Updates On Discovery Rulings in AbbVie v. BI Adalimumab Litigation

We have covered the ongoing AbbVie v. Boehringer Ingelheim litigation concerning Boehringer Ingelheims’s (“BI’s”) aBLA for Cyltezo™ (adalimumab-adbm), a biosimilar version of AbbVie’s Humira® (adalimumab) product, including the grant of a recent motion to compel discovery regarding BI’s unclean hands defense.  Magistrate Judge Lloret issued two additional orders regarding discovery in that case.

In a decision on June 7, 2018, the court denied in part and granted BI’s motion to compel “research and development” materials, which also sought an exception to the default six-year limitation provided in the Delaware Default Standard for Discovery. The court rejected BI’s argument that this case is “unusual, given the number of patents and claims at issue, and the evolution of a ‘patent thicket’ over a lengthy period of time”. However, the court granted, among other relief, that “for the time preceding the six-year period…, AbbVie shall promptly produce documents concerning the research and development of the alleged invention(s) of the patents-in-suit that relate to asserted prior art and to the conception and reduction to practice of any of the alleged inventions of the patents-in-suit,” because “[r]esearch and development information that leads in a plausible and logical fashion to ‘conception and reduction to practice'” is relevant to the litigation.

In a decision on June 8, 2018, the court ordered AbbVie to produce materials from its BLA relating to manufacturing of adalimumab, formulation of adalimumab, and/or treating rheumatoid arthritis or ankylosing spondylitis, as well as certain additional materials from its Investigational New Drug Application (IND).

Download PDF