Amarin Corp Plc (AMRN)

[HDGabor]

Thankfulness to Rob Cos

*Front Row*: Hikma/Reddy's Request for Immediate Ruling was Dismissed...
January 15, 2020

Key Takeaway
Day 2 of AMRN trial was a bit more balanced in our view with both parties making strong cases for/against the induced "infringement" claim. Today concluded w/ the Judge dismissing the defendants' request for an immediate ruling on the induced infringement claim citing AMRN has met the initial burden of proof to continue the trial. Although that ruling was in AMRN's favor, we think the induced infringement claim will continue to be argued by the defense.

Summary: Today began w/ direct/cross-examination of AMRN's expert cardiologist Dr. Matt Budoff. Following redirect of AMRN's witness, the defense asked the judge to rule on the induced infringement claim, stating they believe AMRN failed to meet the burden of proof. Following 5-10 min presentations from both parties, the judge indicated she would need more time to formulate her ruling. The day ended w/ the Judge dismissing the defendants' request to rule on the infringement claim citing the initial burden of proof had been met. We continue to think AMRN is in a good position in the case.

A majority of today's proceedings focused on the induced infringement claim and interpretation of the label; there appears to be more room for debate than initially thought, however. Recall, AMRN is claiming HIkma/Reddy's generic label induces infringement on AMRN's patents that cover treatment with Vascepa for 12 weeks or more. During direct examination, AMRN's witness Dr. Budoff reviewed severe hypertriglyceridemia (SHTG), the label, and systematically provided his reasoning as to why a majority of docs prescribing Vascepa would use it for "chronic treatment" thus any generic using the current label would infringe on AMRN's 12wk+ patents.

During cross-examination, the defense noted nothing in the label explicitly indicates Vascepa has to be used for 12wk+ and highlighted AMRN's own internal and expert testimonies that indicated SHTG could be an acute phenomenon and the label does not limit the drug for chronic use only. Dr. Budoff defended his earlier testimony well by stating if the drug is used as indicated by the label, all acute reasons to use the drug would be excluded thus providing a counterargument to the defense. While the judge has not tipped her hand on which way she is leaning through comments or questions, she has shown keen interest throughout the trial in the defense's arguments and to us looks clearly willing to accept to new information. The bottom line is whether the judge would rule in favor of AMRN because a majority of docs will use it chronically - or in favor of generics because there are situations where "acute use" is OK and that is sufficient to not infringe. That said - the Summary Judgment before the trial did suggest the argument by the defense was weak.

The judge appeared to really mull over the defense's motion to immediately dismiss the induced infringement claim. The judge concluded based on Dr. Budoff testimony, which stated if following the label, "most docs" would prescribe generic EPA chronically, the plaintiff has met the initial burden of proof. It will be interesting see how her interpretation may change following examination of the defense's expert cardiologist witness.

Best,
G