This month, US magistrate judge Richard A. Lloret granted Boehringer Ingelheim (BI)’s motion to compel AbbVie to produce prelitigation disclosures and settlements concerning its brand-name adalimumab, Humira.
This month, US magistrate judge Richard A. Lloret granted Boehringer Ingelheim (BI)’s motion to compel AbbVie to produce prelitigation disclosures as well as settlements concerning its brand-name adalimumab, Humira.
BI is engaged in a lawsuit with AbbVie over biosimilar adalimumab, Cyltezo, and the biosimilar developer had requested that the court require AbbVie to produce relevant information from another such litigation, concerning Amgen’s Amgevita, as well as from settlement agreements that AbbVie entered into with Amgen, Samsung Bioepis, and Mylan regarding their biosimilar adalimumab products.
Judge Lloret found that the disclosures concerning the litigation with Amgen are relevant to the case and can be provided by AbbVie with minimal burden, as long as reasonable confidentiality procedures are followed. He also found that the disclosures related to settlements are likely to be relevant to BI’s defenses of patent invalidity and unenforceability and that, given adequate confidentiality provisions, producing settlement documents does not pose an undue burden for AbbVie.
Separately, Judge Lloret denied AbbVie’s motion to require that BI provide more complete responses to 2 of its questions, one related to BI’s safe harbor defense and the other related to the time at which BI learned about patents that are at issue in the suit.
In the first instance, found Judge Lloret, the probative value of the information sought by AbbVie is “remote” and unlikely to be material to the resolution of the case’s issues. In the second, he found that the burden imposed by the discovery is disproportionate to whatever value it may have to the resolution of the case.
These new developments follow Judge Lloret’s February 2019 order to BI to divulge its launch plans for Cyltezo as part of the patent dispute. According to a memorandum, BI’s plans, and the degree to which AbbVie’s alleged patent thicket for Humira may have delayed those launch plans, may have a legitimate impact on BI’s unclean hands defense: a legal defense 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.
According to BI, AbbVie’s strategy of acquiring what BI describes as overlapping, noninventive patents to hinder biosimilar competition could constitute unclean hands on AbbVie’s part.
Also in February, Judge Lloret ordered AbbVie to turn over 14 different categories of documents, including those related to its patenting program and its efforts directed toward mitigating the impact of biosimilar competition on its business.
The Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
FTC Releases Second Report on PBMs Meddling in Generic Drug Markets
January 19th 2025The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.
Improving Biosimilar Access Through Global Regulatory Convergence
January 15th 2025Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.