Argument Recap

Earlier this week the Federal Circuit heard oral argument in Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA, a patent case we have been following because it attracted amicus briefs. Amarin asked the Federal Circuit to reverse a district court’s judgment of obviousness based on alleged erroneous use of hindsight reasoning. Amarin alleged in its briefs that the district court “fell victim to hindsight” by not “apply[ing] each of the Graham factors, including the common sense objective indicia, before declaring an invention obvious.” Notably, the Federal Circuit granted a Rule 36 summary affirmance yesterday. This is our recap of the oral argument.

Jonathan E. Singer argued for Amarin. He first introduced Amarin’s main argument: “The district court’s errors in this case led it to a conclusion that contradicted medical knowledge at the time of invention.” (He explained that the invention was “a treatment for severe hypertriglyceridemia . . . that had not raised bad cholesterol and thereby raised the risk of heart disease in patients with this condition.”) He contended that, despite the fact that no one had been able to achieve the invention “for upwards of 30 years,” the district court “nonetheless [found the invention] obvious to the person of ordinary skill.”

Singer maintained that the district court reached this conclusion “by impermissibly discounting the real world evidence of nonobviousness that Amarin presented.” According to Singer, the district court “impermissibly discounted the finding of long felt need because it had already found the prima facie case.” Moreover, Singer asserted, the district court “used its prima facie case to reject evidence of skepticism without supporting evidence in the record.” He also criticized the district court as having “erroneously rejected unexpected results based on a mistaken belief that a [prior art] reference was not before the examiner.”

Singer concluded his introduction by stating that the Federal Circuit’s “precedents require more; they require the district court to give credence to those objective indicia that are proven and consider them in the obviousness analysis and not to treat them as an afterthought.”

Judge Dyk began the questions by stating that “we have had cases [indicating] there is nothing wrong with following the prima facie approach, and as a panel, we are bound by those cases.” “So,” he asked, “what’s the problem if that basic approach is permissible?” Singer responded by arguing that, even if a prima facie case is found, “the objective indicia have to be given their due.” Furthermore, Singer asserted that, in the relevant Federal Circuit precedent, “there was no weighing of the secondary indicia against each other like the district court did here.”

Judge Reyna then posed his own question to Singer. He wanted Singer to identify in the record where the district court reached a legal conclusion of obviousness before considering any objective indicia of non-obviousness. Singer contended there were “multiple places,” and he argued that in the “consideration of skepticism, the prima facie case was allowed to bleed into” the analysis.

Judge Dyk expressed difficulty understanding Amarin’s argument. He indicated that the district court judge in this case “certainly considered the secondary considerations,” and asked “What is the problem” with whether he mentioned evidence for secondary consideration in the prima facie case or vice-versa. Singer answered that secondary considerations “can be relevant to both” parts of the analysis, but here the district court found a “weak case of secondary considerations” because of impermissible weighing of secondary indicia against each other.

Charles B. Klein argued for Hikma Pharmaceuticals USA and Dr. Reddy’s Laboratories, the defendants-appellees. Klein began his argument by stating that “Amarin’s appeal is challenging a ruling that the district court never even made.” Moreover, Klein contended, the district court correctly conducted its obviousness analysis by first finding “prima facie obviousness, being very careful to make it clear that the court was only finding prima facie evidence citing the relevant considerations.” Secondly, according to Klein, the district court did its secondary considerations analysis. Finally, Klein asserted, “then and only then [did] the district court [reach] the final determination of obviousness.” Klein emphasized that Federal Circuit precedent completely “defeats [Amarin’s] hindsight theme” on appeal. Notably, the panel of judges did not interrupt Klein to ask a single question.

In rebuttal, Singer reiterated that the district court in this case impermissibly weighed the secondary consideration evidence against each other. Singer argued that this allegedly impermissible weighing of the secondary considerations is the reason why the district court found that the “plaintiffs presented weak evidence” of secondary considerations.

As mentioned, yesterday the Federal Circuit granted a summary affirmance pursuant to Federal Circuit Rule 36.