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Raf - Error for 6/25 Vascepa Rx numbers
The numbers for TRx should equal NRx + Ref. They don't. Can you please check and correct?
Thanks for your work.
Marjac- Re Rule 24/60 AMRN Appeal: Is it certain the appeal can/must be filed w Federal Circuit. Is it possible it might be kicked to the 9th Circ as the Rule 24 question is not directly re patents. My question as a non-lawyer.
Ourrrr out!!!
Kiwi
All branded (and probably generic) drug pricing (including V) is probably best understood as a game of 3 card Monte.
The following $ amounts are estimates for illustration only (don't get lost in the tress and miss the forrest).
V is "priced" at about $310/120 gm. [I think]
But AMRN only sees Net product revenue of about $110/120gm
(=> -COGS 22% => GM $86/120gm)
Where did the other $200 go? Well (for insured patients), Pharmacy + Distributor + PBM + contractual allowance (w Insurors) + Coupon rebate have split that bag o' money.
I'd guess that AMRN would have to decrease 'price' by $2-3 for insuror to see a savings of $1 - but don't really know how the middlemen adjust their charges (as they are eventually a cost to the insurors though appear to be a cost to AMRN and further complicated by PBMs-insurors-pharmacy vertically integrated ). Would love to hear from a health insurance pro, but it seems costs need to be wrung out from PBM and Distributors.
Wonder if AMRN could offer special coupon to patients with documented Marine indication that would undercut generic pricing??? Why would any (non-government covered) Marine patient choose a generic?
BB
I can't seem to find the patent expiration dates for those Marine patents invalidated in Nevada/CFC. Do you know when they would expire if the case was successfully reversed?
Thanks for your efforts.
HDG-
I'm not a lawyer - and the various rules for inducement/infringement invariably leads to confusion. So for a layman can you address the following.
Are Drug Distributors (who are at least the conduit for drugs to get from OEM to Pharmacy - they are a wholesaler between the drug originator and the pharmacy) at risk for inducement or infringement. I don't know if the big chains (CVS, etc) have the distributor function in house, but the same risks would apply to that situation. I'm not talking about the pharmacist in the store.
Thanks for your time.
sts66- Answer to your question might be my post 306348
Lawyers, Invest83838 and others. Could you opine on if Drug Distributors (who are at least the conduit for drugs to get from OEM to Pharmacy - a wholesaler) are at risk for inducing infringement. I don't know if the big chains (CVS, etc) have the distributor function in house, but the same risks would apply to that situation. I'm not talking about the pharmacist in the store.
If they are aware (or made aware) that 95% of V use is for reduce-it indication, shouldn't they be delivering this percentage and if not, inducing infringement?
8nuf
-Du relied on Mori-that's why MORI must be refuted NOT Kurabayashl ???
If APOB claims weren't dismissed, Marine patents would not have been invalidated. Right?
HK- Thanks for your very detailed response per Dr Lavin. I really don't know, but it seems he may think the Hayashi subjects had a sd <100. Maybe I should be able to tell from the table but it is confusing.
HK, Please return to your Hayashi paper. I think you meant to use scatter plots on figure 2 (triglycerides x-axis) rather than figure 1 (chol x-axis). X-axis ends at 400-450 and N is <total population for the y=axis testing. Also, not sure how you got the std curve mean at 300 w std 133. Table 1 TG at baseline 300 +/- 233.
Also, from the paper p26 "LDL cholesterol (LDL-C) concentration was calculated by the Friedewald equation" - so, didn't calculate it for subjects w TG >400 (I guess).
HinduKush-
Been too long for me to recall 1way repeated measures ANOVA. Wondering if differing drop-outs between baseline and 48 weeks for the EPA and "Control" groups can undermine the stat findings. The N for "Control" is 72 at baseline, 69 at week 12, 66 at week 24, 63 at week 48. While for EPA the Ns are 69, 63, 59 and 55 respectively.
Do you (or anyone) know if the 1way repeated measure ANOVA looks at all 4 periods or just baseline and week 48? Do the drop-outs invalidate this approach? Would the p value be the same if only subjects present at week 48 were compared to those same patients at baseline?
Does -- 21 USC 355-2: Actions for delays of generic drugs and biosimilar biological products --affect the generic's access to the API
To find this go to https://uscode.house.gov/advancedSearch.xhtml ....
