Boehringer Cites ‘Massive’ Number of Patents in Humira Biosimilar Suit

Regulatory NewsRegulatory News | 08 November 2018 |  By 

As six companies have now settled with AbbVie over when they can launch their Humira (adalimumab) biosimilars in 2023, Germany-headquartered Boehringer Ingelheim continues to wrangle in court with the Chicago-based AbbVie.
According to documents released Wednesday from the suit between Boehringer and AbbVie, Boehringer said AbbVie’s generalizations “are unproductive and inaccurate.” The comments from both sides offer a window into a dispute that’s continued now for more than a year.
“AbbVie generated a massive number of overlapping and noninventive patents to prevent competition on adalimumab, which has been on sale as Humira since 2003 and was the subject of a patent that expired in 2016,” Boehringer charged. “In choosing to create and assert a thicket of more patents for adalimumab running for at least another decade, AbbVie has opened the door to discovery of facts relating to these adalimumab patents, their generation, and their enforcement, and the prior art history of adalimumab.”
AbbVie, meanwhile, claims that Boehringer “refuses to produce fulsome corporate testimony in response to nearly every topic” related to eight patents in the suit, “unnecessarily enlarging the scope of the parties’ dispute.”
But Boehringer contends that inevitably, the topics AbbVie is pursuing “will lead to discovery disputes concerning the alleged preparation of witnesses designated for these topics. AbbVie does not even defend the topics as such: its approach…is to argue about a small aspect of the topic and then conclude with a request for testimony on ‘the full scope’ of the topic. That gamesmanship makes it difficult for the Court and Boehringer to analyze what AbbVie even tries to justify in part. The Court should reject AbbVie’s positions because of that tactic alone.”
The back-and-forth comes as Boehringer tries to launch ahead of other competitors, all jockeying for a slice of the mega-blockbuster’s earnings.
And as the lawsuit and other settlements play out, sales of Humira biosimilars have begun in Europe, with some Nordic markets seeing upward of 80% discounts.
In the latest earnings call, AbbVie CEO Rick Gonzalez also offered his view on the litigation with Boehringer. “We have confidence in our position,” Gonzalez said, noting that he does not fundamentally believe that having a large number of patents is an issue, while noting the “magnitude and power” of AbbVie’s intellectual property.


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