Amarin Corp Plc (AMRN)

[HDGabor]

Appeal … as I see / think (now):

raf-: If you think, please replace my previous post (sticky) with this one. Thx.

First: few things about the appeal:
- new evidence / fact are not permitted (the District Court (DC) documents could be used)
- meanwhile the Federal Circuit (CAFC) is not obligated to defer to the DC, any factual findings determined by the DC should – technically- be subject to deference by the CAFC and usually they are deferring except clear error (a clear mistake was made, rather than finding that the CAFC disagrees with the finding by the DC).
- legal obviousness / analysis is not equal with FDA approvability or scientific acceptance … the burden is lower: teaching, suggestion on motivation (TSM) is enough … in case of no TSM, “obvious to try” could be enough also.
If something was not published in a peer reviewed medical journal, in a Nutritional journal only does not matter … it is part of the prior art

Second: to treat patients – to reduce TG - having TG above 500 mg/dl with 96% pure ethyl-EPA was prima facie obvious according to the DC and the USPTO … does not worth the effort to challenge it.

Third: few things, which are a narrow escape … a longshot (Could be tried but – maybe – does not worth the effort, the time, as it is an appeal.)

Secondary considerations (prima facie or totality)

Meanwhile it looks like that the DC used prima facie approach

The Court first discusses Defendants’ prima facie obviousness case, … and then discusses each of Plaintiffs’ proffered objective indicia of nonobviousness.

instead of totality, it is not a sure thing

in view of all four Graham factors (including alleged secondary considerations) considerations), Defendants have proven by clear and convincing evidence that all Asserted Claims are invalid as obvious under 35 U.S.C. § 103.

In light of the CAFC “conclude that Thomson has clearly and convincingly established a prima facie case that claims 1 and 31 of the '099 patent are obvious as a matter of law. Accordingly, we turn to Muniauction's attempt to rebut this prima facia case with secondary considerations of nonobviousness.” (Muniauction, 532 F.3d at 1327–28) I see this as a dead-end …
Furthermore, the CAFC could come to the same conclusion (using totality approach) as the DC if nothing other will be different. (I expect – 50/50 – it will be an argument, but definitely not as a main one.)

HTG vs VHTG (different MOA)

Amarin tried to convince the USPTO and the DC about it … without any success. As it is a factual finding, the CAFC could (and most likely will) defer to the DC (and to the USPTO) if Amarin will raise it (I do not expect.).

LDL-C increase (lack of increase)

As a standalone argument, it is moot: Mori “found that the increase of LDL-C with DHA was statistically significant and the increase with EPA was not”. It could be a valid argument only if Amarin raise (and win) the previous argument (HTG vs VHTG) … but as a factual finding the CAFC could (and most likely will) defer to the DC.

What could be raised / argued with a higher chance of success?

USPTO decision

Normally, the basic assumption is that the patent is valid, the USPTO decision is right. Generic has to prove with “clear and convincing evidence” that the patent is invalid, obvious, the USPTO decision was wrong.

In this case the DC ignored the USPTO decision as

the PTO did not have all material facts before it, its considered judgment may lose significant force[.]

. since – according the DC -

the Patent Office’s examiner did not consider Kurabayashi

It is - without any doubt - a clear error, the DC made a clear mistake … “weight must be given to the presumption of validity” Scully Signal Co. v. Electronics Corp. of America, 570 F.2d 355, 196 USPQ 657 (1st. Cir. 1977)

Secondary considerations (SC)

(i)Weighing These Secondary Considerations (SC)

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.

???
(a) SCs are not finite … lack of any of them could not get a “negative” weight. Any SC could support non-obviousness, but a missing SC could not support obviousness.
(b) SC could not weigh in Defendants’ favor … SC could favor Plaintiffs “only” … (Each factor weighs almost exclusively in favor of the patentee (Whelan, supra note 51), though simultaneous invention by another has been used as evidence of obviousness (Ecolochem, 227 F.3d at 1379))

This part of the Order is an absolute non-sense … SC has a weight against prima facie obviousness but does not have against other SCs.

