Argument Preview

Next week is argument week at the Federal Circuit, and two cases slated to be argued attracted amicus briefs. A patent case, Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA, drew interest from both the Aimed Alliance and the Biotechnology Innovation Organization (BIO) on the issue of non-obviousness. In this case, Amarin, a patent owner, asks the Federal Circuit to reverse a district court’s judgment of obviousness based on alleged erroneous use of hindsight. This is our argument preview.

Amarin explains in its opening brief 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.” In this regard, Amarin argues that the district court committed two fundamental errors.

First, Amarin claims “the district court erroneously bifurcated a ‘prima facie’ case of obviousness and the objective indicia of non-obviousness.” And, by so doing, Amarin asserts that “the district court fell into the trap of hindsight—dismissing powerful objective evidence of non-obviousness because the court had already decided the claims were obvious.”

Second, Amarin claims that “[h]indsight also infected the district court’s analysis of the prima facie case.” According to Amarin, “[b]efore Amarin’s invention, all prior treatments for severe hyperriglyceridemia had the same effect—a dramatic rise in LDL-C—not seen in patients with milder forms of the disease.” Amarin asserts that the district court ignored the different impact of its invention on LDL-C levels in severe cases. As a result, according to Amarin, the district court “effectively ruled that ordinary artisans had a reasonable expectation of producing that which had never been achieved before Amarin’s inventions—a triglyceride-lowering therapy for severe hypertriglyceridemia that did not dramatically raise LDL-C.”

In its response brief, Hikma Pharmaceuticals and Dr. Reddy’s claim that Amarin’s lead argument—that the district court “erroneously bifurcated a ‘prima facie’ case of obviousness”—is “legally and factually flawed.” They point out that, “[l]egally, a finding that ‘prima facie evidence, if unrebutted, would be sufficient to establish’ obviousness is ‘entirely appropriate.'” Factually, they further contend that the district court’s holding considered “all four Graham factors.” With regard to Amarin’s second contention, they find it “equally flawed” because the district court “considered Amarin’s positions but correctly found they ‘lack[] evidentiary support.'”

In its reply, Amarin asserts that the “Defendants pretend [that] Amarin’s complaint is only about the language the district court used in reaching its determination.” Amarin, however, contends that its “complaint is about substance.” Amarin recognizes “that a court may correctly analyze obviousness utilizing a framework that looks to a ‘prima facie’ case and then to objective indicia—provided that the court withholds its conclusion until considering the objective indicia.” But the real error committed by the district court, according to Amarin, is “that, substantively, [the court] found obviousness based on the prima facie case alone and then required Amarin to ‘save’ the claims through the objective indicia.”

Aimed Alliance filed an amicus brief in support of Amarin. In it, Aimed Alliance reiterates that the “district court adopted an improper burden-shifting framework.” In so doing, “[i]t first concluded that a prima facie case of obviousness existed and then shifted both the burden of production and persuasion to Amarin to show that secondary considerations militate against that prima facie showing.” Further, Aimed Alliance argues that, from a policy standpoint “[i]f the district court’s decision is left uncorrected, it will discourage pioneering companies from pursuing the development of innovative treatments for serious diseases because they will be unable to rely on their patents to recover their costs.”

BIO filed its own amicus brief in support of neither party. In it, BIO argues that because “two dueling frameworks for evaluating obviousness . . . are not wholly consistent, there is a need for clarity in the law.” BIO describes the dueling frameworks as a “totality framework” and a “prima facie framework.” BIO explains that the “‘totality framework’ . . . evaluates obviousness by making a single determination based on all of the relevant evidence.” BIO argues that, “[c]ompared to the prima facie framework, the totality framework provides a more consistent method for treating all evidence relevant to obviousness equally and minimizing the potential for hindsight bias.” BIO cautions that, “should this Court continue to endorse application of the prima facie framework, more guidance on its application is needed.”

Oral arguments will be heard on Wednesday, September 2. We will keep track of this case and report on any developments.