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LOL, no Raf - Congratulations to Erin Gilbert though indeed. Good for AMRN for putting a woman in the good old boy's club of manufacturing.
Not much to comment on after the end of last March 2020 - UGH. Sad day in Nevada for AMRN longs. Somebody emailed your post to me, otherwise not much to see here other than a long slow grind to gain a little bit of European marketshare.
Hope all is well in NC for you and with all the long suffering longs in this heart rending ticker.
NOAA Science Seminar this morning at 9AM (PST)-
www.nodc.noaa.gov/seminars/
"What is the status of fish stocks around the world and the role of fisheries management?" is the title of the presentation.
If you click on "Expand" then you can register at "Remote Access" to input your email to get an access link for the webinar.
It's a distraction at least from the horrible decision out of Nevada and the corona epidemic.
With Cox trial set for Aug 18th now-
should we ask Judge Andrews to shelter-in-place until then?
Nice 53 degree & sunny day here in Seattle.
Woohooooo! I imagine JT will have fun in SF next month. Yo, he got mo' leverage!
What a way to drag out the label approval announcement today though with Woodcock's foreshadowing. I bet she was having some fun too. LOL. If I've learned nothing else here, it's to expect the unexpected.
I was actually just joking around back.
It can later on be part of the proof of service. Courts generally require some kind of proof of service - or that you've informed the other party such as what you file with the court, the judge will require you to send copies to the other party. You can also ask to have proof of service waived such as when you don't know where the other party is or you could ask to have a different kind of service. If you send it snail mail - then how do you prove later on that the other party was notified?
We've seen proof of service filings with Chanbond vs the 13 in the Pacers. Here in Washington State:
(g) Certified Mail. Whenever the use of "registered" mail is authorized by statutes relating to judicial
proceedings or by rule of court, "certified" mail, with return receipt requested, may be used.
Certified mail, signature required...
Ziploc- that was totally cool to see you on the ADCOM video testifying last month. Nice!
Just to clarify, regarding OMACOR (a drug) in Europe, they said it was not effective at 1 g/day for preventing further heart or blood vessel issues in patients who have had a heart attack. See STS post from 12/14/18 #167148. That decision was appealed to the EMA by BASF and then on March 28th they let their December decision remain. See BiotechRes post#184278 & STS post#184454. As far as I know, OMACOR today is still approved for reduction of >500 TGs in Europe.
www.ema.europa.eu/en/documents/referral/omega-3-acid-ethyl-esters-assessment-report-following-re-examination-procedure_en.pdf
Both O-3 drugs and DS are legal in Europe, Japan and Korea. As they currently are in the US, too.
Different Market/Product Regulatory Categories
Branded Drugs - Lovaza/OMACOR, Vascepa, Epadel, etc.
Generic Drugs - generic Lovaza, generic Epadel
OTC drugs - none?
Medical foods - Hepacor, etc
DS - too many to list
Food - fish, algae drinks & smoothies, infant formula, etc.
Tal10 - did you miss the part this summer where the FDA already noted the qualified health claim for dietary supplements regarding O-3? In the one year I’ve been on this board there have been repeated posts concerning composition of “synthetic” DS.
Zugis- I could only speculate on why MMs distribute or accumulate theIr share inventory and timing the way they do. AMRNBULLFROMCHICAGO provides excellent color and commentary there.
Ziugis, that’s correct - the effect of today’s denial to hear the case is a neutral in the marketplace.
FDA ruling on Amarin’s label expansion is entirely separate from the Supreme Court’s decision to not take up the case..
Ziugis: AMRN was trying to have ALL DS (dietary supplements) blocked from being imported into the US through the ITC. The FDA does not consider fishoil to be a “drug” - it’s a DS. So, this was an attempt to go around the FDA by having the ITC effectively block all imports of DS into the US.
I figured Joe Kennedy, AMRN’s General Counsel, liked the intellectual challenge of attempting to get SCOTUS to hear this. I get it. But, this ITC case was the Mother of Hail Maries all along as I correctly noted last fall.
This means status quo in the marketplace - fishoil will still be a DS. Vascepa will still be a branded drug.
SG filed brief today in Arris v Chanbond says case is different than Thyrv b/c board never issued a final written decision due to time bar. Also, SG adds no need for court to wait for itself on its Thryv decision...
