Summary of the case and DC Order Errors (if I missed something plz add or correct):
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FACTS:
1. Prior to Vascepa, TG viz-a-viz LDL-C mechanism was known to works differently in different POPs i.e. different in Below 500 and above 500mg/DL not clearly understood. It was not about ART, it was about Mechanism of action of reducing the Very high TGs that always resulted in LDL-C going up
2. All prior art treatment, prior to Vascepa, in >= 500 mg/DL resulted LDL-C going up significantly
3. No prior art exists for treatments >=500 mg/DL that resulted in LDL-C going down
4. The known ART: Mori taught EPA 4g resulted in LDL-C going down for patients with TGs <=500mg/DL that was later confirmed with Epadel, Niacins, Fibrates and Lovaza etc.
5. The known art, Mori, never resulted in POSA pursuing EPA 4g treatment since all prior art MOA showed LDL-C going up above 500mg/DL treatments. E.g. Lovaza
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Why we lost the case and Point of argument:
DC decision only focused on MORI and results that MORI taught was that 4gEPA reduced TGs and LDLC. To prove her point she used statements like ‘strongly suggesting that these two Omega-3 fatty acids (DHA and EPA) could have distinct effects on LDL cholesterol levels” and also used statements like ‘Therefore, a skilled artisan would understand from Mori that DHA and EPA work differently’. Moreover ‘Reasonable expectation of success’ legal standard does not require ‘conclusive proof of efficacy. Which infers that a POSA based on Mori could have made a ‘reasonable expectation’ that the same LDL-C reduction would be obtained in Marine population based on the prior art in EPA but really Defendants don’t have to prove this (appx58-59) as reasonable expectation is sufficient. Also DC used the earlier PTO rejections as proof but ignored that the patents were actually awarded after sufficient proof was provided to the USPTO.
All of these ignore the key factor of differentiation: above 500mg/DL TG population that Vascepa was to address as per the patents. Du listened to Toth and all the evidence provided but decided that this boundary has no relevance. Also she considered all prior art 'irrelevant' since they were not 4gEPA.
All of the above was used to render the 6 Marine patents null and void.
(We also lost the case bcos the statistical data (Dr Bhatt article in Nature was not presented by Amarin. Dr Toth was also not a good expert. We should have done better. But all that is now moot).
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Errors/Omissions by DC (Du):
1- Legal Error: The statement: ‘The court first discusses Defendants’ prima facie obviousness case, which the court finds Defendants supported with clear and convincing evidence of obviousness at Trial, and then discusses each of Plaintiffs’ proffered objective indicia of non-obviousness. The court will go on to explain why the court does not find that Plaintiffs’ proffered evidence of secondary considerations saves the Asserted Claims’.
a) What this means is that the court reached the conclusion of Prima Face before considering the Objective Indicia and only then required Amarin to ‘save’ the claim with the Objective Indicia
b) The court devalued the presented Objective Indicia based on already reached conclusion of obviousness
c) The already reached conclusion infected the review of Objective Indicia
2- The main issue is Hindsight. Today it may seems like a great idea for POSA to remove DHA from Lovaza and get the LDL-C down but really 20 years and no one figured it out? So How is that so obvious even though Epadel pure EPA has been on market for 20 yrs? Its so easy now to say this instead of blaming the disease.
3- Thus she failed to:
a. apply each of the Graham factors, including the common sense objective indicia, before declaring an invention obvious
b. follow concepts like ‘motivation to combine’ and ‘reasonable expectation of success’ exist to avoid a hindsight reconstruction of the claims years after the fact, because that which might appear obvious in hindsight often was not obvious at all.
4- Decision that Defendants satisfied the burden of providing ‘clear and convincing evidence’ basing it on Mori even though Mori taught about a different patient population and taught nothing about patients with TG >= 500mg/DL. Is Medicine like Mathematics? Can we Extrapolate medical results like in Mathematics / Stats? It has to be based on factual ‘clear and convincing’ results. No?
5- Toth cited several evidences relationship of LDL-C with TGs but they were all ignored.