Search in version: CURRENT +
SEARCH IN TITLE: 21 +
SEARCH FOR: REMS
I suggest you find this section mentioned above.
Some snippets from this follow to give you my concerns re generics having difficulty getting API. I'm not a lawyer (and barely litterate in my reading anything related to US code) so I might be totally wrong re my concerns.
From the above:
commercially reasonable, market-based terms" means- nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug
"covered product" means- any drug approved under subsection (c) or (j) of section 355 of this title or biological product licensed under subsection (a) or (k) of section 262 of title 42 and does not include any drug or biological product that appears on the drug shortage list in effect under section 356e of this title, unless-
(i) the drug or biological product has been on the drug shortage list in effect under such section 356e of this title continuously for more than 6 months or Secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage
term "eligible product developer" means a person that seeks to develop a product for approval pursuant to an application for approval under subsection (b)(2) or (j) of section 355 of this title or for licensing pursuant to an application under section 262(k) of title 42;
Civil action for failure to provide sufficient quantities of a covered product
An eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the United States alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable, market-based term
as of the date on which the civil action is filed, the eligible product developer has not obtained sufficient quantities of the covered product on commercially reasonable, market-based terms;
that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable, market-based terms-
Affirmative defense
In a civil action brought under paragraph (1), it shall be an affirmative defense, on which the defendant has the burden of persuasion by a preponderance of the evidence-
(A) that, on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder-
(i) neither the license holder nor any of its agents, wholesalers, or distributors was engaged in the manufacturing or commercial marketing of the covered product; and
(ii) neither the license holder nor any of its agents, wholesalers, or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable, market-based terms;
(B) that-
(i) the license holder sells the covered product through agents, distributors, or wholesalers;
(ii) the license holder has placed no restrictions, explicit or implicit, on its agents, distributors, or wholesalers to sell covered products to eligible product developers; and
(iii) the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable, market-based terms from the agents, distributors, or wholesalers of the license holder
4) Remedies
(A) In general
If an eligible product developer prevails in a civil action brought under paragraph (1), the court shall-
(i) order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable, market-based terms;
(ii) award to the eligible product developer reasonable attorney's fees and costs of the civil action; and
(iii) award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable, market-based terms, if the court finds, by a preponderance of the evidence-
B) Maximum monetary amount
A monetary amount awarded under subparagraph (A)(iii) shall not be greater than the revenue that the license holder earned on the covered product during the period-
BB
Did you notice Teva has 500mg cap approved - but not H or R ?
Also- Teva approval letter dated 6/5/2020 states...
The introduction or delivery for introduction into interstate
commerce of this drug product before the final approval date is prohibited... until the Agency issues the final approval letter, this drug product will not be deemed approved for marketing under section 505(j) of the FD&CAct, and will not be listed in the Orange Book. Should you believe that there are grounds for issuing the final approval letter prior to December 13, 2022, you should amend your ANDA accordingly.
With respect to both strengths, the Agency notes that the '0,086, '994, '077, '245, '144, '871, '185, '475,
'041, '892, '826, '272, '001, '984, '985, '986, '537, '954, '517, '287, '935, '936, '937, '840, '924, '925, '861,
and '054 patents were submitted to the Agency after submission of your ANDA. In addition, with
respect to the 1 gram strength, the Agency notes that the '472 and '166 patents were submitted to the Agency after submission of your ANDA. Litigation, if any, with respect to these patents would not create a statutory stay of approval.
HK + HAMOA + NORTH + ATTORNEYS
If you have a few minutes you will probably find this short article interesting.
Judge Michel, Panelists Contemplate the CAFC Past, Present and Future on Day Two of CON2020
9/2/2020 -- note the ignominious date
Judge Paul Michel is a retired U.S. Court of Appeals for the Federal Circuit (CAFC) Chief Judge.
https://www.ipwatchdog.com/2020/09/02/federal-circuit-today-judge-michel-panelists-contemplate-courts-past-present-future-day-two-con2020/id=124826/
There is a short section on Excessive Use of Rule 36.
Suggest reading down to comments- interesting. Maybe consider adding a comment there re 20-1723
North, Marjac etal
Is there still a chance for a de novo review before a ruling? If yes, what does this entail - just reading all 100,000 or so pages of the district materials (including depositions) + appellate briefs? Would it ever include the judges getting a statistician amicus opinion? Looking at a patent to see Kura listed?
