Boehringer Ingelheim is one of the only—if not the only—biosimilar makers still challenging AbbVie’s Humira patents in court. And the German drugmaker just won a skirmish in that high-stakes battle, gaining access to documents AbbVie had fought to keep secret.
In a sternly worded filing, Judge Richard Lloret ordered AbbVie in Delaware federal court on Friday to fork over documents it wanted to keep out of Boehringer’s hands. The judge previously ordered the company to hand over documents, and when AbbVie did, Boehringer found some were missing.
Boehringer then asked the court to force AbbVie to produce its documents, and AbbVie pushed back, claiming the new request included extra documents. Judge Lloret wrote Friday that the “the requested documents are within the scope of Boehringer’s defense" and went a step further to write that AbbVie set up a "straw man" to mislead the court about BI's argument.
“This is unhelpful, to put it politely,” the judge wrote. “It convinces me that I need not spend inordinate time on AbbVie’s objection.”
After winning FDA approval for its Humira biosimilar back in 2017, Boehringer is working to launch it in the U.S., but must contend with a lawsuit from AbbVie alleging infringement on dozens of Humira patents. And AbbVie has plenty of incentive to fight BI; Humira is the world’s best-selling drug and pulled in almost $20 billion last year worldwide.
In response to the lawsuit, Boehringer filed a defense of "unclean hands," arguing that AbbVie unfairly pursued overlapping and noninventive patents, and used the patent litigation system itself to delay competition. The company says AbbVie’s entire infringement lawsuit should be struck aside because of those abuses. If the judge agreed, that could put BI one step closer to actually rolling out its biosimilar.
But the case has been stuck in discovery for months as the companies fight over what's relevant for the case. Now, Judge Lloret has had enough.
“AbbVie chose to fight the ‘unclean hands’ discovery to the last ditch,” he wrote in Friday’s order. “I am declaring the fight over. AbbVie will produce the documents. The parties may fight over the viability of the unclean hands defense at summary judgment, with all the available and potentially relevant facts. That is where the fight belongs, and that is how it will be conducted.”
The judge additionally clued the sides to his perspective of the "unclean hands" defense. In the order, he said the argument "is an important, not peripheral, part of this case." He added that if it's substantiated, Boehringer's defense is "potentially dispositive."
Boehringer is hoping to avoid the fate of other drugmakers who will have to wait several years to market Humira biosims. Already, at least eight biosim companies have inked settlements with AbbVie allowing their U.S. launches throughout 2023.
Meanwhile, biosims already launched in Europe in the fall and have taken a big bite out of AbbVie’s pricing power. In one market, the company reportedly offered up an 80% discount to retain a contract, according to reports.