My emphasis below on what SG is saying today is difference btw Thryv and Arris (v Chanbond), pg 13 and 14. www.supremecourt.gov/search.aspx?filename=/docket/docketfiles/html/public/19-455.html
If this Court concludes in Thryv that Section 314(d)
precludes judicial review of the USPTO’s Section 315(b)
determinations on appeal from a final written decision,
that holding would provide an additional ground for
concluding that the Federal Circuit lacked jurisdiction
to review petitioner’s challenges to the USPTO’s noninstitution decisions here. But even if this Court renders a contrary holding in Thryv, its decision is unlikely
14
to cast doubt on the Federal Circuit’s dismissal of petitioner’s appeals. The question in Thryv is whether, in
exercising its jurisdiction to review the Board’s final
written decision on the merits of patentability, the court
of appeals can consider the patent holder’s contention
that Section 315(b) barred the review. Here, by contrast, the Board never issued an appealable final written decision because the USPTO declined to institute the requested review.
Because the Board never issued a final written decision, this case (unlike Thryv) does not present any questions concerning the scope of the Federal Circuit’s review authority under Section 319. And as explained above, the Federal Circuit’s decision in this case rests
on the independent ground that no provision in the AIA
or the APA affirmatively authorizes judicial review of
the USPTO’s non-institution decision. Dismissal of the
appeals on that ground was correct, regardless of
whether or how Section 314(d) applies to Section 315(b)
determinations. There is accordingly no need for the
Court to hold the petition in this case pending the
Court’s disposition of Thryv.
CONCLUSION
The petition for a writ of certiorari should be denied.
Respectfully submitted.
NOEL J. FRANCISCO
Solicitor General
JOSEPH H. HUNT
Assistant Attorney General
MELISSA N. PATTERSON
SARAH E. WEINER
Attorneys
DECEMBER 2019
BrokeAgent, Arris (COMM) IPR was time barred as we know.
Specialneeds, maybe one of our national newspapers of record will give this case more coverage once we get a ruling on it.
I looked over the list of organizations that filed Amicus Curiae briefs. Just some quick top-level observations FWIW,
- NYIPLA: filed in both RPX and Thryv. No surprise there; job security.
- I-MAK: Initiatives for Medicines Access & Knowledge in RPX b/c they want more IPRs to send more drug patents to the trash bin = more generics to the market faster => cheaper drugs
- AARP: filed in Thryv. Replaced I-MAK role. Same goal - cheap drugs.
- PhRMA: filed in Thryv. Drug lobbying group, protect drug patents.
- BIO: filed in Thryv. Biotech lobbying group, protect drug patents.
- Intel/members of tech community: filed in Thryv and RPX variously, protect tech patents.
My guess would be, gamble for a decision that would provide a rallying campaign point for 2020 election cycle provided the behind-the-scenes pressure on SCOTUS.
We know executive office, candidates, and Congress have been banging on about cheaper drug coverage. An attempt to get Judicial branch to rally & assert itself (jurisdiction) over US Govt position and PTAB to bash on patents (weaken them some more with never-ending appeals from judicial or administrative review; take your pick or use both patent challengers!) was probably too irresistible.
Man is a zoon politikon. My favorite Aristotle quote.
SCOTUS, w/a different case, taking up appeals on PTAB time-bar decisions on Monday in Thryv, Inc. v. Click-to-Call Technologies, LP (SCT docket no. 18-916)
patentlyo.com/patent/2019/12/supreme-appealability-appeal.html
Ranjo, yes BioB is right. I'm happy to see some of the big names in lipid sci on it. YES!!! to momentum
Dancing- very funny, you wrote "stuck"holders.
Zu, I thought so, too, and it matched up with what JT said back in August. It sounds like you have a firm understanding of supply chain dynamics.
More interpretations of the Veramaris (DSM-Evonik) algae O-3 claim-
www.undercurrentnews.com/2019/11/06/a-breakthrough-year-for-algae-omega-3/
Will Lar, 10-15% raw material allocation shifts would be more interesting.
1% pharma to 2% pharma - that's interesting in that it shows the category is growing. I'd consider that evolutionary growth...potentially setting the stage for much more.
AMRN has a ways to go before its actually disruptive. That is the idea with V though - create more value-add.