6- DC shifted burden on Amarin to prove that the 2 populations were different (prima facie) – here burden shifting should not have been onto Amarin. It should have stayed with Defendants to prove that the 2 populations are similar. (Burden shifting to Plaintiff only occurs for Secondary considerations not prima facie). Toth explained this population difference issue but Du ignored it citing Mori when in reality Mori exactly did that: show it is different population
7- Factual error: The court equalized (conflated) the 2 patient populations and extrapolated that if in patients with TGs <500mg/DL the LDL-C went down, POSA could have extrapolated that that would occur in the patients with TGs >=500mg/DL – THE CRUX OF THE OBVIOUSNESS CASE – she did that based on Toth’s testimony where he was only talking about TGs and not LDL-C. ‘There was no reason to expect differently for LDL-C.’ This was her own opinion based on nothing but air. This is where she is completely wrong and has no evidence to back this.
8- Conclusory Error (legal) : Dr Heienckes’ conclusory opinion that a skilled artisan would reasonably expect from Moriet al. that EPA would not raise LDL-C in the severe hypertriglyceridemia population. This was a firkin opinion. Heinecke extended those Mori studies to severe hypertriglyceridemia merely by agreeing with counsel that, in his opinion, a skilled artisan would not “have expected a different result in patients above 500,” and not, for example, by citing to prior art that supported such an expectation. The district court’s analysis was same i.e. conclusory—relying on off-point testimony from Dr. Toth that medications that reduced triglycerides in patients with triglycerides below 500 would likely also reduce triglycerides in patients with severe hypertriglyceridemia and then faulting Amarin for providing “no reason to expect differently for LDL-C” in the key finding copied from Defendants. OMG.
9- Decided without considering all of the evidence collectively including ‘long-felt unmet need’ (not a single person ever thought of combining Mori + Lovaza) and the ‘commercial success’ which could not have happened if the invention did not address an unmet need. If there was no unmet need or commercial success we would not be here fighting to save our awarded patents.
10- Legal error with no precedent: She improperly weighed these two very strong proven objective indicia against those the district court decided Amarin had not proven, as if Amarin’s alleged failures to prove praise or skepticism carried independent evidentiary weight. So much evidence was provided to support praise and skepticism but was also ignored. Weighing of these indica against each other resulted in a ‘weak’ case for Amarin. Hence the burden shifting.
11- Pure EPA’s TG reducing abilities was very well known prior art for 17 yrs and Mori (TGs <500) was known for 13 years but no one invented a treatment to reduce TGs and LDL-C in 500>=mg/DL patients – only hindsight would suggest it was obvious
12- Based on prior art with LDL-C going up for all severe TGs treatments, the reading of Mori by DC was opposite of what is should have been
13- DC referred to Kurabayashi and Hayashi – all for different TGs population – not related to Vascepa’s patient populations
14- In reprinting Table 3 of Kurabayashi’s Apo-B results, the district court’s opinion cut off the inter-group statistical comparison – it was a key indicator showing indifference in the 2 populations in Kura
15- DC completely ignore the skepticism being faced by Dr. Manku at time of conceiving the invention – a clear discounting of a major secondary consideration
16- Factual and Legal error: Another discounting of skepticism was ignoring the group of experts that Amarin hired to get their view on LDL-C reduction who all had opined and showed skepticism that LDLC would go down with 4gEPA in very high TG population stating they were unaware of Mori – she was wrong, they were all aware of Mori
17- There was praise when Marine results came out – but was also discounted by DC ‘more qualified and equivocal’
18- Assumption that Hayashi had at least one patient above 500mg/DL
19- Clear error in ruling that the PTO had not considered Kuraabayashi
20- Using Hayashi and Kurabayashi as references even though completely different population than for which the patents were awarded
21- The entire argument about the secondary consideration ‘unexpected benefits’ was discounted because of Mori ignoring all other prior art like Niacins, Fibrates and Lovaza which actually increased LDL-C.
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This is how i see the case based on the DC order and the various briefs. Now you decided if we win or lose.
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Note: I have copied text from Briefs and DC order in some places
