I've been trying to post this for some time. First chance and with trial on Tuesday, wanted to get this out. Very long post so ignore if bores you since copy and pasted from my word doc.
My thoughts on the trial this coming Tuesday:
I’m focusing on the Secondary Considerations because to me this is where the true meat and potatos of the trial will come down to.
A few disclaimers on how I think first. I’m not saying that these are how you think. Only saying these are how I think:
1. Procedural errors are much more likely to be overturned than factual errors.
2. Generally the judges do not want to overturn their colleagues. I think this is generally true in all professions and I know it is in mine.
3. We on the board who have been here for many years have first hand experienced the obviousness claims by the patent office and how we overcame it, know all the untruths and doubt about V even for the Marine indiction. We are going to be more expert in the science and facts than the judicial system
4. Although the facts can be considered DeFacto, the judges will need a reason to review it new and just “he said she said” and Judge Du’s interpretation of the facts isn’t going to cut the mustard in them wanting to overturn her interpretation of the facts.
Because of this, it will come down to procedural error to give the judges an “out” to overturn a colleagues ruling. Note how Singer ties everything around procedural error including Du’s findings on Mori etc.
Although the Prima Facia argument is extremely important, if we get a reversal, it will be catalized around the procedural error concerning the secondary considerations IMO. The most blatant is the weighting SC against each other. This CANNOT be dismissed and the judges will have to have discussions about the language Du used in the final judgement on this. The reason is that if they do not, this could create new precedent in patent law. From the Final Judgement (I put in bold the areas of focus):
“The Court thus finds that the satisfaction of long-felt need and commercial success secondary considerations weigh in Plaintiffs’ favor, and the remaining secondary considerations weigh in Defendants’ favor. More specifically, the Court finds that Vascepa is a commercial success even though it has not yet turned a profit, and that there was long felt need for a single pill that reduced TG levels without increasing LDL-C levels. However, these secondary considerations are outweighed by the fact that the Court found Plaintiffs’ other proffered secondary considerations favor Defendants. Thus, at best, Plaintiffs have presented weak evidence of the existence of secondary considerations, which do not overcome the Court’s finding that all Asserted Claims are prima facie obvious. See, e.g., ZUP, 896 F.3d at 1373 (holding that “a strong showing of obviousness may stand even in the face of considerable evidence of secondary considerations”). For the reasons discussed above, in view of all four Graham factors (including alleged secondary considerations), Defendants have proven by clear and convincing evidence that all Asserted Claims are invalid as obvious under 35 U.S.C. §”
As mentioned many times, the secondary considerations have been weighted against each other. Here is what Amarin has to say about this:
“Equally flawed was the district court’s consideration of the objective indicia. For one, despite crediting Amarin’s evidence of a long-felt but unmet need and Case: 20-1723 Document: 30 Page: 41 Filed: 05/12/2020 30 commercial success, the district court found that “these secondary considerations [were] outweighed by the fact that the Court found Plaintiffs’ other proffered secondary considerations favor Defendants”—in essence finding that Amarin would have been better off had it not presented evidence concerning these other objective indicia.”
Second, the district court discounted evidence of long-felt need and commercial success because the district court found that other objective indicia were not proven.
In addition to improperly pitting objective indicia against a “prima facie” case of obviousness, the district court also legally erred by pitting the categories of objective indicia against each other. Specifically, the Court held that the objective indicia it found present were “outweighed by the fact that the Court found” other categories of objective indicia not present. (Appx69.) The district court did not cite any caselaw supporting this approach, because there is none.
To the contrary, this Court has specifically held that a lack of objective indicia “does not weigh in favor of obviousness.” Miles Labs, Inc. v. Shandon Inc., 997 F.2d 870, 878 (Fed. Cir. 1993) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955 (Fed. Cir. 1986)). Nor is there any reason why one of the objective indicia, such as commercial success, should be “outweighed” by the purported failure to prove another, such as praise. Following the district court’s logic, Amarin would have been better off had it simply brought less evidence, because then there would have been fewer categories of objective indicia to count against those that the district court found. This cannot be the law.”
Generics responses:
Thus, even if the district court were correct that only two objective indicia favored plaintiffs—and it was not—there was no reason to devalue those two categories because Amarin did not succeed in proving other, unrelated objective indicia. This additional legal error further minimized the weight that the district court gave to objective indicia, and further warrants reversal.
“For the reasons discussed above, in view of all four Graham factors (including alleged secondary considerations), Defendants have proven by clear and convincing evidence that all Asserted Claims are invalid as obvious under 35 Case: 20-1723 Document: 49 Page: 16 Filed: 06/16/2020 3 U.S.C. § 103.” Appx69 (emphasis added). Instead, Amarin mischaracterizes the court’s opinion by arguing that it failed to evaluate secondary considerations before concluding the claims were obvious. In so arguing, Amarin ignores the court’s explicit statement that it considered all four Graham factors before reaching its obviousness holding.
Amarin is also incorrect to argue that the court “legally erred by pitting the categories of objective indicia against each other.” Br. 45. The court simply found that certain alleged secondary considerations did “not weigh in favor of finding the Asserted Claims nonobvious.” Appx66, Appx68-69. It did not find that the absence of these considerations favored obviousness.
Regardless, a “strong showing of obviousness may stand even in the face of considerable evidence of secondary considerations.” ZUP, LLC v. Nash Mfg., Inc., 896 F.3d 1365, 1374 (Fed. Cir. 2018) (quotation omitted). Here, the court found that Amarin’s secondary-considerations evidence was far from “considerable.” The court concluded that, “at best,” Amarin’s evidence was “weak.” Appx69. Amarin thus fails to show any legal error, much less harmful error.