Some are already pleased:
Coca Cola, PepsiCo, Tab...RC and moonpies-
I don't use Coca Cola as an analogy for IPE because they have COMPLETELY different supply and demand structures. It is understandable how diffuse the analogy became because AMRN used Coke vs Pom to argue their ITC case. And the analogy also works to an extent in that patients should have it within reach like a Coke and AMRN is attempting a hybrid position in terms of DTC pharma marketing.
But, Coke is regulated like a CPG not a drug. In consumer research on beverages, there is NO product testing level at which Americans say "no, that's too sweet." Even if you discount that research somewhat because consumer panels want to please the researchers (CPG world is broken after all - look at Nielsen split this month as Connect isn't as profitable as it once was), it still shows that soda makers know they can keep adding more sugar, concentrating it further with a new flavor and slapping a new label on it to chase "premiumization", and we like it more. It's a very short time table from R&D to new label in CPG land compared to pharma.
In the US according to the USDA we consume per capita annually
40 lbs of sugar
22 lbs of hfcs
10 lbs of other sweeteners (excluding alcohol sugars).
Practically all regions on the planet grow sugar cane, sugar beets and/or corn.
Global supply in a given year of those 3 sweetener sources alone is about:
290,000,000 million mt
190,000,000 annual production (and the rest is carryover stock or in some phase of production)
The price of sugar trades between $0.14-$.0.25/lb because of all the subsidies, IMF loans, and its cash crop status for developing countries. It is easy to sell more sweetener - people crave it and the source is everywhere and cheap.
So, like soy and seed oils (close to 600,000,000 million mt annual production) the world consumes a lot of these easily mass produced sweet & addictive energy sources.
Contrast that with fishoil supply- 1,000,000 mt which in recent el nino years has been down as low as 835,000 mt. From that, O-3 DHC demand fluctuates with current (revised) numbers "showing" 185,000...210,000 mt (from 165,000-185,000 mt in the last decade).
There's a bit of a structural difference between these analogies.
See below for more trade data:
LOL Tasty! I think you DO have AMRN options fevaaah!
Happy Thanksgiving ALL!
Another year has rolled around and here's the 2019 John Lewis (and Waitrose) Christmas ad- Edgar has inflammation problems...
John Lewis
Tastytreat, will you still be a fan of cutting IR left and right once you win bigly in AMRN options?
-.75% negative rates on accounts valued at
DKK 750,000 = USD 81,000.
I know - first world absurd problem because at least there will be a lot to draw down when negative rates make it across the ocean!
I've heard through the UOIP grapevine that there are direct flights from Sea-Tac into Philadelphia with a very short drive over to Wilmington, DE.
I'm tempted to book last minute (b/c if it settles beforehand) once a judge sets a trial date for next year.
Let's see these Cable Companies lose in front of a jury. Hell yeah.
After January, I wonder if the trial will get some press. Chanbond/UOIP has very sympathetic patent holders and this is a very good story -- the long and winding road to their day in court to seek justice. Is justice like revenge, a dish best served up cold.
Excellent reports Zombywolf, Magnus & L-T!
The clock tick-tocks down...heigh-ho, heigh-ho.
Seven Dwarfs
STS - speaking of risk exposures--last fall I posted about hearing Mr. Wonderful (Kevin O'Leary of Shark Tank) speak in Seattle and his insistence on the 5% rule as being one of the very few (only?) "gifts" for retailer investing.
Well, look at his poor wife, she's actually been charged up in Canada when the other boat didn't have their lights on in the dark!! www.usatoday.com/story/entertainment/celebrities/2019/09/24/shark-tank-star-kevin-olearys-wife-charged-fatal-boat-crash/2429471001/
That's some kind of risk exposure - a boat appearing out of nowhere in the dark, but its her fault?
Yes, on Chesapeake Bay - a quick internet search turns up that harvests have gone from 17-20 million bushels of oysters before 1900 to now no more than 600,000 bushels. Farming oysters, if the bay's water quality can be maintained, will be the real future of this hard-shelled aphrodisiac.
Did you see this one in the WAPO? Statistical value of doggies' lives: www.washingtonpost.com/business/2019/11/22/researchers-have-finally-put-price-tag-life-dog/
Raf, I believe you.
I also believe int'l trade statistics...stuff like reams of paperwork that make even the most earnest bureaucrats groan. The two don't have to be mutually exclusive, as I think most of this is posturing by all sides jockeying to have maximum flexibility.
