Biotech General Discussion

My high level thoughts after a bit more consideration, and at risk of being swayed by market reaction today, is that the panel of judges named in the case and the oral arguments reduce my 25-33% chance of success to a 10-20% chance as a rough estimate for AMRN overturning the district court's ruling. We will publish more info about next steps for AMRN should they lose in the coming weeks.

More details:

Regarding the judges named in the case, and ANDA obviousness cases with secondary considerations, especially looking at these 3 judges, is that it is rare for these judges to overturn an obviousness finding in what we have seen thus far. In 17 cases that had 1 of these judges on the panel (1 of them had 2 of these judges), only 1 case was reversed from obviousness to non-obviousness with one of these justices and that was the cyclobenzaprine case where judge Reyna was one of the justices. The only other overturn we saw in 1 case, was a case where judge Dyke overturned from non-obvious to obvious.

Regarding the hearing, the judges were very active in questioning AMRN's counsel about why he thought it mattered that the district court judge (DC) weighed secondary factors and asked him to show them precisely where in the DC opinion, the DC judge reached a conclusion of obviousness before weighing secondary indicia. AMRN's counsel pointed to some pages in the DC opinion and explained, although I did not find the explanation that crisp. One of the judge's focused a lot on the prior NOVO case, which was a case relied on by the defendants because it is a case where the court used a similar legal analysis to the DC judge in the AMRN case, and the Federal Circuit upheld the DC's obviousness ruling.

I thought the Hikma's counsel nicely laid out their strongest arguments, that the key elements of the claims were in the prior art references, and this was a case about the facts without a legitimate legal issue. Oddly, I do not recall any questions by the judges for Hikma's counsel. Then AMRN's counsel had his rebut time since AMRN was plaintiff, but again I did not find his arguments that crisp to follow.

Initial thoughts (revised above after further thought and review of more cases for judges on panel)

My high level initial thoughts are that the panel of judges named in the case and the oral arguments did not change my 25-33% chance of success rough estimate for AMRN overturning the district court, and likely put it more on the lower end of that range in my view. I am preparing more detailed comments and we are going deeper into the judge's history on legally similar pharma cases now.

More details:

The judges were very active in questioning AMRN's counsel about why he thought it mattered that the district court judge (DC) weighed secondary factors and asked him to show them precisely where in the DC opinion, the DC judge reached a conclusion of obviousness before weighing secondary indicia. AMRN's counsel pointed to some pages in the DC opinion and explained, although I did not find the explanation that crisp. One of the judge's focused a lot on the prior NOVO case, which was a case relied on by the defendants because it is a case where the court used a similar legal analysis to the DC judge in the AMRN case, and the Federal Circuit upheld the DC's obviousness ruling.

I thought the Hikma's counsel nicely laid out their strongest arguments, that the key elements of the claims were in the prior art references, and this was a case about the facts without a legitimate legal issue. Oddly, I do not recall any questions by the judges for Hikma's counsel. Then AMRN's counsel had his rebut time since AMRN was plaintiff, but again I did not find his arguments that crisp to follow.