Boehringer compelled to reveal Humira biosimilar launch plans

AbbVie and Boehringer Ingelheim are engaged in litigation over Humira (adalimumab) and the potential for the former to launch a competitor biosimilar in the US.

The potential market being that Boehringer could gain access to is significant, with AbbVie releasing full-year financial figures for 2018 that showed Humira sales of $13.6bn (€11.9bn) in the US.

AbbVie applied to the District Court for the District of Delaware for Boehringer to be compelled to outline its launch plans, arguing that such information is necessary evidence to the latter’s “unclean hands” defense.

The unclean hands defense is used so that a party cannot have the help of a court if it has carried out unethical behaviour in relation to a lawsuit.

Boehringer claims that AbbVie’s “patent thicket”, a series of overlapping patents, are non-inventive and has harmed the company by slowing down the launch of its biosimilar, in order to substantiate the relevance of its unclean hands defense.

Boehringer’s Cyltezo was given US approval in August 2017​ but has not yet reached the market.

However, District Court Judge, Richard Lloret concluded, “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.”​

As a result, Boehringer would need to disclose its launch plans for Cyltezo to prove it had been delayed, after AbbVie highlighted public statements indicating that its would-be competitor was looking to launch prior to the expiration of its Humira patents.

A spokesperson for Boehringer told us, "Boehringer Ingelheim contends that AbbVie created an illegitimate “patent thicket,” comprising more than a hundred overlapping and non-inventive patents, for the sole purpose of extending its monopoly far beyond the 2016 expiration date of the core patent for Humira. AbbVie’s conduct has prevented competition in the use of adalimubab, to the detriment of US patients, doctors and third-party payers." ​

Not following the crowd​

Boehringer stands alone in the case against AbbVie, after other companies that had developed biosimilars to Humira sought licensing agreements with AbbVie.

This has seen Amgen, Mylan, Pfizer, Samsung Bioepis, and Sandoz​ all reach agreements that will see their biosimilars released in 2023 onto the US market.

In Europe, the first wave of Humira biosimilars reached Europe in mid-October​ and the introduction has already seen some countries stress the savings​ that could be achieved.