Did you see that Mehar Manku who you met at the ADCOM, was at Laxdale (later AMRN) in Stirling, Scotland (2001-2004)? Same city (lipid knowledge cluster) as DR Tocher. These guys may know one another since they were doing applied research even if in different specialties (see below Lancet link for salmon/human studies mention). Perhaps, a shuffling is going on in re-ranking various biochemical theories of oxidation reactions by cellular locations, after R-it, which hints at some differences between the theories and real world.
www.thelancet.com/pdfs/journals/lancet/PIIS0140673603130462.pdf
Vleino- BASF will reserve specific inventory details for each of the actual buyers of VascEPA or EPAdel (that is companies associated with API supply chain). Wouldn't you guess they would only manufacture to what their customers have requested? BASF wouldn't produce speculatively in other words. So, they are "sold out."
Trust your own DD (it isn't 2013 anymore). industries.basf.com/en/Omega-3/Omega-3-Pharma-solutions.tt~product.v~overview.html
I've done some DD on BASF, too. See my post# 194546.
Hey Slim, I think Maine will continue to play an important role in America's ocean policies as Sen Susan Collins is pragmatic and supportive. One of my friends back east has an inter-disciplinary masters from UMO in bio-economics. It sounds like you would be very familiar with how strong UMO's program is in marine science and the sames kinds of topics I've discussed with him regarding New England's coastal community challenges. Although I will say I didn't expect Hollywood type challenges such as this summer when I saw signs warning of shark attacks at Cape Cod National Seashore beaches. Amity Island, really?
Board mods mentioned before that it is free for all Ihub to send private messages on Fridays - but, I don't know the window of time, assuming its EST and not PST. Happy to chat more via PM or exchange email addresses that way to hear more about what's going on up in the great state of Maine.
Slimhere, FDA is more a symptom than a cause in your example. The Bay of Fundy like the Grand Banks collapsed back in the 1970s due to overfishing. But, if you have a link to the FDA regulation on guts that you cite, I'd be interested in the (market? safety??) rationale behind it. The Bay of Fundy has become dependent on salmon aquaculture, which in turn is also dependent on fishoil in the feed for growth and health. Too little marine ingredients in their diet and the salmon become more susceptible to disease.
Here's a Seattle Times article from 2005 on a sardine plant in Maine - https://www.seattletimes.com/business/one-us-sardine-plant-left/
Here was the same owner of that Maine sardine plant in that article above, filing this past week in bankruptcy court according to the WSJ - www.wsj.com/articles/pro-bankruptcy-briefing-fcf-fishery-bids-for-bumble-bee-insys-faces-creditor-over-legal-releases-food-co-ops-trustee-sues-ex-brass-for-80-million-11574432391?mod=searchresults&page=1&pos=3
And here's the sad state of affairs of Bay of Fundy sardines (technically, herring) - its all about the jobs and not sustainability. oceansnorth.org/en/blog/2019/08/why-decision-makers-are-in-the-dark-on-atlantic-herring/
Scientists have been scratching their heads for decades now, wondering why these regions have not bounced back like everyone thought they would. It's poked holes in the idea that fisheries can just bounce back from collapse if you leave them alone.
Long term & Zombywolf- I'm looking forward to hearing your court coverage tomorrow. Thanks for going!
<fingers crossed>
Orbapu - does MarketEDGE consider 6 weeks or so about the length of the cycle (up to JPM) I was asking AFish's TA opinion on ...to be intermediate?
Or is MarketEdge defining intermediate term to be more like 20 weeks out?
Slimhere- Sardines off US coasts? Cannery Row days are long since passed. From the NOAA link you posted:
You can't fish on a population that low or it won't be around to reproduce.
I posted the other day about mesopelagics *research* which at some point may be exploited. This is the zone below the pelagic zone where most ocean life lives like sardines and anchovies. See below for mesopelagic zone:
Also, I posted a study by DR Tocher. He made a good comment on O-3s along the lines of - demand is easy to model. Supply is not.
With this chart you can see how minuscule fish oil supply is at 1 million mt/annually compared to other edible oils which makes it harder to garner investor interest:
Agree with you that AMRN already has relationships with the largest API EPA EE refiners validated by articles, filings, etc listed over the years. Those refiners represent the bulk of API purifying capacity with BASF being the largest judging from the associated press. It's a lot to manage if you don't own the plants because you have to continually negotiate for your portion of their capacity (money and volume carries a big stick, but so do other considerations). AMRN is a marketing company that owns the rights to Reduce-It's TBD patient population not the oil refiner itself.
