Judge orders Boehringer to disclose Humira biosimilar plans
A US judge has ordered Boehringer Ingelheim to release its rollout plans for a biosimilar version of Humira (adalimumab), following a request from AbbVie.
On Friday, February 22, Judge Richard Lloret granted AbbVie’s request to compel the release of more information about Boehringer’s launch plans for the arthritis medication.
AbbVie, which is the holder of Biologic License Application number 125,057 for Humira, had accused Boehringer of infringing 74 patents in a claim filed in August 2017 at the US District Court for the District of Delaware. However, AbbVie’s claim only involves eight patents.
Under the Biologics Price Competition and Innovation Act, Boehringer had the ability to cap the number of patents at issue in the suit, rather than “litigate all of AbbVie’s patents efficiently in a single wave and without delay”, according to AbbVie.
In its bid to seek more information, AbbVie alleged that Boehringer’s reported indication that it intends to launch a biosimilar adalimumab product before AbbVie’s patents expire, “would directly contradict Boehringer’s claim that AbbVie’s patents are somehow improperly keeping Boehringer off the market”.
AbbVie also claimed that if Boehringer was stockpiling product that could be commercially sold in anticipation of the launch, such stockpiling would infringe AbbVie’s patent claims.
In response to the suit, Boehringer claimed that AbbVie had generated “a vast portfolio of dubious, overlapping patents” years after the launch of Humira as part of a “larger scheme to thwart adalimumab competition”.
AbbVie said that if the discovery reveals that Boehringer has discounted the “patent thicket” in making its launch plans, this would undermine Boehringer’s contention that the thicket has harmed it by slowing down the launch.
On the other side of the dispute, Boehringer claimed that its launch plans are irrelevant to its unclean hands defence and that the “patent thicket” has harmed it and the public in different ways.
Late last week, Lloret ordered Boehringer to hand over its launch plans and said: “In short, if
Boehringer argues—as it does—that the purpose and effect of the ‘patent thicket’ was to
delay competition and damage competitors, and seeks to prove this purpose and effect,
it cannot refuse to quantify the delay and the damage. That would be unfair.”
Humira is reportedly the world’s best-selling drug, generating sales of nearly $19.9 billion in 2018 and accounting for 61% of AbbVie’s total revenue.
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