BI Granted Motion to Compel Discovery in Ongoing Adalimumab Case

June 8, 2018
Kelly Davio

This week, a Delaware District court granted Boehringer Ingelheim’s (BI) motion to compel discovery in AbbVie v Boehringer Ingelheim, an ongoing litigation over adalimumab (Humira).

This week, a Delaware District court granted Boehringer Ingelheim’s (BI) motion to compel discovery in AbbVie v Boehringer Ingelheim, an ongoing litigation over adalimumab (Humira).

BI had asked the court to compel AbbVie, maker of Humira, to produce relevant documents related to BI’s unclean hands defense (a legal doctrine 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, whether by fraud or other improper dealings).

According to BI, AbbVie improperly delayed competition for its innovator adalimumab by pursuing a strategy involving overlapping, noninventive patents that would create a “thicket” of over 100 patents. While BI in September 2017 acknowledged that adalimumab itself is a “true scientific achievement,” it alleged that what AbbVie has patented (including formulations, production processes, and dosing regimens) do not represent such achievements, but are instead uses of the patenting process to delay competition for a lucrative drug product.

AbbVie argued that BI had failed to properly plead its unclean hand defense, and so should be denied the request for discovery.

In granting the motion, US Magistrate Judge Richard A. Lloret said that BI’s theory of unclean hands “may or may not be viable as a patent defense or as a basis for relief by way of counterclaim. The viability of the claim as a matter of law may be tested through summary judgment,” and that BI is entitled to discovery that is reasonably and proportionately directed to its claims.

AbbVie had originally filed suit against BI in August 2017, seeking a judgment that the biosimilar developer has infringed or will infringe on 1 or more of AbbVie’s patents by manufacturing or offering its FDA-approved biosimilar adalimumab product, Cyltezo, for sale in the United States.

Two other biosimilar developers, Amgen and Samsung Bioepis, have reached settlements with AbbVie over their adalimumab biosimilars. In September 2018, Amgen announced that it had reached an agreement with AbbVie that would allow Amgen to launch its Amgevita in the European Union on October 16, 2018. In the United States, the same product will be marketed under a slightly different name—Amjevita—and will not launch until January 31, 2023.

The Samsung Bioepis settlement will allow the biosimilar Imraldi to launch in the European Union on the same day as Amgevita, and to potentially launch in the United States on June 30, 2023 (the Samsung Bioepis product is not yet approved in the United States, though it is currently under FDA review).