Thanks to all the lawyers for their time in providing opinions.
zip1
To the lawyers well acquainted with FC proceedures
Would the FC consider appointing a statistics rapporteur to advise the court - if the generics refused to accept a statistical error exists? (Assuming the court seeks truth).
Rmitra , Megc
Sorry for being OCD, but on 4/3 post#261017 I said
Hamoa
Would the FC consider appointing a statistics rapporteur to advise the court - if the generics refused to accept a statistical error exists?
BTW, some say Bhatt analysis is for JAMA publication - I don't think so. Paper is on SSRN / Elsevier.
Not tooting my own horn - but - I said something like this in a post here on 4/3/20 (#261017).
Lawyers-
Can you explain what a Yes vs No vote means for this compensation question?
Kiwi - CVR proposal
I posted this a month ago (#271421) but doubt anyone saw it.
A modest proposal for BP-AMRN
CB, #s11 and zmanindc re AMRN valuation w appeal(s) overhang.
A variable CVR (exchange listed) could answer concerns re US value. Value of CVR is based on # of V gms sold x cents/gm. Currently we net $1.10 per gm and have gross margin of circa 77% ($0.85). BP's SG&A for V would be a negligible fraction of A's.
So can we agree on a #cents/gm? I would favor coming up with a number to use while no generic competition and a 2nd smaller number when generics are marketed.
For illustration only: FOR US ONLY- While no generic competition (but no later than end 2029 -don't recall exact date) - if they agree to about 60% of current gross margin (ie 0.50). Once generic market competition present (up to end 2029) - about 30% of current gross margin (ie 0.25).
With these cents/gm - 1 patient = 365 x 4g/d = 1460 g/yr. If no generic = 1460 x 0.50 = $730. If there is a generic = 1460 x 0.25 = $365/yr
If you think V sells w/o competition x 9 yrs and patient numbers are 1-2-3-4-5-5-5-5-5 M... you get to $25.550 B. If you think V sells w competition starting now and V sells to 0.5 M patients for all 9 years ... you get to $1.643 B. (This may highlight BP and A valuation difference of opinion)
I would also like to see CVR protection from transfer of V marketing rights, payments for recovery from generic at risk launch and periodic payouts (keeping tax consequences in mind). Need to prevent problems w V importation from Canada, Europe etc.
I've been long 4ever and lurking for a year. Just signed up cause I wanted to see if the lawyers felt a stat person could present graphics to Judge Du to demonstrate the deficiencies in the Mori paper. Sorry if this is duplicative - Im hundreds of posts behind.
Problems w Mori(2000) which negate any value in evaluating AMRN patent
1. Baseline (N=19) TG level FOR EPA GROUP reported as 2.01 ± 0.19 mmol/L [x ± SEM]. Converting SEM to sd --> 0.19 * sqrt 19 = 2.01 ± 0.8282 [x ± sd]. 1.96 sd = 1.623. So 97.5% of group have a baseline TG < 3.633 mmol/L == 321.8 mg/dl.(ie expect >18.5 of 19 patients in the EPA group to have a TG < 322). Aren't the patents in question in patients with TG >500?
2. Post treatment decrease in TG levels 21.6% greater for DHA than EPA - so expect LDL-C to increase more in the DHA group. I don't know if it is proper to refer to the Friedewald equation, but LDL-C est as = TC- HDL-C - (TG/5) suggests that decreasing TG by 21% more could increase LDL-C by 4.2% more.
3. Post treatment LDL-C INCREASED in the EPA Group from 4.28 ± 0.19 [x ± SEM] to 4.46 ± 0.10 [x ± SEM] (+ 4.0%) while in the DHA Group from 4.27 ± 0.17 to 4.64 ± 0.10 (+ 8.7%). How do we know a 21% greater reduction in TG levels (by DHA cf EPA) shouldn't be expected to increase LDL-C by this amount over EPA? It seems to concur with the 4.2% expected above.
4. The paper compared the EPA group to the control and the DHA group to the contol - but not to each other. Converting to std dev gives a post treatment LDL-C range [x-sd to x+sd] of 4.024 - 4.896 for the EPA group and 4.248 - 5.052 in the DHA group. I think we would need to know the TG and LDL-C levels for each individual patient to know for sure, but I'd bet there would be enormous overlap between these 2 groups and some stats guru could prove.