Dirty hands.

Enough is enough.

That was the message from a fed-up magistrate judge in Delaware, who ordered pharma giant AbbVie to turn over requested discovery materials to Boehringer Ingelheim in a patent fight over Humira, the world's best-selling drug.

That AbbVie's all-star legal team from Wilmer Cutler Pickering Hale and Dorr; Latham & Watkins; Finnegan, Henderson, Farabow, Garrett & Dunner; Pepper Hamilton and McCarter & English would fight tooth and nail against producing the materials is not surprising.

Humira raked in $20 billion in sales for AbbVie last year. The last thing plaintiff AbbVie wants is the tables turned by Boehringer, which is pushing a novel unclean hands defense that could potentially prove dispositive.

“AbbVie chose to fight the 'unclean hands' discovery to the last ditch. I am declaring the fight over. AbbVie will produce the documents,” wrote U.S. Magistrate Judge Richard Lloret, who is visiting Delaware from the Eastern District of Pennsylvania.

“As for the discovery taking lots of time, I disagree,” Lloret continued. “AbbVie has already elected to spend its time resisting discovery. It litigated and lost, twice. Months will not be absorbed with compliance. AbbVie will engage in rapid and punctilious compliance with my order.”

He added, “I have no doubt that AbbVie, with its vast resources and superb attorneys, can accomplish this duty with efficiency and dispatch.”

Indeed, AbbVie—which seems to have adopted a more-is-more approach to its legal team—is represented by an abundance of first chair litigators including Wilmer's Bill Lee; Mike Morin of Latham & Watkins; William Raish of Finnegan Henderson and Michael Schwartz of Pepper Hamilton.

Lee and Morin did not respond to requests for comment.

Boehringer Ingelheim has tapped Bruce Wexler and Eric Dittmann of Paul Hastings, plus local counsel Saul Ewing.

“We are pleased with the careful attention given by the court to this issue of great importance,” Dittmann said.

The fight began in 2017, when AbbVie sued Boehringer for infringing 74 of its patents on Humira, a biologic drug used to treat arthritis as well as Crohn's disease, ulcerative colitis and psoriasis.

“While AbbVie has spent vast resources over decades developing Humira, Boehringer seeks to copy AbbVie's work and ignore AbbVie's patents,” the complaint states.

Shortly after the lawsuit was filed, Boehringer announced that it had received FDA approval of its biosimilar to Humira, which it calls Cyltezo.

In part, Boehringer is defending the patent infringement claims by focusing on AbbVie's strategies to avoid biosimilar competition.

“The bottom line here is that unclean hands is predicated on AbbVie's own conduct, including, for example, delaying biosimilar competition at all costs and cultivating a culture of manipulating the patent system,” Dittmann said during an August 2 teleconference with the magistrate judge and opposing counsel, according to a transcript of the proceedings.

“The unclean hands theory in this case is based on a very specific set of facts,” he said. “It's based on the biosimilar pathway and AbbVie's competitive scheme to create a patent thicket designed to prevent biosimilar competition.”

A patent thicket?

In court papers, Boehringer described this as “pursuing numerous overlapping and non-inventive patents for the purpose of developing a 'patent thicket,' using the patenting process itself as a means to seek to delay competition.”

AbbVie's lawyers are adamant that the company has done nothing improper.

“Unclean hands is an equitable defense based on supposedly unconscionable and egregious conduct that shocks the moral sensibility,” noted Wilmer's Amy Wigmore during the teleconference.

“They are calling our conduct, with respect to the various activities of obtaining large numbers of patents, providing inventors incentives and compensation, making statements to the public about patents and enforcement, and obtaining patents on various formulations and processes—They're calling those activities unconscionable and immoral.”

It does sound a lot like business as usual, but still, Lloret was not persuaded to squelch Boehringer's discovery request.

“Boehringer's theory may or may not be viable as a patent defense or as a basis for relief by way of counterclaim,” he wrote in June when he first ordered AbbVie to hand over the requested materials. “The viability of the claim as a matter of law may be tested through summary judgment. A discovery motion is not a good mechanism for litigating the substance of the defense. At this stage of the litigation, Boehringer is entitled to discovery that is reasonably and proportionately directed to its claims.”

But even after the order, Boehringer said AbbVie resisted full compliance.

Lloret agreed there were some glaring holes in what AbbVie produced.

“It seems clear enough that AbbVie did have a 'patenting program designed [at least in part] to mitigate biosimilar entry' that might have an impact on Humira sales. It is hard to imagine that there was no 'financial analyses, sales, revenues, costs, profits, and projections,'” he wrote. “A company of AbbVie's sophistication would be unlikely to undertake such a patenting program without counting the costs and benefits.”

He also blasted AbbVie for arguing “that documents relating to its 'strategy to mitigate biosimilar entry' would exceed the scope of Boehringer's unclean hands defense, which relates to 'patent strategy.'”

“AbbVie has omitted the crucial qualifier in Boehringer's deficiency category, a qualifier that makes AbbVie's argument nonsense,” Lloret wrote. “AbbVie has set up a 'straw man' to knock it down. This is unhelpful, to put it politely. It convinces me that I need not spend inordinate time on AbbVie's objection.”

Perhaps more ominous for AbbVie, he specified that the “issue at stake is the 'unclean hands' defense, which is an important, not peripheral, part of this case,” Lloret wrote. “The amount in controversy in this case is vast, and the unclean hands defense, if substantiated, is potentially dispositive.”

 

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