Factually, Amarin ignores the district court’s holding, which considered “all four Graham factors (including alleged secondary considerations).” Appx69. Nor did the court hold that any secondary consideration was “‘outweighed’ by the purported failure to prove another.” Br. 45. The court simply found—correctly—that Amarin’s evidence “does not weigh in favor of … nonobvious[ness].” This is EXTREMELY WEAK and almost comical IMO with their response.
“Amarin also argues that the district court “legally erred by pitting the categories of objective indicia against each other.” Br. 45. This argument is based on a single sentence in the district court’s opinion stating that evidence of long-felt need and commercial success were “outweighed by the fact that the Court found Plaintiffs’ other proffered secondary considerations favor Defendants.” But Amarin takes this statement out of context. The next sentence makes clear that the court’s comment was simply a lead-in to its factual determination that Amarin “presented weak evidence of the existence of secondary considerations.” When the whole paragraph is read this once again is a weak argument for the generics.
“Regardless, any alleged legal error in the court’s secondary considerations analysis would be harmless. Given Amarin’s “weak evidence of … secondary considerations” (Appx69), the claims are invalid no matter how that evidence is weighed.” Once again seems very very weak response. Of course they play a HUGE factor after finding two supporting Amarin.
These are the basic arguments each side has concerning the SC which IMO is the pivot point for this case. The judges can’t just blow this off and not comment on the weighting SC against each other. If they remain silent, they will be creating new precedent. So how could they handle this in the generics favor?
1. Although Judge Du weighted the SC against each other which is improper, we find that with correctly applying SC as they should be that Amarin does not overcome Prima Facia obviousness.
2. Secondary considerations can be weighted against each other as Judge Du has determined and thus her finding is correct (I just don’t see this happening)
3. Judge Du was not weighting the SC against each other but was saying that examination of each of the SC results in weak evidence of SC overcoming PF obviousness (seems unlikely with the wording of her judgement and them having to take a very large latitude in interpretation)
My thinking is that the judges will determine that this is procedural error and it is this angle which will allow them to open mindedly look at this case de novo.
So lets look at the secondary considerations and see if they will be able to overcome PFO in case we get 3 judges who do not see it inappropriate to declare PFO and then consider the SC to overcome obviousness.
Praise will not benefit our efforts on SC IMO. I don’t feel that Singer’s arguments will be persuasive.
With unexpected benefits, we have a chance since Judge Du’s decision that we failed in this area was “As explained above as to Defendants’ prima facie obviousness case, Mori found that EPA did not raise LDL-C levels, and Kurabayashi suggested that EPA reduced Apo B levels. (ECF No. 373 at 76-80, 246-47.) Further, while the Patent Office found that a decrease in Apo B was an unexpected benefit constituting a valid secondary consideration, the Patent Office’s examiner did not consider Kurabayashi. (Id. at 246-47.) Where “the PTO did not have all material facts before it, its considered judgment may lose significant force[.]” See i4i, 564 U.S. at 95. Thus, the Court finds that the unexpected benefits secondary consideration does not weigh in favor of finding the Asserted Claims nonobvious”
But the PTO office DID consider Kurabashi and it is clear that her flawed understanding that PTO DID NOT consider Kurabashi was a VERY large indicator why she determined that SC in unexpected benefits did not weigh in our favor.
Amarin’s rebuttal to her flawed/mistake filled statement on Kurabayashi:
The district court also erroneously rejected unexpected results, but based that finding primarily on its prima facie case. (Appx66.) Accordingly, we address that error primarily in Section B, below.
Examiner was aware of Kurabayashi
As to VASCEPA®’s unexpected lowering of Apo-B, the district court erred in brushing this aside based on Kurabayashi. While we address below in Section B the district court’s error in relying on Kurabayashi as part of its prima facie case, the district court’s only other basis for rejecting this unexpected result was its statement that the examiner, who cited Apo-B lowering as an unexpected result in allowing the claims, was not aware of Kurabayashi. (Appx62.) This is wrong, as Kurabayashi was before the examiner during prosecution and listed on the face of the patents-in-suit. (Appx79.)”
So it will come down to whether we can convince the judges that relying of Kurabayashi was in error because it is clear error that Kurabayashi was considered. If we can do this, then we win unexpected need. This will be pivotal on us grabbing another SC in our favor to overcome PFO if we get a couple of judges who agree with PFO but recognize the procedural error in weighting the SC against each other.
Commercial Success-Slam Dunk and will support our claim on secondary considerations overcoming PFO.
Long Felt but unmet need-Unless the tables turn (even though not as strong as commercial success) will be supportive for SC to overcome PFO.
Skepticism-we lose
So the literal Billion dollar question is with Commercial Success, Long Felt but unmet need do we win reversal with a panel of judges which may not be as procedural or patent savvy? If we add a third SC such as unexpected benefits does that then give us 3 strong SC to overcome PFO for those who do not believe in weighting all 4 Graham factors as a group?
Now my crystal ball guess which is as worth as much as you are paying for this which is nothing more than one person’s opinion.
1. With 3 non procedural and non patent friendly judges about a 30-35% chance of reversal
2. With 2 non procedural and non patent friendly judges and 1 which is either patent or procedurally friendly (50-55% chance of reversal)
3. With 1 non procedural and 2 patent and procedural friendly judges or with 3 patent and procedural friendly judges (75% chance of reversal). The more patent and procedurally friendly, the more the Prima Facia arguments on determining these without all the facts were present and determining this through biased eyes since determined before totality of facts will lean even more in our favor.
As a side note, I do not believe that this is remanded back to Du.