(ii) Commercial success

In sum, the DC found that Vascepa is a commercial success (and we could assume – meanwhile DC did not state explicitly– that it is a relevant / strong secondary consideration) and it supports, makes stronger the Long-Felt Need.

(iii) Long-Felt Need

Both the DC and the USPTO determined it; however, the DC explicitly stated it is a weak one, as. meanwhile it is an improvement compared to the existing therapies, it is a prima facie obvious one

POSA would be motivated to combine the Lovaza PDR with the finding from Mori that EPA did not raise LDL-C levels

OK … Fine .. Umm, wait a minute:
- How a prima facie obvious thing could be a long-felt need?
- The primary function of the SC to avoid hindsight bias … not vica versa

The underlying rationale for accepting long-felt demand as evidence of nonobviousness partially overlaps with that for accepting evidence of commercial success. Both concepts assume that a defect in the market creates economic incentives that lead inventors to find a solution and, therefore, to reap economic rewards.
An industry’s desire for an improvement in technology provides a motivation for invention. Because it can be assumed that a market exists for a product that satisfies a long-felt need, an inventor or businessperson working in the field has an incentive to develop a solution. If the demand for a solution persists over time, despite this potential reward, the solution may be assumed to be nonobvious. Thus, if a patentee can prove that his invention satisfies a long-felt need, the invention is likely nonobvious.
An invention composed entirely of pieces of prior art was nonetheless nonobvious, based largely on the fact that the patented invention fulfilled a long-felt need, achieved commercial success, and was the subject of skepticism on the part of experts, which the court called “strong evidence of nonobviousness. (Envtl. Designs, Ltd. v. Union Oil Co. of Cal., 713 F.2d 693, 697–98 (Fed. Cir. 1983))

The existence of this SC nil (overcome) findings of Mori, the “EPA did not raise LDL-C levels” obviousness.

(iv) Unexpected benefit

The USPTO based on
(a) The prior art is either silent or teaches that there is no statistically significant change in Apo-B levels
(b) Applicant also presented convincing arguments against the three references presented by the Examiner Connor et al, Fisher et al and Park et al regarding the predictability of lowering Apo-B determined that it was completely unexpected to observe a decrease in Apo-B.

On the other hand, the DC determined that Kurabayashi suggested that EPA reduced Apo B levels

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.

(emphasis added), and

In light of the statistically-significant differential effects reported between the EPA and control groups, a POSA would have attributed the reduction in Apo B to EPA.

… so the unexpected benefits does not exist.

It looks like that the DC saw the Apo-B reduction (compared to baseline) as enough basis for “suggestion” (TSM) … in light of the SS result in the EPA arm and NS result in the control arm.

What could be seen as a TSM?

The prior art must be considered in its entirety; the prior art is good for everything it teaches, not just the invention it describes or claims. “It is impermissible within the framework of section 103 to pick and choose from any one reference only so much of it as will support a given position, to the exclusion of other parts necessary to the full appreciation of what such reference fairly suggests to one of ordinary skill in the art.” In re Wesslau, 353 F.2d 238, 241 (CCPA 1965); see also Bausch & Lomb, Inc. v. Barnes-Hind/Hydrocurve, Inc., 796 F.2d 443, 449-49 (Fed. Cir. 1986) (holding that the district court, by failing to consider a prior art reference in its entirety, ignored portions of the reference that led away from obviousness)

I guess many other cases could be cited … but I do not think we will find an exact determination of TSM … it is more subjective than objective. Furthermore, as a factual findings the CAFC could defer.

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Sum: IF (and it is an if) Apo-B / “Kurabayashi” will be counted as unexpected benefit … Amarin will be OK … w/o it the chance is not zero, since Long-felt need (supported by commercial success) could be enough.

(Due to more than one legal / procedural error, I do not expect a remand: it will be affirmed or reversed.)
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It should be seen as an appeal (CAFC) not as a trial (DC) … the burden of proof is on Amarin side now …
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Best,
G