This Ihub board uses rather loosely the term "API capacity" when often I think members are referring to how much allocation volume AMRN has of that API capacity. They are two different things.
To me, API capacity means total refinery output volume as I've mentioned in the past. % capacity utilization is another point altogether, maybe some have been operating at 50-60% capacity or whatever % is enough to keep the lights on, right? Hypothetically, AMRN may receive 85% of one refiner's capacity for example. And only 5% of another plant's capacity that could produce EPADEL/LOVAZA/OMACOR/GENERICS. Agreements to grow and increasingly shift over capacity allocation to AMRN will be underpinned by the FDA's decision here in a few weeks.
Yes, AFish. Thanks for the TA interpretation! -SK
HAHA Flubber. I checked my old school.
Turns out UA is our sponsor, too.
My simple & short list of undated AMRN events:
- FDA announces expanded label. Whatever it is. Just do it already.
- BO
Ya, Ya. I know there's other reportage, but it lacks the same frisson.
STS - anybody can go out and buy Under Armour beefie-briefies. Not anyone can get V.
No RX needed for 20% growth:
Of course, it'd be nice if revenue comes in at $1.2B next year. But, I'll stick with $750m-$800m for now, too. However, I could see JT going all magnum XL (instead of more typically sandbagging slightly) on 2020 revenue estimates if he needed to push a suitor a little to close the gap to try & get a deal done. So, there is that.
Chas - Cool, I just wondered if you had looked into the nano-crystal tech, but right MTNB for the DPA is not the play here. It's yes, most likely either BB being BB or less likely the other tech like ILT and I are wondering about.
As I've said before, there are no appreciable quantities of DPA - .5 - 5-6% depending on the species of fish. For refining, I also don't see a solid argument because for EPA you already are refining to a level to remove all the other fatty acids. What's the gain other than another product for refiners to find a new market for?
Simply idle curiosity on the feasibility of nano crystal tech improvements on the delivery system for the EPA EE even if a ways out.
R&D continues on nano-crystals - not just for pharma, but for food as well to reduce sodium content while still tasting just as salty due to more surface area per crystal (old article, but in 2019 the crystal tech is in potato chips)
www.wsj.com/articles/SB10001424052748704534904575131602283791566
Ok thanks guys. Agree, that’s most likely it then.
Yep, Invest83. Big oil is the best fitting analogy out there.
Chas, what’s your take on why BakerBros opened a position on MTNB? It seems you’ve dug into it somewhat.
I thought that was interesting. I’d taken a dim view of MTNB’s prospects before, DPA please (where’s the beef?). But, that gave me pause to wonder what they found intriguing enough to take a flyer on it. And with Ballantyne as an advisor.
And no I don’t view them as I think I stated last year as a threat AT ALL to AMRN. More I’m curious if Felix is thinking there might be some of kind tech advantage for V to be researched. Move EPA EE from 2ndGen tech, to 5thGen nano-crystal delivery. That’s what I’m wondering - any possibilities of a 5G delivery system from MTNB’s tech to improve V’s bioavailability.
Probably just long-term R&D, but curious nonetheless.
That’s a good question Invest83838. On the one hand, as you suggest I’d say yes just for sheer size and bully potential, right?
However, AMRN has been living in Mr. Roger’s neighborhood for quite some time. That secondary over the summer, gave them needed flexibility. If I were to put it into colorful trader vernacular - they grew a pair from acorn to cantaloupe size.
GSK, AZN and BASF would know every corner and alleyway as well.
The real synergies are on the sales and back office side of things. A plant producing aspirin can’t produce V in other words. And there’s only so much annual superior croppage to concentrate and purify. What you don’t want is a situation where bidders come in from competing pharma interests who bid that crop price up...counter-intuitively, buyers make the price go up.
In the end, probably a wash on this front btw GIA or BO.
Interestingly, last week - I don’t know if anybody else caught it. But, the DOJ opened an investigation into the major salmon aquaculture players (following the EU on this) for price-fixing to US retailers. I viewed that as another little favorable for AMRN regardless of the investigation’s outcome.