Judge Says Boehringer Ingelheim Must Divulge Biosimilar Launch Plans in Humira Case

This week, US Magistrate Judge Richard Lloret directed Boehringer Ingelheim (BI) to disclose its launch plans for its biosimilar adalimumab, Cyltezo, as part of a long-running patent dispute with AbbVie, maker of the reference adalimumab, Humira.

AbbVie filed a request to compel BI to detail its launch plans, saying that the plans are relevant to BI’s “unclean hands” defense, a legal defense that bars a party who is asking for a judgment from receiving the court’s help if that party has behaved unethically with respect to the subject of the lawsuit. According to BI, AbbVie’s strategy of acquiring what BI describes as overlapping, noninventive patents to hinder biosimilar competition could constitute unclean hands on AbbVie’s part.

According to AbbVie, BI’s public statements that it intends to launch Cyltezo prior to Humira’s patent expiry contradict BI’s claim that AbbVie’s patent estate has blocked BI from bringing its drug to the US market.

AbbVie also claims that BI is stockpiling Cyltezo ahead of a launch, an action that AbbVie says would infringe its patents.

BI, however, argues that the Biologics Price Competition and Innovation Act (BPCIA)’s provision of a 180-day notice of commercial marketing would be disrupted if the company were compelled to make its launch plans known to AbbVie.

Judge Lloret wrote in his memorandum that the BPCIA does not prevent or limit discovery in a biosimilar litigation, and that “Boehringer reads too much into the statute…the 180-day notice requirement is not designed to cloak launch plans with a broad ranging privilege against disclosure before the notice is filed.”

The judge also wrote that BI’s account of the motive behind and the consequences of AbbVie’s alleged misconduct related a patent thicket is central to its argument. The degree to which Humira’s patents delayed BI’s launch of its biosimilar “may have a legitimate impact on a fact-finder’s assessment of whether AbbVie has unclean hands,” he wrote. If BI argues that a patent thicket was created in order to delay competition and harm competitors, then it “would be unfair” for BI to refuse to quantify the damage caused.

Judge Lloret wrote that he will allow limited discovery and would require BI to state whether it contends that an alleged patent thicket delayed its launch plans for Cyltezo; if BI says that its plans were not delayed, “that will be an end to the discovery dispute.”

With respect to AbbVie’s concerns about BI’s alleged stockpiling of Cyltezo, however, the judge wrote that discovery would have minimal value and would pose a disproportionate burden, and he denied AbbVie’s request.

This latest development comes just weeks after Judge Lloret directed AbbVie to turn over to BI its documents related to its efforts to obtain patents on Humira. The judge agreed with BI that AbbVie had failed to produce numerous documents related to its patenting program and ordered AbbVie to “engage in rapid and punctilious compliance” with the order to produce the relevant materials.