Case Name: Pharmacyclics LLC v. Alvogen Pine Brook LLC, Civ. No. 19-434-CFC, 2024 WL 1885677 (D. Del. Apr. 30, 2024) (Connolly, J.)

Drug Product and Patent(s)-in-Suit: Imbruvica® (ibrutinib); U.S. Patents Nos. 8,008,309 (“the ’309 patent”), 8,754,090 (“the ’090 patent”), 9,655,857 (“the ’857 patent”), and 9,725,455 (“the ’455 patent”)

Nature of the Case and Issue(s) Presented: Alvogen filed an ANDA with FDA seeking approval to market generic ibrutinib tablets. Pharmacyclics filed suit, alleging patent infringement of 18 patents. The Alvogen was litigated alongside a related action involving other defendants seeking approval for generic versions of Imbruvica capsules (the Capsule Action). The Capsule Action and the Alvogen action were not fully consolidated, but parts of the suits were coordinated with respect to discovery, and the actions were tried together in October 2020. After the pretrial conference, Pharmacyclics narrowed its case to nine claims across the four patents-in-suit. One day before trial, Alvogen stipulated that its ANDA product infringed one asserted claim in each of the ’309, ’090, and ’455 patents. At trial, Alvogen was found to infringe the ’857 patent and that all of the asserted claims from the patents-in-suit were not invalid. The Federal Circuit affirmed. Before the court is Pharmacyclics motion for attorneys’ fees and experts’ fees, which the court denied.

Why Alvogen Prevailed: “There is no question in my mind that Alvogen engaged in vexatious conduct in this case.” For example, Alvogen sought to exclude Pharmacyclics’ proposed factual findings, including Pharmacyclics’ assertion that “[t]his is an action for patent infringement arising from the submission to FDA by Defendants of an ANDA seeking approval of generic versions of Plaintiffs’ Imbruvica® Tablets.” Alvogen also objected in its post-trial briefing to Pharmacyclics’ statement that “[t]his matter came before the Court for a bench trial on October 13–21, 2020.” Both proposed facts are undeniably true. “I was at the trial. And so was Alvogen’s counsel.” Alvogen also argued in its post-trial reply brief that certain of Pharmacyclics’ exhibits should be excluded because they were not discuss at trial. The court arbitrarily selected three of the challenged exhibits to see if they were discussed at trial, and, sure enough, all three exhibits were in fact discussed in detail at trial. “Another part of Alvogen’s vexatious litigation strategy was to require Pharmacyclics (and the Court) to engage in unnecessary claim construction.” Alvogen’s counsel advised the court that it would not raise claim construction issues already being litigated in the related Capsule Action. But that is exactly what Alvogen asked the court to do for four of the ten claim terms litigated in the Markman hearing in the Alvogen case.

“I could go on. But I won’t, because Pharmacyclics is also guilty of vexatious conduct in this action, and therefore, having considered the totality of the circumstances, I do not think an award of attorney fees is appropriate in this case.”

Pharmacyclics’ insistence on litigating so many patents and claims was unreasonable and placed undue and unnecessary burdens on Alvogen and the court. Nine days after the court issued its claim construction order, Alvogen sent Pharmacyclics a proposed draft stipulation in which Alvogen stated that it would agree to stipulate to infringement “so long as those claims are not determined in a final and unappealable decision to be invalid, unpatentable, or unenforceable.” Pharmacyclics waited nearly three weeks before responding and unreasonably insisted on deleting from the stipulation the phrase “so long as those claims are not determined in a final and unappealable decision to be invalid, unpatentable, or unenforceable.” While negotiating the final stipulation, Alvogen told Pharmacyclics that there was no reason for Pharmacyclics’ experts to address those claims in their report so “any harm from the service of ‘unnecessary’ expert reports by Pharmacyclics was self-inflicted.”

“Alvogen was a vexatious litigant in this case. Its hands were dirty in this regard. But so were Pharmacyclics’. I will therefore deny Pharmacyclics’ request for attorney and expert fees.”

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