (aa) of the forfeiture analysis is December 1, 2011, the earlier of these two dates.
For the second part of the analysis under item (bb), presume that on January 1, 2013, a court entered a final decision (from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken) that the relevant patent is invalid and not infringed in an infringement action against a subsequent applicant for this RLD whose ANDA received tentative approval at some point before FDA makes the forfeiture determination. The relevant forfeiture date for ANDA A pursuant to subitem (AA) is March 17, 2013, 75 days after the date on which the court issued its decision. Notably, this date applies even though ANDA A in this example was not the subject of the litigation.
In this scenario, the failure to market forfeiture provision requires the first applicant to market by March 17, 2013, the later of the dates applicable under item (aa) (December 1, 2011) and item (bb) (March 17, 2013). In this example, if ANDA A applicant did not begin commercial marketing until after March 17, 2013, it would forfeit its exclusivity.
Hikma has to market (to get 180-day excluvity) on or before the 75th day after CAFC decision.
+ Q15 and Q16
Guidance for Industry, 180-Day Exclusivity: Questions and Answers
Best,
G
N-
About exclusivity.
FDA ANDA approval comes - sometimes - during the 180 days, when the clock is running (due to court decision) already.
Best,
G
g-
The FDA approval does not trigger a 180-day period. It is
a.) market launch or
b.) court decision
IIRC there is other condition also ... launch within 180 day after approval
Best,
G
ps.: Please note I did not fully DD the topic and the DD was weeks ago. I do not see it as a material issue / topic
B-
earliest: recommendation for approval by EMA by end of June ... approval by the EU by late August / early September (if Amarin answered the 120-day letter before end of April and no Phase 3 process)
"standard"#1: recommendation for approval by EMA by end of September ... approval by the EU by late November / early December (if Amarin will answer the 120-day letter before end of June and no Phase 3 process)
"standard"#2: recommendation for approval by EMA by end of January 2021 ... approval by the EU by late March / early April (if Amarin will answer the 120-day letter before end of June and Day-180 letter before end of December and Phase 3 will exist)
latest: recommendation for approval by EMA by end of June 2021 ... approval by the EU by late August / early September (if Amarin request extension of time - to reply - in Phase 2 and Phase 3 also and Phase 3 will exist
risk: after US and Canada approval ... 0.000000%. It is a question of when only.
Best,
G
I stopped to (closely) follow or project script# years ago ... (just like stopped P&L, BS, CF - long-term - projections). These are not relevant for me since beginning of 2018.
Don't worry ... you were correct (Typo on my side).
K-
Teva has to wait 6 mths following a launch by Hikma
They didn't burn any cash in Q1
JL-
Any idea what certain customary circumstance might be?
JL-
Actually the rule in most cases is the cheapest alternative is awarded the Tier one and in most cases that is the generic..
Its just it will not be Amarin vs Lovaza it will be Teva {if they make gen Lovaza} against Reddi and Hikma..
The same thing will happen to the generics unless they can sell gen Vascepa cheaper than gen Lovaza..(not likely)
sts-
they filed ANDAs in 2016 when the 5 yr NCE exclusivity expired.
V was approved in 2011
t-
I was giving you a compliment.
I don’t always agree with your style