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Judge Robinson Grants Summary Judgment of No Willfulness, Denies Motions for Summary Judgment of No Lost Profits and to Exclude Expert that was Not Excluded during Liability Phase

Judge Robinson recently considered motions arising from Mylan’s at risk launch of a generic version of Anesta’s Amrix product. In 2011, Judge Robinson held a bench trial and determined that although the generic products infringed the patents-in-suit, certain asserted claims were obvious. Mylan launched its generic product the next day. A week later, Judge Robinson granted Anesta’s motion for a temporary restraining order and later issued a preliminary injunction pending appeal to the Federal Circuit. A few days later, Mylan filed an emergency motion with the Federal Circuit, seeking to stay the injunction pending briefing. The Federal Circuit granted the motion and Mylan began selling its generic product again. When it reached the merits of the motion shortly over a month later in July 2011, the Federal Circuit denied the motion in part, prohibition sale of Mylan’s product during the appeal, and granted it in part, staying a portion of Judge Robinson’s preliminary injunction that required Mylan to “take all reasonable steps to recall” its product. In April 2012, the Federal Circuit reversed the finding of invalidity and dismissed the appeal of the preliminary injunction. In April 2012, Judge Robinson entered a final judgment and permanent injunction. Against this background, Judge Robinson recently reviewed motions by Mylan for summary judgment of no lost profits and partial summary judgment of no willfulness. Anesta AG, et al. v. Mylan Pharms., Inc., et al., C.A. No. 08-889-SLR, Memo. Or. at 1-2 (D. Del. Aug. 14, 2014).

Her Honor denied the motion as to plaintiff’s claim for lost profits. Mylan’s argument was “that plaintiffs should be precluded from claiming lost profits because their expert . . . failed to consider price elasticity in his lost profits analysis. When asked at his deposition about price elasticity, [plaintiffs’ expert] explained that price elasticity under the circumstances at bar was ‘relatively modest’ and ‘offset’ by other factors.” Id. at 4. Judge Robinson explained that the Federal Circuit’s “demand for a ‘credible economic analysis’ can be met by a variety of evidence – both fact and expert – depending on the facts of the case and the nature of the markets at issue . . . [and] plaintiffs have presented plausible evidence that the case at bar presents an unusually complex set of facts vis a vis calculating lost profits, due in part to the unique nature of the relevant market and due in part to the brevity of the damages period. Having rejected defendants’ proposition that there are rigid standards applicable to every case, I decline to take the issue of lost profits damages away from the jury.” Id. at 6.

Judge Robinson granted Mylan’s motion for summary judgment of no willful infringement, however, stating “I agree with defendants that, although their launch was at risk, it was not illegal when it took place and, absent a directive from the Federal Circuit to recall their generic products, defendants had no legal obligation to do so. Having committed no illegalities vis a vis the launch, and willfulness generally being irrelevant in the context of ANDA cases, I grant defendants’ motion for partial summary judgment” of no willfulness. Id. at 4.

Finally, Judge Robinson denied Mylan’s motion to exclude a Dr. Steiner. Dr. Steiner had been allowed to testify during the liability phase of the bifurcated trial because it was recognized that he possessed clinical expertise regarding the products at issue. Accordingly, this expertise was relevant and admissible in the damages phase of the trial as well. Id. at 7.

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