In a Win for Boehringer Ingelheim, AbbVie Must Turn Over Humira Documents

In a long-running patent dispute with biosimilar developer Boehringer Ingelheim, AbbVie, maker of the brand-name adalimumab, Humira, has been ordered to produce documents related to its efforts to obtain patents that could shield its blockbuster drug from biosimilar competition.
The Center for Biosimilars Staff
February 12, 2019
In a long-running patent dispute with biosimilar developer Boehringer Ingelheim (BI), AbbVie, maker of the brand-name adalimumab, Humira, has been ordered to produce documents related to its efforts to obtain patents that could shield its blockbuster drug from biosimilar competition.

Law360 reported that US Magistrate Judge Richard A. Lloret found that AbbVie has not fully complied with an earlier discovery order to produce documents related to the drug maker’s efforts to obtain patents on Humira.

AbbVie first sued BI for patent infringement in 2017, saying that BI would infringe on 74 patents covering adalimumab in developing its biosimilar, which was approved just months later by the FDA under the brand name Cyltezo.

Then, in June 2018, Judge Lloret granted BI’s motion to compel discovery in the case after BI argued that it needed relevant documents related to its allegations that AbbVie has “unclean hands”; the unclean hands doctrine is 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 that create a patent “thicket” could constitute unclean hands on AbbVie’s part. 

In this month’s ruling, Judge Lloret agreed with BI that AbbVie had failed to produce documents in 14 separate categories, including documents related to AbbVie’s patenting program and its efforts directed toward mitigating the effects of biosimilar competition. The judge ordered AbbVie to “engage in rapid and punctilious compliance with my order” to turn over the documents. 

In his June 2018 decision, the judge said that the unclean hands argument “may or may not be viable as a patent defense or as a basis for relief by way of counterclaim,” and in this month’s ruling, he reiterated that the unclean hands question can be addressed during the summary judgment briefing, “where the fight belongs.”

The order compelling AbbVie to turn over its documents is a win for BI, which has been pursuing its patent litigation with the Humira maker even as a bevy of other biosimilar developers have settled their patent disputes, with no settlement allowing an adalimumab biosimilar to enter the US market prior to 2023. BI, however, told The Center for Biosimilars® in November 2018 that its focus is on bringing its product to US patients “as soon as possible, and certainly before 2023.”

In addition to pursuing an earlier launch date than its adalimumab competitors, BI is also the only biosimilar developer to have publicly announced that it is undertaking a study specifically designed to earn its product an interchangeable designation from the FDA.

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