Biotech General Discussion

May 28, 2020

Re: Legal considerations stemming from the FDA approval of Hikma’s generic

Vascepa®

By: Michael Mand, PhD (licensed patent agent, and John Marshall law student); and

Manny Vacchiano, J.D., PhD (licensed patent attorney in California and Illinois)

There are very complex patent, federal procedural, and regulatory legal issues at

play in the analysis and conclusions provided herein. The authors specialize in patent

analysis and have done their best to analyze these various issues. However, readers

are cautioned to doublecheck the facts and legal analysis provided herein, with your

legal, financial, and regulatory professionals. No attorney-client relationship is

established by your purchase of this report (1).

HIGH LEVEL SUMMARY

In a significant but not totally unexpected development in Amarin's fight to protect

Vascepa® (icosapent ethyl) from near-term generic entry, last week the generic

equivalent of Vascepa® (generic icosapent ethyl capsules) from Hikma, one of the

generic companies that recently won a district court decision against AMRN that is

currently up on appeal, was approved by the FDA, presumably with the severe-

hypertriglyceridemia label (https://www.hikma.com/media/2805/vascepa-approval-

press-release-final.pdf). Why should Amarin investors care? This gives Hikma the ability

to launch its generic Icosapent ethyl capsule product any time now, at least from an

FDA regulatory perspective, and possibly take some of Vascepa's revenue starting this

year. What is not clear, is whether Hikma plans to launch at-risk while the substantive

patent obviousness appeal is pending, and whether AMRN can get a court to grant a

preliminary injunction to stop Hikma from launching while the substantive appeal is still

pending.

(1) Please review disclaimers at end of this report.

From our research of this matter, as discussed in more detail in this article, we

reach the following high-level conclusions that should be helpful to investors in

appreciating the uncertainty and risk in the present situation:

1) Although it is possible that Hikma will attempt to launch its generic icosapent

ethyl capsule product at-risk while the present substantive patent case is working its

way through the courts, we feel it is slightly more likely that they will not launch at risk.

2) Since Hikma’s generic icosapent ethyl capsule product is now FDA approved,

Amarin likely can file a preliminary injunction motion now to try to stop Hikma from being

able to legally launch generic icosapent ethyl capsules while the substantive patent

lawsuit is pending in the courts, regardless of whether Hikma launches or explicitly

publicizes that it plans to launch its generic product at risk.

3) In our view, unless Hikma launches its generic icosapent ethyl capsule product

at risk, or at least expressly puts Amarin on notice of a planned at-risk launch, it is

unlikely that Amarin would file a motion for preliminary injunction. In fact, we speculate

that the parties may have explicitly or impliedly reached an agreement in agreeing

to an expedite appellate briefing schedule, that Amarin would not file a

preliminary injunction until/unless Hikma launches its generic product, or puts

them on notice that an at-risk launch is planned.

4) It is hard to predict with high confidence whether the district court would grant

Amarin’s preliminary injunction motion, should they file one, and whether the appellate

court would rule in Amarin’s favor on an appeal of a preliminary injunction motion ruling

at the district court. In other words, if AMRN does file a preliminary injunction

motion, there is considerable risk that that it would not be granted by the district

court, and even if it were granted, would not withstand appellate review.

5) If Amarin files a motion for a preliminary injunction, the likelihood that

the appellate court would rule in Amarin’s favor on an appeal will depend, in part,

on the specific 3-judge panel that is assigned and any biases they might have for

granting preliminary injunctions, especially related to prior art validity issues.

We explain our legal and factual basis for these conclusions below for those of

you that want to get deeper into the legal analysis, with our most detailed analysis

related to conclusion 4 above. As an aside, it is noteworthy from Manny’s and Amp’s

investment standpoint, that we have not reduced our investment in Amarin since before

the district court invalidity ruling, and likely will not reduce our investment even if generic

icosapent ethyl capsules are launched at risk. However, we continue to reconsider our

investment as we monitor and analyze the legal and factual issues as they develop.

Furthermore, we feel that although they are fighting an uphill battle now, Amarin

currently has at least a 25% chance to win in the end on its pending substantive patent

case. Finally, there are substantial revenue opportunities for Vascepa® outside the U.S.

that help to justify Amarin’s present enterprise value.

The full ~10 pg article is available for download here:

#AMRN #Vascepa #triglycerides #cardiovascular #ANDA #patents